List of Substances Under PSUR WS Scheme and Other Substances

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ABCDEFGHIJKL List of substances under PSUR Work Sharing scheme and other substances contained in Nationally Authorised Products with DLP synchronised Status July 2013 In brown font: changes made since last publication on 30th June 2013 1 Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? sulbactam No, except if required nationally 19871116 201311 Pfizer AT/H/PSUR/0004/003 201402 Work Sharing by a competent 3 authority idarubicin No, except if required nationally 19891129 201311 Pfizer AT/H/PSUR/0005/003 201402 Work Sharing by a competent 4 authority dexibuprofen No, except if required nationally 20000725 31/08/2014 Gebro Pharma AT/H/PSUR/0009/003 29/11/2014 Work Sharing by a competent 5 authority nicorandil No, except if required nationally 19900209 201302 Merck AT/H/PSUR/0023/002 201305 Work Sharing by a competent 6 authority azelastine Request from MEDA Pharma GmbH & Co.KG to amend the DLP to 31/12/2014. Request agreed by the P- No, except if RMS AT. The substance has required nationally 20/11/1990 201309 Meda been moved to the EURD AT/H/PSUR/0038/001 201312 Work Sharing by a competent list as detailed in the cover note "Assessment of authority Periodic Safety Update Reports for National 7 Authorised" Product biperiden No, except if required nationally 19550816 201308 Abbott AT/H/PSUR/0039/001 201311 Work Sharing by a competent 8 authority calcium carbonate, No, except if colecalciferol required nationally 01/01/1960 201310 Nycomed AT/H/PSUR/0040/001 201401 Work Sharing by a competent 9 authority The PSURs submitted for human coagulation factor IX products containing human coagulation factor IX and authorised nationally will be assessed under a single assessment procedure with the centrally No, except if authorised product required nationally 12/07/1985 201307 Baxter AT/H/PSUR/0041/001 201310 Work Sharing Nonafact. For more by a competent details, please refer to authority the EURD list: http://www.emea.europa .eu/ema/index.jsp?curl=p ages/regulation/documen t_listing/document_listing _000361.jsp&mid=WC0b 10 01ac058066f910 human coagulation factor VII No, except if required nationally 01/11/1975 201310 Baxter AT/H/PSUR/0042/001 201401 Work Sharing by a competent 11 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? human coagulation factor No, except if VIII (inhibitor bypassing required nationally 04/02/1977 31/01/2014 AT/H/PSUR/0043/001 01/05/2014 Work Sharing fraction) by a competent 12 authority domperidone / domperidone The previous entry maleate, cinnarizine "domperidone maleate, cinnarizine " with procedure number 19780300 201301 J&J BE/H/PSUR/0005/003 yearly PSURs 201401 201304 Yes Work Sharing BE/H/PSUR/0020/00X has been merged with the entry "domperidone " 13 standalone 14 vecuronium bromide 19901101 201311 Organon CZ/H/PSUR/0002/003 201402 Yes Work Sharing 15 levobunolol 19890608 01/06/2014 Allergan CZ/H/PSUR/0006/003 30/08/2014 Yes Work Sharing tirofiban No, except if required nationally 20030514 201305 IROKO DE/H/PSUR/0001/002 201308 Work Sharing by a competent 16 authority 17 ezetimibe + simvastatin Inegy 20040402 201403 MSD DE/H/PSUR/0020/002 201406 Yes Work Sharing 18 mefloquine 19850517 30/04/2013 Roche DE/H/PSUR/0022/003 19/02/2014 29/07/2013 Yes Work Sharing moxifloxacin (systemic use) 19990531 201305 Bayer Schering DE/H/PSUR/0023/004 2 yearly PSURs 201308 Yes Work Sharing 19 dienogest + ethinylestradiol No, except if Omitted from the required nationally Valette 19950214 201303 Bayer Schering publication on DE/H/PSUR/0030/002 201306 Work Sharing by a competent 27/03/2013 20 authority gabapentin No, except if Substance omitted in required nationally 19930205 201302 Pfizer DE/H/PSUR/0035/002 201305 Work Sharing publication of March 2013 by a competent 21 authority modafinil No, except if required nationally 19940901 201308 Cephalon DE/H/PSUR/0044/003 yearly PSURs 201311 Work Sharing by a competent 22 authority ciprofloxacin hydrochloride, No, except if dexamethasone acetate (ear Alcon Pharma DE volunteered to act as required nationally 31/05/2012 30/04/2013 DE/H/PSUR/0047/001 29/07/2013 Work Sharing drops, suspension) GmbH P-RMS by a competent 23 authority atorvastatin (paediatric No, except if indication) DE accepts to act as P- required nationally 07/11/1996 31/10/2013 Pfizer DE/H/PSUR/0048/001 yearly PSURs 29/01/2014 