05 January 2021 EMA/CHMP/708314/2020 Human Medicines Division
Committee for medicinal products for human use (CHMP) Minutes for the meeting on 09-12 November 2020 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes
Disclaimers
Some of the information contained in these minutes is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available.
Of note, these minutes are a working document primarily designed for CHMP members and the work the Committee undertakes.
Note on access to documents
Some documents mentioned in the minutes cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006).
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Table of contents
1. Introduction 8 1.1. Welcome and declarations of interest of members, alternates and experts ...... 8 1.2. Adoption of agenda ...... 8 1.3. Adoption of the minutes ...... 8
2. Oral Explanations 9 2.1. Pre-authorisation procedure oral explanations ...... 9 2.1.1. glucagon - EMEA/H/C/005391 ...... 9 2.1.2. somapacitan - Orphan - EMEA/H/C/005030 ...... 9 2.2. Re-examination procedure oral explanations ...... 9 2.2.1. Elzonris - tagraxofusp - Orphan - EMEA/H/C/005031 ...... 9 2.2.2. Gamifant - emapalumab - Orphan - EMEA/H/C/004386 ...... 10 2.3. Post-authorisation procedure oral explanations ...... 10 2.4. Referral procedure oral explanations ...... 10
3. Initial applications 11 3.1. Initial applications; Opinions ...... 11 3.1.1. Onbevzi - bevacizumab - EMEA/H/C/005640 ...... 11 3.1.2. Phesgo - pertuzumab / trastuzumab - EMEA/H/C/005386 ...... 11 3.1.3. Roclanda - netarsudil / latanoprost - EMEA/H/C/005107 ...... 12 3.1.4. Xofluza - baloxavir marboxil - EMEA/H/C/004974 ...... 12 3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable) ...... 13 3.2.1. estetrol / drospirenone - EMEA/H/C/005336...... 13 3.2.2. trastuzumab deruxtecan - EMEA/H/C/005124 ...... 13 3.2.3. estetrol / drospirenone - EMEA/H/C/005382...... 13 3.2.4. glucagon - EMEA/H/C/005391 ...... 13 3.2.5. somapacitan - Orphan - EMEA/H/C/005030 ...... 14 3.2.6. adalimumab - EMEA/H/C/005188 ...... 14 3.3. Initial applications; List of questions (Day 120; Day 90 for procedures with accelerated assessment timetable) ...... 15 3.3.1. abiraterone acetate - EMEA/H/C/005649 ...... 15 3.3.2. lisocabtagene maraleucel / lisocabtagene maraleucel - Orphan - ATMP - EMEA/H/C/00473115 3.3.3. dabigatran etexilate - EMEA/H/C/005639 ...... 15 3.3.4. risdiplam - Orphan - EMEA/H/C/005145 ...... 15 3.3.5. imatinib - EMEA/H/C/005595 ...... 16 3.4. Update on on-going initial applications for Centralised procedure ...... 16 3.4.1. abiraterone acetate - EMEA/H/C/005408 ...... 16
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3.4.2. risperidone - EMEA/H/C/005406 ...... 16 3.4.3. satralizumab - Orphan - EMEA/H/C/004788 ...... 17 3.4.4. bevacizumab - EMEA/H/C/005433 ...... 17 3.4.5. tirbanibulin mesilate - EMEA/H/C/005183 ...... 17 3.4.6. tafasitamab - Orphan - EMEA/H/C/005436 ...... 17 3.4.7. eladocagene exuparvovec - Orphan - ATMP - EMEA/H/C/005352 ...... 18 3.5. Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004 ...... 18 3.5.1. Aplidin - plitidepsin - Orphan - EMEA/H/C/004354 ...... 18 3.5.2. Elzonris - tagraxofusp - Orphan - EMEA/H/C/005031 ...... 18 3.5.3. Gamifant - emapalumab - Orphan - EMEA/H/C/004386 ...... 19 3.6. Initial applications in the decision-making phase ...... 19 3.7. Withdrawals of initial marketing authorisation application ...... 20 3.7.1. Puldysa - idebenone - Orphan - EMEA/H/C/005123 ...... 20 3.7.2. Roctavian - valoctocogene roxaparvovec - Orphan - ATMP - EMEA/H/C/004749 ...... 20
4. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 20 4.1. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Opinion ...... 20 4.1.1. Nuceiva - botulinum toxin type A - EMEA/H/C/004587/X/0005 ...... 20 4.1.2. Pradaxa - dabigatran etexilate - EMEA/H/C/000829/X/0122/G ...... 21 4.1.3. Tivicay - dolutegravir - EMEA/H/C/002753/X/0058/G ...... 21 4.1.4. Trimbow - beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium - EMEA/H/C/004257/X/0008/G ...... 22 4.1.5. Xarelto - rivaroxaban - EMEA/H/C/000944/X/0074/G ...... 23 4.2. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 180 list of outstanding issues ...... 23 4.2.1. Diacomit - stiripentol - EMEA/H/C/000664/X/0032 ...... 23 4.2.2. Elebrato Ellipta - fluticasone furoate / umeclidinium / vilanterol - EMEA/H/C/004781/X/0014/G ...... 24 4.2.3. Lacosamide Accord - lacosamide - EMEA/H/C/004443/X/0007 ...... 24 4.2.4. Sirturo - bedaquiline - Orphan - EMEA/H/C/002614/X/0036/G ...... 24 4.2.5. Temybric Ellipta - fluticasone furoate / umeclidinium / vilanterol - EMEA/H/C/005254/X/0004/G ...... 25 4.2.6. Tepadina - thiotepa - EMEA/H/C/001046/X/0036 ...... 25 4.2.7. Trelegy Ellipta - fluticasone furoate / umeclidinium / vilanterol - EMEA/H/C/004363/X/0012/G ...... 26 4.2.8. Tysabri - natalizumab - EMEA/H/C/000603/X/0116 ...... 26 4.3. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 120 List of question ...... 26 4.3.1. Pheburane - sodium phenylbutyrate - EMEA/H/C/002500/X/0026 ...... 26
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4.3.2. Pheburane - sodium phenylbutyrate - EMEA/H/C/002500/X/0028 ...... 27 4.4. Update on on-going extension application according to Annex I of Commission Regulation (EC) No 1234/2008 ...... 27 4.5. Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008 ...... 27
5. Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/2008 27 5.1. Type II variations - variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008; Opinions or Requests for supplementary information ...... 27 5.1.1. Brilique - ticagrelor - EMEA/H/C/001241/II/0047/G ...... 27 5.1.2. Doptelet - avatrombopag - EMEA/H/C/004722/II/0004/G ...... 28 5.1.3. Kyprolis - carfilzomib - Orphan - EMEA/H/C/003790/II/0045 ...... 28 5.1.4. Lonquex - lipegfilgrastim - EMEA/H/C/002556/II/0058/G ...... 29 5.1.5. Nulojix - belatacept - EMEA/H/C/002098/II/0070 ...... 29 5.1.6. Xyrem - sodium oxybate - EMEA/H/C/000593/II/0076 ...... 30 5.1.7. Zinforo - ceftaroline fosamil - EMEA/H/C/002252/II/0048 ...... 30 5.1.8. WS1840 OPDIVO - nivolumab - EMEA/H/C/003985/WS1840/0089 Yervoy - ipilimumab - EMEA/H/C/002213/WS1840/0084 ...... 31 5.2. Update on on-going Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 ...... 31 5.2.1. Kaftrio - elexacaftor / tezacaftor / ivacaftor - Orphan - EMEA/H/C/005269/II/0001 ...... 31 5.2.2. Xtandi - enzalutamide - EMEA/H/C/002639/II/0047/G ...... 31 5.3. Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 ...... 32
6. Ancillary medicinal substances in medical devices 32 6.1. Ancillary medicinal substances in medical devices; Opinions/ Day 180 list of outstanding issues / Day 120 list of questions ...... 32 6.2. Update of Ancillary medicinal substances in medical devices ...... 32
7. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use) 32 7.1. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use)32
8. Pre-submission issues 33 8.1. Pre-submission issue ...... 33 8.1.1. odevixibat - H0004691 ...... 33 8.1.2. capecitabine - H0005683 ...... 33 8.1.3. pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) - H0005451 ...... 33 8.1.4. temozolomide - H0005684 ...... 33 8.2. Priority Medicines (PRIME) ...... 34
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8.2.1. List of applications received ...... 34 8.2.2. Recommendation for PRIME eligibility ...... 34
9. Post-authorisation issues 34 9.1. Post-authorisation issues ...... 34 9.1.1. Alpivab - peramivir - EMEA/H/C/004299 ...... 34 9.1.2. Dukoral - cholera vaccine (inactivated, oral) - EMEA/H/C/00476/II/0062/G ...... 34 9.1.3. Ervebo - recombinant vesicular stomatitis virus - Zaire ebolavirus vaccine (live) - EMEA/H/C/004554/II/0008/G ...... 35 9.1.4. Isturisa – osilodrostat - EMEA/H/C/004821 ...... 35 9.1.5. Mysimba – naltrexone hydrochloride/ bupropion hydrochoride - EMEA/H/C/003687/ANX/001.5 ...... 35 9.1.6. Nulojix - belatacept - EMEA/H/C/002098/II/0065/G ...... 36 9.1.7. Ocaliva - obeticholic acid - EMEA/H/C/004093/R/0023, Orphan ...... 36 9.1.8. Udenyca - pegfilgrastim - EMEA/H/C/004413 ...... 36 9.1.9. Veklury - remdesivir - EMEA/H/C/005622/II/0012 ...... 36
10. Referral procedures 37 10.1. Procedure for Centrally Authorised products under Article 20 of Regulation (EC) No 726/2004 ...... 37 10.2. Requests for CHMP Opinion under Article 5(3) of Regulation (EC) No 726/2004 . 37 10.3. Procedure under Articles 5(2) and 10 of Regulation (EC) No 726/2004 ...... 37 10.4. Disagreement between Member States on application for medicinal product (potential serious risk to public health) –under Article 29(4) of Directive 2001/83/EC ...... 37 10.5. Harmonisation - Referral procedure under Article 30 of Directive 2001/83/EC .... 37 10.6. Community Interests - Referral under Article 31 of Directive 2001/83/EC ...... 38 10.6.1. Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group - EMEA/H/A- 31/1471 ...... 38 10.6.2. Esmya (CAP); NAP - ulipristal acetate - EMEA/H/A-31/1496 ...... 38 10.7. Re-examination Procedure under Article 32(4) of Directive 2001/83/EC ...... 39 10.8. Procedure under Article 107(2) of Directive 2001/83/EC ...... 39 10.9. Disagreement between Member States on Type II variation– Arbitration procedure initiated by MAH under Article 6(13) of Commission Regulation (EC) No 1084/2003 ...... 39 10.10. Procedure under Article 29 of Regulation (EC) 1901/2006...... 39 10.11. Referral under Article 13 Disagreement between Member States on Type II variation– Arbitration procedure initiated by Member State under Article 13 (EC) of Commission Regulation No 1234/2008 ...... 39
11. Pharmacovigilance issue 39 11.1. Early Notification System ...... 39
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12. Inspections 40 12.1. GMP inspections ...... 40 12.2. GCP inspections ...... 40 12.3. Pharmacovigilance inspections ...... 40 12.4. GLP inspections ...... 40
13. Innovation Task Force 40 13.1. Minutes of Innovation Task Force ...... 40 13.2. Innovation Task Force briefing meetings ...... 40 13.3. Requests for CHMP Opinion under Article 57(1)J and (1)P of Regulation (EC) No 726/2004 ...... 40 13.4. Nanomedicines activities ...... 40
14. Organisational, regulatory and methodological matters 41 14.1. Mandate and organisation of the CHMP ...... 41 14.1.1. Election of CHMP Co-opted Members ...... 41 14.1.2. Update on CHMP Co-opted Members ...... 41 14.2. Coordination with EMA Scientific Committees...... 41 14.2.1. Pharmacovigilance Risk Assessment Committee (PRAC) ...... 41 14.2.2. Paediatric Committee (PDCO) ...... 42 14.2.3. Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh)42 14.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups ...... 42 14.3.1. Biologics Working Party (BWP) ...... 42 14.3.2. Scientific Advice Working Party (SAWP) ...... 43 14.4. Cooperation within the EU regulatory network ...... 43 14.5. Cooperation with International Regulators...... 43 14.6. Contacts of the CHMP with external parties and interaction with the Interested Parties to the Committee ...... 43 14.7. CHMP work plan ...... 43 14.8. Planning and reporting ...... 43 14.9. Others ...... 43
15. Any other business 43 15.1. AOB topic ...... 43 15.1.1. Update on COVID-19 ...... 43 15.1.2. Reflection paper – EMA considerations on Covid-19 vaccines approval ...... 44 15.1.3. COVID-19 Vaccine (ChAdOx1-S [recombinant]) - H0005675 ...... 44 15.1.4. COVID-19 mRNA vaccine (nucleoside-modified) - H0005735 ...... 44 15.1.5. COVID-19 vaccine - EMEA/H/C/005791 ...... 44 15.1.6. CoreRMP19 requirements and guidance for COVID-19 vaccines ...... 45
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15.1.7. Invitation to participate in a MCDA (Multi Criteria Decision Analysis) exercise for benefit risk45
16. List of participants 46 17. Explanatory notes 51
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1. Introduction
1.1. Welcome and declarations of interest of members, alternates and experts
The participants had no objection to hold the meeting remotely.
In accordance with the Agency’s policy on handling of declarations of interests of scientific Committees’ members and experts, based on the declarations of interest submitted by the Committee members, alternates and experts and based on the topics in the agenda of the current meeting, the Committee Secretariat announced the restricted involvement of some meeting participants in upcoming discussions as included in the pre-meeting list of participants and restrictions. See November 2020 CHMP minutes for the list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the CHMP plenary session held 09-12 November 2020.
Participants in this meeting were asked to declare any changes, omissions or errors to their declared interests and/or additional restrictions concerning the matters for discussion. No new or additional interests or restrictions were declared.
Discussions, deliberations and voting took place in full respect of the restricted involvement of Committee members and experts in line with the relevant provisions of the Rules of Procedure and as included in the list of participants. All decisions taken at this meeting were made in the presence of a quorum of members (i.e. 16 or more members were present remotely). All decisions, recommendations and advice were agreed by consensus, unless otherwise specified.
1.2. Adoption of agenda
CHMP agenda for 09-12 November 2020
The CHMP adopted the agenda.
1.3. Adoption of the minutes
ORGAM minutes from meeting held on 3 November 2020.
The Minutes of the November 2020 CHMP ORGAM meeting held on 3 November 2020, together with all decisions taken at that meeting, were adopted.
CHMP minutes for 14-17 September 2020.
The CHMP adopted the September 2020 minutes.
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2. Oral Explanations
2.1. Pre-authorisation procedure oral explanations
2.1.1. glucagon - EMEA/H/C/005391
treatment of severe hypoglycaemia in adults, adolescents and children aged 2 years and over with diabetes mellitus.
Scope: Possible oral explanation
Action: Oral explanation to be held on Wednesday, 11 November 2020 at 09:00
List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 30.04.2020.
The CHMP agreed that an oral explanation was not needed at this time.
See 3.2
2.1.2. somapacitan - Orphan - EMEA/H/C/005030
Novo Nordisk A/S; indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
Scope: Oral explanation,
Updated draft list of experts for the ad-hoc expert group (AHEG) meeting scheduled on 29 October 2020 adopted via written procedure on 28 October 2020,
AHEG report
Action: Oral explanation to be held on Tuesday, 10 November 2020 at 16:00
List of Outstanding Issues adopted on 17.09.2020, 25.06.2020. List of Questions adopted on 30.01.2020.
Participation of a patient representative.
The CHMP noted the ad-hoc expert group meeting report.
An oral explanation was held on Tuesday, 10 November 2020. The presentation by the applicant focused on the clinical data in support of the application.
See 3.2
2.2. Re-examination procedure oral explanations
2.2.1. Elzonris - tagraxofusp - Orphan - EMEA/H/C/005031
Stemline Therapeutics B.V.; treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Scope: Oral explanation,
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Draft list of experts for the SAG Oncology meeting scheduled on 4 November 2020 adopted via written procedure on 4 November 2020,
SAG report
Action: Oral explanation to be held on Tuesday, 10 November 2020 at 14:00
New active substance (Article 8(3) of Directive No 2001/83/EC)
Opinion adopted on 23.07.2020. List of Outstanding Issues adopted on 26.03.2020, 25.06.2019. List of Questions adopted on 24.04.2019.
The CHMP noted the SAG report.
An oral explanation was held on Tuesday, 10 November 2020. The presentation of the applicant focused on the grounds for refusal.
See 3.5
2.2.2. Gamifant - emapalumab - Orphan - EMEA/H/C/004386
Swedish Orphan Biovitrum AB; treatment of paediatric patients with primary haemophagocytic lymphohistiocytosis (HLH).
Scope: Oral explanation,
Draft list of experts for the ad-hoc expert group (AHEG) meeting scheduled on 30 October 2020 adopted via written procedure on 28 October 2020,
AHEG report
Action: Oral explanation to be held on Tuesday, 10 November 2020 at 09:00
New active substance (Article 8(3) of Directive No 2001/83/EC)
Opinion adopted on 23.07.2020. List of Outstanding Issues adopted on 25.06.2020, 27.06.2019. List of Questions adopted on 13.12.2018.
Participation of a patient representative.
The CHMP noted the ad-hoc expert group meeting report.
An oral explanation was held on Tuesday, 10 November 2020. The presentation of the applicant focused on the grounds for refusal.
See 3.5
2.3. Post-authorisation procedure oral explanations
No items
2.4. Referral procedure oral explanations
No items
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3. Initial applications
3.1. Initial applications; Opinions
3.1.1. Onbevzi - bevacizumab - EMEA/H/C/005640
Samsung Bioepis NL B.V.; the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
Scope: Opinion
Action: For adoption
Similar biological application (Article 10(4) of Directive No 2001/83/EC)
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable.
The Icelandic and Norwegian Members were in agreement with the CHMP recommendation.
The legal status was agreed as medicinal product subject to restricted medical prescription.
The summary of opinion was circulated for information.
The CHMP adopted the similarity assessment report.
3.1.2. Phesgo - pertuzumab / trastuzumab - EMEA/H/C/005386
Roche Registration GmbH; treatment of early breast cancer, metastatic breast cancer.
Scope: Opinion
Action: For adoption
Fixed combination application (Article 10b of Directive No 2001/83/EC)
List of Outstanding Issues adopted on 15.10.2020. List of Questions adopted on 28.05.2020.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable.
The Icelandic and Norwegian Members were in agreement with the CHMP recommendation.
The legal status was agreed as medicinal product subject to restricted medical prescription.
The summary of opinion was circulated for information.
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3.1.3. Roclanda - netarsudil / latanoprost - EMEA/H/C/005107
Aerie Pharmaceuticals Ireland Limited; reduction of elevated intraocular pressure.
Scope: Opinion
Action: For adoption
Fixed combination application (Article 10b of Directive No 2001/83/EC)
List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 30.04.2020.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable.
The Icelandic and Norwegian Members were in agreement with the CHMP recommendation.
The legal status was agreed as medicinal product subject to restricted medical prescription.
The CHMP noted the letter of recommendation dated 11.11.2020.
The summary of opinion was circulated for information.
3.1.4. Xofluza - baloxavir marboxil - EMEA/H/C/004974
Roche Registration GmbH; treatment of influenza in patients aged 12 and above, including patients at high risk of developing influenza-related complications and for post-exposure prophylaxis of influenza in individuals aged 12.
Scope: Opinion
Action: For adoption
New active substance (Article 8(3) of Directive No 2001/83/EC)
List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 26.03.2020.
The Committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable.
Furthermore, the CHMP considered that baloxavir marboxil is a new active substance, as claimed by the applicant.
The Icelandic and Norwegian Members were in agreement with the CHMP recommendation.
The legal status was agreed as medicinal product subject to medical prescription.
The CHMP noted the letter of recommendation dated 09.11.2020.
The summary of opinion was circulated for information.
Post meeting note: The final SmPC was adopted via written procedure on 13.11.2020.
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3.2. Initial applications; List of outstanding issues (Day 180; Day 120 for procedures with accelerated assessment timetable)
3.2.1. estetrol / drospirenone - EMEA/H/C/005336
oral contraceptive.
Scope: List of outstanding issues
Action: For adoption
List of Questions adopted on 25.06.2020.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a list of outstanding issues with a specific timetable.
3.2.2. trastuzumab deruxtecan - EMEA/H/C/005124
Accelerated assessment
treatment of unresectable or metastatic HER2-positive breast cancer.
Scope: List of outstanding issues
Action: For adoption
List of Questions adopted on 15.09.2020.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a list of outstanding issues with a specific timetable.
3.2.3. estetrol / drospirenone - EMEA/H/C/005382
oral contraception.
Scope: List of outstanding issues
Action: For adoption
List of Questions adopted on 25.06.2020.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a list of outstanding issues with a specific timetable.
3.2.4. glucagon - EMEA/H/C/005391
treatment of severe hypoglycaemia in adults, adolescents and children aged 2 years and over with diabetes mellitus.
Scope: List of outstanding issues
Action: For adoption
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List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 30.04.2020.
See 2.1
The Committee was reminded of the status of this application and its remaining outstanding issues.
The CHMP agreed that an oral explanation was not needed at this time.
The Committee adopted a list of outstanding issues with a specific timetable.
3.2.5. somapacitan - Orphan - EMEA/H/C/005030
Novo Nordisk A/S; indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
Scope: Oral explanation,
Updated draft list of experts for the ad-hoc expert group meeting scheduled on 29 October 2020 adopted via written procedure on 28 October 2020,
AHEG report
Action: Oral explanation to be held on Tuesday, 10 November 2020 at 16:00
List of Outstanding Issues adopted on 17.09.2020, 25.06.2020. List of Questions adopted on 30.01.2020.
Participation of a patient representative.
The CHMP noted the ad-hoc expert group meeting report.
An oral explanation was held on Tuesday, 10 November 2020. The presentation by the applicant focused on the clinical data in support of the application.
The Committee adopted a 3rd list of outstanding issues with a specific timetable.
3.2.6. adalimumab - EMEA/H/C/005188
treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, juvenile idiopathic arthritis, enthesitis-related arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa (HS), Crohn’s disease, paediatric Crohn's disease, ulcerative colitis, uveitis, paediatric uveitis.
Scope: List of outstanding issues
Action: For adoption
List of Questions adopted on 23.07.2020.
The Committee was reminded of the status of this application and its remaining outstanding issues.
The Committee adopted a list of outstanding issues with a specific timetable.
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3.3. Initial applications; List of questions (Day 120; Day 90 for procedures with accelerated assessment timetable)
3.3.1. abiraterone acetate - EMEA/H/C/005649
treatment of prostate cancer in adult men.
Scope: List of questions
Action: For adoption
The Committee discussed the issues identified in this application.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions.
3.3.2. lisocabtagene maraleucel / lisocabtagene maraleucel - Orphan - ATMP - EMEA/H/C/004731
Celgene Europe BV; treatment of large B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B)
Scope: List of questions
Action: For information
The CHMP was updated on discussions at the CAT. The Committee discussed the issues identified in this application.
The Committee endorsed the list of questions as adopted by the CAT.
3.3.3. dabigatran etexilate - EMEA/H/C/005639
prevention of venous thromboembolic events.
Scope: List of questions
Action: For adoption
The Committee discussed the issues identified in this application.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions.
3.3.4. risdiplam - Orphan - EMEA/H/C/005145
Accelerated assessment
Roche Registration GmbH; treatment of spinal muscular atrophy (SMA)
Scope: List of questions
Action: For adoption
The Committee discussed the issues identified in this application.
The Committee adopted the CHMP recommendation and scientific discussion together with
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the list of questions.
3.3.5. imatinib - EMEA/H/C/005595
treatment of Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML), Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), myelodysplastic/myeloproliferative diseases (MDS/MPD), hypereosinophilic syndrome (HES), eosinophilic leukaemia (CEL), Kit (CD 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST), and unresectable dermatofibrosarcoma protuberans (DFSP)
Scope: List of questions
Action: For adoption
The Committee discussed the issues identified in this application.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions.
3.4. Update on on-going initial applications for Centralised procedure
3.4.1. abiraterone acetate - EMEA/H/C/005408
treatment of metastatic prostate cancer.
Scope: Letter from the applicant dated 27 October 2020 requesting an extension of clock- stop to respond to the list of outstanding issues adopted in October 2020.
Action: For adoption
List of Outstanding Issues adopted on 15.10.2020. List of Questions adopted on 30.01.2020.
The CHMP agreed to the request by the applicant for an extension of clock-stop to respond to the list of outstanding issues adopted in October 2020.
3.4.2. risperidone - EMEA/H/C/005406
treatment of schizophrenia
Scope: Request by the applicant for an extension to the clock stop to respond to the list of outstanding issues adopted in October 2020.
Action: For adoption
List of Outstanding Issues adopted on 15.10.2020. List of Questions adopted on 28.05.2020.
The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the list of outstanding issues adopted in October 2020.
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3.4.3. satralizumab - Orphan - EMEA/H/C/004788
Roche Registration GmbH; treatment of adult and adolescent patients from 12 years of age with neuromyelitis optica spectrum disorders (NMOSD).
