List of nationally authorised medicinal products

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1 3 December 2015 EMA/40805/2016 Procedure Management and Committees Support Active substance: human anti-d immunoglobulin Procedure No.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is provided the source is acknowledged.

2 National Rhesonativ SE/H/0541/ Octapharma Pharmazeutika Produktionsgesmbh Csl Behring Gmbh Austria Rhogam BE Belgium BE BE Csl Behring Gmbh Belgium BE Rhesonativ SE/H/0541/ Octapharma (Ip)-Ltd. Bulgaria Rhesonativ HR-H Jana Pharm D.O.O. Croatia Austria Rhesonativ SE/H/0541/ Hi-Med Solutions Cyprus (Cyprus) Ltd Rhesonativ SE/H/0541/001 59/134/06-C Octapharma (Ip)-Ltd. Czech Republic 59/587/07-C Csl Behring Gmbh Czech Republic Rhesonativ SE/H/0541/ Octapharma Ab Denmark Csl Behring Gmbh Denmark Csl Behring Gmbh Denmark Rhesonativ SE/H/0541/ Octapharma (Ip)-Ltd. Estonia Rhesonativ SE/H/0541/ Octapharma Ab Finland Csl Behring Gmbh Finland Rhesonativ SE/H/0541/ Octapharma France France NL Csl Behring Gmbh France NL Csl Behring Gmbh France Rhesonativ PEI.H Octapharma Gmbh Germany PEI.H Csl Behring Gmbh Germany PEI.H / Csl Behring Mepe Greece EMA/40805/2016 Page 2/5

3 National Rhesonativ SE/H/0541/001 OGYI-T-20152/01 OGYI-T-20152/02 OGYI-T-20152/03 Octapharma (Ip)-Ltd. OGYI-T-20431/01 Csl Behring Gmbh Hungary Rhesonativ SE/H/541/01 IS/1/07/052/01 Octapharma Ab Iceland IS/1/03/021/01 Csl Behring Gmbh Iceland IS/1/03/021/02 Csl Behring Gmbh Iceland Rhesonativ SE/H/0541/001 PA 521/11/2 Octapharma-Ltd Ireland PA 0800/006/002 Csl Behring Gmbh Ireland Immunorho Italy Immunorho Italy /M Csl Behring Gmbh Italy /M Rhesonativ SE/H/541/ Octapharma (Ip)-Ltd. Latvia Rhesonativ SE/H/0541/001 LT/1/08/1082/001 LT/1/08/1082/002 LT/1/08/1082/003 Rhesonativ SE/H/0541/ : (1X1ML) : (1X2ML) : (10X2ML) Octapharma (Ip)-Ltd. Octapharma Benelux S.A./N.V. Hungary Lithuania Luxembourg Rhogam Kedrion Spa Luxembourg 1013/ Csl Behring Gmbh Luxembourg 1013/ Rhesonativ SE/H/0541/001 MA754/03001 Octapharma (Ip)-Ltd. Malta Rhesonativ SE/H/0541/001 RVG Octapharma Benelux S.A./N.V. RVG Csl Behring Gmbh RVG Netherlands Netherlands EMA/40805/2016 Page 3/5

4 National Rhesonativ SE/H/541/ (1ML, 2ML) Octapharma A/S Norway Csl Behring Gmbh Norway Csl Behring Gmbh Norway Rhesonativ SE/H/0541/ Octapharma (Ip)-Ltd. Poland Csl Behring Gmbh Poland Rhesonativ SE/H/0541/ Octapharma Produtos Farmaceuticos, Lda. Csl Behring Gmbh Winrho 1500 LQ Cangene Europe Limited Rhesonativ SE/H/541/ /2013/ Octapharma (Ip)-Ltd. Romania Rhogam 4735/2004/01 Romania 4735/2004/ /2004/03 Rhesonativ SE/H/0541/001 59/0078/08-S Octapharma (Ip)-Ltd. Slovakia 59/0397/07-S Csl Behring Gmbh Slovakia Rhesonativ SE/H/0541/ I-994/14 Octapharma (Ip)-Ltd. Slovenia 5363-I-995/ I-996/ I-144/12 Csl Behring Gmbh Slovenia Csl Behring Gmbh Spain Rhesonativ SE/H/0541/ Octapharma Ab Sweden Csl Behring Gmbh Sweden D-Gam PL 08801/0047 Bio Products Laboratory United Kingdom PL 08801/0048 PL 08801/0049 PL 15036/0019 Csl Behring Gmbh United Kingdom EMA/40805/2016 Page 4/5

5 National Rhesonativ SE/H/0541/ /2010 Octapharma Italy S.P.A. Immunorho AA128/00501 Kedrion SPA Malta Italy EMA/40805/2016 Page 5/5

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