Other RMS by a competent 24 authority dorzolamide + timolol No, except if required nationally Cosopt 19980306 201302 MSD DK/H/PSUR/0001/003 201305 Work Sharing by a competent 25 authority 26 oxcarbazepine 19990810 201308 Novartis DK/H/PSUR/0002/003 201311 Yes Work Sharing 27 bicalutamide 19950228 201402 AstraZeneca DK/H/PSUR/0006/003 201405 Yes Work Sharing fluconazole No, except if required nationally 19880303 201403 Pfizer DK/H/PSUR/0008/003 201406 Work Sharing by a competent 28 authority 29 pimecrolimus 20011214 201303 Novartis DK/H/PSUR/0009/006 yearly PSURs 201403 201306 Yes Work Sharing technetium (99mTc) bicisate No, except if required nationally 19831008 201310 LANTHEUS MI DK/H/PSUR/0012/003 201401 Work Sharing by a competent 30 authority 31 misoprostol 19840628 30/06/2014 Pfizer DK/H/PSUR/0014/003 28/09/2014 Yes Work Sharing 32 epirubicin 19820628 30/06/2014 Pfizer DK/H/PSUR/0016/003 28/09/2014 Yes Work Sharing 33 acitretin 19871201 201310 Actavis DK/H/PSUR/0024/003 yearly PSURs 201401 Yes Work Sharing

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? etoposide No, except if required nationally 19760217 201302 BMS DK/H/PSUR/0029/002 201305 Work Sharing by a competent 34 authority 35 gadoteridol 19921029 201302 Bracco DK/H/PSUR/0030/002 201305 Yes Work Sharing budesonide No, except if AstraZeneca / required nationally 19920430 201304 DK/H/PSUR/0041/002 201307 Work Sharing Dr. Falk Pharma by a competent 36 authority 37 ebastine 19960101 201305 Almirall DK/H/PSUR/0043/002 201308 Yes Work Sharing ferumoxsil (siloxane coated No, except if superparamagnetic required nationally 19930122 201305 Guerbet DK/H/PSUR/0044/002 201308 Work Sharing ironoxide) by a competent 38 authority technetium(99mTc) macrosalb No, except if required nationally 19900302 201302 Ge Healthcare DK/H/PSUR/0048/002 201305 Work Sharing by a competent 39 authority ethinylestradiol + Nordette, Stediril, levonorgestrel Follimin, Trinordiol, Nordiol, Ovran 21, Neogestrenol, Stediril-d, Lorette, 19650422 / No, except if Lowette, Alesse, 19760427 / Pfizer / Bayer required nationally 201304 DK/H/PSUR/0054/002 201307 Work Sharing Loette, Gravistat 19650422 / Schering by a competent 125, Microgynon, 19970327 authority Monostep, Minisiston, Triquilar, Miranova, Neogynon 40 sodium iodide [123I] No, except if required nationally 19950131 201303 Ge Healthcare DK/H/PSUR/0056/001 201306 Work Sharing by a competent 41 authority mepivacaine No, except if required nationally 19560401 201303 AstraZeneca DK/H/PSUR/0057/001 201306 Work Sharing by a competent 42 authority mepivacaine + adrenaline No, except if Carbocaine- required nationally 19560401 201303 Astrazeneca DK/H/PSUR/0058/001 201306 Work Sharing Adrenaline by a competent 43 authority ethinylestradiol + gestodene Combination transferred from FR to DK Minesse, 19990614 / No, except if Harmonet, Tri- 19950317 / Pfizer / Bayer Awaiting outcome of the required nationally minulet, Minulet, 201403 DK/H/PSUR/0060/001 201406 Work Sharing 19980127 / Schering on-going EU referral by a competent Mirelle, Meliane, 19860709 procedure to know authority Femovan, Milvane whether the DLP needs to 44 be modified. nortriptyline No, except if required nationally 19630331 201303 Lundbeck EE/H/PSUR/0010/002 201306 Work Sharing by a competent 45 authority cinitapride No, except if required nationally 19930311 201306 Almirall ES/H/PSUR/0001/002 201309 Work Sharing by a competent 46 authority lovastatin No, except if required nationally 19870721 201307 MSD ES/H/PSUR/0002/002 201310 Work Sharing by a competent 47 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? hydroquinidine No, except if required nationally 19940311 201403 Sanofi Aventis ES/H/PSUR/0004/002 201406 Work Sharing by a competent 48 authority clebopride No, except if required nationally 19790222 30/06/2014 Almirall ES/H/PSUR/0005/003 28/09/2014 Work Sharing by a competent 49 authority almotriptan No, except if required nationally 19991223 30/06/2014 Almirall ES/H/PSUR/0008/003 28/09/2014 Work Sharing by a competent 50 authority rupatadine PSUR frequency changed No, except if to 6-month in Feb2012, required nationally 20051212 201306 J. Uriach y Cia ES/H/PSUR/0009/005 6 months 201312 201309 Work Sharing when pediatric oral by a competent 51 solution was authorised. authority paricalcitol No, except if required nationally 19980417 201308 Abbott ES/H/PSUR/0016/003 201311 Work Sharing by a competent 52 