List of nationally authorised medicinal products
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- Bathsheba Ford
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1 23 September 2015 EMA/729829/2015 Procedure Management and Committees Support Active substance: furosemide 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 provided the source is acknowledged.
2 Diretif UK/H/1241/01/DC Claris Lifesciences (Uk) Limited IT Diretif UK/H/1241/01/DC Claris Lifesciences (Uk) Limited IT Diural Actavis Group Hf. DK Diural Actavis Group Hf. DK Diural Actavis Group Hf. DK Diural Actavis Group Hf. DK Diural Actavis Group Hf. DK Diural Actavis Group Hf. NO Diural Actavis Group Hf. NO Diural Actavis Group Hf. NO Diural Actavis Group Hf. NO Diurapid Mibe Gmbh Arzneimittel Edemid NOT APPLICABLE UP/I /06-02/207 Sandoz D.O.O. HR Edemid NOT APPLICABLE UP/I /12-01/386 Sandoz D.O.O. HR Edemid NP/H/0337/001 H/92/00524/001 Lek Pharmaceuticals D.D. Ljubljana SI Edemid NP/H/0337/002 H/92/00524/002 Lek Pharmaceuticals D.D. Ljubljana SI Edemid NP/H/0337/003 H/92/00524/003 Lek Pharmaceuticals D.D. Ljubljana SI Edemid NP/H/0337/004 H/92/00524/004 Lek Pharmaceuticals D.D. Ljubljana SI EMA/729829/2015 Page 2/26
3 Fruside PA0281/087/001 Pinewood Laboratories Limited IE Frusol PL 00427/0109 Rosemont Pharmaceuticals Limited GB Frusol PL 00427/0110 Rosemont Pharmaceuticals Limited GB Frusol PL 00427/0111 Rosemont Pharmaceuticals Limited GB Fudesix S00982/ Montechem Pharma Ltd CY Fudesix 28224/ Help S.A. GR Fudesix 28225/ Help S.A. GR Fudesix 28226/ Help S.A. GR Furanthril Actavis Ead BG Furanthril Medphano Arzneimittel Gmbh Furesis 2675 Orion Oyj FI Furesis 4351 Orion Oyj FI Furesis 7115 Orion Oyj FI Furesis 8681 Orion Oyj FI Furesis Special 6908 Orion Oyj FI Furix Takeda Pharma A/S DK Furix Takeda Pharma A/S DK Furix Takeda Pharma A/S DK EMA/729829/2015 Page 3/26
4 Furix 9898 Takeda Pharma A/S DK Furix 9899 Takeda Pharma A/S DK Furix IS/1/03/005/01 Takeda Pharma A/S IS Furix IS/1/03/005/02 Takeda Pharma A/S IS Furix IS/1/03/006/01 Takeda Pharma A/S IS Furix 6816 Takeda Nycomed As NO Furix 6817 Takeda Nycomed As NO Furix 6818 Takeda Nycomed As NO Furix 7324 Takeda Nycomed As NO Furix Takeda Pharma Ab SE Furix 9548 Takeda Pharma Ab SE Furix 9550 Takeda Pharma Ab SE Furix Retard Takeda Pharma A/S DK Furix Retard Takeda Pharma A/S DK Furix Retard 7909 Takeda Nycomed As NO Furix Retard 7910 Takeda Nycomed As NO Furix Retard Takeda Pharma Ab SE Furix Retard Takeda Pharma Ab SE EMA/729829/2015 Page 4/26
5 Furix Retard 9549 Takeda Pharma Ab SE Furobeta Betapharm Arzneimittel Gmbh Furobeta Betapharm Arzneimittel Gmbh Furobeta Betapharm Arzneimittel Gmbh Furo-Ct Abz-Pharma Gmbh, Graf-Arco- Str. 3 Furo-Ct Abz-Pharma Gmbh, Graf-Arco- Str. 3 Furo-Ct Abz-Pharma Gmbh, Graf-Arco- Str. 3 Furohexal Hexal Pharma Gmbh AT Furohexal Hexal Pharma Gmbh AT Furohexal Hexal Pharma Gmbh AT Furon Ratiopharm Arzneimittel Vertriebs-Gmbh AT Furon Ratiopharm Arzneimittel Vertriebs-Gmbh AT Furon Ratiopharm Arzneimittel Vertriebs-Gmbh AT Furon Ratiopharm Arzneimittel Vertriebs-Gmbh AT Furon Ratiopharm Arzneimittel Vertriebs-Gmbh AT Furon 50/233/92-C Ratiopharm Gmbh CZ Furon OGYI-T-5554/01 Teva Gyógyszergyár Zrt HU Furon OGYI-T-5554/02 Teva Gyógyszergyár Zrt HU EMA/729829/2015 Page 5/26
