List of nationally authorised medicinal products
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1 04 January 2016 EMA/1461/2016 Procedure Management and Committees Support Active substance: paracetamol (IV formulation) 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 authorised provided the source is acknowledged.
2 Algocit 20113/13/ DEMO S.A. Greece Acamol DE-H DC 4750/2012/01-08 Teva Pharmaceuticals S.R.L. Romania Apotel 09/H/0171/001 Uni-Pharma Kleon Tsetis Portugal Apotel 43355/12/ Uni-Pharma Kleon Tsetis Apotel Max / Uni-Pharma Kleon Tsetis Apotel S00546 Uni-Pharma Kleon Tsetis Apotel NL/H/2857/ Uni-Pharma Kleon Tsetis Apotel NL/H/2857/001 RVG Uni-Pharma Kleon Tsetis Apotel Max Uni-Pharma Kleon Tsetis Exopon 70077/14/ Ioulia And Irene Tseti Exopon NL/H/2857/001/DC $ $ $ Uni-Pharma Kleon Tsetis Exopon NL/H/2857/ Uni-Pharma Kleon Tsetis Exopon NL/H/2857/ Uni-Pharma Kleon Tsetis EMA/716269/2015 Page 2/13 Greece Greece Cyprus Denmark Netherlands Cyprus Greece Italy Sweden Germany Helporal Solution for 42623/12/ Medicus S.A. Greece Infusion 10mg/ml Lekadol UP/I /12-01/358 Sandoz D.O.O. Croatia
3 DE-H DC PA 749/145/1 Teva Pharma B.V. Computerweg Ireland 10 B DE/H/3084/001/DC NL B. Melsungen Ag Art 57 France B. DE/H/3084/001 07/0159/12-S B. Melsungen Ag Art 57 Slovakia B. DE/H/3084/ B. Melsungen Ag Art 57 Austria B. DE/H/3084/ B. Melsungen Ag Art 57 Latvia B. DE/H/3084/ B. Melsungen Ag Art 57 Poland B. DE/H/3084/ B. Melsungen Ag Art 57 Sweden B. DE/H/3084/ $ B. Melsungen Ag Art 57 Portugal B. DE/H/3084/ B. Melsungen Ag Art 57 Estonia B. DE/H/3084/ B. Melsungen Ag Art 57 Germany B. DE/H/3084/001 PL 03551/0128 B. Melsungen Ag Art 57 United Kingdom B. DE/H/3084/001 RVG B. Melsungen Ag Art 57 Netherlands B. DE/H/3084/001/DC 07/221/12-C B. Melsungen Ag Czech Republic EMA/1461/2016 Page 3/13
4 B. B. B. B. B. B. B. B. B. DE/H/3084/001/DC B. Melsungen Ag Art 57 Norway DE/H/3084/001/DC B. Melsungen Ag Art 57 Luxembourg DE/H/3084/001/DC B. Melsungen Ag Art 57 Finland DE/H/3084/001/DC 4714/2012/01-02 B. Melsungen Ag Art 57 Romania DE/H/3084/001/DC B. Melsungen Ag Art 57 Denmark DE/H/3084/001/DC 5363-I-1511/12,5363-I-1510/12 B. Medical, S.A. Art 57 Slovenia DE/H/3084/001/DC B. Melsungen Ag Art 57 Spain DE/H/3084/001/DC BE $ BE $ BE B. Melsungen Ag Art 57 Belgium DE/H/3084/001/DC LT/1/12/2954/001 $ LT/1/12/2954/002 $ B. Melsungen Ag Art 57 Lithuania LT/1/12/2954/003 B. DE/H/3084/001/DC PA 0736/035/001 B. Melsungen Ag Art 57 Ireland UP/I /13-01/02 B. Adria D.O.O. Croatia B. Color Color Pharma, Lda. Portugal Combino PT/H/1902/001/DC , , , , Combino Pharm S.L Portugal EMA/1461/2016 Page 4/13