authority bemiparin No, except if Laboratorios required nationally 19980416 201304 farmacéuticos ES/H/PSUR/0020/002 201307 Work Sharing by a competent ROVI, S.A. 53 authority gasiloxe No, except if Venter Pharma New active substance required nationally 10/11/2011 26/07/2013 ES/H/PSUR/0022/001 6 months 26/01/2014 04/10/2013 Work Sharing S.L. added with ES as P-RMS by a competent 54 authority azithromycin No, except if required nationally 19910404 201404 Pfizer FI/H/PSUR/0007/003 29/07/2014 Work Sharing by a competent 55 authority meloxicam No, except if Boehringer required nationally 19950508 201307 FR/H/PSUR/0001/002 201310 Work Sharing Ingelheim by a competent 56 authority tixocortol / chlorhexidine As agreed by FR, gluconate, tixocortol pivalate products containing the combinations "chlorhexidine gluconate, No, except if tixocortol pivalate " will required nationally 19761118 201311 Pfizer be assesssed together FR/H/PSUR/0004/002 201402 Work Sharing by a competent with "tixocortol authority standalone ". The combination has therefore been removed 57 from the EURD list. pravastatin No, except if required nationally 19890331 201403 BMS FR/H/PSUR/0007/003 201406 Work Sharing by a competent 58 authority irinotecan No, except if required nationally 19950505 04/05/2014 Pfizer FR/H/PSUR/0009/003 02/08/2014 Work Sharing by a competent 59 authority 60 ropinirole 19960708 201307 GSK FR/H/PSUR/0010/002 201310 Yes Work Sharing pravastatin + acetylsalicylic No, except if acid required nationally Selktine Plus ASA 19890331 201403 BMS FR/H/PSUR/0011/004 201406 Work Sharing by a competent 61 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? buprenorphine Reckitt & 19820330 31/07/2014 FR/H/PSUR/0012/003 29/10/2014 Yes Work Sharing 62 Benckiser ferumoxtran10 No, except if (superparamagnetic required nationally 19940823 31/08/2014 Guerbet FR/H/PSUR/0013/003 29/11/2014 Work Sharing ironoxide) by a competent 63 authority 64 alprazolam 19800312 201303 Pfizer FR/H/PSUR/0036/002 201306 Yes Work Sharing ivermectin No, except if required nationally 20041119 201304 MSD FR/H/PSUR/0037/002 201307 Work Sharing by a competent 65 authority sulproston No, except if required nationally 19801217 201304 Bayer Schering FR/H/PSUR/0038/002 201307 Work Sharing by a competent 66 authority benazepril + No, except if hydrochlorothiazide required nationally Cibadrex 19920519 201305 Novartis FR/H/PSUR/0043/002 201308 Work Sharing by a competent 67 authority pefloxacin No, except if required nationally 19840807 31/08/2014 Sanofi Aventis FR/H/PSUR/0049/003 29/11/2014 Work Sharing by a competent 68 authority captopril + No, except if hyrochlorothiazide BMS / Sanofi required nationally Captea 19800415 201304 FR/H/PSUR/0050/002 201307 Work Sharing Aventis by a competent 69 authority fosfomycin (IV formulation) No, except if required nationally 19830713 201307 Sanofi Aventis FR/H/PSUR/0061/002 201310 Work Sharing by a competent 70 authority macrogol 4000 No, except if required nationally 19950505 201305 Ipsen FR/H/PSUR/0062/002 201308 Work Sharing by a competent 71 authority macrogol 4000 and No, except if combinations required nationally Fortrans 19950505 201305 Ipsen FR/H/PSUR/0063/001 201308 Work Sharing by a competent 72 authority fosfomycin (oral formulation) No, except if required nationally 19860827 201307 Zambon FR/H/PSUR/0064/002 201310 Work Sharing by a competent 73 authority chlorpromazine No, except if required nationally 19520529 31/05/2014 Sanofi Aventis FR/H/PSUR/0065/002 29/08/2014 Work Sharing by a competent 74 authority 75 bromazepam 19730901 31/08/2014 Roche FR/H/PSUR/0066/002 29/11/2014 Yes Work Sharing paracetamol (IV formulation) 201301 BMS FR/H/PSUR/0072/001 yearly PSURs 07/05/2014 201304 Yes Work Sharing 76 hydrotalcite No, except if required nationally 19920301 201303 Bayer Schering HU/H/PSUR/0022/002 201306 Work Sharing by a competent 77 authority 78 aceclofenac 19900319 201403 Almirall HU/H/PSUR/0030/002 201406 Yes Work Sharing danaparoid No, except if required nationally 19921201 201311 Organon IE/H/PSUR/0004/003 201402 Work Sharing by a competent 79 authority simvastatin No, except if required nationally 19880406 05/04/2014 MSD IE/H/PSUR/0009/003 04/07/2014 Work Sharing by a competent 80 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? octreotide No, except if required nationally 19950623 30/06/2014 Novartis IE/H/PSUR/0010/003 28/09/2014 Work Sharing by a competent 81 