6 Furon OGYI-T-5554/03 Teva Gyógyszergyár Zrt HU Furon OGYI-T-5554/04 Teva Gyógyszergyár Zrt HU Furon OGYI-T-5554/05 Teva Gyógyszergyár Zrt HU Furon 50/0233/92-C/S Ratiopharm Gmbh SK Furo-Puren Actavis Deutschland Gmbh & Co. Kg Furo-Puren Actavis Deutschland Gmbh & Co. Kg Furorese 1325/97 50/047/99-C Hexal Ag CZ Furorese 1326/97 50/048/99-C Hexal Ag CZ Furorese 1327/97 50/049/99-C Hexal Ag CZ Furorese 1328/97 50/050/99-C Hexal Ag CZ Furorese 1329/97 50/119/99-C Hexal Ag CZ Furorese Hexal Ag Furorese Hexal Ag Furorese Hexal Ag Furorese Hexal Ag Furorese Hexal Ag Furorese Hexal Ag Furorese Hexal Ag EMA/729829/2015 Page 6/26
7 Furorese Hexal Ag Furorese Hexal Ag Furorese Hexal Ag Furorese Hexal Ag Furorese Hexal Ag LU Furorese / Hexal Ag LU Furorese 0715/02/01/8097 Hexal Ag LU Furorese 240/1997/1 50/0147/02-S Hexal Ag SK Furorese 240/1997/3 50/0149/02-S Hexal Ag SK Furorese Comp Hexal AG Furorese Comp Hexal AG Abz-Pharma Gmbh, Graf-Arco- Furosemid Str. 3 Furosemid OGYI-T-3371/01 Sanofi-Aventis Private Co Ltd HU Furosemid OGYI-T-3371/02 Sanofi-Aventis Private Co Ltd HU Furosemid OGYI-T-3371/03 Sanofi-Aventis Private Co Ltd HU Furosemid OGYI-T-3371/04 Sanofi-Aventis Private Co Ltd HU Furosemid OGYI-T-3371/05 Sanofi-Aventis Private Co Ltd HU Furosemid 1 A Pharma A Pharma Gmbh EMA/729829/2015 Page 7/26
8 Furosemid 1 A Pharma A Pharma Gmbh Furosemid 1 A Pharma A Pharma Gmbh Furosemid 1 A Pharma A Pharma Gmbh Furosemid 1a Pharma a Pharma Gmbh AT Furosemid Acis Acis Arzneimittel Gmbh Furosemid Acis Acis Arzneimittel Gmbh Furosemid Aliud Pharma Aliud Pharma Gmbh Furosemid Aliud Pharma Aliud Pharma Gmbh Furosemid Arena 80/2007/01-02 Arena Group S.A RO Furosemid Biotika 50/804/92-S/C Bb Pharma A.S. CZ Furosemid Biotika 50/0804/92-S Bb Pharma A.S. SK Furosemid Claris UK/H/1241/01/DC Claris Lifesciences (Uk) Limited DK Furosemid Copyfarm UK/H/0754/ Copyfarm A/S DK Furosemid Copyfarm UK/H/0754/ Copyfarm A/S DK Furosemid Copyfarm UK/H/0754/ Copyfarm A/S SE Furosemid Copyfarm UK/H/0754/ Copyfarm A/S SE Furosemid Dura Mylan Dura Gmbh Furosemid Forte Biotika 50/766/92-S/C Bb Pharma A.S. CZ EMA/729829/2015 Page 8/26
