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