authority acamprosate No, except if required nationally 19870724 01/07/2014 Merck KGaA IE/H/PSUR/0011/003 29/09/2014 Work Sharing by a competent 82 authority flurbiprofen No, except if required nationally 19761110 201311 Abbott IT/H/PSUR/0001/003 201402 Work Sharing by a competent 83 authority bacillus clausii multi No, except if antibioresistant spores required nationally 19781103 201311 Sanofi Aventis IT/H/PSUR/0002/003 201402 Work Sharing by a competent 84 authority indobufen No, except if required nationally 19840505 04/05/2014 Pfizer IT/H/PSUR/0004/003 02/08/2014 Work Sharing by a competent 85 authority ioxaglic acid No, except if Substance omitted in required nationally 19790800 201302 Guerbet IT/H/PSUR/0020/003 201305 Work Sharing publication of March 2013 by a competent 86 authority nicardipine No, except if required nationally 19810531 201305 Astellas IT/H/PSUR/0021/002 201308 Work Sharing by a competent 87 authority folinic acid / (di)sodium No, except if folinate / calcium folinate required nationally 19820304 31/08/2014 Bracco IT/H/PSUR/0024/002 29/11/2014 Work Sharing by a competent 88 authority chlorprothixene No, except if required nationally 19590331 201303 Lundbeck LV/H/PSUR/0003/002 201306 Work Sharing by a competent 89 authority piribedil No, except if required nationally 19901001 201403 Servier LV/H/PSUR/0004/002 201406 Work Sharing by a competent 90 authority benzylnicotine + camphora + No, except if dimethyl sulphate + required nationally Capsicam 19940101 201303 JSC Grindeks LV/H/PSUR/0008/002 201306 Work Sharing turpentine oil by a competent 91 authority dienogest + estradiol No, except if required nationally Climodien 20001213 201306 Bayer Schering NL/H/PSUR/0001/003 201309 Work Sharing by a competent 92 authority rizatriptan No, except if required nationally 19980211 201306 MSD NL/H/PSUR/0002/002 201309 Work Sharing by a competent 93 authority mirtazapine No, except if required nationally 19940901 201309 Organon NL/H/PSUR/0006/003 201312 Work Sharing by a competent 94 authority amsacrine No, except if required nationally 19820423 01/06/2014 NordMedica NL/H/PSUR/0011/002 30/08/2014 Work Sharing by a competent 95 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? solifenacin No, except if required nationally 20040608 08/06/2014 Astellas NL/H/PSUR/0012/002 06/09/2014 Work Sharing by a competent 96 authority quetiapine No, except if required nationally 19970731 31/07/2014 AstraZeneca NL/H/PSUR/0021/005 29/10/2014 Work Sharing by a competent 97 authority trandolapril No, except if required nationally 19920219 201402 Abbott NL/H/PSUR/0027/002 201405 Work Sharing by a competent 98 authority 99 ribavirin (i.v. application) 20020409 201307 Roche NL/H/PSUR/0036/005 yearly PSURs 201310 Yes Work Sharing drospirenone, No, except if ethinylestradiol required nationally 07/03/2000 06/09/2013 Bayer Schering NL/H/PSUR/0037/003 05/12/2013 Other by a competent 100 authority fenoterol + ipratropium No, except if Boehringer required nationally Berodual 201302 NL/H/PSUR/0046/002 201305 Work Sharing Ingelheim by a competent 101 authority trandolapril + verapamil No, except if Combination omitted in required nationally Tarka 19950316 201303 Abbott NL/H/PSUR/0047/002 201306 Work Sharing publication of March 2013 by a competent 102 authority losartan + Hyzaar, Cozaar No, except if hydrochlorothiazide Plus, Fortzaar required nationally 19950215 201302 MSD NL/H/PSUR/0057/002 201305 Work Sharing by a competent 103 authority sertraline The P-RMSship was No, except if transferred from SK to required nationally 19900301 201403 Pfizer NL, as NL is the NL/H/PSUR/0059/002 201406 Work Sharing by a competent rapporteur for the ® authority 104 innovator product Zoloft cilastatin + imipenem No, except if required nationally Tienam 19840628 27/06/2014 MSD NO/H/PSUR/0003/002 25/09/2014 Work Sharing by a competent 105 authority labetalol No, except if GSK required nationally 19770304 201302 NO/H/PSUR/0011/002 201305 Work Sharing Aspen Pharma by a competent 106 authority nafarelin No, except if required nationally 19900215 201302 Pfizer NO/H/PSUR/0012/002 201305 Work Sharing by a competent 107 authority brotizolam No, except if Boehringer required nationally 19830515 201312 PT/H/PSUR/0001/003 201403 Work Sharing Ingelheim by a competent 108 authority tioconazole No, except if required nationally 19810413 01/04/2014 Pfizer PT/H/PSUR/0003/003 30/06/2014 Work Sharing by a