9 Furosemid Forte Biotika 50/0766/92-S Bb Pharma A.S. SK Genericon Pharma Gesellschaft Furosemid Genericon M.B.H. AT Furosemid Hexal /H/0517/ Hexal Ag Furosemid Hexal /H/0517/ Hexal A/S DK Furosemid Hexal /H/0517/ Hexal A/S SE Furosemid Kabi /H/0141/001 50/294/07-C Fresenius Kabi S.R.O Czech Republic CZ Furosemid Kabi /H/0141/001 50/0249/07-S Fresenius Kabi S.R.O Czech Republic SK Furosemid Lph 6906/2006/01-02 Labormed Pharma S.A. RO Furosemid Mcc 81/2007/01 Magistra C&c RO Furosemid Nycomed Takeda Pharma As EE Furosemid Orion 6227 Orion Corporation NO Furosemid Orion 6683 Orion Corporation NO Furosemid Orion 6684 Orion Corporation NO Furosemid Polpharma LT/1/94/0890/001 Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna LT Furosemid Polpharma LT/1/94/0934/001 Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna LT Furosemid Ratiopharm Ratiopharm Gmbh Furosemid Ratiopharm 0687/03/12/7946 Ratiopharm Gmbh LU Furosemid Ratiopharm 0687/03/12/7947 Ratiopharm Gmbh LU EMA/729829/2015 Page 9/26
10 Furosemid Ratiopharm 0687/03/12/7948 Ratiopharm Gmbh LU Furosemid Recip 9747 Recip Ab SE Furosemid Recip 9748 Recip Ab SE Furosemid Recip 9749 Recip Ab SE Furosemid Recip 9750 Recip Ab SE Furosemid Sandoz Hexal Ag Furosemid Sandoz Hexal Ag Furosemid Slavia 79/2007/01-02 Slavia Pharm Srl RO Furosemid Slovakofarma 50/052/73-S/C Zentiva A.S. CZ Furosemid Slovakofarma 50/0052/73-S Zentiva, A.S. SK Furosemid Slovakofarma 50/0407/69-S Zentiva, A.S. SK Furosemid Stadapharm Stadapharm Gmbh Furosemid Stadapharm Stadapharm Gmbh Furosemid Stadapharm Stadapharm Gmbh Furosemid Zentiva 3515/2011/01 S.C. Zentiva S.A. RO Furosemid Zentiva 69/2007/01 S.C. Zentiva S.A. RO Furosemid Zentiva 3515/2011/02 S.C. Zentiva S.A. RO Furosemida Apotex 40 Mg Apotex Europe Bv ES EMA/729829/2015 Page 10/26
11 Furosemida Basi Furosemida Basi Furosemida Basi Laboratórios Basi Indústria Farmacêutica, S.A. Laboratórios Basi Indústria Farmacêutica, S.A. Laboratórios Basi Indústria Farmacêutica, S.A. Furosemida Bexal 04/ Bexal Farmacéutica S.A. ES Furosemida Cinfa Laboratorios Cinfa, S.A. ES Furosemida Cinfa Cinfa Portugal, Lda. Furosemida Cinfa Cinfa Portugal, Lda. Furosemida Cinfa Cinfa Portugal, Lda. Furosemida Cinfa Cinfa Portugal, Lda. Furosemida Cinfa Cinfa Portugal, Lda. Furosemida Fresenius Kabi /H/0141/ Fresenius Kabi España S.A.U. ES Furosemida Fresenius Kabi /H/0141/ Fresenius Kabi Pharma Portugal Lda. Furosemida Fresenius Kabi /H/0141/ Fresenius Kabi Pharma Portugal Lda. Furosemida Fresenius Kabi /H/0141/ Fresenius Kabi Pharma Portugal Lda. Furosemida Inibsa Inibsa Hospital S.L.U. ES Furosemida Kern Pharma Kern Pharma, S.L. ES Furosemida Labesfal Labesfal Laboratorios Almiro, S.A. Furosemida Labesfal Labesfal Laboratorios Almiro, S.A. EMA/729829/2015 Page 11/26
12 Furosemida Labesfal Labesfal Laboratorios Almiro, S.A. Furosemida Mylan Mylan Pharmaceuticals S.L. ES Furosemida Pharmakern Pharmakern Portugal Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Furosemida Pharmakern Pharmakern Portugal Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Furosemida Pharmakern Pharmakern Portugal Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Furosemida Pharmakern Pharmakern Portugal Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Furosemida Pharmakern Pharmakern Portugal Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Furosemida Ratiopharm Ratiopharm Lda Furosemida Ratiopharm Ratiopharm Lda Furosemida Ratiopharm Ratiopharm Lda Furosemida Ratiopharm Ratiopharm Lda Furosemida Reig Jofre Laboratorio Ramon Sala, S.L ES Furosemida Reig Jofré Laboratorio Ramon Sala, S.L ES Furosemida Sala Laboratorio Ramon Sala, S.L ES Furosemida Sala Laboratorio Ramon Sala, S.L ES Furosemida Sandoz 04/ Sandoz Farmacéutica, S.A. ES EMA/729829/2015 Page 12/26