Scope: Letter from the applicant dated 22 October 2020 requesting an extension of clock- stop to respond to the list of outstanding issues adopted in May 2020.
Action: For adoption
List of Outstanding Issues adopted on 28.05.2020. List of Questions adopted on 10.12.2019.
The CHMP agreed to the request by the applicant for an extension of clock-stop to respond to the list of outstanding issues adopted in May 2020.
3.4.4. bevacizumab - EMEA/H/C/005433
indicated in adults for the treatment of neovascular macular degeneration associated with aging and diabetes.
Scope: Letter from the applicant dated 27 October 2020 requesting an extension of clock- stop to respond to the list of questions adopted in September 2020.
Action: For adoption
List of Questions adopted on 17.09.2020.
The CHMP agreed to the request by the applicant for an extension of clock-stop to respond to the list of questions adopted in September 2020.
3.4.5. tirbanibulin mesilate - EMEA/H/C/005183
topical field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis.
Scope: Letter from the applicant dated 21 October 2020 requesting an extension of clock- stop to respond to the list of questions adopted in June 2020.
Action: For adoption
List of Questions adopted on 25.06.2020.
The CHMP agreed to the request by the applicant for an extension of clock-stop to respond to the list of questions adopted in June 2020.
3.4.6. tafasitamab - Orphan - EMEA/H/C/005436
Morphosys AG; is indicated in combination with lenalidomide followed by tafasimab monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B- cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).
Scope: Letter from the applicant dated 09 November 2020 requesting an extension of clock- stop to respond to the list of questions adopted in September 2020.
List of Questions adopted on 17.09.2020
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The CHMP agreed to the request by the applicant for an extension of clock-stop to respond to the list of questions adopted in September 2020.
3.4.7. eladocagene exuparvovec - Orphan - ATMP - EMEA/H/C/005352
PTC Therapeutics International Limited; treatment of aromatic L-amino aciddecarboxylase (AADC) deficiency
Scope: Request by the applicant for an extension to the clock stop to respond to the list of questions adopted in May 2020.
Action: For information
List of Questions adopted on 20.05.2020.
The CHMP noted the extension of clock stop as adopted by CAT.
3.5. Re-examination of initial application procedures under Article 9(2) of Regulation no 726/2004
3.5.1. Aplidin - plitidepsin - Orphan - EMEA/H/C/004354
Pharma Mar, S.A.; treatment of multiple myeloma.
Scope: Implementation of Judgement of the General Court in Case-T-594/18, confirmation of rapporteurs, draft timetable
Action: For adoption
New active substance (Article 8(3) of Directive No 2001/83/EC)
Opinion re-examination adopted on 22.03.2018. Opinion adopted on 14.12.2017
The timetable will be adopted via written procedure.
3.5.2. Elzonris - tagraxofusp - Orphan - EMEA/H/C/005031
Stemline Therapeutics B.V.; treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Scope: Oral explanation,
Draft list of experts for the SAG Oncology meeting scheduled on 4 November 2020 adopted via written procedure on 4 November 2020,
SAG report
Action: For adoption
New active substance (Article 8(3) of Directive No 2001/83/EC)
Opinion adopted on 23.07.2020. List of Outstanding Issues adopted on 26.03.2020, 25.06.2019. List of Questions adopted on 24.04.2019.
See 2.2
An oral explanation was held on Tuesday, 10 November 2020. The presentation of the
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applicant focused on the grounds for refusal.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion recommending the granting of a marketing authorisation under exceptional circumstances by consensus together with the CHMP assessment report and translation timetable.
The Icelandic and Norwegian Members were in agreement with the CHMP recommendation.
The legal status was agreed as medicinal product subject to restricted medical prescription.
The CHMP noted the letter of recommendation dated 12.11.2020.
The summary of opinion was circulated for information.
3.5.3. Gamifant - emapalumab - Orphan - EMEA/H/C/004386
Swedish Orphan Biovitrum AB; treatment of paediatric patients with primary Haemophagocytic Lymphohistiocytosis (HLH).
Scope: Oral explanation,
Report from the ad-hoc expert group meeting scheduled on 30 October 2020
Action: For adoption
New active substance (Article 8(3) of Directive No 2001/83/EC)
Opinion adopted on 23.07.2020. List of Outstanding Issues adopted on 25.06.2020, 27.06.2019. List of Questions adopted on 13.12.2018.
See 2.2
The CHMP noted the ad-hoc expert group meeting report.
An oral explanation was held on Tuesday, 10 November 2020. The presentation of the applicant focused on the grounds for refusal.
The CHMP adopted a negative opinion by majority (27 negative votes out of 29 votes), recommending the refusal of the marketing authorisation.
The Icelandic and Norwegian Members were in agreement with the CHMP recommendation.
The divergent position (Sinan B. Sarac, John Joseph Borg) was appended to the opinion.
The CHMP noted the EMA question and answer document.
3.6. Initial applications in the decision-making phase
No items
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3.7. Withdrawals of initial marketing authorisation application
3.7.1. Puldysa - idebenone - Orphan - EMEA/H/C/005123
Santhera Pharmaceuticals (Deutschland) GmbH; treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) not using glucocorticoids.
Scope: Withdrawal of initial marketing authorisation application
Action: For information
Hybrid application (Article 10(3) of Directive No 2001/83/EC)
List of Outstanding Issues adopted on 30.04.2020. List of Questions adopted on 17.10.2019.
The CHMP noted the withdrawal of initial marketing authorisation application.
3.7.2. Roctavian - valoctocogene roxaparvovec - Orphan - ATMP - EMEA/H/C/004749
Accelerated assessment
BioMarin International Limited; treatment of haemophilia A.
Scope: Withdrawal of initial marketing authorisation application
Action: For information
New active substance (Article 8(3) of Directive No 2001/83/EC)
List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 24.04.2020.
The CHMP noted the withdrawal of initial marketing authorisation application.
4. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008
4.1. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Opinion
4.1.1. Nuceiva - botulinum toxin type A - EMEA/H/C/004587/X/0005
Evolus Pharma Limited
Rapporteur: Peter Kiely, PRAC Rapporteur: Adam Przybylkowski
Scope: “Extension application to add a new strength of 50 U for botulinum toxin type A for powder for solution for injection in vial (glass), for intramuscular administration.”
Action: For adoption
List of Outstanding Issues adopted on 15.10.2020. List of Questions adopted on 28.05.2020.
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The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP recommendations.
The CHMP noted the letter of recommendation dated 09.11.2020.
4.1.2. Pradaxa - dabigatran etexilate - EMEA/H/C/000829/X/0122/G
Boehringer Ingelheim International GmbH
Rapporteur: Kirstine Moll Harboe, Co-Rapporteur: Jean-Michel Race, PRAC Rapporteur: Anette Kirstine Stark
Scope: “Extension application to add two new pharmaceutical forms for Pradaxa (coated granules (20 mg, 30 mg, 40 mg, 50 mg, 110 mg, 150 mg) and powder and solvent for oral solution (6.25 mg/ml)), grouped with: - A type II variation (C.I.6.a) - Extension of indication to include new indication for Pradaxa 75 mg, 110 mg, 150 mg capsules based on the paediatric trials 1160.106 and 1160.108. As a consequence, sections 4.1, 4.2, 4.3, 4.4, 4.5, 4.7, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC are updated. The package leaflet and labelling are updated in accordance. In addition, the marketing authorisation holder took the opportunity to update the list of local representatives in the package leaflet. The RMP version 37.0 has also been submitted. - Type IB (B.I.b.1.c) - Type IA (B.I.b.1.b) - Type IB (B.I.b.1.d) - Type IA (B.I.b.2.a) - Type IA (B.I.b.1.d) - Type IA (B.I.d.1.a.1) - Type IA (B.II.d.1.a) - Type IB (B.II.d.1.d) - Type IA (B.II.d.2.a) - Type IA (B.II.c.1.c)”
Action: For adoption
List of Outstanding Issues adopted on 15.10.2020, 23.07.2020. List of Questions adopted on 27.02.2020.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP recommendations.
4.1.3. Tivicay - dolutegravir - EMEA/H/C/002753/X/0058/G
ViiV Healthcare B.V.
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Rapporteur: Filip Josephson, PRAC Rapporteur: Martin Huber
Scope: “- Extension application to add a new pharmaceutical form associated with new strength (5 mg dispersible tablet). The new presentation is indicated for the treatment of HIV infected children from 4 weeks of life and weighing at least 3 kilograms.
- Type II variation (C.I.4) to update the currently approved Product Information, Labelling and Package Leaflet for the existing film-coated tablets (10 mg, 25 mg and 50 mg) for children 6 years and older and weighing at least 15 kg.
In addition, the applicant took the opportunity to amend section 4.1 of SmPC the indication for the approved Tivicay film-coated tablets to clarify that children should be “aged at least 6 years” as the current approved indication is inclusive of those aged 6 years.
The RMP (version 16) is updated in accordance.”
Action: For adoption
List of Outstanding Issues adopted on 15.10.2020. List of Questions adopted on 28.05.2020.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP recommendations.
4.1.4. Trimbow - beclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium - EMEA/H/C/004257/X/0008/G
Chiesi Farmaceutici S.p.A.
Rapporteur: Janet Koenig, Co-Rapporteur: Peter Kiely, PRAC Rapporteur: Jan Neuhauser
Scope: “Extension of indication to add ‘Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year’ for Trimbow 87 μg/5 μg/9 μg. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet and labelling are updated in accordance. In addition, the MAH took the opportunity to revise the product information in line with the EC guideline on excipients. Furthermore, the PI is brought in line with the latest QRD template version 10.1. The risk management plan version 6.5 is acceptable.”
Action: For adoption
List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 26.03.2020.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP
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recommendations.
4.1.5. Xarelto - rivaroxaban - EMEA/H/C/000944/X/0074/G
Bayer AG
Rapporteur: Kristina Dunder, PRAC Rapporteur: Ulla Wändel Liminga
Scope: “Extension application to introduce a new pharmaceutical form, granules for oral suspension, 1 mg/ml.
Extension of indication to include treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in term neonates, infants and toddlers, children and adolescents aged less than 18 years following initiation of standard anticoagulation treatment for Xarelto 15 and 20 mg tablets.
As a consequence, sections 4.2, 4.4, 4.5, 4.8, 4.9, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated accordingly.
In addition, sections 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC is updated for all other dose strengths (2.5/10 and 15/20 mg initiation packs) of Xarelto and corresponding sections of the Package Leaflet. Section 4.4 has been updated with regards to sodium content according to the Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668).
The RMP version 12.1 has also been submitted.”
Action: For adoption
List of Outstanding Issues adopted on 17.09.2020, 23.07.2020. List of Questions adopted on 30.04.2020.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP recommendations.
4.2. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 180 list of outstanding issues
4.2.1. Diacomit - stiripentol - EMEA/H/C/000664/X/0032
BIOCODEX
Rapporteur: Alar Irs, PRAC Rapporteur: Maia Uusküla
Scope: “Extension application to add a new strength of 100 mg capsules. The RMP (version 2.0) is updated in accordance.”
Action: For adoption
List of Questions adopted on 25.06.2020.
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The Committee discussed the issues identified in this application, mainly concerning quality aspects and the environmental risk assessment.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable.
4.2.2. Elebrato Ellipta - fluticasone furoate / umeclidinium / vilanterol - EMEA/H/C/004781/X/0014/G
GlaxoSmithKline Trading Services Limited
Rapporteur: Peter Kiely, Co-Rapporteur: Janet Koenig, PRAC Rapporteur: Annika Folin
Scope: “Extension application to introduce a new strength (184 mcg/55 mcg/22 mcg) grouped with a type II variation (C.I.6.a) to add a new indication (asthma). Whilst the new indication is applicable also to the existing presentations (EU/1/17/1237/001-3), the new strength is indicated only for the treatment of asthma. The RMP (version 2.2) is updated in accordance.”
Action: For adoption
List of Questions adopted on 25.06.2020.
The Committee discussed the issues identified in this application, mainly concerning clinical efficacy and safety aspects.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable.
4.2.3. Lacosamide Accord - lacosamide - EMEA/H/C/004443/X/0007
Accord Healthcare S.L.U.
Rapporteur: John Joseph Borg, PRAC Rapporteur: Ulla Wändel Liminga
Scope: “Extension application to introduce a new pharmaceutical form (solution for infusion), a new strength (10 mg/ml) and a new route of administration (intravenous use).”
Action: For adoption
List of Questions adopted on 26.03.2020.
The Committee discussed the issues identified in this application, mainly concerning quality aspects.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable.
4.2.4. Sirturo - bedaquiline - Orphan - EMEA/H/C/002614/X/0036/G
Janssen-Cilag International NV
Rapporteur: Filip Josephson, PRAC Rapporteur: Ulla Wändel Liminga
Scope: “Extension application to add a new strength (20 mg tablets) grouped with a type II variation (C.I.6) to extend the existing Sirturo indication to include paediatric patients aged from 5 years to less than 18 years of age and weighing more than 15 kg, based on the
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results of the week 24 analysis of Cohort 2 (paediatric subjects aged ≥5 to <12 years) of study TMC207-C211. Sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 and the product leaflet are updated to support the extended indication. The RMP (version 4.4) is updated in accordance.”
Action: For adoption
List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 30.04.2020.
The Committee discussed the issues identified in this application, concerning clinical aspects.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable.
4.2.5. Temybric Ellipta - fluticasone furoate / umeclidinium / vilanterol - EMEA/H/C/005254/X/0004/G
GlaxoSmithKline Trading Services Limited
Rapporteur: Peter Kiely, Co-Rapporteur: Janet Koenig, PRAC Rapporteur: Annika Folin
Scope: “Extension application to introduce a new strength (184 mcg/55 mcg/22 mcg) grouped with a type II variation (C.I.6.a) to add a new indication (asthma). Whilst the new indication is applicable also to the existing presentations (EU/1/19/13781237/001-3), the new strength is indicated only for the treatment of asthma. The RMP (version 2.2) is updated in accordance.”
Action: For adoption
List of Questions adopted on 25.06.2020.
The Committee discussed the issues identified in this application, mainly concerning clinical efficacy and safety aspects.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable.
4.2.6. Tepadina - thiotepa - EMEA/H/C/001046/X/0036
ADIENNE S.r.l.
Rapporteur: Alexandre Moreau, PRAC Rapporteur: Tiphaine Vaillant
Scope: “Extension application to introduce a new pharmaceutical form associated with a new strength (400 mg powder and solvent for solution for infusion).”
Action: For adoption
List of Outstanding Issues adopted on 17.09.2020. List of Questions adopted on 26.03.2020.
The Committee discussed the issues identified in this application, concerning a clinical safety aspect and the similarity assessment.
The Committee adopted the CHMP recommendation and scientific discussion together with the 2nd list of outstanding issues and a specific timetable.
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4.2.7. Trelegy Ellipta - fluticasone furoate / umeclidinium / vilanterol - EMEA/H/C/004363/X/0012/G
GlaxoSmithKline Trading Services Limited
Rapporteur: Peter Kiely, Co-Rapporteur: Janet Koenig, PRAC Rapporteur: Annika Folin
Scope: “Extension application to introduce a new strength (184 mcg/55 mcg/22 mcg) grouped with a type II variation (C.I.6.a) to add a new indication (asthma). Whilst the new indication is applicable also to the existing presentations (EU/1/17/1236/001-3), the new strength is indicated only for the treatment of asthma. The RMP (version 2.2) is updated in accordance.”
Action: For adoption
List of Questions adopted on 25.06.2020.
The Committee discussed the issues identified in this application, mainly concerning clinical efficacy and safety aspects.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable.
4.2.8. Tysabri - natalizumab - EMEA/H/C/000603/X/0116
Biogen Netherlands B.V.
Rapporteur: Jan Mueller-Berghaus, PRAC Rapporteur: Brigitte Keller-Stanislawski
Scope: “Extension application to introduce a new pharmaceutical form (solution for injection), associated with a new strength (150 mg) and a new route of administration (subcutaneous use). The RMP (version 26.1) is updated accordingly.”
Action: For adoption
List of Questions adopted on 23.07.2020.
The Committee discussed the issues identified in this application, concerning clinical aspects and the RMP.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of outstanding issues and a specific timetable.
4.3. Extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008; Day 120 List of question
4.3.1. Pheburane - sodium phenylbutyrate - EMEA/H/C/002500/X/0026
Eurocept International B.V.
Rapporteur: Jayne Crowe, PRAC Rapporteur: Rhea Fitzgerald
Scope: “Extension application to introduce a new pharmaceutical form associated with a new strength (350 mg/ml oral solution). The RMP (version 0.1) is updated in accordance.”
Action: For adoption
The Committee discussed the issues identified in this application, concerning bioequivalence
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aspects.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions.
4.3.2. Pheburane - sodium phenylbutyrate - EMEA/H/C/002500/X/0028
Eurocept International B.V.
Rapporteur: Jayne Crowe, PRAC Rapporteur: Rhea Fitzgerald
Scope: “Extension application to introduce a new pharmaceutical form associated with a new strength (500 mg film-coated tablets). The RMP (version 0.1) is updated in accordance.”
Action: For adoption
The Committee discussed the issues identified in this application, concerning bioequivalence aspects.
The Committee adopted the CHMP recommendation and scientific discussion together with the list of questions.
4.4. Update on on-going extension application according to Annex I of Commission Regulation (EC) No 1234/2008
No items
4.5. Re-examination procedure of extension of marketing authorisation according to Annex I of Commission Regulation (EC) No 1234/2008
No items
5. Type II variations - variation of therapeutic indication procedure according to Annex I of Commission Regulation (EC) No 1234/2008
5.1. Type II variations - variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008; Opinions or Requests for supplementary information
5.1.1. Brilique - ticagrelor - EMEA/H/C/001241/II/0047/G
AstraZeneca AB
Rapporteur: Johann Lodewijk Hillege, Co-Rapporteur: Maria Concepcion Prieto Yerro, PRAC Rapporteur: Menno van der Elst
Scope: “Extension of indication to include, in co-administration with acetylsalicylic acid (ASA), the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) without a history of myocardial
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infarction who have undergone percutaneous coronary intervention (PCI) based on the final results of study D513BC00001 (THEMIS), a phase III multinational, randomised, double- blind, placebo controlled study to evaluate the effect of ticagrelor twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with T2DM. As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. Update of section 4.8 of the SmPC regarding with new safety information on traumatic haemorrhages based on the final results from study D513BC00001 (THEMIS) and data from the ticagrelor clinical development programme and post-marketing data. The package leaflet is updated in accordance. The RMP version 12 has also been submitted.”
Action: For adoption
Request for Supplementary Information adopted on 28.05.2020, 14.11.2019.
The Committee discussed the issues identified in this application, mainly concerning clinical efficacy and safety aspects.
The Committee adopted a 3rd request for supplementary information with a specific timetable.
5.1.2. Doptelet - avatrombopag - EMEA/H/C/004722/II/0004/G
Swedish Orphan Biovitrum AB (publ)
Rapporteur: Sinan B. Sarac, Co-Rapporteur: Andrea Laslop, PRAC Rapporteur: Eva A. Segovia
Scope: “Extension of indication to include the treatment of chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. Consequently, sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1 and 5.2 of the SmPC are updated. Additionally, the SmPC section 5.3 is updated with data from juvenile toxicity studies. Furthermore, an additional pack size has been introduced with subsequent updates of sections 6.5 and 8.0 of the SmPC. The package leaflet and labelling are updated in accordance. Version 2.1 of the RMP has also been submitted. Furthermore, the PI is brought in line with the latest QRD template version 10.1.”
Action: For adoption
Request for Supplementary Information adopted on 17.09.2020, 28.05.2020.
The Committee discussed the issues identified in this application, mainly concerning pharmacokinetics, SmPC changes and the RMP.
The Committee adopted a 3rd request for supplementary information with a specific timetable.
5.1.3. Kyprolis - carfilzomib - Orphan - EMEA/H/C/003790/II/0045
Amgen Europe B.V.
Rapporteur: Blanca Garcia-Ochoa, Co-Rapporteur: Alexandre Moreau
Scope: “Extension of existing indication to include combination of Kyprolis with daratumumab and dexamethasone. As a consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated. The package leaflet is updated in accordance.”
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Action: For adoption
Request for Supplementary Information adopted on 28.05.2020.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP recommendations.
The summary of opinion was circulated for information.
5.1.4. Lonquex - lipegfilgrastim - EMEA/H/C/002556/II/0058/G
Teva B.V.
Rapporteur: Outi Mäki-Ikola, Co-Rapporteur: Johann Lodewijk Hillege, PRAC Rapporteur: Kirsti Villikka
Scope: “Extension of indication to include treatment of the paediatric population for Lonquex and introduction of an age appropriate presentation in vials. As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The package leaflet is updated in accordance. Version 12.0 of the RMP has also been submitted. In addition, the marketing authorisation holder (MAH) took the opportunity to update the list of local representatives in the package leaflet. Furthermore, the PI is brought in line with the latest QRD template version 10.1.”
Action: For adoption
The Committee discussed the issues identified in this application, mainly concerning non- clinical and clinical aspects.
The Committee adopted a request for supplementary information.
The CHMP agreed to the request by the company for an extension to the clock stop with a specific timetable.
5.1.5. Nulojix - belatacept - EMEA/H/C/002098/II/0070
Bristol-Myers Squibb Pharma EEIG
Rapporteur: Filip Josephson, Co-Rapporteur: Romaldas Mačiulaitis, PRAC Rapporteur: Ulla Wändel Liminga
Scope: “Extension of indication to include the use of belatacept in conversion from a calcinerin inhibitor-based regimen to a belatacept-based regimen post transplantation. As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. The package leaflet is updated in accordance. Version 18.0 of the RMP has also been submitted. Furthermore, the PI is brought in line with the latest QRD template version 10.1 and requirement on sodium excipients is added.”
Action: For adoption
The Committee discussed the issues identified in this application, concerning clinical aspects.
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The Committee adopted a request for supplementary information with a specific timetable.
5.1.6. Xyrem - sodium oxybate - EMEA/H/C/000593/II/0076
UCB Pharma S.A.
Rapporteur: Bruno Sepodes, Co-Rapporteur: Kirstine Moll Harboe, PRAC Rapporteur: Ana Sofia Diniz Martins
Scope: “Extension of indication to include adolescents and children older than 7 years for Xyrem. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 5.3 of the SmPC are updated. The package leaflet is updated in accordance. The updated version (9.0) of the RMP was submitted.”
Action: For adoption
Request for Supplementary Information adopted on 17.09.2020, 28.05.2020, 12.12.2019, 29.05.2019, 15.11.2018.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP recommendations.
The summary of opinion was circulated for information.
5.1.7. Zinforo - ceftaroline fosamil - EMEA/H/C/002252/II/0048
Pfizer Ireland Pharmaceuticals
Rapporteur: Alar Irs
Scope: “Extension of indication for the treatment of community acquired pneumonia (CAP) to include concurrent bacteraemia due to Streptococcus pneumoniae (SP) for all age groups, based on the results of previously submitted studies: FOCUS 1 (study P903-08) and FOCUS 2 (study P903-09), paediatric CAP study (study P903-31) and relevant post- marketing safety experience with ceftaroline for bacteraemic Streptococcus pneumoniae CAP. As a consequence, sections 4.1 and 5.1 of the SmPC are updated accordingly. No RMP has been provided within this application.”
Action: For adoption
Request for Supplementary Information adopted on 23.07.2020, 12.12.2019.
The Committee discussed the issues identified in this application, concerning clinical aspects.
The Committee adopted a 3rd request for supplementary information with a specific timetable.
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5.1.8. WS1840 OPDIVO - nivolumab - EMEA/H/C/003985/WS1840/0089 Yervoy - ipilimumab - EMEA/H/C/002213/WS1840/0084
Bristol-Myers Squibb Pharma EEIG
Lead Rapporteur: Blanca Garcia-Ochoa, PRAC Rapporteur: Brigitte Keller-Stanislawski
Scope: “Extension of indication to include treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (CRC) for combination treatment with Opdivo and Yervoy. As a consequence, sections 4.1, 4.2, 4.4, 4.8 and 5.1 of the SmPC are updated. The package leaflet is updated in accordance. Version 18.0 for Opdivo and version 29.0 for Yervoy of the RMP has also been submitted.”
Action: For adoption
The Committee discussed the issues identified in this application, relating to clinical aspects.
The Committee adopted a request for supplementary information with a specific timetable.
5.2. Update on on-going Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008
5.2.1. Kaftrio - elexacaftor / tezacaftor / ivacaftor - Orphan - EMEA/H/C/005269/II/0001
Vertex Pharmaceuticals (Ireland) Limited; treatment of cystic fibrosis.
Rapporteur: Johann Lodewijk Hillege, Co-Rapporteur: Peter Kiely, PRAC Rapporteur: Martin Huber
Scope: “Extension of indication of Kaftrio to patients with CF aged 12 years and older who have at least one F508del mutation in the CFTR gene, regardless of the second allele (F/any). Efficacy data are summarised from study 104, which was conducted in subjects heterozygous for F508del and a gating (G) or residual function (RF) mutation (F/G and F/RF genotypes). As a consequence, update of SmPC sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 are requested. Package insert is updated accordingly. The RMP is updated version 1.1”,
Letter from third party,
Response letter
Action: For adoption
The CHMP noted the letter from a third party and adopted the response letter.