competent 109 authority buflomedil No, except if required nationally 19790523 201405 Amdipharm PT/H/PSUR/0004/003 201408 Work Sharing by a competent 110 authority oxatomide No, except if required nationally 201301 J&J PT/H/PSUR/0005/005 yearly PSURs 201401 201304 Work Sharing by a competent 111 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? desogestrel No, except if required nationally 19980701 201307 Organon SE/H/PSUR/0001/003 201310 Work Sharing by a competent 112 authority 113 finasteride 19980417 201308 MSD SE/H/PSUR/0002/007 yearly PSURs 201311 Yes Work Sharing tolterodine No, except if required nationally 19970905 201309 Pfizer SE/H/PSUR/0003/003 201312 Work Sharing by a competent 114 authority levosimendan No, except if required nationally 20000922 201309 Orion SE/H/PSUR/0004/003 201312 Work Sharing by a competent 115 authority tibolone No, except if required nationally 19871201 201312 Organon SE/H/PSUR/0006/003 201403 Work Sharing by a competent 116 authority formoterol No, except if required nationally 19900629 31/05/2014 AstraZeneca SE/H/PSUR/0009/003 29/08/2014 Work Sharing by a competent 117 authority latanoprost + timolol No, except if Missing from the previous required nationally Xalcom 19960605 04/06/2014 Pfizer SE/H/PSUR/0010/003 02/09/2014 Work Sharing publicaion on 27.03.13 by a competent 118 authority budesonide + formoterol No, except if required nationally Symbicort 20000825 201308 AstraZeneca SE/H/PSUR/0012/004 201311 Work Sharing by a competent 119 authority valsartan No, except if required nationally 19960513 201304 Novartis SE/H/PSUR/0024/004 201307 Work Sharing by a competent 120 authority enalapril No, except if required nationally 20041101 201303 MSD SE/H/PSUR/0037/002 201306 Work Sharing by a competent 121 authority felodipine + ramipril No, except if AstraZeneca / required nationally Unimax, Tazko 19890110 201303 SE/H/PSUR/0038/002 201306 Work Sharing Sanofi Aventis by a competent 122 authority ketoprofen (topical use only) Sanofi Aventis / 19850910 201309 SE/H/PSUR/0049/003 yearly PSURs 201312 Yes Work Sharing Bayer Schering 123 dinoprostone No, except if SE accepts to act as P- required nationally 26/09/1972 30/09/2013 Pfizer SE/H/PSUR/0051/001 29/12/2013 Work Sharing RMS by a competent 124 authority doxylamine SE volunteered to act as 07/04/1948 28/08/2013 Bayer SE/H/PSUR/0052/001 6 months 28/02/2014 06/11/2013 Yes Work Sharing 125 P-RMS. carteolol No, except if Laboratoire required nationally 19840307 201403 SK/H/PSUR/0002/003 201406 Work Sharing Théa by a competent 126 authority 127 lomustine 19760126 201306 BMS SK/H/PSUR/0007/002 201309 Yes Work Sharing sertindole No, except if required nationally 20020711 201307 Lundbeck UK/H/PSUR/0004/003 6-monthly PSURs 201401 201310 Work Sharing by a competent 128 authority piroxicam No, except if required nationally 19790403 01/04/2014 Pfizer UK/H/PSUR/0009/003 30/06/2014 Work Sharing by a competent 129 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? lanreotide No, except if required nationally 19940516 16/05/2014 Ipsen UK/H/PSUR/0010/003 14/08/2014 Work Sharing by a competent 130 authority lercanidipine No, except if required nationally 19960322 31/08/2014 Recordati UK/H/PSUR/0011/002 29/11/2014 Work Sharing by a competent 131 authority etoricoxib No, except if required nationally 20020213 201303 MSD UK/H/PSUR/0032/005 yearly PSURs 201306 Work Sharing by a competent 132 authority artemether + lumefantrin No, except if required nationally Riamet, Coartem 19981014 201310 Novartis UK/H/PSUR/0049/002 201401 Work Sharing by a competent 133 authority mesalazine No, except if required nationally Salofalk 19840220 201302 Dr. Falk Pharma UK/H/PSUR/0052/002 201305 Work Sharing by a competent 134 authority latanoprost (products with Re-start of the PSUR paediatric indication) cycle with 6 monthly No, except if submissions following the required nationally 19960605 201310 Pfizer UK/H/PSUR/0064/006 6-monthly PSURs 201401 Work Sharing extension of the by a competent indication for children authority 135 (Article 29 paediatric). methylphenidate No, except if required nationally 19541006 201310 Novartis UK/H/PSUR/0068/005 Yearly PSURs 201401 Work Sharing by a competent 136 authority lubiprostone No, except if Sucampo UK volunteered to act as required nationally 31/01/2006 31/07/2013 Pharma Europe, UK/H/PSUR/0077/001 6-monthly PSURs 31/01/2014 09/10/2013 Work Sharing P-RMS by a competent Ltd 