5 DE/H/1902/001/DC Accord Healthcare S.L.U. Spain Combino Pharm Farmoz $ $ $ Farmoz - Sociedade Técnico Portugal Medicinal, S.A. DE/H/2511/ Norge As Norway DE/H/2511/ Ab Finland DE/H/2511/ Ab Sweden DE/H/2511/ Ab Denmark DE/H/2511/001 PA 566/57/1 $ PA 566/57/2 Limited Ireland DE/H/2511/001 PL 08828/0226 Limited United Kingdom DE/H/2511/001 RVG Nederland B.V. Netherlands DE/H/2511/001 $ BE $ BE $ BE $ Nv/Sa Belgium DE/H/2511/001/DC BE G.E.S G.E.S. Genéricos Españoles Spain Laboratorio, S.A. Generis $ Generis Farmacêutica, S.A. Portugal Kabi UP/I /12-01/271 D.O.O. Croatia Kabi DE/H/2511/ / Deutschland Gmbh Luxembourg EMA/1461/2016 Page 5/13
6 Kabi DE/H/2511/001 07/0728/10-S S.R.O Slovakia Kabi DE/H/2511/001 07/967/10-C S.R.O Czech Republic Kabi DE/H/2511/ Austria Gmbh Austria Kabi DE/H/2511/ Polska Sp. Z O.O. Latvia Kabi DE/H/2511/ Polska Sp. Z O.O. Poland Kabi DE/H/2511/ /13/ Hellas A.E. Greece Kabi DE/H/2511/ $ $ $ Pharma Portugal Portugal $ $ $ $ $ $ $ $ $ $ Lda. Kabi DE/H/2511/ I-1521/13 $ 5363-I-1522/13 $ Deutschland Slovenia I-1720/11 $ 5363-I-1721/11 $ 5363-I- 1722/11 $ 5363-I-1723/11 $ 5363-I- 1724/11 $ 5363-I-1725/11 $ 5363-I- 1726/11 $ 5363-I-1727/11 Gmbh Kabi DE/H/2511/ Polska Sp. Z O.O. Estonia Kabi DE/H/2511/ España S.A.U. Spain Kabi DE/H/2511/ Deutschland Germany Gmbh Kabi DE/H/2511/001 $ DE/H/2511/001/DC LT/1/10/2268/001 $ LT/1/10/2268/002 $ LT/1/10/2268/003 $ LT/1/10/2268/004 $ LT/1/10/2268/005 $ LT/1/10/2268/006 $ LT/1/10/2268/007 $ LT/1/10/2268/008 $ LT/1/10/2268/009 $ LT/1/10/2268/010 $ LT/1/10/2268/011 $ LT/1/10/2268/012 $ LT/1/10/2268/013 $ LT/1/10/2268/014 Polska Sp. Z O.O. Lithuania EMA/1461/2016 Page 6/13
7 Kabi DE/H/2511/001 $ DE/H/2511/001/DC OGYI-T-21800/01 $ OGYI-T-21800/02 $ OGYI-T-21800/03 $ OGYI-T-21800/04 $ OGYI-T-21800/05 $ OGYI-T-21800/06 $ OGYI-T-21800/07 $ OGYI-T-21800/08 $ OGYI-T-21800/09 $ OGYI-T-21800/10 $ OGYI-T-21800/11 $ OGYI-T-21800/12 $ OGYI-T-21800/13 $ OGYI-T-21800/14 Kabi DE/H/2511/001/DC 3225/2011/01 $ 3225/2011/02 $ 3225/2011/03 $ 3225/2011/04 $ 3225/2011/05 $ 3225/2011/06 $ 3225/2011/07 $ 3225/2011/08 $ 3225/2011/09 $ 3225/2011/10 $ 3225/2011/11 $ 3225/2011/12 $ 3225/2011/13 $ 3225/2011/14 Hungary Kft. Romania S.R.L. Hungary Romania Kern Pharma Maco Pharma Maco Pharma Macopharma Macopharma Macopharma PT/H/1003/001/DC Kern Pharma, S.L. Spain FR/H/0472/001 PA 931/10/01 Maco Pharma (Uk) Ltd Ireland FR/H/0472/001 PL12580/0021 Maco Pharma (Uk) Ltd United Kingdom FR/H/0472/001 ENR Maco Pharma International Germany Gmbh FR/H/0472/001 BE $ BE $ BE $ BE Maco Pharma Benelux Belgium $ BE FR/H/0472/001 BE $ BE $ BE $ BE Maco Pharma Benelux Belgium $ BE EMA/1461/2016 Page 7/13