5.2.2. Xtandi - enzalutamide - EMEA/H/C/002639/II/0047/G
Astellas Pharma Europe B.V.
Rapporteur: Maria Concepcion Prieto Yerro, PRAC Rapporteur: Eva A. Segovia
Scope: “C.1.6: Extension of indication to include the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) for Xtandi in combination with androgen deprivation therapy; As a consequence, sections 4.1, 4.7, 4.8, 5.1, 5.3 and 6.6 of the SmPC
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are updated. Furthermore, the MAH took the opportunity to make corrections to section 4.7. The Package Leaflet is updated in accordance. The RMP version 13.0 has also been submitted. C.1.4: Update of section 5.1 of the SmPC based the 5-year Overall Survival (OS) results obtained from the PREVAIL study (MDV310003), a phase 3 study of enzalutamide in chemotherapy naïve patients with metastatic prostate cancer that progressed on ADT.”
Letter by the applicant dated 09 November 2020 requesting an extension to the clock stop to respond to the Request for Supplementary Information adopted on 28.05.2020
Action: For adoption
Request for Supplementary Information adopted on 28.05.2020, 17.10.2019.
The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the Request for Supplementary Information adopted on 28.05.2020
5.3. Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008
No items
6. Ancillary medicinal substances in medical devices
6.1. Ancillary medicinal substances in medical devices; Opinions/ Day 180 list of outstanding issues / Day 120 list of questions
No items
6.2. Update of Ancillary medicinal substances in medical devices
No items
7. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use)
7.1. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use)
No items
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8. Pre-submission issues
8.1. Pre-submission issue
8.1.1. odevixibat - H0004691
progressive familial intrahepatic cholestasis (PFIC).
Scope: Briefing note and the Rapporteurs’ recommendation on the request for accelerated assessment.
Action: For adoption
The CHMP agreed to the request for accelerated assessment and adopted the briefing note and Rapporteurs’ recommendation on the Request for Accelerated Assessment.
8.1.2. capecitabine - H0005683
indicated as an adjuvant treatment after surgery of colon cancer:
- for the treatment of metastatic colorectal cancer;
- for first-line treatment of advanced gastric cancer;
- metastatic breast cancer.
Scope: Briefing note and the Rapporteurs’ recommendation on the request for accelerated assessment.
Action: For adoption
The CHMP did not agree to the request for accelerated assessment and adopted the briefing note and Rapporteurs’ recommendation on the Request for Accelerated Assessment.
8.1.3. pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) - H0005451
active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults aged 18 years and older.
Scope: Briefing note and the Rapporteurs’ recommendation on the request for accelerated assessment.
Action: For adoption
The CHMP did not agree to the request for accelerated assessment and adopted the briefing note and Rapporteurs’ recommendation on the Request for Accelerated Assessment.
8.1.4. temozolomide - H0005684
indicated for newly diagnosed malignant glioma such as glioblastoma multiforme and anaplastic astrocytoma.
Scope: Briefing note and the Rapporteurs’ recommendation on the request for accelerated assessment.
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Action: For adoption
The CHMP did not agree to the request for accelerated assessment and adopted the briefing note and Rapporteurs’ recommendation on the Request for Accelerated Assessment.
8.2. Priority Medicines (PRIME)
Disclosure of information related to priority medicines cannot be released at present time as these contain commercially confidential information
8.2.1. List of applications received
Action: For information
The CHMP noted the information.
8.2.2. Recommendation for PRIME eligibility
Action: For adoption
The CHMP adopted the recommendation for PRIME eligibility. The CHMP reviewed 6 recommendations for eligibility to PRIME: 3 were accepted and 3 were denied.
The individual outcomes are listed in the PRIME Monthly Report on the EMA website.
9. Post-authorisation issues
9.1. Post-authorisation issues
9.1.1. Alpivab - peramivir - EMEA/H/C/004299
Biocryst UK Limited
Rapporteur: Ingrid Wang, Co-Rapporteur: Janet Koenig
Scope: Withdrawal of marketing authorisation
Action: For information
The CHMP noted the withdrawal of marketing authorisation.
9.1.2. Dukoral - cholera vaccine (inactivated, oral) - EMEA/H/C/00476/II/0062/G
Valneva Sweden AB
Rapporteur: Kristina Dunder
Scope: Adoption of revised opinion documents
Action: For adoption
The CHMP adopted the revised opinion documents by consensus.
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9.1.3. Ervebo - recombinant vesicular stomatitis virus - Zaire ebolavirus vaccine (live) - EMEA/H/C/004554/II/0008/G
Merck Sharp & Dohme B.V.
Rapporteur: Christophe Focke
Scope: “(Type IB) B.II.b.3.z - (Type II) C.I.11.b - Update to Annex II to delete specific obligations 2 and 4 and conversion to marketing authorisation not subject to specific obligations. In addition, the MAH is updating section 5.1 of the SmPC and section 6 of the package leaflet to delete the conditional marketing authorisation details. The MAH has taken the opportunity to propose a progress report to be provided following a post-authorisation measure”
Action: For adoption
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP recommendations.
9.1.4. Isturisa – osilodrostat - EMEA/H/C/004821
Recordati Rare Diseases; indicated for the treatment of endogenous Cushing’s syndrome in adults.
Rapporteur: Kristina Dunder, Co-Rapporteur: Karin Janssen van Doorn, PRAC Rapporteur: Eva A. Segovia
Scope: Adoption of revised opinion documents
Action: For adoption
The CHMP adopted the revised opinion documents by consensus.
9.1.5. Mysimba – naltrexone hydrochloride/ bupropion hydrochoride - EMEA/H/C/003687/ANX/001.5
Orexigen Therapeutics Ireland Limited
Rapporteur: Kirstine Moll Harboe, Co-Rapporteur: Andrea Laslop
Scope: MAH Response to ANX-001.4 [PASS, Study no. NB-CVOT Study 2] as adopted in June 2020: A multicentre, randomised, double-blind, placebo-controlled, phase 4 study to assess the effect of naltrexone extended release (ER) /bupropion ER on the occurrence of major adverse cardiovascular events (MACE) in overweight and obese subjects.
Action: For adoption
The Committee discussed the issues identified, concerning the PASS protocol.
The Committee adopted a request for supplementary information with a specific timetable.
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9.1.6. Nulojix - belatacept - EMEA/H/C/002098/II/0065/G
Bristol-Myers Squibb Pharma EEIG
Rapporteur: Filip Josephson
Scope: “B.I.a.2.c B.I.b.1.c B.I.b.2.b”
Action: For adoption
Request for Supplementary Information adopted on 12.03.2020.
The Committee discussed the issues identified in this application, mainly relating to quality and clinical aspects.
The Committee adopted a request for supplementary information with a specific timetable.
9.1.7. Ocaliva - obeticholic acid - EMEA/H/C/004093/R/0023, Orphan
Intercept Pharma International Limited
Rapporteur: Blanca Garcia-Ochoa, PRAC Rapporteur: Liana Gross-Martirosyan
Scope: Renewal of conditional marketing authorisation
Action: For adoption
The Committee adopted a positive opinion by consensus together with the CHMP Assessment Report and translation timetable.
The CHMP was of the opinion that the renewal for this conditional Marketing Authorisation can be granted.
The Marketing Authorisation remains conditional.
The Icelandic and Norwegian CHMP members were in agreement with the CHMP recommendations.
9.1.8. Udenyca - pegfilgrastim - EMEA/H/C/004413
ERA Consulting GmbH; treatment of neutropenia.
Rapporteur: Martina Weise, Co-Rapporteur: Johann Lodewijk Hillege, PRAC Rapporteur: Menno van der Elst
Scope: Withdrawal of marketing authorisation
Action: For information
Similar biological application (Article 10(4) of Directive No 2001/83/EC)
The CHMP noted the withdrawal of marketing authorisation.
9.1.9. Veklury - remdesivir - EMEA/H/C/005622/II/0012
Gilead Sciences Ireland UC
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Rapporteur: Janet Koenig
Scope: “Submission of the final D28 mortality data by ordinal scale categories of study COUS-540-5776 (NIAID-ACTT1), listed as a specific obligation in the Annex II of the product information, in order to confirm the efficacy and safety of remdesivir in patients on invasive mechanical ventilation and extracorporeal membrane oxygenation (IMV/ECMO). In addition, the marketing authorisation holder discuss the potential imbalance in the use of corticosteroids and effect modification in study CO-US-540-5776. As a consequence, Annex II is updated accordingly.”
Action: For adoption
The Committee discussed the issues identified in this application, concerning clinical aspects.
The Committee adopted a request for supplementary information with a specific timetable.
10. Referral procedures
10.1. Procedure for Centrally Authorised products under Article 20 of Regulation (EC) No 726/2004
No items
10.2. Requests for CHMP Opinion under Article 5(3) of Regulation (EC) No 726/2004
No items
10.3. Procedure under Articles 5(2) and 10 of Regulation (EC) No 726/2004
No items
10.4. Disagreement between Member States on application for medicinal product (potential serious risk to public health) –under Article 29(4) of Directive 2001/83/EC
No items
10.5. Harmonisation - Referral procedure under Article 30 of Directive 2001/83/EC
No items
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10.6. Community Interests - Referral under Article 31 of Directive 2001/83/EC
10.6.1. Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group - EMEA/H/A-31/1471
MAHs: various
Overall Rapporteur: Martina Weise, Co-Rapporteurs: Candesartan: Kristina Dunder, Irbesartan: Concepcion Prieto Yerro, Losartan: Johann Lodewijk Hillege, Olmesartan: Milena Stain, Valsartan: Armando Genazzani
Scope: Impact of the Article 5(3) referral on nitrosamines in human medicinal products on the referral under article 31 of Directive 2001/83/EC for sartans medicinal products containing a tetrazole ring.
Action: For adoption
The CHMP adopted an opinion by consensus recommending to align the recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines. In line with previous recommendations, companies should have appropriate control strategies to prevent or limit the presence of nitrosamine impurities as much as possible and, where necessary, improve their manufacturing processes. Companies should also evaluate the risk of nitrosamines being present in their medicines and carry out appropriate tests.
The Icelandic and Norwegian Members were in agreement with the CHMP recommendation.
The CHMP adopted the EMA public health communication.
10.6.2. Esmya (CAP); NAP - ulipristal acetate - EMEA/H/A-31/1496
MAH(s): Gedeon Richter Plc.; various
Referral PRAC Rapporteur: Annika Folin, Referral PRAC Co-Rapporteur: Menno van der Elst, CHMP Rapporteurs (Esmya): Kristina Dunder, CHMP Co-Rapporteur (Esmya): Paula Boudewina van Hennik
Scope: CHMP Opinion
Action: For adoption
Review of the benefit-risk balance following notification by the European Commission of a referral under Article 31 of Directive 2001/83/EC, based on pharmacovigilance data; PRAC recommendation.
Having considered the PRAC recommendation, the CHMP adopted an opinion by majority (19 votes out of 31 votes), recommending to restrict the use of medicines containing ulipristal acetate 5 mg (Esmya and generic medicines) as a result of cases of serious liver injury. The medicines can now only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolisation) are not appropriate or have not worked. The medicines must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment.
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The member from Iceland agreed with the CHMP recommendation, the member from Norway did not agree.
The divergent position (Sinan B. Sarac, Christophe Focke, Ewa Balkowiec Iskra, Kristina Dunder, Bruno Sepodes, Ilko Getov, Jan Mueller-Berghaus, Alexandre Moreau, Armando Genazzani, Martina Weise, Jayne Crowe, Konstantinos Markopoulos, Bjorg Bolstad) was appended to the opinion.
The CHMP adopted the EMA public health communication.
10.7. Re-examination Procedure under Article 32(4) of Directive 2001/83/EC
No items
10.8. Procedure under Article 107(2) of Directive 2001/83/EC
No items
10.9. Disagreement between Member States on Type II variation– Arbitration procedure initiated by MAH under Article 6(13) of Commission Regulation (EC) No 1084/2003
No items
10.10. Procedure under Article 29 of Regulation (EC) 1901/2006
No items
10.11. Referral under Article 13 Disagreement between Member States on Type II variation– Arbitration procedure initiated by Member State under Article 13 (EC) of Commission Regulation No 1234/2008
No items
11. Pharmacovigilance issue
11.1. Early Notification System
November 2020 Early Notification System on envisaged CHMP/CMDh outcome accompanied by communication to the general public.
Action: For information
The CHMP noted the information.
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12. Inspections
12.1. GMP inspections
Information related to GMP inspections will not be published as it undermines the purpose of such inspections
12.2. GCP inspections
Information related to GCP inspections will not be published as it undermines the purpose of such inspections
12.3. Pharmacovigilance inspections
Information related to Pharmacovigilance inspections will not be published as it undermines the purpose of such inspections
12.4. GLP inspections
Information related to GLP inspections will not be published as it undermines the purpose of such inspections
13. Innovation Task Force
13.1. Minutes of Innovation Task Force
No items
13.2. Innovation Task Force briefing meetings
No items
13.3. Requests for CHMP Opinion under Article 57(1)J and (1)P of Regulation (EC) No 726/2004
No items
13.4. Nanomedicines activities
No items
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14. Organisational, regulatory and methodological matters
14.1. Mandate and organisation of the CHMP
14.1.1. Election of CHMP Co-opted Members
Election of CHMP co-opted member in light of the expiry of the mandate of co-opted member Jan Mueller-Berghaus on 13 November 2020.
Agreed areas of expertise: Quality, safety and efficacy of biological medicinal products, including advanced therapies and with specific emphasis on vaccines.
Action: For adoption
The CHMP re-elected Jan Mueller-Berghaus as CHMP co-opted member for another 3 year term.
14.1.2. Update on CHMP Co-opted Members
Call for nomination of CHMP co-opted member in light of Koenraad Norga’s resignation as CHMP co-opted member as of 30 September 2020.
Adoption of the area of expertise following discussions at ORGAM.
Action: For adoption
The CHMP agreed on the area of expertise:
Pharmaco-Epidemiology; especially for methodology (bias, effect modifications etc.) and interpretation of data, in particular study designs (observational studies, RWD etc.), strengths and weaknesses.
Please send nominations. The election is planned at the January 2021 Plenary.
14.2. Coordination with EMA Scientific Committees
14.2.1. Pharmacovigilance Risk Assessment Committee (PRAC)
Summary of recommendations and advice of PRAC meeting held on 26-29 October 2020
Action: For information
The CHMP noted the summary of recommendations and advice.
List of Union Reference Dates and frequency of submission of Periodic Safety Update Reports (EURD list) for November 2020
Action: For adoption
The CHMP adopted the EURD list.
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14.2.2. Paediatric Committee (PDCO)
PIPs reaching D30 at November 2020 PDCO
Action: For information
The CHMP noted the information.
Report from the PDCO meeting held on 10-13 November 2020
Action: For information
The CHMP noted the report.
14.2.3. Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh)
Chair: Kora Doorduyn-van der Stoep
CMDh questions to CHMP on NDMA detected in metformin containing medicinal products
Action: For adoption
The CHMP noted the question from the CMDh and provided a response.
Proposal for Multidisciplinary Expert Group on Interim limits
Action: For discussion
The CHMP noted the update to support setting interim limits for critical products with nitrosamines.
14.3. Coordination with EMA Working Parties/Working Groups/Drafting Groups
14.3.1. Biologics Working Party (BWP)
Chair: Sol Ruiz/Nanna Aaby Kruse
Reports from BWP November 2020 meeting to CHMP for adoption:
- 8 reports on products in scientific advice and protocol assistance
- 5 reports on products in pre-authorisation procedures
- 3 reports on products in plasma master file
Action: For adoption
The CHMP adopted the BWP reports.
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14.3.2. Scientific Advice Working Party (SAWP)
Chair: Anja Schiel
Report from the SAWP meeting held on 26-29 October 2020. Table of conclusions
Action: For information
The CHMP noted the report.
Scientific advice letters:
Disclosure of information related to scientific advice letters cannot be released at present time as these contain commercially confidential information.
14.4. Cooperation within the EU regulatory network
No items
14.5. Cooperation with International Regulators
No items
14.6. Contacts of the CHMP with external parties and interaction with the Interested Parties to the Committee
No items
14.7. CHMP work plan
No items
14.8. Planning and reporting
No items
14.9. Others
No items
15. Any other business
15.1. AOB topic
15.1.1. Update on COVID-19
Action: For information
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The CHMP noted the update.
15.1.2. Reflection paper – EMA considerations on Covid-19 vaccines approval
Action: For discussion
The CHMP discussed the reflection paper and agreed to the presented principles.
15.1.3. COVID-19 Vaccine (ChAdOx1-S [recombinant]) - H0005675
intramuscular (IM) injection of vaccine for coronavirus disease 2019 (COVID-19).
Scope: Updated non-clinical rolling review timetable adopted via written procedure on 6 November 2020
Action: For information
The CHMP noted the updated timetable.
15.1.4. COVID-19 mRNA vaccine (nucleoside-modified) - H0005735
is indicated for prophylactic vaccination against Severe Acute Respiratory Syndrome (SARS)-CoV-2.
Scope: Updated non-clinical timetable adopted via written procedure on 6 November 2020
Action: For information
The CHMP noted the updated timetable.
Scope: 2nd Rolling Review timetable adopted via written procedure on 30. October 2020
Action: For information
The CHMP noted the timetable for the Rolling Review adopted via written procedure.
Post meeting note: Following the November Plenary the 2nd Rolling Review timetable was shortened and adopted via written procedure on 17.11 2020
15.1.5. COVID-19 vaccine - EMEA/H/C/005791
Active immunization against coronavirus disease 2019 (COVID-19) caused by the SARSCoV-2 virus in persons 18 years of age and older.
Scope: 1st Rolling Review timetable adopted via written procedure on 17.11.2020
Action: For information
The CHMP noted the updated timetable.
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15.1.6. CoreRMP19 requirements and guidance for COVID-19 vaccines
Scope: Consideration on core requirements for RMPs of COVID-19 vaccines and CoreRMP19 guidance for adoption via written procedure on 5 November 2020
Action: For information
The CHMP noted the document which was adopted via written procedure on 5 November 2020.
15.1.7. Invitation to participate in a MCDA (Multi Criteria Decision Analysis) exercise for benefit risk
Action: For information
The CHMP noted the update.
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16. List of participants
List of participants including any restrictions with respect to involvement of members/alternates/experts following evaluation of declared interests for the 09-12 November 2020 CHMP meeting.
Name Role Member Outcome Topics on agenda for State or restriction which restrictions apply affiliation following evaluation of e-DoI Harald Enzmann Chair Germany No interests declared Andrea Laslop Member Austria No interests declared Milena Stain Alternate Austria No interests declared Christophe Focke Member Belgium No restrictions applicable to this meeting Karin Janssen van Alternate Belgium No interests Doorn declared Ilko Getov Member Bulgaria No interests declared Margareta Bego Member Croatia No interests declared Selma Arapovic Alternate Croatia No interests Dzakula declared Emilia Alternate Cyprus No restrictions Mavrokordatou applicable to this meeting Ondřej Slanař Member Czech No restrictions Republic applicable to this meeting Tomas Alternate Czech No interests Radimersky Republic declared Sinan B. Sarac Member Denmark No interests declared Kirstine Moll Alternate Denmark No interests Harboe declared Alar Irs Member Estonia No restrictions applicable to this meeting Edward Laane Alternate Estonia No restrictions applicable to this meeting Outi Mäki-Ikola Member Finland No restrictions applicable to this meeting Alexandre Moreau Member France No interests declared Jean-Michel Race Alternate France No interests declared Martina Weise Member Germany No restrictions applicable to this meeting
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Name Role Member Outcome Topics on agenda for State or restriction which restrictions apply affiliation following evaluation of e-DoI Janet Koenig Alternate Germany No interests declared Konstantinos Member Greece No interests Markopoulos declared Eleftheria Alternate Greece No interests Nikolaidi declared Agnes Gyurasics Alternate Hungary No interests declared Hrefna Alternate Iceland No interests Gudmundsdottir declared Jayne Crowe Member Ireland No interests declared Peter Kiely Alternate Ireland No interests declared Armando Member Italy No interests Genazzani declared Elita Poplavska Member Latvia No interests declared Romaldas Member Lithuania No restrictions Mačiulaitis applicable to this meeting Martine Trauffler Member Luxembourg No interests declared John Joseph Borg Member Malta No interests declared Johann Lodewijk Member Netherlands No interests Hillege declared Paula Boudewina Alternate Netherlands No interests van Hennik declared Bjorg Bolstad Member Norway No restrictions applicable to this meeting Ingrid Wang Alternate Norway No interests declared Ewa Balkowiec Member Poland No interests Iskra declared Bruno Sepodes Member (Vice- Portugal No interests Chair) declared Fatima Ventura Alternate Portugal No restrictions applicable to this meeting Simona Badoi Member Romania No interests declared Dana Alternate Romania No interests Gabriela Marin declared Francisek Drafi Member Slovakia No interests declared Dorota Distlerova Alternate Slovakia No Tysabri - natalizumab - participation in EMEA/H/C/000603/X/0116 discussions, final Angiotensin-II-receptor deliberations antagonists (sartans) and voting on containing a tetrazole group - EMEA/H/A-31/1471
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Name Role Member Outcome Topics on agenda for State or restriction which restrictions apply affiliation following evaluation of e-DoI Nevenka Trsinar Alternate Slovenia No interests Brodt declared Maria Concepcion Member Spain No interests Prieto Yerro declared Blanca Garcia- Alternate Spain No interests Ochoa declared Kristina Dunder Member Sweden No interests declared Filip Josephson Alternate Sweden No interests declared Christian Gartner Co-opted Austria No restrictions member applicable to this meeting Jan Mueller- Co-opted Germany No interests Berghaus member declared Blanka Co-opted Czech No interests Hirschlerova member Republic declared Sol Ruiz Co-opted Spain No interests member declared Expert - via No interests Christina Hojelse telephone* Denmark declared Expert - via No interests Helle Mulvad telephone* Denmark declared No restrictions Steen Werner Expert - via applicable to Hansen telephone* Denmark this meeting Tina Visholm Expert - via No interests Jensen telephone* Denmark declared Expert - via No interests Gritta Janka telephone* Germany declared Susan Webb Expert - via Spain No restrictions telephone* applicable to this meeting Expert - via No interests Filip van Nuffel Adobe* Belgium declared Expert - via No interests Olga Kholmaskikh Adobe* Belgium declared Aaron Sosa Expert - via Denmark No restrictions Adobe* applicable to this meeting Mette Linnert Expert - via No interests Jensen Adobe* Denmark declared Mogens Expert - via No interests Westergaard Adobe* Denmark declared Independent Expert - via scientific No interests Daniel Morales Adobe* expert declared Independent Brigitta Expert - via scientific No interests Grundmark Adobe* expert declared Expert - via No interests Muriel Uzzan Adobe* France declared Expert - via No interests Philippe Zamia Adobe* France declared
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Name Role Member Outcome Topics on agenda for State or restriction which restrictions apply affiliation following evaluation of e-DoI Expert - via No interests Tiphaine Vaillant Adobe* France declared Expert - via No interests Andreas Brandt Adobe* Germany declared Expert - via No interests Christoph Unkrig Adobe* Germany declared Expert - via No interests Elena Wolff-Holz Adobe* Germany declared Expert - via No interests Katrin Buss Adobe* Germany declared Expert - via No interests Martin Huber Adobe* Germany declared Martina Expert - via No interests Schussler-Lenz Adobe* Germany declared Expert - via No interests Maxim Frizler Adobe* Germany declared Expert - via No interests Regine Lehnert Adobe* Germany declared Stephanie Expert - via No interests Buchholz Adobe* Germany declared Uta Buckpesch- Expert - via No interests Heberer Adobe* Germany declared Expert - via No interests Ailise Carleton Adobe* Ireland declared Expert - via No interests Brian Aylward Adobe* Ireland declared Expert - via No interests Catherine Byrne Adobe* Ireland declared Expert - via No interests Finbarr Leacy Adobe* Ireland declared Expert - via No interests Geraldine O`Dea Adobe* Ireland declared Expert - via No interests Antonella Isgro Adobe* Italy declared Expert - via No interests Danila Renzo Adobe* Italy declared Odoardo Maria Expert - via No interests Olimpieri Adobe* Italy declared Expert - via No interests Frank Holtkamp Adobe* Netherlands declared Hinke Johanna Expert - via No interests van der Woude Adobe* Netherlands declared Expert - via No interests Jan Welink Adobe* Netherlands declared Johannes Expert - via No interests Theodorus Span Adobe* Netherlands declared Expert - via No interests Joost Romme Adobe* Netherlands declared Expert - via No interests Lies van Vlijmen Adobe* Netherlands declared Expert - via No interests Louise Claessen Adobe* Netherlands declared Menno van der Expert - via No interests Elst Adobe* Netherlands declared
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Name Role Member Outcome Topics on agenda for State or restriction which restrictions apply affiliation following evaluation of e-DoI Expert - via No interests Nienke Rodenhuis Adobe* Netherlands declared Expert - via No interests Sabine Straus Adobe* Netherlands declared Expert - via No interests Anja Schiel Adobe* Norway declared Expert - via No interests Erlend J Egeland Adobe* Norway declared Expert - via No interests Maria Almlof Adobe* Norway declared Expert - via No interests Venke Skibeli Adobe* Norway declared Mario Miguel Coelho da Silva Expert - via No interests Rosa Adobe* Portugal declared No restrictions Expert - via applicable to Susan Webb Adobe* Spain this meeting Expert - via No interests Birger Scholz Adobe* Sweden declared No restrictions Expert - via applicable to Dariush Mokhtari Adobe* Sweden this meeting no part in somapacitan - discussions, EMEA/H/C/005030 final deliberations Covid-19 mRNA vaccine - Tom Meyerson Expert - via and voting as H0005735 Goldschmidt Adobe* Sweden appropriate
Meeting run with the help of EMA staff
*Experts were only evaluated against the product(s) they have been invited to talk about
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17. Explanatory notes
The notes below give a brief explanation of the main sections and headings in the CHMP agenda and should be read in conjunction with the agenda or the minutes.