137 authority acetylsalicylic Acid, bisoprolol No, except if ASA Pharma UK volunteered to act as required nationally 05/11/2010 05/11/2013 UK/H/PSUR/0078/001 6-monthly PSURs 05/05/2014 14/01/2014 Work Sharing PLC P-RMS by a competent 138 authority clevidipine No, except if The Medicines UK volunteered to act as required nationally 23/11/2011 23/05/2013 Company UK UK/H/PSUR/0079/001 6-monthly PSURs 23/11/2013 01/08/2013 Work Sharing P-RMS by a competent Ltd 139 authority lisdexamfetamine No, except if Shire UK volunteered to act as required nationally 01/02/2013 31/07/2013 Pharmaceutical UK/H/PSUR/0080/001 6-monthly PSURs 31/01/2014 09/10/2013 Work Sharing P-RMS by a competent Contracts Ltd. 140 authority acetylsalicylic acid No, except if required nationally 19570105 201302 201305 Other by a competent 141 authority Deletion of the entries acetylsalicylic acid No, except if "Substance + combinations required nationally 201302 combinations " as it 201305 Other by a competent causes confusion for authority 142 stakeholders acetylsalicylic acid, No, except if esomeprazole required nationally 12/08/2011 29/08/2013 27/11/2013 Other by a competent 143 authority aciclovir, hydrocortisone No, except if required nationally 31/07/2009 31/07/2013 29/10/2013 Other by a competent 144 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? dihydrotachysterol No, except if required nationally 19590401 201303 201306 Other by a competent 207 authority diphtheria vaccine (adsorbed) No, except if required nationally 14/11/1979 01/04/2013 30/06/2013 Other by a competent 208 authority dutasteride, tamsulosin No, except if hydrochloride HU kindly volunteered to required nationally 20/11/2001 19/05/2013 HU/H/PSUR/0033/001 17/08/2013 Work Sharing act as P-RMS by a competent 209 authority ebastine, pseudoephedrine No, except if required nationally Not Available* 31/05/2013 29/08/2013 Other by a competent 210 authority ethinylestradiol + lynestrenol No, except if required nationally 19730330 201303 201306 Other by a competent 211 authority F(ab’)2 fragments of equine No, except if antirabies immunoglobulin required nationally 22/05/2000 21/05/2013 19/08/2013 Other by a competent 212 authority felbamate Innovator product withdrawn from FR (last 19940515 201309 Merck & Co. procedure number was 201312 Yes Work Sharing FR/H/PSUR/0002/001). 213 Need for new P-RMS 214 fenofibrate 04/11/1974 31/07/2014 29/10/2014 Yes Other fenoterol No, except if required nationally 201302 201305 Other by a competent 215 authority 216 fenspiride 08/12/1993 08/04/2014 07/07/2014 Yes Other ferumoxides No, except if required nationally Not Available* 30/08/2014 28/11/2014 Other by a competent 217 authority flunitrazepam Innovator product withdrawn from IE (last procedure number was No, except if Roche IE/H/PSUR/0039/001). required nationally 20000101 201310 201401 Work Sharing CHEPLAPHARM Need for new P-RMS by a competent The MAH stated that the authority product is still available in 218 DE, AT, GR and IT. fluorescein (systemic use) No, except if required nationally 30/11/1971 30/04/2014 29/07/2014 Other by a competent 219 authority fluorodopa No, except if required nationally Not Available* 10/03/2014 08/06/2014 Other by a competent 220 authority furosemide, spironolactone No, except if required nationally 11/01/1961 01/01/2014 01/04/2014 Other by a competent 221 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? hydrocortisone / This entry has been hydrocortisone (indicated in renamed adrenal insufficiency except "Hydrocortisone / the modified release tablets Hydrocortisone formulation) (indicated in adrenal No, except if insufficiency except required nationally 05/08/1952 31/08/2014 the modified release 29/11/2014 Other by a competent tablets formulation ” in authority order to avoid confusion with the CAP included in the EURD list and to harmonise the DLP of the 235 products concerned. hydroxycarbamide No, except if required nationally 22/03/1966 21/03/2014 19/06/2014 Other by a competent 236 authority 237 ibuprofen 19/02/1969 18/02/2014 19/05/2014 Yes Other 238 ibuprofen, pseudoephedrine 18/09/1989 18/07/2013 16/10/2013 Yes Other icodextrin No, except if required nationally Not Available* 30/04/2014 29/07/2014 Other by a competent 239 authority ifenprodil No, except if required nationally 19740306 201303 201306 Other by a competent 240 authority indapamide, perindopril No, except if required nationally 