8 Macopharma Macopharma Morningside Healthcare Ltd Noridem Noridem Noridem Enterprises Ltd. Normon NL Maco Pharma France FR/H/0472/001/MR 1211/ Maco Pharma Luxembourg PL 20117/0204 Morningside Healthcare Ltd United Kingdom PT/H/1003/001/DC $ $ $ Noridem Enterprises Ltd Portugal $ $ $ $ PT/H/1003/001/DC Noridem Enterprises Ltd Germany PT/H/1003/001/DC PL 24598/0028 Noridem Enterprises Ltd United Kingdom Laboratorios Normon, S.A. Spain FR/H/0355/ Panmedica Norway FR/H/0355/ Panmedica Latvia FR/H/0355/ Panmedica Poland FR/H/0355/ Panmedica Sweden FR/H/0355/ Panmedica Finland EMA/1461/2016 Page 8/13
9 FR/H/0355/ /2011/01 $ 3337/2011/02 $ 3337/2011/03 $ 3337/2011/04 $ 3337/2011/05 $ 3337/2011/06 Panmedica Romania FR/H/0355/001 NL Panmedica France FR/H/0355/ $ $ Panmedica France $ $ $ $ $ $ $ $ $ $ $ $ FR/H/0355/ Panmedica Denmark FR/H/0355/001 LT/1/10/2343/001 $ LT/1/10/2343/002 $ Panmedica Lithuania LT/1/10/2343/003 $ LT/1/10/2343/004 $ LT/1/10/2343/005 $ LT/1/10/2343/006 $ LT/1/10/2343/007 $ LT/1/10/2343/008 $ LT/1/10/2343/009 $ LT/1/10/2343/010 $ LT/1/10/2343/011 $ LT/1/10/2343/012 EMA/1461/2016 Page 9/13
10 FR/H/0355/001 OGYI-T-21749/01 $ OGYI-T-21749/02 $ Panmedica Hungary OGYI-T-21749/03 $ OGYI-T-21749/04 $ OGYI-T-21749/05 $ OGYI-T-21749/06 $ OGYI-T-21749/07 $ OGYI-T-21749/08 $ OGYI-T-21749/09 $ OGYI-T-21749/10 $ OGYI-T-21749/11 $ OGYI-T-21749/12 $ OGYI-T-21749/13 $ OGYI-T-21749/14 $ OGYI-T-21749/15 PT/H/0554/ $ $ $ Pentafarma - Sociedade Tecnico- Portugal Pentafarma Medicinal S.A. UP/I /12-01/168 Pharmaswiss česká Republika Croatia Pharmaswiss S.R.O. DE/H/3247/ Zaklady Farmaceutyczne Poland Polpharma "polpharma" Spolka Akcyjna FR/H/0355/ Panmedica Germany Rotexmedica Sandoz DE/H/3248/001 BE Sandoz N.V. Belgium Sandoz DE/H/3248/001 PL 04416/1388 Sandoz Ltd United Kingdom Ltd PT/H/554/001/DC , , , Tecnimede España Ind. Fca., Spain Tecnigen S.A. Teva DE-H DC Teva Denmark A/S Denmark Teva DE-H DC 51688/ Teva Pharma B.V. Computerweg Greece 10 Teva DE-H DC Teva Pharma Belgium N.V. Luxembourg Teva DE-H DC BE $ BE Teva Pharma Belgium N.V. Belgium EMA/1461/2016 Page 10/13