Oral explanations (section 2)
The items listed in this section are those for which marketing authorisation holders (MAHs) or applicants have been invited to the CHMP plenary meeting to address questions raised by the Committee. Oral explanations normally relate to on-going applications (section 3, 4 and 5) or referral procedures (section 10) but can relate to any other issue for which the CHMP would like to discuss with company representatives in person.
Initial applications (section 3)
This section lists applications for marketing authorisations of new medicines that are to be discussed by the Committee.
Section 3.1 is for medicinal products nearing the end of the evaluation and for which the CHMP is expected to adopt an opinion at this meeting on whether marketing authorisation should be granted. Once adopted, the CHMP opinion will be forwarded to the European Commission for a final legally binding decision valid throughout the EU.
The other items in the section are listed depending on the stage of the evaluation, which is shown graphically below:
The assessment of an application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is interrupted by at least one ‘clock-stop’ during which time the applicant prepares the answers to questions from the CHMP. The clock stop happens after day 120 and may also happen after day 180, when the CHMP has adopted a list of questions or outstanding issues to be addressed by the company. Related discussions are listed in the agenda under sections 3.2 (Day 180 List of outstanding issues) and 3.3 (Day 120 list of questions).
CHMP discussions may also occur at any other stage of the evaluation, and these are listed under section 3.4, update on ongoing new applications for centralised procedures.
The assessment leads to an opinion from the CHMP by day 210. Following a CHMP opinion the European Commission takes usually 67 days to issue a legally binding decision (i.e. by day 277 of the procedure). CHMP discussions on products that have received a CHMP opinion and are awaiting a decision are listed under section 3.6, products in the decision making phase.
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Extension of marketing authorisations according to Annex I of Reg. 1234/2008 (section 4)
Extensions of marketing authorisations are applications for the change or addition of new strengths, formulations or routes of administration to existing marketing authorisations. Extension applications follow a 210-day evaluation process, similarly to applications for new medicines (see figure above).
Type II variations - Extension of indication procedures (section 5)
Type II variations are applications for a change to the marketing authorisation which requires an update of the product information and which is not covered in section 4. Type II variations include applications for a new use of the medicine (extension of indication), for which the assessment takes up to 90 days. For the applications listed in this section, the CHMP may adopt an opinion or request supplementary information from the applicant.
Ancillary medicinal substances in medical devices (section 6)
Although the EMA does not regulate medical devices it can be asked by the relevant authorities (the so-called Notified Bodies) that are responsible for regulating these devices to give a scientific opinion on a medicinal substance contained in a medical device.
Re-examination procedures (new applications) under article 9(2) of regulation no 726/2004 (section 3.5)
This section lists applications for new marketing authorisation for which the applicant has requested a re-examination of the opinion previously issued by the CHMP.
Re-examination procedures (section5.3)
This section lists applications for type II variations (including extension of indication applications) for which the applicant has requested re-examination of the opinion previously issued by the CHMP.
Withdrawal of application (section 3.7)
Applicants may decide to withdraw applications at any stage during the assessment and a CHMP opinion will therefore not be issued. Withdrawals are included in the agenda for information or discussion, as necessary.
Procedure under article 83(1) of regulation (EC) 726/2004 (compassionate use) (section 7)
Compassionate use is a way of making available to patients with an unmet medical need a promising medicine which has not yet been authorised (licensed) for their condition. Upon request, the CHMP provides recommendations to all EU Member States on how to administer, distribute and use certain medicines for compassionate use.
Pre-submission issues (section 8)
In some cases the CHMP may discuss a medicine before a formal application for marketing authorisation is submitted. These cases generally refer to requests for an accelerated assessment for medicines that are of major interest for public health or can be considered a therapeutic innovation. In case of an accelerated assessment the assessment timetable is reduced from 210 to 150 days.
Post-authorisation issues (section 9)
This section lists other issues concerning authorised medicines that are not covered elsewhere in the agenda. Issues include supply shortages, quality defects, some annual reassessments or renewals or type II variations to marketing authorisations that would require specific discussion at the plenary.
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Referral procedures (section 10)
This section lists referrals that are ongoing or due to be started at the plenary meeting. A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the EMA is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. Further information on such procedures can be found here.
Pharmacovigilance issues (section 11)
This section lists issues that have been discussed at the previous meeting of the PRAC, the EMA’s committee responsible for evaluating and monitoring safety issues for medicines. Feedback is provided by the PRAC. This section also refers to the early notification system, a system used to notify the European regulatory network on proposed EMA communication on safety of medicines.
Inspections Issues (section 12)
This section lists inspections that are undertaken for some medicinal products. Inspections are carried out by regulatory agencies to ensure that marketing authorisation holders comply with their obligations. Inspection can relate to good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP) or good pharmacovigilance practice (GVP).
Innovation task force (section 13)
The Innovation Task Force (ITF) is a body set up to encourage early dialogue with applicants developing innovative medicines. Minutes from the last ITF meeting as well as any related issue that requires discussion with the CHMP are listed in this section of the agenda. Further information on the ITF can be found here.
Scientific advice working party (SAWP) (section 14.3.1)
This section refers to the monthly report from the CHMP’s Scientific Advice Working Party (SAWP) on scientific advice given to companies during the development of medicines. Further general information on SAWP can be found here.
Satellite groups / other committees (section 14.2)
This section refers to the reports from groups and committees making decisions relating to human medicines: the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), the Committee for Orphan Medicinal Products (COMP), the Committee for Herbal Medicinal Products (HMPC), Paediatric Committee (PDCO), the Committee for Advanced Therapies (CAT) and the Pharmamacovigilance Risk Assessment Committee (PRAC).
Invented name issues (section 14.3)
This section list issues related to invented names proposed by applicants for new medicines. The CHMP has established the Name Review Group (NRG) to perform reviews of the invented names. The group's main role is to consider whether the proposed names could create a public-health concern or potential safety risk. Further information can be found here.
More detailed information on the above terms can be found on the EMA website: www.ema.europa.eu/
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05 January 2021 EMA/CHMP/708333/2020
Annex to 09-12 November 2020 CHMP Minutes Pre-submission and post-authorisations issues
A. PRE-SUBMISSION ISSUES ...... 3 A.1. ELIGIBILITY REQUESTS ...... 3 A.2. Appointment of Rapporteur / Co-Rapporteur Full Applications ...... 3 A.3. PRE-SUBMISSION ISSUES FOR INFORMATION ...... 3
B. POST-AUTHORISATION PROCEDURES OUTCOMES ...... 3 B.1. Annual re-assessment outcomes ...... 3 B.1.1. Annual reassessment for products authorised under exceptional circumstances ...... 3 B.2. RENEWALS OF MARKETING AUTHORISATIONS OUTCOMES ...... 4 B.2.1. Renewals of Marketing Authorisations requiring 2nd Renewal ...... 4 B.2.2. Renewals of Marketing Authorisations for unlimited validity ...... 4 B.2.3. Renewals of Conditional Marketing Authorisations ...... 5 B.3. POST-AUTHORISATION PHARMACOVIGILANCE OUTCOMES...... 6 B.4. EPARs / WPARs ...... 10 B.5. TYPE II VARIATION, WORKSHARING PROCEDURE OUTCOMES ...... 13 B.5.1. CHMP assessed procedures scope: Pharmaceutical aspects ...... 13 B.5.2. CHMP assessed procedures scope: Non-Clinical and Clinical aspects ...... 18 B.5.3. CHMP-PRAC assessed procedures ...... 28 B.5.4. PRAC assessed procedures ...... 32 B.5.5. CHMP-CAT assessed procedures ...... 40 B.5.6. CHMP-PRAC-CAT assessed procedures ...... 41 B.5.7. PRAC assessed ATMP procedures ...... 41 B.5.8. Unclassified procedures and worksharing procedures of type I variations ...... 41 B.5.9. Information on withdrawn type II variation / WS procedure ...... 44 B.5.10. Information on type II variation / WS procedure with revised timetable ...... 44 B.6. START OF THE PROCEDURES TIMETABLES FOR INFORMATION ...... 45 B.6.1. Start of procedure for New Applications: timetables for information ...... 45 B.6.2. Start of procedure for Extension application according to Annex I of Reg. 1234/2008): timetables for information ...... 45 B.6.3. Restart of procedure - responses received to Day 120 List of Questions timetables: for information ...... 47
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© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. B.6.4. Annual Re-assessments: timetables for adoption ...... 47 B.6.5. Renewals of Marketing Authorisations: timetables for adoption provided only if the validation has been completed ...... 47 B.6.6. VARIATIONS – START OF THE PROCEDURE ...... 48 B.6.7. Type II Variations scope of the Variations: Extension of indication ...... 48 B.6.8. CHMP assessed procedures scope: Pharmaceutical aspects ...... 51 B.6.9. CHMP assessed procedures scope: Non-Clinical and Clinical aspects ...... 52 B.6.10. CHMP-PRAC assessed procedures ...... 52 B.6.11. PRAC assessed procedures ...... 52 B.6.12. CHMP-CAT assessed procedures ...... 52 B.6.13. CHMP-PRAC-CAT assessed procedures ...... 52 B.6.14. PRAC assessed ATMP procedures ...... 52 B.6.15. Unclassified procedures and worksharing procedures of type I variations ...... 52 B.7. DOCUMENTS TABLED IN MMD AFTER THE CHMP PLENARY ...... 55 B.7.1. Yearly Line listing for Type I and II variations ...... 55 B.7.2. Monthly Line listing for Type I variations ...... 55 B.7.3. Opinion on Marketing Authorisation transfer (MMD only) ...... 55 B.7.4. Notifications in accordance with Article 61(3) of Council Directive 2001/83/EC (MMD only) ...... 55 B.7.5. Request for supplementary information relating to Notification of Type I variation (MMD only) ...... 55 B.7.6. Notifications of Type I Variations (MMD only) ...... 55
C. Annex C - Post-Authorisation Measures (PAMs), (Line listing of Post authorisation measures with a description of the PAM. Procedures starting in that given month with assessment timetabled) ...... 55
D. Annex D - Post-Authorisation Measures (PAMs), (Details on PAMs including description and conclusion, for adoption by CHMP in that given month, or finalised ones with PRAC recommendation and no adoption by CHMP needed) ...... 55
E. Annex E - EMEA CERTIFICATION OF PLASMA MASTER FILES ...... 55 E.1. PMF Certification Dossiers:...... 55 E.1.1. Annual Update ...... 55 E.1.2. Variations: ...... 55 E.1.3. Initial PMF Certification: ...... 55 E.2. Timetables – starting & ongoing procedures: For information ...... 55
F. ANNEX F - Decision of the Granting of a Fee Reduction/Fee Waiver .... 56 F.1. Pursuant to Article 9 of Council Regulation (EC) No. 2743/98 of 14 December 1998, as amended ...... 56 F.2. Request for scientific opinion on justification of exceptional circumstance and for imperative grounds of public health ...... 56
G. ANNEX G ...... 56 G.1. Final Scientific Advice (Reports and Scientific Advice letters): ...... 56 G.2. Ongoing procedures ...... 56 G.3. PRIME ...... 56 G.3.1. List of procedures concluding at 09-12 November 2020 CHMP plenary: ...... 56
EMA/CHMP/708333/2020 Page 2/57 G.3.2. List of procedures starting in November 2020 for December 2020 CHMP adoption of outcomes ...... 57
H. ANNEX H - Product Shared Mailboxes – e-mail address ...... 57
A. PRE-SUBMISSION ISSUES
A.1. ELIGIBILITY REQUESTS
Report on Eligibility to Centralised Procedure for Adopted. November 2020: For adoption
A.2. Appointment of Rapporteur / Co-Rapporteur Full Applications
Final Outcome of Rapporteurship allocation for Adopted. November 2020: For adoption
A.3. PRE-SUBMISSION ISSUES FOR INFORMATION
Information related to pre-submission of initial applications cannot be released at the present time as these contain commercially confidential information.
B. POST-AUTHORISATION PROCEDURES OUTCOMES
B.1. Annual re-assessment outcomes
B.1.1. Annual reassessment for products authorised under exceptional circumstances
Atriance - nelarabine - Positive Opinion adopted by consensus together EMEA/H/C/000752/S/0051 with the CHMP assessment report and Novartis Europharm Limited, Rapporteur: Sinan translation timetable. B. Sarac, PRAC Rapporteur: Hans Christian The Marketing Authorisation remains under Siersted exceptional circumstances.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP opinion.
Brineura - cerliponase alfa - Request for Supplementary Information adopted EMEA/H/C/004065/S/0028, Orphan with a specific timetable. BioMarin International Limited, Rapporteur: Martina Weise, PRAC Rapporteur: Ulla Wändel Liminga Request for Supplementary Information adopted on 12.11.2020.
IMVANEX - smallpox vaccine (live modified Positive Opinion adopted by consensus together vaccinia virus Ankara) - with the CHMP assessment report and EMEA/H/C/002596/S/0054 translation timetable. Bavarian Nordic A/S, Rapporteur: Jan Mueller-
EMA/CHMP/708333/2020 Page 3/57 Berghaus, Co-Rapporteur: Christophe Focke, The Marketing Authorisation remains under PRAC Rapporteur: Brigitte Keller-Stanislawski exceptional circumstances.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP opinion.
Mepsevii - vestronidase alfa - Request for Supplementary Information adopted EMEA/H/C/004438/S/0017, Orphan with a specific timetable. Ultragenyx Germany GmbH, Rapporteur: Johann Lodewijk Hillege, PRAC Rapporteur: Eva A. Segovia Request for Supplementary Information adopted on 12.11.2020.
Naglazyme - galsulfase - Positive Opinion adopted by consensus together EMEA/H/C/000640/S/0083 with the CHMP assessment report and BioMarin International Limited, Rapporteur: translation timetable. Fátima Ventura, PRAC Rapporteur: Ana Sofia The Marketing Authorisation remains under Diniz Martins exceptional circumstances.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP opinion.
B.2. RENEWALS OF MARKETING AUTHORISATIONS OUTCOMES
B.2.1. Renewals of Marketing Authorisations requiring 2nd Renewal
B.2.2. Renewals of Marketing Authorisations for unlimited validity
Amlodipine-Valsartan Mylan - amlodipine / Positive Opinion adopted by consensus together valsartan - EMEA/H/C/004037/R/0008 with the CHMP assessment report and Mylan S.A.S, Generic, Generic of Exforge, translation timetable. Rapporteur: Ewa Balkowiec Iskra, PRAC Based on the review of the available Rapporteur: Anette Kirstine Stark information, the CHMP was of the opinion that Request for Supplementary Information adopted the renewal of the marketing authorisation can on 17.09.2020. be granted with unlimited validity.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP Opinion.
Descovy - emtricitabine / tenofovir Positive Opinion adopted by consensus together alafenamide - EMEA/H/C/004094/R/0051 with the CHMP assessment report and Gilead Sciences Ireland UC, Rapporteur: Bruno translation timetable. Sepodes, Co-Rapporteur: Jean-Michel Race, Based on the review of the available PRAC Rapporteur: Ana Sofia Diniz Martins information, the CHMP was of the opinion that Request for Supplementary Information adopted the renewal of the marketing authorisation can on 15.10.2020. be granted with unlimited validity.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP Opinion.
Eliquis - apixaban - Positive Opinion adopted by consensus together
EMA/CHMP/708333/2020 Page 4/57 EMEA/H/C/002148/R/0077 with the CHMP assessment report and Bristol-Myers Squibb / Pfizer EEIG, Rapporteur: translation timetable. Johann Lodewijk Hillege, Co-Rapporteur: Based on the review of the available Christophe Focke, PRAC Rapporteur: Menno van information, the CHMP was of the opinion that der Elst the renewal of the marketing authorisation can be granted with unlimited validity.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP Opinion.
Flixabi - infliximab - Request for supplementary information adopted EMEA/H/C/004020/R/0064 with a specific timetable. Samsung Bioepis NL B.V., Rapporteur: Jan Mueller-Berghaus, Co-Rapporteur: Kirstine Moll Harboe, PRAC Rapporteur: Ulla Wändel Liminga Request for Supplementary Information adopted on 12.11.2020.
Galafold - migalastat - Request for supplementary information adopted EMEA/H/C/004059/R/0027, Orphan with a specific timetable. Amicus Therapeutics Europe Limited, Rapporteur: Johann Lodewijk Hillege, Co- Rapporteur: Ondřej Slanař, PRAC Rapporteur: Ulla Wändel Liminga Request for Supplementary Information adopted on 12.11.2020.
IDELVION - albutrepenonacog alfa - Request for supplementary information adopted EMEA/H/C/003955/R/0047, Orphan with a specific timetable. CSL Behring GmbH, Rapporteur: Jan Mueller- Berghaus, Co-Rapporteur: Andrea Laslop, PRAC Rapporteur: Menno van der Elst Request for Supplementary Information adopted on 12.11.2020.
Odefsey - emtricitabine / rilpivirine / Positive Opinion adopted by consensus together tenofovir alafenamide - with the CHMP assessment report and EMEA/H/C/004156/R/0049 translation timetable. Gilead Sciences Ireland UC, Rapporteur: Bruno Based on the review of the available Sepodes, Co-Rapporteur: Armando Genazzani, information, the CHMP was of the opinion that PRAC Rapporteur: Ana Sofia Diniz Martins the renewal of the marketing authorisation can be granted with unlimited validity.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP Opinion.
B.2.3. Renewals of Conditional Marketing Authorisations
OCALIVA - obeticholic acid - See agenda 9.1 EMEA/H/C/004093/R/0023, Orphan Positive Opinion adopted by consensus together Intercept Pharma International Limited, with the CHMP assessment report and Rapporteur: Blanca Garcia-Ochoa, PRAC
EMA/CHMP/708333/2020 Page 5/57 Rapporteur: Liana Gross-Martirosyan translation timetable. Request for Supplementary Information adopted The CHMP was of the opinion that the renewal on 17.09.2020. for this conditional Marketing Authorisation can be granted.
The Marketing Authorisation remains conditional.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP Opinion.
SIRTURO - bedaquiline - Positive Opinion adopted by consensus together EMEA/H/C/002614/R/0040, Orphan with the CHMP assessment report and Janssen-Cilag International NV, Rapporteur: translation timetable. Filip Josephson, PRAC Rapporteur: Ulla Wändel The CHMP was of the opinion that the renewal Liminga for this conditional Marketing Authorisation can be granted.
The Marketing Authorisation remains conditional.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP Opinion.
B.3. POST-AUTHORISATION PHARMACOVIGILANCE OUTCOMES
SIGNAL DETECTION
PRAC recommendations on signals adopted at the PRAC November 2020 meeting which was held on 26-29 October 2020 PRAC:
Signal of sarcoidosis Adopted.
Tafinlar, Mekinist - dabrafenib, trametinib, Rapporteur: various, Co-Rapporteur: various, Scope: PRAC recommendation on a variation Action: for adoption
Signal of Hepatitis E Adopted.
Imbruvica – ibrutinib, Rapporteur: Filip Josephson, Co-Rapporteur: Sinan B. Sarac, Scope: PRAC recommendation on a variation/review hepatotoxicity in PSUR Action: for adoption
PSUR PROCEDURES
PRAC recommendations for variation of the terms of the MA at its November 2020 meeting which was held on 26-29 October 2020 PRAC:
EMEA/H/C/PSUSA/00001210/202004 The CHMP, having considered in accordance with
EMA/CHMP/708333/2020 Page 6/57 (emtricitabine / tenofovir disoproxil) Article 28 of Regulation (EC) No 726/2004 the CAPS: PSUR on the basis of the PRAC recommendation Truvada (EMEA/H/C/000594) (emtricitabine / and the PRAC assessment report as appended, tenofovir disoproxil), Gilead Sciences Ireland UC, recommends by consensus, the variation to the Rapporteur: Bruno Sepodes, PRAC Rapporteur: terms of the marketing authorisation(s) for the Ana Sofia Diniz Martins, “Period Covered From: above mentioned medicinal product(s), 03/04/2019 To: 02/04/2020” concerning the following change(s): Update of sections 4.4 and 5.1 of the SmPC to amend the information on bone effects. Annex II and the Package leaflet are updated accordingly. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00002892/202003 The CHMP, having considered in accordance with (tenofovir disoproxil) Article 28 of Regulation (EC) No 726/2004 and CAPS: Article 107g(3) of Directive 2001/83/EC the Tenofovir disoproxil Mylan PSUR on the basis of the PRAC recommendation (EMEA/H/C/004049) (tenofovir disoproxil), and the PRAC assessment report as appended, Mylan S.A.S, Rapporteur: Romaldas Mačiulaitis recommends by consensus the variation to the Tenofovir disoproxil Zentiva terms of the marketing authorisations for the (EMEA/H/C/004120) (tenofovir disoproxil), medicinal products containing the above- Zentiva k.s., Rapporteur: John Joseph Borg referred active substance, concerning the Viread (EMEA/H/C/000419) (tenofovir following changes: disoproxil), Gilead Sciences Ireland UC, Update of section 4.4 of the SmPC to amend the Rapporteur: Jean-Michel Race information on bone effects. Annex II and the NAPS: Package leaflet are updated accordingly. NAPs - EUR Update of section 4.6 of SmPC to downgrade the PRAC Rapporteur: Adrien Inoubli, “Period current recommendation for breast-feeding for Covered From: 31/03/2019 To: 31/03/2020” products indicated in the treatment of HBV. The Package leaflet is updated accordingly. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00003152/202003 The CHMP, having considered in accordance with (zonisamide) Article 28 of Regulation (EC) No 726/2004 and CAPS: Article 107g(3) of Directive 2001/83/EC the Zonegran (EMEA/H/C/000577) (zonisamide), PSUR on the basis of the PRAC recommendation Eisai GmbH, Rapporteur: Peter Kiely and the PRAC assessment report as appended, NAPS: recommends by consensus the variation to the NAPs - EU terms of the marketing authorisation(s) for the PRAC Rapporteur: Rhea Fitzgerald, “From: medicinal products containing the above referred 01/04/2019 To: 31/03/2020” active substance(s), concerning the following change(s): Update of section 4.4 of the SmPC to add a warning on hyperammonaemia. The Package leaflet is updated accordingly. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMA/CHMP/708333/2020 Page 7/57 EMEA/H/C/PSUSA/00009147/202003 The CHMP, having considered in accordance with (exenatide) Article 28 of Regulation (EC) No 726/2004 the CAPS: PSUR on the basis of the PRAC recommendation Bydureon (EMEA/H/C/002020) (exenatide), and the PRAC assessment report as appended, AstraZeneca AB, Rapporteur: Kristina Dunder recommends by consensus, the variation to the BYETTA (EMEA/H/C/000698) (exenatide), terms of the marketing authorisation(s) for the AstraZeneca AB, Rapporteur: Kristina Dunder, above mentioned medicinal product(s), PRAC Rapporteur: Annika Folin, “Period Covered concerning the following change(s): From: 01/04/2019 To: 31/03/2020” Update of section 4.8 of the SmPC to add ‘delayed gastric emptying’ as a new ADR. The Package leaflet is updated accordingly. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00009200/202003 The CHMP, having considered in accordance with (ipilimumab) Article 28 of Regulation (EC) No 726/2004 the CAPS: PSUR on the basis of the PRAC recommendation Yervoy (EMEA/H/C/002213) (ipilimumab), and the PRAC assessment report as appended, Bristol-Myers Squibb Pharma EEIG, Rapporteur: recommends by consensus, the variation to the Paula Boudewina van Hennik, PRAC Rapporteur: terms of the marketing authorisation(s) for the Menno van der Elst, “Period Covered From: above mentioned medicinal product(s), 24/03/2019 To: 24/03/2020” concerning the following change(s): Update of sections 4.4 and 4.8 of the SmPC to add solid organ transplant rejection with a frequency not known and to amend the information on the adverse reaction haemophagocytic lymphohistiocytosis. The Package leaflet is updated accordingly. The MAH took also the occasion to include some editorial changes in the package leaflet. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00010061/202004 The CHMP, having considered in accordance with (alogliptin, alogliptin / metformin, alogliptin / Article 28 of Regulation (EC) No 726/2004 the pioglitazone) PSUR on the basis of the PRAC recommendation CAPS: and the PRAC assessment report as appended Incresync (EMEA/H/C/002178) (alogliptin / recommends by consensus the variation to the pioglitazone), Takeda Pharma A/S, Rapporteur: terms of the marketing authorisation(s) for the Johann Lodewijk Hillege above mentioned medicinal product(s), Vipdomet (EMEA/H/C/002654) (alogliptin / concerning the following change(s): metformin / metformin hydrochloride), Takeda Update of section 4.4 of the SmPC to add a Pharma A/S, Rapporteur: Johann Lodewijk warning on post-marketing reports of bullous Hillege pemphigoid in patients taking DPP-4 inhibitors Vipidia (EMEA/H/C/002182) (alogliptin), Takeda including alogliptin, and if bullous pemphigoid is Pharma A/S, Rapporteur: Johann Lodewijk suspected alogliptin should be discontinued. Hillege, PRAC Rapporteur: Menno van der Elst, Update of section 4.8 of the SmPC to include the “From: 14/04/2019 To: 14/04/2020” new adverse drug reactions ‘Bullous pemphigoid’ and ‘Interstitial nephritis’ (with frequency unknown). The package leaflet is updated
EMA/CHMP/708333/2020 Page 8/57 accordingly. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00010077/202003 The CHMP, having considered in accordance with (canagliflozin, canagliflozin / metformin) Article 28 of Regulation (EC) No 726/2004 the CAPS: PSUR on the basis of the PRAC recommendation Invokana (EMEA/H/C/002649) (canagliflozin), and the PRAC assessment report as appended, Janssen-Cilag International NV, Rapporteur: recommends by consensus, the variation to the Martina Weise terms of the marketing authorisation(s) for the Vokanamet (EMEA/H/C/002656) (canagliflozin above mentioned medicinal product(s), / metformin), Janssen-Cilag International NV, concerning the following change(s): Rapporteur: Martina Weise, PRAC Rapporteur: - Update of section 4.8 of the SmPC to reflect Martin Huber, “Period Covered From: the post-marketing information on treatment 29/03/2019 To: 28/03/2020” interruption in case of UTI. - Update of section 4.4 to add a warning on UTI. The package leaflet section 2 is updated accordingly. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00010319/202004 The CHMP, having considered in accordance with (nintedanib (respiratory indication)) Article 28 of Regulation (EC) No 726/2004 the CAPS: PSUR on the basis of the PRAC recommendation OFEV (EMEA/H/C/003821) (nintedanib), and the PRAC assessment report as appended Boehringer Ingelheim International GmbH, recommends by consensus, the variation to the Rapporteur: Peter Kiely, PRAC Rapporteur: terms of the marketing authorisation(s) for the Nikica Mirošević Skvrce, “From: 15/10/2019 To: above mentioned medicinal product, concerning 15/04/2020” the following change: Update of section 4.4 of SmPC to add a warning on the risk of ischaemic colitis, and corresponding update of PL. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00010645/202003 The CHMP, having considered in accordance with (dupilumab) Article 28 of Regulation (EC) No 726/2004 the CAPS: PSUR on the basis of the PRAC recommendation Dupixent (EMEA/H/C/004390) (dupilumab), and the PRAC assessment report as appended, sanofi-aventis groupe, Rapporteur: Jan Mueller- recommends by consensus, the variation to the Berghaus, PRAC Rapporteur: Kimmo Jaakkola, terms of the marketing authorisation(s) for the “From: 28/09/2019 To: 28/03/2020” above mentioned medicinal product(s), concerning the following change(s): Update of sections 4.4 and 4.8 of the SmPC to add the adverse reactions Keratitis and Ulcerative keratitis with a frequency ‘Uncommon’ in AD and Keratitis with frequency ‘Rare’ for Asthma are proposed. Respective warning is proposed to be added in the SmPC section 4.4.