30/08/2001 24/10/2013 22/01/2014 Other by a competent 241 authority influenza vaccine (H1N1)ν No, except if (split virion, inactivated) required nationally 15/09/2009 29/11/2013 27/02/2014 Other by a competent 242 authority influenza vaccine (H1N1)ν No, except if (surface antigens, required nationally 04/11/2009 31/05/2013 29/08/2013 Other inactivated, prepared in cell by a competent 243 cultures, adjuvanted) authority influenza vaccine (surface Seasonal influenza antigen, inactivated) vaccines: PSUR frequency of Vaccine covered by the EURD No, except if 8 months from list entry " Seasonal influenza required nationally 23/04/2000 30/04/2013 1/9/2012 to 31/08/2013 09/07/2013 Other vaccines ". Therefore deletion by a competent 30/04/2013 and 4 from the PSUR WS list required authority months from 01/05/13 to 244 31/08/2013 influenza vaccine (surface Seasonal influenza antigen, inactivated, vaccines: PSUR frequency of virosome) Vaccine covered by the EURD No, except if 8 months from list entry " Seasonal influenza required nationally Not Available* 30/04/2013 1/9/2012 to 31/08/2013 09/07/2013 Other vaccines ". Therefore deletion by a competent 30/04/2013 and 4 from the PSUR WS list required authority months from 01/05/13 to 245 31/08/2013

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? influenza vaccine (whole Seasonal influenza virion, inactivated) vaccines: PSUR frequency of Vaccine covered by the EURD No, except if 8 months from list entry " Seasonal influenza required nationally 01/11/1970 30/04/2013 1/9/2012 to 31/08/2013 09/07/2013 Other vaccines ". Therefore deletion by a competent 30/04/2013 and 4 from the PSUR WS list required authority months from 01/05/13 to 246 31/08/2013 influenza vaccine (split virion, PSURs for seasonal inactivated) (non centrally influenza vaccines will be authorised products) assessed separately: at national level for Seasonal influenza National/MRP/DCP vaccines products and by the PSUR frequency of No, except if PRAC for Centrally 8 months from 1st required nationally 08/08/1996 30/04/2013 Novartis 31/08/2013 09/07/2013 Other Authorised Products September 30th by a competent April and 4 months authority This entry notably covers from 1st May to Begrivac, Fluarix alpha- 31st August Rix Influsplit SSW, Fluarix Tetra, Vaxigrip, Afluria, Mutagrip 247 influenza vaccine (split virion, PSURs for seasonal inactivated, prepared in cell influenza vaccines will be Seasonal influenza cultures) assessed separately: at vaccines national level for PSUR frequency of No, except if National/MRP/DCP 8 months from 1st required nationally 20/09/2010 30/04/2013 BAXTER S.P.A products and by the 31/08/2013 09/07/2013 Other September 30th by a competent PRAC for Centrally April and 4 months authority Authorised Products from 1st May to 31st August This entry notably covers 248 Preflucel influenza vaccine (surface antigen, inactivated, PSURs for seasonal influenza vaccines will be virosome) Seasonal influenza assessed separately: at vaccines national level for PSUR frequency of No, except if National/MRP/DCP CRUCELL ITALY 8 months from 1st required nationally 31/10/2001 30/04/2013 products and by the 31/08/2013 09/07/2013 Other S.R.L. September 30th by a competent PRAC for Centrally April and 4 months authority Authorised Products from 1st May to 31st August This entry notably covers ISIFLU and INFLEXAL V 249 influenza vaccine (surface PSURs for seasonal antigen, inactivated, influenza vaccines will be Seasonal influenza adjuvanted) assessed separately: at vaccines national level for PSUR frequency of No, except if National/MRP/DCP 8 months from 1st required nationally 23/04/2000 30/04/2013 Novartis products and by the 31/08/2013 09/07/2013 Other September 30th by a competent PRAC for Centrally April and 4 months authority Authorised Products from 1st May to 31st August This entry notably covers 250 FLUAD