11 Teva DE-H DC Teva Pharmaceuticals Bulgaria Bulgaria 10mg/Ml Eood Teva, DE-H DC RVG Teva Nederland B.V. Netherlands Uni- NL/H/2857/ $ $ $ Uni-Pharma Kleon Tsetis Portugal Pharma Uni- NL/H/2857/001 PL 20989/0010 Uni-Pharma Kleon Tsetis United Kingdom Pharma - DE-H DC Ratiopharm Gmbh Germany Ratiopharm o Galenica Senese DE/H/2052/1/DC $ $ $ $ Industria Farmaceutica Galenica Senese S.R.L.. Italy o S.A.L.F. National $ $ $ $ Salf Spa Laboratorio Farmacologico Italy o $ $ $ Hospira Italy Hospira 10 mg/ml soluzione per infusione $ o B. DE/H/3084/001 $ $ $ B. Melsungen Ag Art 57 Italy DE/H/3084/001/DC o Kabi DE/H/2511/ $ $ $ $ $ $ $ $ $ $ $ $ $ Italia S.R.L. Italy EMA/1461/2016 Page 11/13
12 Parafusiv Pharma Bavaria Internacional Portugal Portugal Unip. Lda Parafusiv Pharma Bavaria Internacional Portugal Portugal Unip. Lda Perfalgan FR/H/0197/ $ Bristol-Myers Squibb S.R.L. Italy Perfalgan FR/H/0197/ Bristol-Myers Squibb S.R.L. Italy Perfalgan FR/H/0197/001 07/306/03-C Bristol-Myers Squibb Spol. S Czech Republic R.O. Perfalgan FR/H/0197/ Bristol-Myers Squibb Gesmbh Austria Perfalgan FR/H/0197/ Bristol-Myers Squibb Gesmbh Denmark Perfalgan FR/H/0197/ Bristol-Myers Squibb AB Finland Perfalgan FR/H/0197/ Bristol-Myers Squibb Latvia Gyogyszerkereskedelmi Kft. Perfalgan FR/H/0197/ Bristol-Myers Squibb France Perfalgan FR/H/0197/ Bristol-Myers Squibb Polska Sp. z Poland o.o. Perfalgan FR/H/0197/ Bristol-Myers Squibb France Perfalgan FR/H/0197/ $ $ $ Bristol-Myers Squibb Portugal $ Farmacêutica Portuguesa, Sa Perfalgan FR/H/0197/ Bristol-Myers Squibb Estonia Gyogyszerkereskedelmi Kft. Perfalgan FR/H/0197/ Bristol-Myers Squibb Gmbh & Co. Germany Kgaa Perfalgan FR/H/0197/ Bristol-Myers Squibb Spain Perfalgan FR/H/0197/001 LT/1/05/0219/001 $ LT/1/05/0219/002 Bristol-Myers Squibb Gyogyszerkereskedelmi Kft. Lithuania EMA/1461/2016 Page 12/13
13 Perfalgan FR/H/0197/001 PA 2/69/1 Bristol-Myers Squibb Ireland Pharmaceuticals Limited Perfalgan FR/H/0197/001 PL 11184/0094 Bristol-Myers Squibb United Kingdom Pharmaceuticals Limited Perfalgan FR/H/197/01 IS/1/01/049/01 Bristol-Myers Squibb Ab Iceland Supofen Laboratórios Basi Indústria Portugal Farmacêutica, S.A. Tachipirina National $ $ $ Aziende Chimiche Riunite Italy Angelini Francesco - A.C.R.A.F. S.P.A. парацетамол б. DE/H/3084/ B. Melsungen Ag Art 57 Bulgaria браун парацетамол Biopharm Engineering Bulgaria биофарм парацетамол каби DE/H/2511/ Bulgaria Eood Bulgaria FR/H/0355/ Panmedica Bulgaria Renaudin Laboratoire Renaudin France EMA/1461/2016 Page 13/13
List of nationally authorised medicinal products
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List of nationally authorised medicinal products
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