EMA/CHMP/708333/2020 Page 9/57 The package leaflet is updated accordingly. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00010662/202003 The CHMP, having considered in accordance with (ocrelizumab) Article 28 of Regulation (EC) No 726/2004 the CAPS: PSUR on the basis of the PRAC recommendation Ocrevus (EMEA/H/C/004043) (ocrelizumab), and the PRAC assessment report as appended, Roche Registration GmbH, Rapporteur: Kirstine recommends by consensus, the variation to the Moll Harboe, PRAC Rapporteur: Brigitte Keller- terms of the marketing authorisation(s) for the Stanislawski, “Period Covered From: 27/03/2019 above mentioned medicinal product(s), To: 27/03/2020” concerning the following change(s): Update of sections 4.4 and 4.8 of the SmPC to add the adverse reaction late onset of neutropenia with a frequency not known. The package leaflet is updated accordingly. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
EMEA/H/C/PSUSA/00010818/202003 The CHMP, having considered in accordance with (siponimod) Article 28 of Regulation (EC) No 726/2004 the CAPS: PSUR on the basis of the PRAC recommendation Mayzent (EMEA/H/C/004712) (siponimod), and the PRAC assessment report as appended, Novartis Europharm Limited, Rapporteur: recommends by consensus, the variation to the Kirstine Moll Harboe, PRAC Rapporteur: Maria terms of the marketing authorisation(s) for the del Pilar Rayon, “Period Covered From: above mentioned medicinal product(s), 25/09/2019 To: 25/03/2020” concerning the following change(s): Addition of Basal Cell Carcinoma in section 4.8 of the SmPC. The warning about cutaneous neoplasms is updated with the new information regarding the increase of the cases with long– term exposure. The Icelandic and the Norwegian CHMP members agree with the above-mentioned recommendation of the CHMP.
B.4. EPARs / WPARs
Fintepla - fenfluramine - For information only. Comments can be sent to EMEA/H/C/003933, Orphan the PL in case necessary. Zogenix ROI Limited, treatment of seizures associated with Dravet syndrome in children aged 2 years to 17 years and adults., Known active substance (Article 8(3) of Directive No 2001/83/EC)
Isturisa – osilodrostat - For information only. Comments can be sent to EMEA/H/C/004821 the PL in case necessary. Recordati Rare Diseases; indicated for the treatment of endogenous Cushing’s syndrome in
EMA/CHMP/708333/2020 Page 10/57 adults. New active substance (Article 8(3) of Directive No 2001/83/EC)
2nd Corrected EPAR
Lenalidomide Mylan - lenalidomide - For information only. Comments can be sent to EMEA/H/C/005306 the PL in case necessary. Mylan Ireland Limited, treatment of multiple myeloma, Generic, Generic of Revlimid, Generic application (Article 10(1) of Directive No 2001/83/EC)
Leqvio - inclisiran - EMEA/H/C/005333 For information only. Comments can be sent to Novartis Europharm Limited, treatment for the PL in case necessary. primary hypercholesterolaemia or mixed dyslipidaemia, New active substance (Article 8(3) of Directive No 2001/83/EC)
Libmeldy - autologous CD34+ cell enriched For information only. Comments can be sent to population that contains hematopoietic the PL in case necessary. stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene - EMEA/H/C/005321, Orphan, ATMP Orchard Therapeutics (Netherlands) BV, treatment of metachromatic leukodystrophy (MLD), New active substance (Article 8(3) of Directive No 2001/83/EC)
Oxlumo - lumasiran - EMEA/H/C/005040, For information only. Comments can be sent to Orphan the PL in case necessary. Alnylam Netherlands B.V., primary hyperoxaluria type 1 (PH1), New active substance (Article 8(3) of Directive No 2001/83/EC)
Palforzia - defatted powder of arachis For information only. Comments can be sent to hypogaea l., semen (peanuts) - the PL in case necessary. EMEA/H/C/004917 Aimmune Therapeutics Ireland Limited, desensitization of children and adolescents to peanut allergy, New active substance (Article 8(3) of Directive No 2001/83/EC)
Puldysa - idebenone - EMEA/H/C/005123, For information only. Comments can be sent to Orphan the PL in case necessary. Santhera Pharmaceuticals (Deutschland) GmbH, treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) not using glucocorticoids, Hybrid application (Article 10(3) of Directive No 2001/83/EC) WPAR
EMA/CHMP/708333/2020 Page 11/57 Rekambys - rilpivirine - EMEA/H/C/005060 For information only. Comments can be sent to Janssen-Cilag International N.V., treatment of the PL in case necessary. human of human immunodeficiency virus type 1 (HIV-1), Known active substance (Article 8(3) of Directive No 2001/83/EC)
Roctavian (WD) - valoctocogene For information only. Comments can be sent to roxaparvovec - EMEA/H/C/004749, the PL in case necessary. Orphan, ATMP BioMarin International Limited, treatment of haemophilia A, New active substance (Article 8(3) of Directive No 2001/83/EC) WPAR
Tecartus - autologous peripheral blood T For information only. Comments can be sent to cells CD4 and CD8 selected and CD3 and the PL in case necessary. CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3- zeta chimeric antigen receptor and cultured - EMEA/H/C/005102, Orphan, ATMP Kite Pharma EU B.V., treatment of adult patients with relapsed or refractory Mantle cell lymphoma (MCL), New active substance (Article 8(3) of Directive No 2001/83/EC)
TRIXEO AEROSPHERE - formoterol For information only. Comments can be sent to fumarate dihydrate / glycopyrronium the PL in case necessary. bromide / budesonide - EMEA/H/C/004983 AstraZeneca AB, maintenance treatment in adult patients with moderate to very severe chronic obstructive pulmonary disease (COPD), Fixed combination application (Article 10b of Directive No 2001/83/EC)
Udenyca - pegfilgrastim - For information only. Comments can be sent to EMEA/H/C/004413 the PL in case necessary. ERA Consulting GmbH; treatment of neutropenia, Similar biological application (Article 10(4) of Directive No 2001/83/EC) WPAR
Uplizna (WD) - inebilizumab - For information only. Comments can be sent to EMEA/H/C/005412 the PL in case necessary. Viela Bio, Uplizna is indicated for the treatment of neuromyelitis optica spectrum disorders(NMOSD)., New active substance (Article 8(3) of Directive No 2001/83/EC) WPAR
VOCABRIA - cabotegravir - For information only. Comments can be sent to EMEA/H/C/004976 the PL in case necessary.
EMA/CHMP/708333/2020 Page 12/57 ViiV Healthcare B.V., treatment of Human Immunodeficiency Virus type 1 (HIV-1), New active substance (Article 8(3) of Directive No 2001/83/EC)
B.5. TYPE II VARIATION, WORKSHARING PROCEDURE OUTCOMES
Scopes related to Chemistry, Manufacturing, and Controls cannot be released at the present time as these contain commercially confidential information.
B.5.1. CHMP assessed procedures scope: Pharmaceutical aspects
Benlysta - belimumab - Positive Opinion adopted by consensus on EMEA/H/C/002015/II/0084 06.11.2020. The Icelandic and Norwegian CHMP GlaxoSmithKline (Ireland) Limited, Rapporteur: Members were in agreement with the CHMP Kristina Dunder recommendation. Opinion adopted on 06.11.2020.
Betaferon - interferon beta-1b - Positive Opinion adopted by consensus on EMEA/H/C/000081/II/0129 12.11.2020. The Icelandic and Norwegian CHMP Bayer AG, Rapporteur: Martina Weise Members were in agreement with the CHMP Opinion adopted on 12.11.2020. recommendation. Request for Supplementary Information adopted on 17.09.2020.
CRYSVITA - burosumab - Request for supplementary information adopted EMEA/H/C/004275/II/0017, Orphan with a specific timetable. Kyowa Kirin Holdings B.V., Rapporteur: Kristina
Dunder Request for Supplementary Information adopted on 12.11.2020, 10.09.2020.
Darzalex - daratumumab - Request for supplementary information adopted EMEA/H/C/004077/II/0040, Orphan with a specific timetable. Janssen-Cilag International NV, Rapporteur: Sinan B. Sarac Request for Supplementary Information adopted on 06.11.2020.
Extavia - interferon beta-1b - Positive Opinion adopted by consensus on EMEA/H/C/000933/II/0102 12.11.2020. The Icelandic and Norwegian CHMP Novartis Europharm Limited, Informed Consent Members were in agreement with the CHMP of Betaferon, Rapporteur: Martina Weise recommendation. Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 17.09.2020.
Flucelvax Tetra - influenza vaccine surface Positive Opinion adopted by consensus on antigen inactivated prepared in cell 12.11.2020. The Icelandic and Norwegian CHMP cultures - EMEA/H/C/004814/II/0017 Members were in agreement with the CHMP Seqirus Netherlands B.V., Rapporteur: Sol Ruiz recommendation. Opinion adopted on 12.11.2020. Request for Supplementary Information adopted
EMA/CHMP/708333/2020 Page 13/57 on 08.10.2020.
Gardasil - human papillomavirus vaccine Positive Opinion adopted by consensus on [types 6, 11, 16, 18] (recombinant, 29.10.2020. The Icelandic and Norwegian CHMP adsorbed) - Members were in agreement with the CHMP EMEA/H/C/000703/II/0089/G recommendation. MSD Vaccins, Rapporteur: Kristina Dunder Opinion adopted on 29.10.2020.
Gardasil 9 - human papillomavirus vaccine Positive Opinion adopted by consensus on [types 6, 11, 16, 18, 31, 33, 45, 52, 58] 29.10.2020. The Icelandic and Norwegian CHMP (recombinant, adsorbed) - Members were in agreement with the CHMP EMEA/H/C/003852/II/0043/G recommendation. MSD Vaccins, Rapporteur: Kristina Dunder Opinion adopted on 29.10.2020.
Herzuma - trastuzumab - Positive Opinion adopted by consensus on EMEA/H/C/002575/II/0031 22.10.2020. The Icelandic and Norwegian CHMP Celltrion Healthcare Hungary Kft., Rapporteur: Members were in agreement with the CHMP Jan Mueller-Berghaus recommendation. Opinion adopted on 22.10.2020. Request for Supplementary Information adopted on 03.09.2020.
Hizentra - human normal immunoglobulin - Positive Opinion adopted by consensus on EMEA/H/C/002127/II/0117 22.10.2020. The Icelandic and Norwegian CHMP CSL Behring GmbH, Rapporteur: Jan Mueller- Members were in agreement with the CHMP Berghaus recommendation. Opinion adopted on 22.10.2020. Request for Supplementary Information adopted on 17.09.2020.
Imraldi - adalimumab - Positive Opinion adopted by consensus on EMEA/H/C/004279/II/0037/G 29.10.2020. The Icelandic and Norwegian CHMP Samsung Bioepis NL B.V., Rapporteur: Outi Members were in agreement with the CHMP Mäki-Ikola recommendation. Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 03.09.2020.
Kevzara - sarilumab - Request for supplementary information adopted EMEA/H/C/004254/II/0024/G with a specific timetable. sanofi-aventis groupe, Rapporteur: Jan Mueller- Berghaus Request for Supplementary Information adopted on 29.10.2020.
Lokelma - sodium zirconium cyclosilicate - Request for supplementary information adopted EMEA/H/C/004029/II/0021/G with a specific timetable. AstraZeneca AB, Rapporteur: Romaldas Mačiulaitis Request for Supplementary Information adopted on 06.11.2020.
EMA/CHMP/708333/2020 Page 14/57 Miglustat Gen.Orph - miglustat - Positive Opinion adopted by consensus on EMEA/H/C/004366/II/0013 29.10.2020. The Icelandic and Norwegian CHMP Gen.Orph, Generic, Generic of Zavesca, Members were in agreement with the CHMP Rapporteur: Milena Stain recommendation. Opinion adopted on 29.10.2020.
Mimpara - cinacalcet - Request for supplementary information adopted EMEA/H/C/000570/II/0068 with a specific timetable. Amgen Europe B.V., Rapporteur: Kristina Dunder Request for Supplementary Information adopted on 12.11.2020.
Myozyme - alglucosidase alfa - Positive Opinion adopted by consensus on EMEA/H/C/000636/II/0082 12.11.2020. The Icelandic and Norwegian CHMP Genzyme Europe BV, Co-Rapporteur: Karin Members were in agreement with the CHMP Janssen van Doorn recommendation. Opinion adopted on 12.11.2020.
NovoMix - insulin aspart - Positive Opinion adopted by consensus on EMEA/H/C/000308/II/0105 22.10.2020. The Icelandic and Norwegian CHMP Novo Nordisk A/S, Rapporteur: Kristina Dunder Members were in agreement with the CHMP Opinion adopted on 22.10.2020. recommendation. Request for Supplementary Information adopted on 10.09.2020.
NovoSeven - eptacog alfa (activated) - Request for supplementary information adopted EMEA/H/C/000074/II/0109/G with a specific timetable. Novo Nordisk A/S, Rapporteur: Paula Boudewina van Hennik Request for Supplementary Information adopted on 22.10.2020.
Nucala - mepolizumab - Positive Opinion adopted by consensus on EMEA/H/C/003860/II/0033 22.10.2020. The Icelandic and Norwegian CHMP GlaxoSmithKline Trading Services Limited, Members were in agreement with the CHMP Rapporteur: Peter Kiely recommendation. Opinion adopted on 22.10.2020. Request for Supplementary Information adopted on 17.09.2020.
Nulojix - belatacept - See agenda 9.1 EMEA/H/C/002098/II/0065/G Request for supplementary information adopted Bristol-Myers Squibb Pharma EEIG, Rapporteur: with a specific timetable. Filip Josephson“B.I.a.2.c -
B.I.b.1.c – B.I.b.2.b – Request for Supplementary Information adopted on 12.11.2020, 12.03.2020.
Nulojix - belatacept - Request for supplementary information adopted EMEA/H/C/002098/II/0072/G with a specific timetable. Bristol-Myers Squibb Pharma EEIG, Rapporteur: Filip Josephson
EMA/CHMP/708333/2020 Page 15/57 Request for Supplementary Information adopted on 22.10.2020.
Remsima - infliximab - Positive Opinion adopted by consensus on EMEA/H/C/002576/II/0093/G 22.10.2020. The Icelandic and Norwegian CHMP Celltrion Healthcare Hungary Kft., Rapporteur: Members were in agreement with the CHMP Outi Mäki-Ikola recommendation. Opinion adopted on 22.10.2020.
Repatha - evolocumab - Request for supplementary information adopted EMEA/H/C/003766/II/0044 with a specific timetable. Amgen Europe B.V., Rapporteur: Johann Lodewijk Hillege Request for Supplementary Information adopted on 29.10.2020, 10.09.2020.
Rilutek - riluzole - Positive Opinion adopted by consensus on EMEA/H/C/000109/II/0065 06.11.2020. The Icelandic and Norwegian CHMP Sanofi Mature IP, Rapporteur: Kirstine Moll Members were in agreement with the CHMP Harboe recommendation. Opinion adopted on 06.11.2020. Request for Supplementary Information adopted on 03.09.2020.
Ritonavir Mylan - ritonavir - Positive Opinion adopted by consensus on EMEA/H/C/004549/II/0007/G 06.11.2020. The Icelandic and Norwegian CHMP Mylan S.A.S, Generic, Generic of Norvir, Members were in agreement with the CHMP Rapporteur: John Joseph Borg recommendation. Opinion adopted on 06.11.2020. Request for Supplementary Information adopted on 01.10.2020, 16.07.2020, 17.04.2020.
Rybelsus - semaglutide - Positive Opinion adopted by consensus on EMEA/H/C/004953/II/0006 12.11.2020. The Icelandic and Norwegian CHMP Novo Nordisk A/S, Rapporteur: Johann Lodewijk Members were in agreement with the CHMP Hillege recommendation. Opinion adopted on 12.11.2020.
Rybelsus - semaglutide - Request for supplementary information adopted EMEA/H/C/004953/II/0007 with a specific timetable. Novo Nordisk A/S, Rapporteur: Johann Lodewijk Hillege Request for Supplementary Information adopted on 12.11.2020.
Sancuso - granisetron - Request for supplementary information adopted EMEA/H/C/002296/II/0058 with a specific timetable. Kyowa Kirin Holdings B.V., Rapporteur: Simona Stankeviciute Request for Supplementary Information adopted on 12.11.2020, 03.09.2020.
Simponi - golimumab - Positive Opinion adopted by consensus on EMEA/H/C/000992/II/0093 22.10.2020. The Icelandic and Norwegian CHMP
EMA/CHMP/708333/2020 Page 16/57 Janssen Biologics B.V., Rapporteur: Kristina Members were in agreement with the CHMP Dunder recommendation. Opinion adopted on 22.10.2020.
Simponi - golimumab - Positive Opinion adopted by consensus on EMEA/H/C/000992/II/0095 12.11.2020. The Icelandic and Norwegian CHMP Janssen Biologics B.V., Rapporteur: Kristina Members were in agreement with the CHMP Dunder recommendation. Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 10.09.2020.
Trepulmix - treprostinil sodium - Positive Opinion adopted by consensus on EMEA/H/C/005207/II/0002/G, Orphan 06.11.2020. The Icelandic and Norwegian CHMP SciPharm Sarl, Rapporteur: Johann Lodewijk Members were in agreement with the CHMP Hillege recommendation. Opinion adopted on 06.11.2020. Request for Supplementary Information adopted on 03.09.2020.
Trulicity - dulaglutide - Positive Opinion adopted by consensus on EMEA/H/C/002825/II/0053/G 22.10.2020. The Icelandic and Norwegian CHMP Eli Lilly Nederland B.V., Rapporteur: Martina Members were in agreement with the CHMP Weise recommendation. Opinion adopted on 22.10.2020.
Trulicity - dulaglutide - Request for supplementary information adopted EMEA/H/C/002825/II/0054 with a specific timetable. Eli Lilly Nederland B.V., Rapporteur: Martina Weise Request for Supplementary Information adopted on 29.10.2020.
Zavicefta - ceftazidime / avibactam - Request for supplementary information adopted EMEA/H/C/004027/II/0023/G with a specific timetable. Pfizer Ireland Pharmaceuticals, Rapporteur: Bjorg Bolstad Request for Supplementary Information adopted on 06.11.2020, 01.10.2020.
WS1870/G Positive Opinion adopted by consensus on Entresto-EMEA/H/C/004062/WS1870/ 22.10.2020. The Icelandic and Norwegian CHMP 0033/G Members were in agreement with the CHMP Neparvis-EMEA/H/C/004343/WS1870/ recommendation. 0030/G Novartis Europharm Limited, Lead Rapporteur: Johann Lodewijk Hillege Opinion adopted on 22.10.2020. Request for Supplementary Information adopted on 23.07.2020.
WS1926/G Request for supplementary information adopted Hexacima-EMEA/H/C/002702/WS1926/ with a specific timetable. 0106/G
EMA/CHMP/708333/2020 Page 17/57 Hexaxim-EMEA/H/W/002495/WS1926/ 0111/G Hexyon-EMEA/H/C/002796/WS1926/ 0110/G Sanofi Pasteur, Lead Rapporteur: Jan Mueller- Berghaus Request for Supplementary Information adopted on 12.11.2020.
B.5.2. CHMP assessed procedures scope: Non-Clinical and Clinical aspects
Betaferon - interferon beta-1b - Positive Opinion adopted by consensus on EMEA/H/C/000081/II/0130 29.10.2020. The Icelandic and Norwegian CHMP Bayer AG, Rapporteur: Martina Weise, “C.I.4 Members were in agreement with the CHMP Update of sections 4.4 and 4.8 of the SmPC in recommendation. order to amend an existing warning on Thrombotic Microangiopathy by adding information about Haemolytic anaemia and add Haemolytic anaemia to the list of adverse drug reactions (ADRs) with frequency unknown based on the cumulative review of available data including case reports from post-marketing surveillance and scientific literature. The Package Leaflet has been updated accordingly. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet.” Opinion adopted on 29.10.2020.
Biktarvy - bictegravir / emtricitabine / Positive Opinion adopted by consensus on tenofovir alafenamide - 29.10.2020. The Icelandic and Norwegian CHMP EMEA/H/C/004449/II/0034 Members were in agreement with the CHMP Gilead Sciences Ireland UC, Rapporteur: Jean- recommendation. Michel Race, “Update of section 4.8 of the SmPC in order to add the Stevens-Johnson Syndrome (SJS) to the list of adverse drug reactions (ADRs) with frequency “rare” based on an internal cumulative safety review performed by the company and prompted by a spontaneous case report of a HIV patient who experienced SJS during treatment with Biktarvy. The Package Leaflet is updated accordingly.” Opinion adopted on 29.10.2020.
ELOCTA - efmoroctocog alfa - Request for supplementary information adopted EMEA/H/C/003964/II/0039 with a specific timetable. Swedish Orphan Biovitrum AB (publ),
Rapporteur: Jan Mueller-Berghaus, “Update of sections 4.2, 4.8 and 5.1 of the SmPC to include the results of study 997HA306 in previously untreated patients which have previously been
EMA/CHMP/708333/2020 Page 18/57 assessed as an Article 46 paediatric submission and renewal (EMEA/H/C/003964/R/0036).” Request for Supplementary Information adopted on 12.11.2020, 10.09.2020.
Erleada - apalutamide - Positive Opinion adopted by consensus on EMEA/H/C/004452/II/0007/G 12.11.2020. The Icelandic and Norwegian CHMP Janssen-Cilag International N.V., Rapporteur: Members were in agreement with the CHMP Blanca Garcia-Ochoa, “Update of section 4.8 of recommendation. the SmPC in order to add toxic epidermal necrolysis and decreased appetite to the list of adverse drug reactions (ADRs) with frequency 'not known' and 'very common' respectively based on cumulative safety reviews; the Package Leaflet is updated accordingly.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 10.09.2020.
