10 September 2015 EMA/677092/2015 Procedure Management and Committees Support Active substance: glatiramer Procedure no.: PSUSA/00001529/201411 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact An agency of the European Union European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.
MRP/DCP Copaxone 363.840-1 Teva Santé FR Copaxone UP-I-530-09- Pliva Hrvatska D.O.O.; Prilaz Baruna Filipovica HR 12-02-139 25, 10000 Zagreb, Croatia Copaxone 20 Mg/Ml UK-H-0453-002 52069.00.01 Teva Pharma Gmbh DE Copaxone 20 Mg/Ml UK-H-0453-002 / -004 035418045 IT Copaxone 20 Mg/Ml UK-H-0453-002 / -004 1-25380 Teva Pharma Gmbh AT Copaxone 20 Mg/Ml UK-H-0453-002 / -004 59/0463/06-S Teva Pharmaceuticals Cr, S.R.O. SK Copaxone 20 Mg/Ml UK-H-0453-002 / -004 59/481/06-C Teva Pharmaceuticals Cr, S.R.O. CZ Copaxone 20 Mg/Ml UK-H-0453-002 / -004 OGYI-T- 9993/01 Copaxone 40mg UK/H/0453/002-004 n/a Teva Pharma Gmbh AT Copaxone UK/H/0453/002-004 BE260881 BE Copaxone UK/H/0453/002-004 BE467902 BE Copaxone UK/H/0453/002-004 n/a Pliva Hrvatska D.O.O.; Prilaz Baruna Filipovica HR 25, 10000 Zagreb, Croatia Copaxone UK/H/0453/002-004 20187 CY Copaxone UK/H/0453/002-004 n/a CY Copaxone UK/H/0453/002-004 PL/10921/0026 UK EMA/677092/2015 Page 2/7
MRP/DCP Copaxone UK/H/0453/002-004 PL 10921/0023 UK Copaxone UP-I-530-09-12-02-139 UP-I-530-09- Pliva Hrvatska D.O.O.; Prilaz Baruna Filipovica HR 12-02-139 25, 10000 Zagreb, Croatia Copaxone n/a 20040256 BG Copaxone n/a 363.840-1 Teva Santé FR Copaxone UK/H/0453/002-004 n/a Copaxone UK/H/0453/002-004 5363-I-1251/13 Teva Pharmaceuticals ltd; Ridings Point, Copaxone UK/H/0453/002-004 n/a Teva Pharmaceuticals ltd; Ridings Point, Copaxone UK/H/0453/002-004 65983 Teva Pharmaceuticals ltd; Ridings Point, Copaxone UK/H/0453/002-004 20043 Copaxone UK/H/0453/002-004 49557 Copaxone UK/H/0453/002-004 03-2205 Copaxone UK/H/0453/002-004 n/a Copaxone UK/H/0453/002-004 12562 SK SL ES ES ES SE NO PL PL EMA/677092/2015 Page 3/7
MRP/DCP Copaxone UK/H/0453/002-004 4937686 Copaxone UK/H/0453/002-004 5633136 Copaxone UK/H/0453/002-004 7380/2015/01-04 copaxone UK/H/0453/002-004 2008069847 Copaxone UK/H/0453/002-004 n/a Copaxone UK/H/0453/002-004 MA/504/00102 Copaxone UK/H/0453/002-004 MA/504/00104 Copaxone UK/H/0453/002-004 RVG 30086 Copaxone UK/H/0453/002-004 RVG 113849 Copaxone UK/H/0453/002-004 13-9600 Copaxone UK/H/0453/002-004 15-0026 Copaxone UK/H/0453/002-004 /1/05/0240/0 06-008 PT PT RO LU LU MT MT NL NL NO LV EMA/677092/2015 Page 4/7
MRP/DCP COPAXONE UK/H/0453/002-004 /1/05/0240/0 04 COPAXONE UK/H/0453/002-004 /1/05/0240/0 03 COPAXONE UK/H/0453/002-004 /1/05/0240/0 05 COPAXONE UK/H/0453/002-004 /1/05/0240/0 02 Copaxone UK/H/0453/002-004 PA 1014/001/004 Copaxone UK/H/0453/002-004 035418058 IT Copaxone UK/H/0453/002-004 035418033 IT Copaxone UK/H/0453/002-004 035418021 IT Copaxone UK/H/0453/002-004 n/a IT Copaxone UK/H/0453/002-004 035418045 IT Copaxone UK/H/0453/002-004 06-0274 LV 993/05 9993/02 IE EMA/677092/2015 Page 5/7
MRP/DCP 9903/04 9903/01-03 Copaxone UK/H/0453/002-004 IS/1/04/002/01 IS Copaxone UK/H/0453/002-004 IS/1/14/096/01 IS Copaxone UK/H/0453/002-004 PA IE 1014/001/002 COPAXONE UK/H/0453/002-004 n/a FI Acetate de glatiramere UK/H/0453/002-004 n/a Teva Santé FR Teva Copaxone UK/H/0453/002-004 90395.00.00 Teva Pharma Gmbh DE Copaxone UK/H/0453/002-004 58960.16.09.20 08 Copaxone UK/H/0453/002-004 n/a GR 9993/03 Copaxone UK/H/0453/002-004 59/043/15-C Teva Pharmaceuticals Cr, S.R.O. CZ Copaxone UK/H/0453/002-004 52806 Copaxone UK/H/0453/002-004 35719 Copaxone UK/H/0453/002-004 527006 GR DK DK EE EMA/677092/2015 Page 6/7
MRP/DCP Copaxone UK/H/0453/002-004 863414 COPAXONE UK/H/0453/002-004 18786 EE FI EMA/677092/2015 Page 7/7