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? influenza vaccine (surface PSURs for seasonal antigen, inactivated) influenza vaccines will be assessed separately: at national level for Seasonal influenza National/MRP/DCP vaccines products and by the PSUR frequency of No, except if Abbott PRAC for Centrally 8 months from 1st required nationally 16/02/1998 30/04/2013 31/08/2013 09/07/2013 Other Biologicals B.V. Authorised Products September 30th by a competent April and 4 months authority This entry notably covers from 1st May to Influvac, Xanaflu, Vaccino 31st August Influenzale Novartis, FLUVIRIN, Vacciflu, Batrevac, AGRIPPAL 251 inosine dimepranol acedoben No, except if required nationally 01/08/1978 01/08/2013 30/10/2013 Other by a competent 252 authority ipratropium No, except if Boehringer HU kindly volunteered to required nationally 14/08/1974 20/11/2013 HU/H/PSUR0034/001 18/02/2014 Work Sharing Ingelheim act as P-RMS by a competent 253 authority ipratropium, salbutamol No, except if HU kindly volunteered to required nationally 22/03/1994 14/01/2014 HU/H/PSUR0035/001 14/04/2014 Work Sharing act as P-RMS by a competent 254 authority isoniazide, rifampicin No, except if required nationally 01/05/1968 01/05/2013 30/07/2013 Other by a competent 255 authority ispaghula husk + mebeverine No, except if required nationally 201302 201305 Other by a competent 256 authority itopride No, except if required nationally 30/06/1995 30/06/2013 28/09/2013 Other by a competent 257 authority lactobacillus acidophilus No, except if required nationally 01/01/1983 30/06/2014 28/09/2014 Other by a competent 258 authority lactobacillus fermentum, No, except if lactobacillus rhamnosus, required nationally Not Available* 30/06/2014 28/09/2014 Other lactobacillus salivarius, by a competent 259 lactobacillus vaginalis authority lanthanum carbonate hydrate No, except if required nationally Not Available* 18/03/2014 16/06/2014 Other by a competent 260 authority 261 lenograstim 11/10/1991 31/10/2013 29/01/2014 Yes Other 262 levodopa Not Available* 31/10/2013 29/01/2014 Yes Other levosalbutamol No, except if Deletion of this entry as required nationally Not Available* 31/01/2014 levosalbutamol has been 01/05/2014 Other by a competent merged with salbutamol 263 authority lithium No, except if required nationally 19670220 201302 201305 Other by a competent 264 authority

PSUR Work Sharing list - July 2013 ABCDEFGHIJKL Are PSURs required for Substances under PSUR Submission of Innovator brand products referred Work Sharing scheme PSURs by name (for fixed DLP (year Allocated PRMS / Note on PSUR to in Articles or Others (contained in Active substance name (INN) EU HBD Firm's Name Comments Next DLP (DLP + 90 combination and month) Procedure number cycle 10(1), 10a, 14 and Nationally Authorised days by products only) 16a of Directive Products including default) 2001/83/EC as MRP/DCP) 2 amended? levosalbutamol / salbutamol No, except if required nationally 31/01/1969 31/01/2014 01/05/2014 Other by a competent 314 authority secnidzole No, except if required nationally 19730605 201303 201306 Other by a competent 315 authority sotalol No, except if required nationally 22/08/1973 21/08/2014 19/11/2014 Other by a competent 316 authority stibogluconate No, except if required nationally 19660330 201303 201306 Other by a competent 317 authority 318 suxamethonium 14/08/1952 13/08/2014 11/11/2014 Yes Other technetium (99mTc) No, except if oxidronate required nationally 19830321 201303 201306 Other by a competent 319 authority technetium (99mTc) No, except if pertechnetate required nationally Not Available* 27/03/2014 25/06/2014 Other by a competent 320 authority testosterone undecylate No, except if injection required nationally 25/11/2003 24/11/2013 22/02/2014 Other by a competent 321 authority thiocolchicoside No, except if required nationally 19560704 201303 201306 Other by a competent 322 authority thioridazine No, except if required nationally 19590201 201302 201305 Other by a competent 323 authority thyrotropine releasing No, except if hormone (synthetic) required nationally 19790501 201302 201305 Other by a competent 324 authority tickborne encephalitis No, except if Vaccine (inactivated) required nationally 29/01/2001 31/01/2014 01/05/2014 Other by a competent 325 authority tinzaparine No, except if required nationally 19910228 201302 201305 Other by a competent 326 authority tosylchloramide No, except if required nationally 201303 201306 Other by a competent 327 authority 328 tramadol 18/04/1973 22/05/2014 20/08/2014 Yes Other treprostinil DLP changed from 01/05/2013 following 21/05/2002 21/05/2013 request from the 19/08/2013 Yes Other innovator company to 329 align DLP with IBD triamcinolone (intraocular No, except if Name of the formulation formulations) required nationally 31/03/2011 31/03/2014 changed from "ophtalmic" yearly PSURs 29/06/2014 Other by a competent to "intraocular" 330 authority

PSUR Work Sharing list - July 2013