Ervebo - recombinant vesicular stomatitis See 9.1 virus - Zaire ebolavirus vaccine (live) - Positive Opinion adopted by consensus on EMEA/H/C/004554/II/0008/G 12.11.2020. Merck Sharp & Dohme B.V., Rapporteur: Christophe Focke, “(Type IB) B.II.b.3.z In addition, the CHMP, having considered the (Type II) C.I.11.b - Update to Annex II to delete application as set out in the appended Specific Obligations 2 and 4 and conversion to assessment report and on the basis of the marketing authorisation not subject to specific evidence of compliance with the specific obligations. In addition, the MAH is updating obligations submitted by the marketing section 5.1 of the SmPC and section 6 of the authorisation holder, was of the opinion that the Package Leaflet to delete the conditional risk-benefit balance of the above mentioned marketing authorisation details. medicinal product remains favourable. As all The MAH has taken the opportunity to propose a specific obligations laid down in Annex II have progress report to be provided following a Post- been fulfilled, pursuant to Article 7 of Regulation Authorisation Measure ” (EC) No 507/2006, the CHMP recommended by Opinion adopted on 12.11.2020. consensus the granting of a Marketing Authorisation in accordance with Article 14(1) of Regulation (EC) No 726/2004 for the above mentioned medicinal product, pursuant the Article 14-(8) of Regulation (EC) No 726/2004.
The Icelandic and Norwegian CHMP Members were in agreement with the CHMP recommendation.
Extavia - interferon beta-1b - Positive Opinion adopted by consensus on EMEA/H/C/000933/II/0103 29.10.2020. The Icelandic and Norwegian CHMP Novartis Europharm Limited, Informed Consent Members were in agreement with the CHMP of Betaferon, Rapporteur: Martina Weise, “Type recommendation. II variation to update SmPC section 4.8 with the addition of haemolytic anaemia (HA) as an adverse drug reaction of 'unknown' frequency' based on cumulative review of available data including case reports from post-marketing
EMA/CHMP/708333/2020 Page 19/57 surveillance and scientific literature. Section 4.4 of the SmPC and corresponding sections in the PL are updated with a precautionary statement, considering the importance of drug discontinuation for patients with Thrombotic Microangiopathy TMA/HA, to reflect the most recent post-marketing experience.” Opinion adopted on 29.10.2020.
Eylea - aflibercept - Request for supplementary information adopted EMEA/H/C/002392/II/0066 with a specific timetable. Bayer AG, Rapporteur: Alexandre Moreau, “Submission of final CSR for study 17514 (CENTERA). This is an international, multi- center, prospective, interventional, single-arm, open- label, phase 4 study on the efficacy, durability, posology and safety of the T&E regimen in subjects with macular edema secondary to CRVO.” Request for Supplementary Information adopted on 29.10.2020.
Gardasil - human papillomavirus vaccine Positive Opinion adopted by consensus on [types 6, 11, 16, 18] (recombinant, 06.11.2020. The Icelandic and Norwegian CHMP adsorbed) - EMEA/H/C/000703/II/0087 Members were in agreement with the CHMP MSD Vaccins, Rapporteur: Kristina Dunder, recommendation. “Update of section 5.1 of the SmPC in order to update the information of the duration of immunity following a 2-dose schedule of Gardasil based on the results from extension Protocol V501-167; this was a randomized clinical trial that assessed the immunogenicity of a 2 dose schedule of the qHPV in adolescents 9 to 13 years of age compared to a 3-dose schedule in young women 16 to 26 years of age. In addition, the MAH is taking the opportunity to update the product information in line with the Excipients guideline (SANTE-2017-11668) and the Guideline on quality aspects included in the product information for vaccines for human use (EMA/CHMP/BWP/133540/2017). Furthermore, the PI is being brought in line with the latest QRD template (version 10.1) and some minor editorial changes regarding the nomenclature for excipients have been implemented.” Opinion adopted on 06.11.2020. Request for Supplementary Information adopted on 10.09.2020.
Gardasil 9 - human papillomavirus vaccine Request for supplementary information adopted
EMA/CHMP/708333/2020 Page 20/57 [types 6, 11, 16, 18, 31, 33, 45, 52, 58] with a specific timetable. (recombinant, adsorbed) - EMEA/H/C/003852/II/0040 MSD Vaccins, Rapporteur: Kristina Dunder, “Update of section 4.8 of the SmPC in relation to the post-marketing safety experience information, currently based on the post- marketing safety experience for the quadrivalent HPV vaccine, based on 4 years of post-marketing experience of the 9vHPV vaccine. The package leaflet is updated accordingly. In addition, the MAH took the opportunity to update the wording regarding sodium according to the Guideline on quality aspects included in the product information for vaccines for human use EMA/CHMP/BWP/133540/2017 and to implement an editorial change in sections 5.1 and 9 of the SmPC, and the package leaflet.” Request for Supplementary Information adopted on 06.11.2020, 10.09.2020.
Imnovid - pomalidomide - Positive Opinion adopted by consensus on EMEA/H/C/002682/II/0038, Orphan 12.11.2020. The Icelandic and Norwegian CHMP Celgene Europe BV, Rapporteur: Blanca Garcia- Members were in agreement with the CHMP Ochoa, “Update of sections 4.2, 4.8, 5.1 and 5.2 recommendation. of the SmPC with information from a paediatric study in patients aged 4 to 18 years with recurrent or progressive high-grade glioma, medulloblastoma, ependymoma or diffuse intrinsic pontine glioma (DIPG) with primary location in the CNS.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 17.09.2020.
Jivi - damoctocog alfa pegol - Positive Opinion adopted by consensus on EMEA/H/C/004054/II/0015 12.11.2020. The Icelandic and Norwegian CHMP Bayer AG, Rapporteur: Kirstine Moll Harboe, Members were in agreement with the CHMP “Update of sections 4.8 and 5.1 of the SmPC to recommendation. reflect the final study report of the long-term extension study 15912 (PROTECT Kids) in children. This extension study is a category 3 study of the Jivi RMP. The MAH took the opportunity to update the list of local representatives in the PIL.” Opinion adopted on 12.11.2020.
Lorviqua - lorlatinib - Positive Opinion adopted by consensus on EMEA/H/C/004646/II/0008 12.11.2020. The Icelandic and Norwegian CHMP Pfizer Europe MA EEIG, Rapporteur: Sinan B. Members were in agreement with the CHMP Sarac, “Update of sections 4.2, 4.4 and 4.8 to recommendation.
EMA/CHMP/708333/2020 Page 21/57 include the new term “Psychotic effects” as an adverse drug reaction (ADR) based on the cumulative review of the data available through Clinical Databases and Safety Database. The package leaflet has been updated accordingly.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 17.09.2020.
LUTATHERA - lutetium (177Lu) Request for supplementary information adopted oxodotreotide - with a specific timetable. EMEA/H/C/004123/II/0022, Orphan Advanced Accelerator Applications, Rapporteur: Janet Koenig, “Update of sections 4.2, 4.4, 4.5, 4.6 and 4.8 of the SmPC in order to introduce structural changes in the dosing and administration and warnings and precautions section, include clarifications in the pregnancy and overdose sections, update instructions for use based on end user feedback and update of amino acid solution information based on review and approval of LysaKare; the Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet and to include correction of typographical errors and editorial changes in the PI in line with the latest QRD template version 10.1.” Request for Supplementary Information adopted on 12.11.2020.
Myozyme - alglucosidase alfa - Positive Opinion adopted by consensus on EMEA/H/C/000636/II/0081 22.10.2020. The Icelandic and Norwegian CHMP Genzyme Europe BV, Rapporteur: Alexandre Members were in agreement with the CHMP Moreau, “Update of section 5.1 of the SmPC on recommendation. long term clinical effects of alglucosidase alfa based on the review of published scientific literature. In addition, the MAH took the opportunity to update the Product Information to mention the change on contact details of local representatives for Italy and Malta and to add traceability statement as per QRD template version 10.1.” Opinion adopted on 22.10.2020. Request for Supplementary Information adopted on 25.06.2020.
OFEV - nintedanib - Positive Opinion adopted by consensus on EMEA/H/C/003821/II/0033 06.11.2020. The Icelandic and Norwegian CHMP Boehringer Ingelheim International GmbH, Members were in agreement with the CHMP Rapporteur: Peter Kiely, “Update of SmPC recommendation. section 5.1. to include additional clinical
EMA/CHMP/708333/2020 Page 22/57 information from an open-label extension trial 1199.33 (INPULSIS-ON) of the pivotal phase III, randomised, double-blind, placebo- controlled studies with identical design (INPULSIS-1 (1199.32) and INPULSIS-2 (1199.34)). This trial provides safety and efficacy data up to 192 weeks.” Opinion adopted on 06.11.2020. Request for Supplementary Information adopted on 16.07.2020.
OFEV - nintedanib - Request for supplementary information adopted EMEA/H/C/003821/II/0034 with a specific timetable. Boehringer Ingelheim International GmbH, Rapporteur: Peter Kiely, “Update of section 5.1 of the SmPC to include results of a double-blind, randomised, parallel-group trial to evaluate the efficacy and safety of Ofev co-administered with oral sildenafil, compared to treatment with Ofev alone (INSTAGE Trial).” Request for Supplementary Information adopted on 22.10.2020, 16.07.2020.
Praluent - alirocumab - Positive Opinion adopted by consensus on EMEA/H/C/003882/II/0059 12.11.2020. The Icelandic and Norwegian CHMP sanofi-aventis groupe, Rapporteur: Johann Members were in agreement with the CHMP Lodewijk Hillege, “Update of sections 4.2, 4.8, recommendation. 5.1 and 5.2 of the SmPC in order to change posology recommendations, the undesirable effects section and pharmacokinetic and pharmacodynamic sections with information on paediatric population, based on final results from study EFC14660, a category 3 open-label study in the RMP, to evaluate the efficacy and safety of alirocumab in children and adolescents with homozygous familial hypercholesterolemia; the Package Leaflet is updated accordingly.” Opinion adopted on 12.11.2020.
Repatha - evolocumab - Positive Opinion adopted by consensus on EMEA/H/C/003766/II/0043 29.10.2020. The Icelandic and Norwegian CHMP Amgen Europe B.V., Rapporteur: Johann Members were in agreement with the CHMP Lodewijk Hillege, “C.I.4, recommendation. Update of section 5.1 of the SmPC based on final results from study 20167869 (EVOPACS). It was a randomised, double-blind, placebo- controlled, multicenter study assessing the superiority of evolocumab vs. placebo administered during the acute phase of ACS (within 72 hours).” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted
EMA/CHMP/708333/2020 Page 23/57 on 23.07.2020.
Somavert - pegvisomant - Positive Opinion adopted by consensus on EMEA/H/C/000409/II/0097 12.11.2020. The Icelandic and Norwegian CHMP Pfizer Europe MA EEIG, Rapporteur: Jean-Michel Members were in agreement with the CHMP Race, “Update of sections 4.4, 4.6 and 5.3 of recommendation. the SmPC in order to add a new warning on acromegaly control and adjustment of doses during pregnancy, include information on use during pregnancy and effects on fertility, as well as an update on the effects of the drug product on the early embryonic development and embryo-foetal development in pregnant rabbits, following international regulatory procedure outcomes and literature review. The MAH took the opportunity to make editorial changes to the Package Leaflet.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 17.09.2020.
Spravato - esketamine - Request for supplementary information adopted EMEA/H/C/004535/II/0004 with a specific timetable. Janssen-Cilag International N.V., Rapporteur: Martina Weise, “to update the Spravato Product Information at section 4.2 to replace the current dosing recommendation in patients with Japanese ancestry with a statement that efficacy of Spravato in Japanese patients has not been established to date. This dosing recommendation is supported by the completed Phase 2 study 54135419TRD2005” Request for Supplementary Information adopted on 12.11.2020.
Tresiba - insulin degludec - Positive Opinion adopted by consensus on EMEA/H/C/002498/II/0047 06.11.2020. The Icelandic and Norwegian CHMP Novo Nordisk A/S, Rapporteur: Kristina Dunder, Members were in agreement with the CHMP “Update of section 5.1 of the SmPC in order to recommendation. update the description of day-to-day variability in glucose-lowering effect further to assessment of post-authorisation measure LEG013. In addition, the MAH took the opportunity to make editorial corrections in section 5.2 of the SmPC.” Opinion adopted on 06.11.2020. Request for Supplementary Information adopted on 10.09.2020.
Tysabri - natalizumab - Positive Opinion adopted by consensus on EMEA/H/C/000603/II/0117 29.10.2020. The Icelandic and Norwegian CHMP Biogen Netherlands B.V., Rapporteur: Jan Members were in agreement with the CHMP Mueller-Berghaus, “C.I.4 Update of section 5.2 recommendation. of the SmPC in order to update pharmacokinetic
EMA/CHMP/708333/2020 Page 24/57 information based on an updated PK analysis from 11 studies (both IV and SC administration) and data with serial PK sampling as measured by an industry standard assay.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 28.05.2020.
Veklury - remdesivir - See agenda 9.1 EMEA/H/C/005622/II/0012 Request for supplementary information adopted Gilead Sciences Ireland UC, Rapporteur: Janet with a specific timetable. Koenig, “Submission of the final D28 mortality data by ordinal scale categories of study COUS- 540-5776 (NIAID-ACTT1), listed as a Specific Obligation in the Annex II of the Product Information, in order to confirm the efficacy and safety of remdesivir in patients on Invasive Mechanical Ventilation and Extracorporeal Membrane Oxygenation (IMV/ECMO). In addition, the MAH discuss the potential imbalance in the use of corticosteroids and effect modification in study CO-US-540-5776. As a consequence, Annex II is updated accordingly.” Request for Supplementary Information adopted on 12.11.2020.
Venclyxto - venetoclax - Request for supplementary information adopted EMEA/H/C/004106/II/0031 with a specific timetable. AbbVie Deutschland GmbH & Co. KG, Rapporteur: Filip Josephson, “to update venetoclax SmPC wording regarding tumour lysis syndrome (TLS) prophylaxis and management following an update to the Company Core Data Sheet (CCDS) as result of a medical safety assessment conducted on TLS post-marketing reports. The proposed changes to the SmPC include sections 4.2 and 4.4: - Section 4.2: A more prescriptive table which replaces the text around the risk assessment, prophylaxis and monitoring measures based on the level of tumour burden. In addition, the text on the recommended dose modifications for toxicities is replaced by a table format for clarity. - Section 4.4: the text is revised to emphasise the fact that TLS occur in all patients and requires adequate risk assessment that considers comorbidities, particularly renal impairment, and other risk factors such as splenomegaly.” Request for Supplementary Information adopted
EMA/CHMP/708333/2020 Page 25/57 on 12.11.2020.
Votrient - pazopanib - Positive Opinion adopted by consensus on EMEA/H/C/001141/II/0059 12.11.2020. The Icelandic and Norwegian CHMP Novartis Europharm Limited, Rapporteur: Sinan Members were in agreement with the CHMP B. Sarac, “To update sections 4.2, 4.8, 5.1 and recommendation. 5.2 of the SmPC based on results from studies 2012-001306-20 (ADVL0815 / PZP114411) and study 2013-003595-12 (ADVL1322 / VEG116731 / PZP034X2203) listed in the agreed PIP; these are a phase 1 clinical trial of single-agent pazopanib in children with a relapsed or refractory solid (including CNS) tumour, and a therapeutic-exploratory (phase 2) clinical trials of single-agent pazopanib in children (including adolescents) and young adults with a refractory tumour.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 15.10.2020.
Xagrid - anagrelide - Positive Opinion adopted by consensus on EMEA/H/C/000480/II/0089 06.11.2020. The Icelandic and Norwegian CHMP Shire Pharmaceuticals Ireland Limited, Members were in agreement with the CHMP Rapporteur: Alexandre Moreau, “C.I.4, recommendation. Update of sections 4.5. and 5.2 of the SmPC in order to add drug-drug interaction information with omeprazole, and update pharmacokinetics, based on final results from clinical study SPD- 422-113 a Drug-Drug interaction (DDI) study with Xagrid (anagrelide hydrochloride) assessing the effect of multiple doses omeprazole on anagrelide and 3-OH anagrelide exposure. The study was agreed as a commitment in variation EMEA/H/C/000480/II/0075” Opinion adopted on 06.11.2020. Request for Supplementary Information adopted on 04.09.2020, 05.06.2020.
Xarelto - rivaroxaban - Request for supplementary information adopted EMEA/H/C/000944/II/0081 with a specific timetable. Bayer AG, Rapporteur: Kristina Dunder, “Update of sections 4.2, 4.4, 4.8 and 5.1 of the SmPC following the final results from the VOYAGER PAD study, a multicentre, randomised, double- blind, placebo-controlled phase 3 trial investigating the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization
EMA/CHMP/708333/2020 Page 26/57 procedures. The Package Leaflet is updated accordingly.” Request for Supplementary Information adopted on 12.11.2020.
XOSPATA - gilteritinib - Request for supplementary information adopted EMEA/H/C/004752/II/0003, Orphan with a specific timetable. Astellas Pharma Europe B.V., Rapporteur: Bjorg Bolstad, “C.I.4 Update of section 5.2 of the SmPC in order to update information about Transporter drug-drug interactions based on final results from in vitro transporter studies identified as recommendations by CHMP (REC003) during the initial approval. In addition, the MAH took the opportunity to perform minor corrections and editorial changes in the PI.” Request for Supplementary Information adopted on 29.10.2020, 03.09.2020.
WS1891/G Request for supplementary information adopted CONTROLOC Control-EMEA/H/C/001097/ with a specific timetable. WS1891/0036/G PANTOLOC Control-EMEA/H/C/001100/ WS1891/0041/G PANTOZOL Control-EMEA/H/C/001013/ WS1891/0038/G SOMAC Control-EMEA/H/C/001098/ WS1891/0037/G Takeda GmbH, Lead Rapporteur: Simona Stankeviciute, “Group of variations 1. To update sections 4.4 and 4.8 of the SmPC in order to add warnings related to Hypocalcaemia/Hypokalaemia based on the Signal Evaluation Reports; FORM-0003948 - Takeda Signal Evaluation Report, Products Dexlansoprazole, Lansoprazole and Pantoprazole, Signal: Hypocalcemia, dated February 13, 2020. The Package Leaflet is updated accordingly. 2. To update section 4.8 of the SmPC in order to add DRESS ADR based on the Signal Evaluation Reports; FORM-0003948 - Takeda Signal Evaluation Report, Products Dexlansoprazole, Lansoprazole and Pantoprazole, Signal: Drug reaction with eosinophilia and systemic symptoms (DRESS) dated January 29, 2020. The Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to bring the PI in line with the last QRD template (version 10.1), to update the list of local representatives and implement to editorial corrections to the PI.”
EMA/CHMP/708333/2020 Page 27/57 Request for Supplementary Information adopted on 29.10.2020.
WS1893 Positive Opinion adopted by consensus on Blitzima-EMEA/H/C/004723/WS1893/ 29.10.2020. The Icelandic and Norwegian CHMP 0034 Members were in agreement with the CHMP Ritemvia-EMEA/H/C/004725/WS1893/ recommendation. 0034 Truxima-EMEA/H/C/004112/WS1893/ 0037 Celltrion Healthcare Hungary Kft., Lead Rapporteur: Sol Ruiz, Lead PRAC Rapporteur: Hans Christian Siersted, “To provide CT-P10 3.4 final CSR along with the updated RMP (version 10.1) in compliance with the post-authorisation measure. CT-P10 3.4 was a Phase 3, randomised, parallel-group, active-controlled, double-blind study to compare efficacy and safety between CT-P10 and Rituxan in patients with LTBFL. Study CTP10 3.4 was designed to demonstrate similarity of efficacy of CT-P10 to Rituxan in patients with LTBFL. The patients were randomised in a 1:1 ratio in a double-blinded fashion.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 03.09.2020.
B.5.3. CHMP-PRAC assessed procedures
Imfinzi - durvalumab - Request for supplementary information adopted EMEA/H/C/004771/II/0023 with a specific timetable. AstraZeneca AB, Rapporteur: Sinan B. Sarac, PRAC Rapporteur: David Olsen, “Update of sections 4.2 and 5.1 of the SmPC in order to introduce a new posology regimen of 1500 mg every 4 weeks (Q4W) for the approved indication of the treatment of patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumours express PD-L1 on ≥ 1% of tumour cells and whose disease has not progressed following platinum based chemoradiation therapy. The RMP version 4.1 has also been submitted.” Request for Supplementary Information adopted on 12.11.2020, 15.10.2020.
NINLARO - ixazomib - Positive Opinion adopted by consensus on EMEA/H/C/003844/II/0022, Orphan 12.11.2020. The Icelandic and Norwegian CHMP Takeda Pharma A/S, Rapporteur: Armando Members were in agreement with the CHMP
EMA/CHMP/708333/2020 Page 28/57 Genazzani, PRAC Rapporteur: Annika Folin, “To recommendation. update section 4.8 undesirable effects of the Ninlaro (Ixazomib) Summary of Product Characteristics (SmPC) following the adoption of the CHMP opinion in 25 June 2020 on PSUR assessment procedure EMEA/H/C/PSUSA/00010535/201911. Consequently, ADRs: acute febrile neutrophilic dermatosis, Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy disorders and tumour lysis syndrome have been assigned frequency rare.” Opinion adopted on 12.11.2020.
Ocrevus - ocrelizumab - Request for supplementary information adopted EMEA/H/C/004043/II/0021 with a specific timetable. Roche Registration GmbH, Rapporteur: Kirstine Moll Harboe, PRAC Rapporteur: Brigitte Keller- Stanislawski, “Update of section 4.4 in order to include the term ‘anaphylaxis’ among the possible symptoms of infusion-related reactions (IRRs), following an analysis of cases retrieved by anaphylactic reaction MedDRA narrow SMQ. The MAH took the opportunity to update Annex II.C and D in line with the QRD template. The RMP version 6.0 has been submitted.” Request for Supplementary Information adopted on 29.10.2020.
Rekovelle - follitropin delta - Request for supplementary information adopted EMEA/H/C/003994/II/0022 with a specific timetable. Ferring Pharmaceuticals A/S, Rapporteur: Jean- Michel Race, PRAC Rapporteur: Menno van der Elst, “Update of section 4.2 of the SmPC in order to introduce a new anti-Müllerian hormone (AMH) assay to determine the dose of follitropin delta, following an agreed recommendation. In consequence, RMP version 5.0 was submitted and updated in line with GPV Module V rev.2. The MAH took the opportunity to amend section 4.4. of the SmPC with traceability information, to bring the PI in line with the latest QRD template version 10.1.” Request for Supplementary Information adopted on 29.10.2020.
Rubraca - rucaparib - Positive Opinion adopted by consensus on EMEA/H/C/004272/II/0020 12.11.2020. The Icelandic and Norwegian CHMP Clovis Oncology Ireland Limited, Rapporteur: Members were in agreement with the CHMP Blanca Garcia-Ochoa, PRAC Rapporteur: Annika recommendation. Folin, “Update of sections 4.2 and 5.2 of the SmPC in order to update the information on the
EMA/CHMP/708333/2020 Page 29/57 use of rucaparib in patients with hepatic impairment based on final results from Part I of study CO-338-078 listed as a category 3 study in the RMP; this is a phase 1, open- label, parallel group study to determine the pharmacokinetics, safety and tolerability of rucaparib in patients with an advanced solid tumour and either moderate hepatic impairment or normal hepatic function; the Package Leaflet is updated accordingly. The RMP version 4.2 has also been submitted. In addition, the MAH took the opportunity to make minor corrections in the SmPC, to update the list of local representatives in the Package Leaflet, and to bring the PI in line with the latest QRD template version 10.1 and excipient guideline.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 17.09.2020.
Somavert - pegvisomant - Request for supplementary information adopted EMEA/H/C/000409/II/0098/G with a specific timetable. Pfizer Europe MA EEIG, Rapporteur: Jean-Michel Race, PRAC Rapporteur: Adrien Inoubli, “Variation to update the Risk Management Plan following assessment of the final results of ACROSTUDY, a multicenter, Post Authorisation Safety Study (PASS) of Somavert therapy in patients with acromegaly (procedure number EMEA/H/C/000409/II/0089), grouped with variation to update of section 4.4 of the SmPC to remove the warning on growth hormone secreting tumours, consequential to the removal of pituitary tumour growth as a potential risk from the RMP. The RMP version 2.0 has been submitted and the MAH took the opportunity to update it as per the revised version of the GVP Module V Risk Management Systems, revision 2. The Package Leaflet is updated accordingly.” Request for Supplementary Information adopted on 29.10.2020.
Vargatef - nintedanib - Request for supplementary information adopted EMEA/H/C/002569/II/0035/G with a specific timetable. Boehringer Ingelheim International GmbH, Rapporteur: Sinan B. Sarac, PRAC Rapporteur: Agni Kapou, “Update of sections 4.5, 4.6 and 5.2 of the SmPC to reflect the results of study 1199-0340 conducted in female patients with Systemic Sclerosis associated Interstitial Lung disease (SSc-ILD), to investigate a potential
EMA/CHMP/708333/2020 Page 30/57 interaction between nintedanib and the oral contraceptive Microgynon, a combination of ethynilestradiol and levonorgestrel. Update of sections 4.3 and 4.6 of the SmPC to introduce a new contraindication of pregnancy for Vargatef treatment. This follows the same update for Ofev (nintedanib) introduced in the context of procedure EMEA/H/C/3821/II/0026 and the request from the PRAC in the context of procedure EMEA/H/C/PSUSA/00010318/201910 to consider a similar update for Vargatef. The Package Leaflet is updated accordingly. The RMP version 7.0 has also been submitted reflecting the consequential changes to the submission of study 1199-0340, changes submitted further to the agreement on the same changes implemented for Ofev and other changes requested by the PRAC.” Request for Supplementary Information adopted on 12.11.2020.
WS1664 Positive Opinion adopted by consensus on Keppra-EMEA/H/C/000277/WS1664/0187 12.11.2020. The Icelandic and Norwegian CHMP UCB Pharma S.A., Lead Rapporteur: Karin Members were in agreement with the CHMP Janssen van Doorn, Lead PRAC Rapporteur: recommendation. Laurence de Fays, “Update of section 4.2 of the SmPC to recommend the same dosing for monotherapy and adjunctive therapy based on data from modelling and simulation project. The Package Leaflet is updated accordingly. The RMP version 9.2 has also been submitted. The MAH took the opportunity to move Braille to another box section and to review and adapt the German PI according to the current QRD template.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 17.09.2020, 23.07.2020, 30.04.2020.
WS1830 Positive Opinion adopted by consensus on Entresto-EMEA/H/C/004062/WS1830/ 12.11.2020. The Icelandic and Norwegian CHMP 0032 Members were in agreement with the CHMP Neparvis-EMEA/H/C/004343/WS1830/ recommendation. 0029 Novartis Europharm Limited, Lead Rapporteur: Johann Lodewijk Hillege, Lead PRAC Rapporteur: Anette Kirstine Stark, “C.I.13: Submission of the final report from study CLCZ696D2301 (PARAGON HF) listed as a category 3 study in the RMP. The intention of this submission is to fulfil post-authorisation measure (MEA 003) to evaluate cognitive
EMA/CHMP/708333/2020 Page 31/57 function in this interventional multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. The RMP version 2.0 has also been submitted.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 25.06.2020.
WS1915 Positive Opinion adopted by consensus on Epclusa-EMEA/H/C/004210/WS1915/ 29.10.2020. The Icelandic and Norwegian CHMP 0051 Members were in agreement with the CHMP Harvoni-EMEA/H/C/003850/WS1915/ recommendation. 0091 Vosevi-EMEA/H/C/004350/WS1915/0043 Gilead Sciences Ireland UC, Lead Rapporteur: Filip Josephson, Lead PRAC Rapporteur: Ana Sofia Diniz Martins, “Submission of the final report from study GS-US-248-0123, listed as a category 3 study in the RMP. This is a long-term observational follow-up registry of subjects who did not achieve sustained virologic response in Gilead-sponsored trials in subjects with chronic hepatitis C infection. The RMPs have also been submitted for each of the products in this work- sharing procedure (Harvoni v8.0, Epclusa v7.0 and Vosevi v4.0).” Opinion adopted on 29.10.2020.
B.5.4. PRAC assessed procedures
PRAC Led Positive Opinion adopted by consensus on Betmiga - mirabegron - 29.10.2020. The Icelandic and Norwegian CHMP EMEA/H/C/002388/II/0033 Members were in agreement with the CHMP Astellas Pharma Europe B.V., Rapporteur: Maria recommendation. Concepcion Prieto Yerro, PRAC Rapporteur: Maria del Pilar Rayon, PRAC-CHMP liaison: Maria Concepcion Prieto Yerro, “Final study report of the PASS Study 178-CL-114 – An evaluation of Cardiovascular Events in Users of Mirabegron and Other Treatments for Overactive Bladder.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 11.06.2020, 13.02.2020.
PRAC Led Request for supplementary information adopted Bronchitol - mannitol - with a specific timetable. EMEA/H/C/001252/II/0042, Orphan
EMA/CHMP/708333/2020 Page 32/57 Pharmaxis Europe Limited, PRAC Rapporteur: Adrien Inoubli, “Submission of an updated RMP version 9.0 based on the new RMP template (GVP module V, revision 2). The MAH took the opportunity to review the safety information contained in the RMP and proposed to reclassify “Cough” from an important potential risk to an important identified risk; to remove the important identified risks “Bronchospasm during and after the initiation dose assessment” and “Bronchospasm during long term use”; to remove the important potential risk “Cough- related sequelae”; “Off label use in non-CF bronchiectasis” “Off label use in paediatric/adolescent CF patients (aged 6-17 years)”; “Administration of Bronchitol via the wrong inhaler device”; “Starting Bronchitol treatment without completing the full BIDA dose”; to remove the missing information “Patients requiring home oxygen or needing assisted ventilation”; “Children <6 years of age”; “Pregnancy and lactation”; “Risks associated with long-term use” from the list of safety concerns; to add “Increased risk of respiratory or systemic infection” as an important potential risk combining, replacing “Pulmonary abscess on continued use”, “Septicaemia on continued use”, “Increased risk of bacteria sputum identified or infections with extended use of Bronchitol”, and “Microbial infection via a contaminated inhaler device”, previously classified as important potential risks, which are proposed to be removed from the list of safety concerns. In addition, following the completion of UK CF Registry study (cat 2, PASS) EMEA/H/C/001252/SW/0036, this study has been removed from the RMP, and clinical trial and post-marketing exposure and safety information have been updated to reflect the results of the DPM-CF-303 study previously assessed in EMEA/H/C/001252/II/0034 and the information presented in the latest PSUR #9 (PSUSA/ 0009226/201904).” Request for Supplementary Information adopted on 29.10.2020.
PRAC Led Positive Opinion adopted by consensus on Ceplene - histamine dihydrochloride - 29.10.2020. The Icelandic and Norwegian CHMP EMEA/H/C/000796/II/0040 Members were in agreement with the CHMP Noventia Pharma S.r.l., Rapporteur: Jayne recommendation. Crowe, PRAC Rapporteur: Rhea Fitzgerald,
EMA/CHMP/708333/2020 Page 33/57 PRAC-CHMP liaison: Jayne Crowe, “Submission of an updated RMP version 8.1 in order to include the information about the termination of the non-interventional study (NIS) of category 3 Ceplene-3290 and of the PAES Ceplene Cohort Study 3306. -RMP has been adapted to the new RMP template (GVP V rev.2, mandatory since 31 March 2018). -The safety concerns (Part II Modules SVII and SVIII, Part V, Part VI) have been changed. A new important potential risk, named “Drug effect decreased as a consequence of drug interaction”, has been added to the list of safety concerns. -Part III and Part IV have been updated to include information about the termination of the non-interventional study (NIS) of category 3 Ceplene-3290 and of the PAES Ceplene Cohort Study 3306. -updated information about the other ongoing studies included in the Pharmacovigilance Plan, “Ceplene-3292” and “Ceplene-3298”, have been included in Part III and related parts/modules. -Details about the Marketing Authorisation Holder have been updated accordingly upon implementation of transfer from previous Marketing Authorisation Holder, Meda AB, (positive decision received 08 December 2017)” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 17.04.2020.
PRAC Led Positive Opinion adopted by consensus on Forsteo - teriparatide - 29.10.2020. The Icelandic and Norwegian CHMP EMEA/H/C/000425/II/0054 Members were in agreement with the CHMP Eli Lilly Nederland B.V., Rapporteur: Alexandre recommendation. Moreau, PRAC Rapporteur: Adrien Inoubli, PRAC-CHMP liaison: Alexandre Moreau, “submission of the concluding report of the European Union (EU) component of the post- authorisation safety study (PASS): Study B3D- MC-GHBX(2.1) of Forsteo (teriparatide).” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 09.07.2020.
PRAC Led Request for supplementary information adopted Jinarc - tolvaptan - with a specific timetable. EMEA/H/C/002788/II/0029 Otsuka Pharmaceutical Netherlands B.V., Rapporteur: Armando Genazzani, PRAC
EMA/CHMP/708333/2020 Page 34/57 Rapporteur: Amelia Cupelli, PRAC-CHMP liaison: Armando Genazzani, “To update the RMP for Jinarc to version 14.4 to include dehydration and pregnancy prevention programme as requiring additional risk minimisation measures in accordance with Annex II.” Request for Supplementary Information adopted on 29.10.2020, 11.06.2020.
PRAC Led Positive Opinion adopted by consensus on Olumiant - baricitinib - 29.10.2020. The Icelandic and Norwegian CHMP EMEA/H/C/004085/II/0017 Members were in agreement with the CHMP Eli Lilly Nederland B.V., Rapporteur: Johann recommendation. Lodewijk Hillege, PRAC Rapporteur: Adam Przybylkowski, PRAC-CHMP liaison: Ewa Balkowiec Iskra, “Submission of the final report from study I4V-MC-B010 "Rheumatologist Survey to Assess the Effectiveness of the Risk Minimisation Measures (RMM) for Olumiant" listed as a category 3 study in the RMP. This observational study was a multi-national cross- sectional survey. The RMP version 9.3 has been adopted.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 09.07.2020.
PRAC Led Positive Opinion adopted by consensus on Olumiant - baricitinib - 29.10.2020. The Icelandic and Norwegian CHMP EMEA/H/C/004085/II/0019 Members were in agreement with the CHMP Eli Lilly Nederland B.V., PRAC Rapporteur: Adam recommendation. Przybylkowski, PRAC-CHMP liaison: Ewa Balkowiec Iskra, “Update of sections 4.4 and 4.8 of the SmPC in order to add a new warning on diverticulitis following a signal assessment (EPITT: 19496; Procedure EMEA/H/C/4085/SDA/010); the Package Leaflet is updated accordingly.” Opinion adopted on 29.10.2020.
PRAC Led Positive Opinion adopted by consensus on Ventavis - iloprost - 29.10.2020. The Icelandic and Norwegian CHMP EMEA/H/C/000474/II/0066 Members were in agreement with the CHMP Bayer AG, Rapporteur: Alexandre Moreau, PRAC recommendation. Rapporteur: Adrien Inoubli, PRAC-CHMP liaison: Alexandre Moreau, “Submission of an updated RMP version 8.0 to introduce respiratory tract infection as an important potential risk as requested by PRAC in the conclusions of the periodic safety update report single assessment (PSUSA) procedure (EMEA/H/C/PSUSA/00001724/201709) adopted
EMA/CHMP/708333/2020 Page 35/57 in May 2018. In addition, the MAH took the opportunity to update the RMP in line with revision 2 of GVP module V on ‘Risk management systems’.” Opinion adopted on 29.10.2020.
PRAC Led Positive Opinion adopted by consensus on Xeljanz - tofacitinib - 29.10.2020. The Icelandic and Norwegian CHMP EMEA/H/C/004214/II/0023 Members were in agreement with the CHMP Pfizer Europe MA EEIG, Rapporteur: Armando recommendation. Genazzani, PRAC Rapporteur: Liana Gross- Martirosyan, PRAC-CHMP liaison: Johann Lodewijk Hillege, “Submission of the final report from study A3921205 listed as a category 3 study in the RMP. This is an Observational, Post- Authorization Safety Study (PASS) within the Consortium of Rheumatology Researchers of North America (CORRONA) Registry Comparing Rates of Malignancy, Cardiovascular and Serious Infection Outcomes among Patients Treated for Moderately to Severely Active Rheumatoid Arthritis. The RMP version 10.1 has also been submitted.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 11.06.2020.
PRAC Led Request for supplementary information adopted Yondelis - trabectedin - with a specific timetable. EMEA/H/C/000773/II/0061 Pharma Mar, S.A., Rapporteur: Sinan B. Sarac, PRAC Rapporteur: Hans Christian Siersted, PRAC-CHMP liaison: Sinan B. Sarac, “Submission of an updated RMP version 9.0 in order to reflect new available data from completed studies, removal of safety concerns, removal of a target follow-up questionnaire and update of the format in line with the guidance "EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2”.” Request for Supplementary Information adopted on 29.10.2020.
PRAC Led Positive Opinion adopted by consensus on WS1589 29.10.2020. The Icelandic and Norwegian CHMP Incruse Ellipta-EMEA/H/C/002809/ Members were in agreement with the CHMP WS1589/0029 recommendation. Rolufta Ellipta-EMEA/H/C/004654/ WS1589/0014 GlaxoSmithKline (Ireland) Limited, Lead Rapporteur: Maria Concepcion Prieto Yerro, Lead PRAC Rapporteur: Ilaria Baldelli, PRAC-
EMA/CHMP/708333/2020 Page 36/57 CHMP liaison: Armando Genazzani, “Submission of an updated RMP version 7.2 following completion of a category 3 study (WWE117397) “A Post-authorization safety Electronic Medical Records database retrospective cohort study of new users of inhaled UMEC/VI or new users of inhaled UMEC in the primary care setting". In addition, updates are included relating to the Category 1 study 201038 “Post-authorisation Safety (PAS) Observational Cohort Study to Quantify the Incidence and Comparative Safety of Selected Cardiovascular and Cerebrovascular Events in COPD Patients Using Inhaled UMEC/VI Combination, or Inhaled UMEC versus Tiotropium (Study201038).” The RMP is also updated to align with the Guidance on the Good Pharmacovigilance Practice (GVP) Module V - Risk management systems Revision 2 guidelines.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 09.07.2020.
PRAC Led Positive Opinion adopted by consensus on WS1794 29.10.2020. The Icelandic and Norwegian CHMP Brimica Genuair-EMEA/H/C/003969/ Members were in agreement with the CHMP WS1794/0029 recommendation. Duaklir Genuair-EMEA/H/C/003745/ WS1794/0029 AstraZeneca AB, Lead Rapporteur: Ewa Balkowiec Iskra, Lead PRAC Rapporteur: Adam Przybylkowski, PRAC-CHMP liaison: Ewa Balkowiec Iskra, “Submission of the final study report from study D6570R00002 listed as a category 3 study in the RMP. This is a descriptive, non-interventional, multinational European cohort study of new users of aclidinium, aclidinium/formoterol, and other selected COPD medications. The following safety concerns, listed as missing information in the RMP: ‘safety in patients with hepatic or severe renal impairment’, ‘safety in patients with benign prostatic hyperplasia or urinary retention’ and ‘use in pregnancy or lactation’ are removed. The updated RMP version 5.0 is acceptable.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 09.07.2020.
PRAC Led Positive Opinion adopted by consensus on WS1795 29.10.2020. The Icelandic and Norwegian CHMP
EMA/CHMP/708333/2020 Page 37/57 Bretaris Genuair-EMEA/H/C/002706/ Members were in agreement with the CHMP WS1795/0043 recommendation. Eklira Genuair-EMEA/H/C/002211/ WS1795/0043 AstraZeneca AB, Lead Rapporteur: Ewa Balkowiec Iskra, Lead PRAC Rapporteur: Adam Przybylkowski, PRAC-CHMP liaison: Ewa Balkowiec Iskra, “Submission of the final study report from study D6570R00002 listed as a category 3 study in the RMP. This is a descriptive, non-interventional, multinational European cohort study of new users of aclidinium, aclidinium/formoterol, and other selected COPD medications. The following safety concerns listed as missing information in the RMP: ‘safety in patients with hepatic or severe renal impairment’ and ‘safety in patients with benign prostatic hyperplasia or urinary retention’ are removed. The updated RMP version 8.0 is acceptable.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 09.07.2020.
PRAC Led Request for supplementary information adopted WS1805 with a specific timetable. Advagraf-EMEA/H/C/000712/WS1805/ 0057 Modigraf-EMEA/H/C/000954/WS1805/ 0035 Astellas Pharma Europe B.V., Lead Rapporteur: Jayne Crowe, Lead PRAC Rapporteur: Ronan Grimes, PRAC-CHMP liaison: Jayne Crowe, “Submission of an updated RMP version 3 in order to add a non-interventional post- authorisation safety study related to the safety concerns of use during pregnancy and use during lactation. The two important potential risks, ‘Exchangeability between the granule and capsule formulations of tacrolimus’ for Modigraf and ‘If administered accidentally either arterially or perivascularly, the reconstituted solution may cause irritation at the injection site’ for Prograf concentrate for solution for infusion, are combined into the important identified risk ‘Medication errors’. The RMP is being brought to EU RMP template revision 2.” Request for Supplementary Information adopted on 29.10.2020, 09.07.2020.
PRAC Led Positive Opinion adopted by consensus on WS1849 29.10.2020. The Icelandic and Norwegian CHMP
EMA/CHMP/708333/2020 Page 38/57 Thymanax-EMEA/H/C/000916/WS1849/ Members were in agreement with the CHMP 0045 recommendation. Valdoxan-EMEA/H/C/000915/WS1849/ 0047 Les Laboratoires Servier, Lead Rapporteur: Bjorg Bolstad, Lead PRAC Rapporteur: Pernille Harg, PRAC-CHMP liaison: Bjorg Bolstad, “Submission of an updated RMP version 23.1 in order to revise the safety concerns, important identified and potential risks in line with the new GVP module V. In addition, the completed studies have been deleted and, as agreed in LEG 031, the frequency of the educational material distribution is updated to once a year.” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 03.09.2020.
PRAC Led Positive Opinion adopted by consensus on WS1897 29.10.2020. The Icelandic and Norwegian CHMP Mirapexin-EMEA/H/C/000134/WS1897/ Members were in agreement with the CHMP 0096 recommendation. Sifrol-EMEA/H/C/000133/WS1897/0087 Boehringer Ingelheim International GmbH, Lead Rapporteur: Kirstine Moll Harboe, Lead PRAC Rapporteur: Anette Kirstine Stark, PRAC-CHMP liaison: Kirstine Moll Harboe, “RMP update to implement changes requested by PRAC in the context of the PSUSA procedure (EMEA/H/C/PSUSA/00002491/201904) of the PBRER with a DLP on 06 Apr 2019: · to remove `Cardiac failure' from the list of important identified risks; · to amend the information with regard to the important identified risk `Dopamine agonist withdrawal syndrome' (DAWS).” Opinion adopted on 29.10.2020. Request for Supplementary Information adopted on 04.09.2020.
PRAC Led Positive Opinion adopted by consensus on WS1923 29.10.2020. The Icelandic and Norwegian CHMP Afinitor-EMEA/H/C/001038/WS1923/ Members were in agreement with the CHMP 0068 recommendation. Votubia-EMEA/H/C/002311/WS1923/ 0067 Novartis Europharm Limited, Lead Rapporteur: Janet Koenig, Lead PRAC Rapporteur: Martin Huber, PRAC-CHMP liaison: Janet Koenig, “Submission of the Final Clinical Study Report for study CRAD001MIC03 (TOSCA), an international disease registry collecting data on
EMA/CHMP/708333/2020 Page 39/57 manifestations, interventions and outcomes in patients with tuberous sclerosis complex (TSC), for Votubia. The RMP version 15.0 is submitted to reflect the completion of MEA 14.4 (Votubia) and to remove important safety concerns as recommended by the PRAC (EMEA/H/C/WS1671).” Opinion adopted on 29.10.2020.
B.5.5. CHMP-CAT assessed procedures
Kymriah - tisagenlecleucel - Positive Opinion adopted by consensus on EMEA/H/C/004090/II/0026/G, Orphan, 12.11.2020. The Icelandic and Norwegian CHMP ATMP Members were in agreement with the CHMP Novartis Europharm Limited, Rapporteur: Rune recommendation. Kjeken, CHMP Coordinator: Ingrid Wang Opinion adopted on 12.11.2020, 06.11.2020. Request for Supplementary Information adopted on 09.10.2020.
Kymriah - tisagenlecleucel - Request for supplementary information adopted EMEA/H/C/004090/II/0027, Orphan, with a specific timetable. ATMP Novartis Europharm Limited, Rapporteur: Rune Kjeken, CHMP Coordinator: Ingrid Wang Request for Supplementary Information adopted on 06.11.2020, 09.10.2020.
Kymriah - tisagenlecleucel - Positive Opinion adopted by consensus on EMEA/H/C/004090/II/0028/G, Orphan, 12.11.2020. The Icelandic and Norwegian CHMP ATMP Members were in agreement with the CHMP Novartis Europharm Limited, Rapporteur: Rune recommendation Kjeken, CHMP Coordinator: Ingrid Wang Opinion adopted on 12.11.2020, 06.11.2020.
Zolgensma - onasemnogene abeparvovec - Positive Opinion adopted by consensus on EMEA/H/C/004750/II/0006, Orphan, 12.11.2020. The Icelandic and Norwegian CHMP ATMP Members were in agreement with the CHMP Novartis Gene Therapies EU Limited, recommendation. Rapporteur: Johannes Hendrikus Ovelgonne, CHMP Coordinator: Johann Lodewijk Hillege Opinion adopted on 12.11.2020, 06.11.2020. Request for Supplementary Information adopted on 09.10.2020.
Zolgensma - onasemnogene abeparvovec - Request for supplementary information adopted EMEA/H/C/004750/II/0007/G, Orphan, with a specific timetable. ATMP Novartis Gene Therapies EU Limited, Rapporteur: Johannes Hendrikus Ovelgonne, CHMP Coordinator: Johann Lodewijk Hillege Request for Supplementary Information adopted
EMA/CHMP/708333/2020 Page 40/57 on 06.11.2020.
B.5.6. CHMP-PRAC-CAT assessed procedures
B.5.7. PRAC assessed ATMP procedures
B.5.8. Unclassified procedures and worksharing procedures of type I variations
WS1811 Positive Opinion adopted by consensus on Olanzapine Glenmark-EMEA/H/C/001085/ 22.10.2020. The Icelandic and Norwegian CHMP WS1811/0034 Members were in agreement with the CHMP Olanzapine Glenmark Europe- recommendation. EMEA/H/C/001086/WS1811/0031 Olazax-EMEA/H/C/001087/WS1811/0027 Olazax Disperzi-EMEA/H/C/001088/ WS1811/0029 Glenmark Arzneimittel GmbH, Generic, Generic of Olansek (SRD), Zyprexa, Zyprexa Velotab, Lead Rapporteur: Alexandre Moreau Opinion adopted on 22.10.2020. Request for Supplementary Information adopted on 17.09.2020.
WS1829 Positive Opinion adopted by consensus on Aldurazyme-EMEA/H/C/000477/WS1829/ 12.11.2020. The Icelandic and Norwegian CHMP 0076 Members were in agreement with the CHMP Evoltra-EMEA/H/C/000613/WS1829/0070 recommendation. Fasturtec-EMEA/H/C/000331/WS1829/ 0059 Rilutek-EMEA/H/C/000109/WS1829/0064 Zaltrap-EMEA/H/C/002532/WS1829/0057 sanofi-aventis groupe, Lead Rapporteur: Filip Josephson, “To update the product information with respect to the excipient Sodium in accordance with the updated annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE-2017-11668). The Product Information was also brought in line with the latest QRD template. Finally, the MAH took the opportunity to implement an update of the phone number for the local representative for Italy, Malta Netherlands and Slovakia in section 6 of the Package Leaflet for all products.” Opinion adopted on 12.11.2020. Request for Supplementary Information adopted on 17.09.2020, 23.07.2020.
WS1854 Positive Opinion adopted by consensus on
EMA/CHMP/708333/2020 Page 41/57 Renvela-EMEA/H/C/000993/WS1854/ 12.11.2020. The Icelandic and Norwegian CHMP 0053 Members were in agreement with the CHMP Sevelamer carbonate Winthrop- recommendation. EMEA/H/C/003971/WS1854/0026 Genzyme Europe BV, Lead Rapporteur: Karin Janssen van Doorn, “To update section 2 of the SmPC, labelling and section 2 of the PL for the Powder for oral suspension presentations for Renvela and Sevelamer carbonate Winthrop to clarify the exact quantity and threshold of Propylene glycol per product following the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668). The MAH took the opportunity to include an update about the local representatives in the Pl for Italy, Malta, The Netherlands and Slovakia.” Opinion adopted on 12.11.2020.
WS1864/G Positive Opinion adopted by consensus on Kivexa-EMEA/H/C/000581/WS1864/ 22.10.2020. The Icelandic and Norwegian CHMP 0086/G Members were in agreement with the CHMP Trizivir-EMEA/H/C/000338/WS1864/ recommendation. 0118/G Ziagen-EMEA/H/C/000252/WS1864/ 0113/G ViiV Healthcare B.V., Lead Rapporteur: Jean- Michel Race Opinion adopted on 22.10.2020. Request for Supplementary Information adopted on 03.09.2020.
WS1902/G Positive Opinion adopted by consensus on Ambirix-EMEA/H/C/000426/WS1902/ 22.10.2020. The Icelandic and Norwegian CHMP 0109/G Members were in agreement with the CHMP Fendrix-EMEA/H/C/000550/WS1902/ recommendation. 0072/G Infanrix hexa-EMEA/H/C/000296/ WS1902/0281/G Twinrix Adult-EMEA/H/C/000112/ WS1902/0144/G Twinrix Paediatric-EMEA/H/C/000129/ WS1902/0145/G GlaxoSmithkline Biologicals SA, Lead Rapporteur: Christophe Focke Opinion adopted on 22.10.2020.
WS1913/G Positive Opinion adopted by consensus on Infanrix hexa-EMEA/H/C/000296/ 06.11.2020. The Icelandic and Norwegian CHMP WS1913/0282/G Members were in agreement with the CHMP GlaxoSmithkline Biologicals SA, Lead recommendation. Rapporteur: Christophe Focke
EMA/CHMP/708333/2020 Page 42/57 Opinion adopted on 06.11.2020.
WS1932 Positive Opinion adopted by consensus on Ultibro Breezhaler-EMEA/H/C/002679/ 12.11.2020. The Icelandic and Norwegian CHMP WS1932/0034 Members were in agreement with the CHMP Ulunar Breezhaler-EMEA/H/C/003875/ recommendation. WS1932/0035 Xoterna Breezhaler-EMEA/H/C/003755/ WS1932/0038 Novartis Europharm Limited, Lead Rapporteur: Kirstine Moll Harboe, “To update sections 4.4 and 5.1 of the SmPC related to QT interval prolongation by deleting this reference from the "Warnings and Precautions" section of the proposed SmPC. In addition the MAH has brought the annexes in line with the latest QRD template and a mainly format driven update of the SmPC section 6.6 and PL (i.e. addition of bullets, underline, bold/unbold text, adding spaces between lines etc.).” Opinion adopted on 12.11.2020.
WS1933/G Positive Opinion adopted by consensus on Blitzima-EMEA/H/C/004723/WS1933/ 29.10.2020. The Icelandic and Norwegian CHMP 0036/G Members were in agreement with the CHMP Ritemvia-EMEA/H/C/004725/WS1933/ recommendation. 0036/G Truxima-EMEA/H/C/004112/WS1933/ 0039/G Celltrion Healthcare Hungary Kft., Lead Rapporteur: Sol Ruiz Opinion adopted on 29.10.2020.
WS1934 Positive Opinion adopted by consensus on Azacitidine Celgene-EMEA/H/C/005300/ 12.11.2020. The Icelandic and Norwegian CHMP WS1934/0002 Members were in agreement with the CHMP Vidaza-EMEA/H/C/000978/WS1934/0050 recommendation. Celgene Europe BV, Lead Rapporteur: Paula Boudewina van Hennik, “To update the SmPC sections 4.2, 4.8, 5.1 and 5.2 to reflect the outcome of EMEA/H/C/000978/P46/034 where the paediatric information was updated.”
WS1947/G Positive Opinion adopted by consensus on Blitzima-EMEA/H/C/004723/WS1947/ 12.11.2020. The Icelandic and Norwegian CHMP 0037/G Members were in agreement with the CHMP Ritemvia-EMEA/H/C/004725/WS1947/ recommendation. 0037/G Truxima-EMEA/H/C/004112/WS1947/ 0040/G Celltrion Healthcare Hungary Kft., Duplicate, Duplicate of Truxima, Lead Rapporteur: Sol Ruiz
EMA/CHMP/708333/2020 Page 43/57 Opinion adopted on 12.11.2020.
WS1948 Positive Opinion adopted by consensus on Viagra-EMEA/H/C/000202/WS1948/0107 12.11.2020. The Icelandic and Norwegian CHMP Upjohn EESV, Lead Rapporteur: Johann Members were in agreement with the CHMP Lodewijk Hillege, “To update section 4.4 of the recommendation. SmPC and section 2 of the PL of the Product information for Viagra, Verventi and Sildenafil Pfizer SmPCs in line with the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'. The MAH has proposed wording in the SmPC to correspond to the excipient guideline PIL wording relevant to patients with low sodium diets. The MAH has also taken the opportunity to correct an inaccuracy in the current Viagra 25 mg, 50 mg and 100 mg film-coated tablet SmPC related to the quantity of lactose calculated to be present in each tablet. For Sildenafil Pfizer and Verventi, the SmPCs have been amended to specify the quantity of lactose rather than the quantity of lactose monohydrate thus aligning the text with that of the Viagra SmPC.” Opinion adopted on 12.11.2020.
B.5.9. Information on withdrawn type II variation / WS procedure
B.5.10. Information on type II variation / WS procedure with revised timetable
WS1820 Request by the applicant for an extension of Iscover-EMEA/H/C/000175/WS1820/ the clock-stop to respond to the RSI adopted 0142 on 15.10.2020. Plavix-EMEA/H/C/000174/WS1820/0140 The CHMP agreed to the request by the sanofi-aventis groupe, Lead Rapporteur: Bruno applicant. Sepodes, Lead PRAC Rapporteur: Marcia Sofia Sanches de Castro Lopes Silva, “Update of section 4.2 of the SmPC in order to add 600 mg as an alternative loading dose to the existing 300 mg to be used at initiation of treatment in the indication “Secondary prevention of atherothrombotic events in adult patients suffering from acute coronary syndrome ”. This update is based on a bibliographic review of published studies. The Package Leaflet is updated accordingly. The RMP version 2.0 has also been submitted.”
EMA/CHMP/708333/2020 Page 44/57 Request for Supplementary Information adopted on 15.10.2020, 25.06.2020.
Xenical - orlistat - Request by the applicant for an extension of EMEA/H/C/000154/II/0083 the clock-stop to respond to the RSI adopted on CHEPLAPHARM Arzneimittel GmbH, Rapporteur: 15.10.2020. Jean-Michel Race The CHMP agreed to the request by the Request for Supplementary Information adopted applicant. on 15.10.2020.
B.6. START OF THE PROCEDURES TIMETABLES FOR INFORMATION
B.6.1. Start of procedure for New Applications: timetables for information arachis hypogaea extract - EMEA/H/C/004810, Article 28 treatment of peanut allergy aducanumab - EMEA/H/C/005558 Alzheimer’s disease lenadogene nolparvovec - EMEA/H/C/005047, Orphan, ATMP GenSight Biologics S.A., treatment of vision loss due to Leber Hereditary Optic Neuropathy (LHON) anifrolumab - EMEA/H/C/004975 indicated as an add-on therapy for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), despite standard therapy avacopan - EMEA/H/C/005523, Orphan Vifor Fresenius Medical Care Renal Pharma France, Treatment of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) tecovirimat - EMEA/H/C/005248 treatment of orthopoxvirus disease
B.6.2. Start of procedure for Extension application according to Annex I of Reg. 1234/2008): timetables for information
Cosentyx - secukinumab - EMEA/H/C/003729/X/0067 Novartis Europharm Limited, Rapporteur: Tuomo Lapveteläinen, PRAC Rapporteur: Eva A. Segovia, “Extension application to introduce a new strength of 75 mg solution for injection.”
Rinvoq - upadacitinib -
EMA/CHMP/708333/2020 Page 45/57 EMEA/H/C/004760/X/0006/G AbbVie Deutschland GmbH & Co. KG, Rapporteur: Kristina Dunder, PRAC Rapporteur: Nikica Mirošević Skvrce, “Extension application to introduce a new strength (30 mg prolonged- release tablet), grouped with a type II variation (C.I.6.a) to add a new indication (treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy for Rinvoq). As a consequence, sections 4.1, 4.2, 4.5, 4.8, 5.1, 5.2 and 5.3 of the SmPC as well as the Package Leaflet are updated. The RMP (version 4.0) is updated in accordance. In addition, the marketing authorisation holder (MAH) took the opportunity to include a minor update in the Annex II.”
Vosevi - sofosbuvir / velpatasvir / voxilaprevir - EMEA/H/C/004350/ X/0045/G Gilead Sciences Ireland UC, Rapporteur: Filip Josephson, PRAC Rapporteur: Ana Sofia Diniz Martins, “Extension application to introduce a new strength (200 mg /50 mg /50 mg film- coated tablets). The new presentation is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older OR weighing at least 30 kg. The extension application is grouped with a type II variation (C.I.6.a) to include paediatric use in patients aged 12 years and older OR weighing at least 30 kg to the existing presentation. Sections 4.2, 4.8, 5.1 and 5.2 of the SmPC and the Package Leaflet are updated to support the extended indication. The RMP (version 3.2) is updated in accordance.”
Xeljanz - tofacitinib - EMEA/H/C/004214/X/0030/G Pfizer Europe MA EEIG, Rapporteur: Armando Genazzani, Co-Rapporteur: Johann Lodewijk Hillege, PRAC Rapporteur: Liana Gross- Martirosyan, “Extension application to add a new strength (22 mg prolonged-release tablet) grouped with a type II variation C.I.4: Update of sections 4.1, 4.2, 4.4 , 4.8, 5.1 and 5.2 of Xeljanz 11 mg prolonged-release tablets SmPC in order to include the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to
EMA/CHMP/708333/2020 Page 46/57 either conventional therapy or a biologic agent; as an alternative to the immediate release film- coated tablets; section 4.2 of Xeljanz film- coated tablets is also updated to include switching with the prolonged-release tablet in the treatment of UC. The Package Leaflet is updated accordingly. The RMP version 15.1 has also been submitted.”
B.6.3. Restart of procedure - responses received to Day 120 List of Questions timetables: for information idecabtagene vicleucel - EMEA/H/C/004662, Orphan, ATMP Celgene Europe BV, treatment of multiple myeloma List of Questions adopted on 11.09.2020.
B.6.4. Annual Re-assessments: timetables for adoption
Myalepta - metreleptin - EMEA/H/C/004218/S/0014, Orphan Amryt Pharmaceuticals DAC, Rapporteur: Karin Janssen van Doorn, PRAC Rapporteur: Adam Przybylkowski
Raxone - idebenone - EMEA/H/C/003834/S/0023, Orphan Santhera Pharmaceuticals (Deutschland) GmbH, Rapporteur: John Joseph Borg, PRAC Rapporteur: Amelia Cupelli
Vedrop - tocofersolan - EMEA/H/C/000920/S/0039 Recordati Rare Diseases, Rapporteur: Agnes Gyurasics, PRAC Rapporteur: Melinda Palfi
B.6.5. Renewals of Marketing Authorisations: timetables for adoption provided only if the validation has been completed
CABOMETYX - cabozantinib - EMEA/H/C/004163/R/0018 Ipsen Pharma, Rapporteur: Bjorg Bolstad, Co- Rapporteur: Johann Lodewijk Hillege, PRAC Rapporteur: Menno van der Elst
Epclusa - sofosbuvir / velpatasvir - EMEA/H/C/004210/R/0054 Gilead Sciences Ireland UC, Rapporteur: Filip Josephson, Co-Rapporteur: Alar Irs, PRAC Rapporteur: Ana Sofia Diniz Martins
Qtern - saxagliptin / dapagliflozin -
EMA/CHMP/708333/2020 Page 47/57 EMEA/H/C/004057/R/0030 AstraZeneca AB, Rapporteur: Johann Lodewijk Hillege, Co-Rapporteur: Karin Janssen van Doorn, PRAC Rapporteur: Ilaria Baldelli
Zepatier - elbasvir / grazoprevir - EMEA/H/C/004126/R/0026 Merck Sharp & Dohme B.V., Rapporteur: Johann Lodewijk Hillege, Co-Rapporteur: Alexandre Moreau, PRAC Rapporteur: Ana Sofia Diniz Martins
Zoely - nomegestrol acetate / estradiol - EMEA/H/C/001213/R/0055 Theramex Ireland Limited, Rapporteur: Jean- Michel Race, Co-Rapporteur: Agnes Gyurasics, PRAC Rapporteur: Adrien Inoubli
B.6.6. VARIATIONS – START OF THE PROCEDURE
Timetables for adoption provided that the validation has been completed.
B.6.7. Type II Variations scope of the Variations: Extension of indication
BLINCYTO - blinatumomab - EMEA/H/C/003731/II/0038, Orphan Amgen Europe B.V., Rapporteur: Alexandre Moreau, PRAC Rapporteur: Eva Jirsová, “Extension of indication to include the use of blinatumomab as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B- precursor ALL as consolidation therapy; as a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 13 of the RMP has also been submitted.”
Jardiance - empagliflozin - EMEA/H/C/002677/II/0055 Boehringer Ingelheim International GmbH, Rapporteur: Johann Lodewijk Hillege, PRAC Rapporteur: Eva A. Segovia, “Extension of indication to include treatment of adult patients with heart failure and reduced ejection fraction for Jardiance; as a consequence, sections 4.1, 4.2, 4.4, 4.8, 4.9 and 5.1 of the SmPC are updated. This is based on final results from the EMPEROR HFrEF study, a phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo. The Package Leaflet and Labelling are
EMA/CHMP/708333/2020 Page 48/57 updated in accordance. Version 15.0 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to update the list of local representatives in the Package Leaflet.” Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC) 726/2004)
Jyseleca - filgotinib - EMEA/H/C/005113/II/0001 Gilead Sciences Ireland UC, Rapporteur: Kristina Dunder, Co-Rapporteur: Jean-Michel Race, PRAC Rapporteur: Nikica Mirošević Skvrce, “C.I.6 (Extension of indication) C.I.6a (Extension of indication). Extension of indication to include the treatment of active ulcerative colitis in adults patients for Jyseleca. As a consequence, sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 of the SmPC and the Package Leaflet are updated accordingly. Version 1.1 of the RMP has also been submitted. In addition, the Marketing authorisation holder (MAH) took the opportunity to do minor updates to the Annex II and to implement minor editorial changes in the SmPC and Package Leaflet.”
Nucala - mepolizumab - EMEA/H/C/003860/II/0035 GlaxoSmithKline Trading Services Limited, Rapporteur: Peter Kiely, Co-Rapporteur: Ondřej Slanař, PRAC Rapporteur: Brigitte Keller- Stanislawski, “Extension of indication to include Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) for Nucala (mepolizumab). As a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 7 of the RMP has also been submitted. In addition, the Marketing authorisation holder took the opportunity to update the local (IT) representative in the PL.”
Nucala - mepolizumab - EMEA/H/C/003860/II/0036/G GlaxoSmithKline Trading Services Limited, Rapporteur: Peter Kiely, Co-Rapporteur: Ondřej Slanař, PRAC Rapporteur: Brigitte Keller- Stanislawski, “Extension of indication to include Eosinophilic Granulomatosis with Polyangiitis (EGPA) to Nucala (mepolizumab); as a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2
EMA/CHMP/708333/2020 Page 49/57 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 7 of the RMP has also been submitted. In addition, the Marketing authorisation holder took the opportunity to update the local representative (IT) in the PL. 2 Variations : type I B.11.e.5.a.2 To add a new pack size . As a consequence, sections 6.5 and 8 of SmPCs and section 6 of the PLs are updated accordingly. Annex IIIA is also being updated to include information relating to the new pack sizes.” Request for 1 year of market protection for a new indication (Article 14(11) of Regulation (EC) 726/2004)
Nucala - mepolizumab - EMEA/H/C/003860/II/0037 GlaxoSmithKline Trading Services Limited, Rapporteur: Peter Kiely, Co-Rapporteur: Ondřej Slanař, PRAC Rapporteur: Brigitte Keller- Stanislawski, “Extension of indication to include hypereosinophilic syndrome (HES) for Nucala (mepolizumab); as a consequence, sections 4.1, 4.2, 4.8, 5.1 and 5.2 (in addition 6.6 for the powder for solution for injection ONLY) of the SmPC. The Package Leaflet is updated in accordance. Version 7 of the RMP has also been submitted. In addition, the Marketing authorisation holder took the opportunity to update the local representative (IT) in the PL.”
Teysuno - tegafur / gimeracil / oteracil - EMEA/H/C/001242/II/0045 Nordic Group B.V., Rapporteur: Paula Boudewina van Hennik, PRAC Rapporteur: Menno van der Elst, “Extension of indication to include treatment of metastatic colorectal cancer in adult patients where it is not possible to initiate or continue treatment with another fluoropyrimidine. As a consequence, sections 4.1, 4.2, 4.3, 4.8 and 5.1 of the SmPC are updated. The Package Leaflet is updated in accordance. Version 10 of the RMP has also been submitted.”
WS1937/G Eucreas-EMEA/H/C/000807/WS1937/ 0080/G Icandra-EMEA/H/C/001050/WS1937/
EMA/CHMP/708333/2020 Page 50/57 0083/G Zomarist-EMEA/H/C/001049/WS1937/ 0082/G Novartis Europharm Limited, Lead Rapporteur: Kristina Dunder, “Modification of approved therapeutic indication to simplify wording. Update of SmPC section 5.1 to add VERIFY study data (new study). Existing warning on drugs that may affect renal function or metformin disposition was expanded to include drugs that inhibit renal transporter (OCT2/MATE inhibitors) and corresponding update in Drug Interaction (sections 4.4 and 4.5). PI update to QRD v10.1.”
WS1938/G Galvus-EMEA/H/C/000771/WS1938/ 0066/G Jalra-EMEA/H/C/001048/WS1938/ 0068/G Xiliarx-EMEA/H/C/001051/WS1938/ 0066/G Novartis Europharm Limited, Lead Rapporteur: Kristina Dunder, “Modification of approved therapeutic indication to simplify wording. Update of SmPC section 5.1 to add VERIFY study data (new study).”
B.6.8. CHMP assessed procedures scope: Pharmaceutical aspects
Idacio - adalimumab - Request for supplementary information adopted EMEA/H/C/004475/II/0007 with a specific timetable. Fresenius Kabi Deutschland GmbH, Rapporteur: Johann Lodewijk Hillege Request for Supplementary Information adopted on 12.11.2020.
Strensiq - asfotase alfa - EMEA/H/C/003794/II/0050, Orphan Alexion Europe SAS, Rapporteur: Armando Genazzani
WS1982 Aflunov-EMEA/H/C/002094/WS1982/ 0065 Foclivia-EMEA/H/C/001208/WS1982/ 0061 Seqirus S.r.l, Lead Rapporteur: Armando Genazzani
EMA/CHMP/708333/2020 Page 51/57 B.6.9. CHMP assessed procedures scope: Non-Clinical and Clinical aspects
B.6.10. CHMP-PRAC assessed procedures
B.6.11. PRAC assessed procedures
PRAC Led WS1972 Exviera-EMEA/H/C/003837/WS1972/0049 Viekirax-EMEA/H/C/003839/WS1972/ 0060 AbbVie Deutschland GmbH & Co. KG, Lead Rapporteur: Filip Josephson, Lead PRAC Rapporteur: Maria del Pilar Rayon, “To provide an updated Risk Management Plans (RMP) for Viekirax and Exviera following the outcome of procedure EMEA/H/C/PSA/J/0055 to change the due date for submission of the final study report for the HCC recurrence PASS study .”
B.6.12. CHMP-CAT assessed procedures
B.6.13. CHMP-PRAC-CAT assessed procedures
B.6.14. PRAC assessed ATMP procedures
B.6.15. Unclassified procedures and worksharing procedures of type I variations
WS1940 Adcirca-EMEA/H/C/001021/WS1940/0033 Cialis-EMEA/H/C/000436/WS1940/0093 Tadalafil Lilly-EMEA/H/C/004666/ WS1940/0006 Eli Lilly Nederland B.V., Lead Rapporteur: Maria Concepcion Prieto Yerro, “To include the excipient guidance in the labelling and package leaflet annex. In addition the QRD template has also been implemented. i.e. the MAH has updated the order of presentation in line with QRD for Cialis and Tadalafil Lilly. The details of the local representatives in Lithuania, Latvia, Estonia, France and Slovakia have been updated .”
WS1950 Kinzalmono-EMEA/H/C/000211/WS1950/ 0116 Micardis-EMEA/H/C/000209/WS1950/ 0119
EMA/CHMP/708333/2020 Page 52/57 Pritor-EMEA/H/C/000210/WS1950/0129 Boehringer Ingelheim International GmbH, Lead Rapporteur: Armando Genazzani, “To update section 4.4 of the SmPC and section 2 of the PL in order to implement the wording in compliance with the revised “Annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE-2017-11668), Revision 1 related to sorbitol and sodium content. Furthermore, MAH took this opportunity to implement QRD template version 10.1. Section 6 of the PL was updated to add 'K25' to povidone. Finally, some editorial changes to correct the provided administrative information of the PI are included in the submission: - For Kinzalmono/Pritor: § Correction of the date of latest renewal in section 9 of the SmPC. § Change of the phone number of local representative of MAH in Bulgaria in section 6 of PL. - For Micardis: § Change of the phone number of local representative of MAH in Austria and Lithuania in section 6 of PL. § Removal of “D-“ from the zip code of address of MAH and manufacturer in section 7 of the SmPC, section A of the Annex II, section 6 of the PL and section 11 of the Labelling. - Addition of minor linguistic corrections to the PI of the following languages: LT, FI, SV and EL. Further the MAH took the opportunity and include an editorial change , as agreed with EMA during procedure EMEA/H/C/xxxx /IG1261.”
WS1951 Combivir-EMEA/H/C/000190/WS1951/ 0098 Telzir-EMEA/H/C/000534/WS1951/0102 ViiV Healthcare B.V., Lead Rapporteur: Jean- Michel Race, “To update section 4.4 of the SmPC and section 2 of the PL to update excipients labelling in alignment with excipients guideline (Annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE-2017-11668) related to sodium content for:
EMA/CHMP/708333/2020 Page 53/57 - Telzir (fosamprenavir) 700 mg Film-coated tablets; - Combivir (lamivudine/zidovudine) 150/300 mg Film-coated tablets. In addition, the MAH took the opportunity to apply minor administrative changes in the following languages: LT, SL and FR.”
WS1955 Exelon-EMEA/H/C/000169/WS1955/0130 Prometax-EMEA/H/C/000255/WS1955/ 0130 Novartis Europharm Limited, Lead Rapporteur: Alexandre Moreau, “To update sections 2 and 4.4 of the SmPC for Exelon 2 mg/mL Oral Solution and Prometax 2 mg/mL Oral Solution in line with the current excipients guideline (Annex to the European Commission guideline on `Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE- 2017-11668)) with regards to sodium (from sodium benzoate and sodium citrate dihydrate) and sodium benzoate that are listed under the annex to the excipient guideline. Section 2 of package leaflet (PL) was updated accordingly. In addition, the MAH took this opportunity to bring the product information annexes for all presentations in line with the current QRD template.”
WS1956 Zypadhera-EMEA/H/C/000890/WS1956/ 0043 Zyprexa-EMEA/H/C/000115/WS1956/ 0130 Zyprexa Velotab-EMEA/H/C/000287/ WS1956/0098 Eli Lilly Nederland B.V., Duplicate, Duplicate of Zyprexa, Lead Rapporteur: Outi Mäki-Ikola, “To include new wording on excipients in SmPC section 4.4 and in the package leaflet. The wording takes the new excipient guidance into account. In addition, the MAH has also taken this opportunity to make minor changes in accordance with the QRD template.”
EMA/CHMP/708333/2020 Page 54/57 B.7. DOCUMENTS TABLED IN MMD AFTER THE CHMP PLENARY
B.7.1. Yearly Line listing for Type I and II variations
B.7.2. Monthly Line listing for Type I variations
B.7.3. Opinion on Marketing Authorisation transfer (MMD only)
B.7.4. Notifications in accordance with Article 61(3) of Council Directive 2001/83/EC (MMD only)
B.7.5. Request for supplementary information relating to Notification of Type I variation (MMD only)
B.7.6. Notifications of Type I Variations (MMD only)
C. Annex C - Post-Authorisation Measures (PAMs), (Line listing of Post authorisation measures with a description of the PAM. Procedures starting in that given month with assessment timetabled)
D. Annex D - Post-Authorisation Measures (PAMs), (Details on PAMs including description and conclusion, for adoption by CHMP in that given month, or finalised ones with PRAC recommendation and no adoption by CHMP needed)
E. Annex E - EMEA CERTIFICATION OF PLASMA MASTER FILES
Information related to plasma master files cannot be released at the present time as these contain commercially confidential information.
E.1. PMF Certification Dossiers:
E.1.1. Annual Update
E.1.2. Variations:
E.1.3. Initial PMF Certification:
E.2. Timetables – starting & ongoing procedures: For information
PMF timetables starting and ongoing procedures Tabled in MMD and sent by post mail (folder E).
EMA/CHMP/708333/2020 Page 55/57 F. ANNEX F - Decision of the Granting of a Fee Reduction/Fee Waiver
F.1. Pursuant to Article 9 of Council Regulation (EC) No. 2743/98 of 14 December 1998, as amended
F.2. Request for scientific opinion on justification of exceptional circumstance and for imperative grounds of public health
G. ANNEX G
G.1. Final Scientific Advice (Reports and Scientific Advice letters):
Information related to Scientific Advice cannot be released at the present time as these contain commercially confidential information.
G.2. Ongoing procedures
G.3. PRIME
Some information related to PRIME cannot be released at the present time as these contain commercially confidential information.
G.3.1. List of procedures concluding at 09-12 November 2020 CHMP plenary:
Oncology Lacutamab, Treatment of patients with Sézary The CHMP granted eligibility to PRIME and Syndrome who have received at least two prior adopted the critical summary report. systemic therapies
Dermatology Treatment of moderate to severe chronic hand The CHMP denied eligibility to PRIME and eczema in adults with a history of inadequate adopted the critical summary report. response to TCS or when TCS is medically inadvisable
Treatment of atopic dermatitis The CHMP denied eligibility to PRIME and adopted the critical summary report. Neurology Treatment of Parkinson's disease The CHMP denied eligibility to PRIME and adopted the critical summary report. Pneumology-allergology Brensocatib, Treatment of non-cystic fibrosis The CHMP granted eligibility to PRIME and bronchiectasis adopted the critical summary report.
Vaccines VAC18193, Active immunisation for the The CHMP granted eligibility to PRIME and prevention of lower respiratory tract disease adopted the critical summary report. (LRTD) caused by RSV in adults
EMA/CHMP/708333/2020 Page 56/57 G.3.2. List of procedures starting in November 2020 for December 2020 CHMP adoption of outcomes
H. ANNEX H - Product Shared Mailboxes – e-mail address
EMA/CHMP/708333/2020 Page 57/57