13 Furosemida Sandoz /H/0517/ Sandoz Farmaceutica LDA. Furosemida Sandoz /H/0517/ Sandoz Farmaceutica LDA. Furosemida Zentiva Sanofi - Produtos Farmaceuticos Lda Furosemida Zentiva Sanofi - Produtos Farmaceuticos Lda Furosemida Zentiva Sanofi - Produtos Farmaceuticos Lda Furosemide PL 00289/0185 Teva Uk Limited Brampton Road, Hampden Park GB Furosemide PL 00289/0417 Teva Uk Limited Brampton Road, Hampden Park GB Furosemide PL 00289/0818 Teva Uk Limited Brampton Road, Hampden Park GB Furosemide PL 16201/0013 Mercury Pharma (Generics) Ltd. GB Furosemide PL 16201/0014 Mercury Pharma (Generics) Ltd. GB Teva Uk Limited Brampton Road, Furosemide EE-H DC PL 00289/1420 Hampden Park GB Furosemide UK/H/1241/01/DC PL 20568/0010 Claris Lifesciences (Uk) Limited GB Furosemide PL 4096/0043 Brill Pharma Limited GB Furosemide PL 4096/0044 Brill Pharma Limited GB Furosemide PA 73/59/4 Mercury Pharmaceuticals (Ireland) Ltd. IE Furosemide PA 73/59/5 Mercury Pharmaceuticals (Ireland) Ltd. IE Furosemide PA 73/59/6 Mercury Pharmaceuticals (Ireland) Ltd. IE Furosemide UK/H/1241/01/DC PA 1389/005/001 Claris Lifesciences (Uk) Limited IE EMA/729829/2015 Page 13/26
14 Furosemide MA 079/00602 Mercury Pharma International Ltd MT Furosemide MA079/00601 Mercury Pharma International Ltd MT Furosemide MA079/00603 Mercury Pharma International Ltd MT Furosemide PL274/00401A Goldshield Pharmaceuticals Ltd. MT Bristol Laboratories Ltd Furosemide AA737/01301 (Berkhamsted) MT Furosemide 20 Mg 04556/0042 Pharmvit Limited GB Furosemide 20 Pch RVG Pharmachemie B.V. NL Furosemide 40 Pch RVG Pharmachemie B.V. NL Furosemide 500 Mg Teva EE-H DC RVG Teva Nederland B.V. NL Furosemide 50mg/5ml Solution For Injection PL 2848/0103 Mercury Pharma International Ltd GB Furosemide Abz Abz-Pharma Gmbh, Graf-Arco- Str. 3 Furosemide Abz Abz-Pharma Gmbh, Graf-Arco- Str. 3 Furosemide Accord IE/H/186/001/MR PL 20075/0339 Accord Healthcare Limited GB Furosemide Accord IE/H/186/001/MR PA 1390/049/001 Accord Healthcare Limited IE Furosemide Accord IE/H/186/001/MR PA 1390/049/002 Accord Healthcare Limited IE Furosemide Actavis RVG Actavis B.V. NL Furosemide Actavis Uk Ltd. 0142/ /0090 Actavis Uk Ltd. GB Furosemide Actavis Uk Ltd. 0142/ /0091 Actavis Uk Ltd. GB EMA/729829/2015 Page 14/26
15 Furosemide Actavis Uk Ltd. 0142/ /0371 Actavis Uk Ltd. GB Furosemide Angenerico Angenerico Spa IT Furosemide Apotex 40 Mg RVG Apotex Europe Bv NL Furosemide Arrow NL NL Arrow Generiques FR Furosemide Arrow NL NL Arrow Generiques FR Furosemide Aurobindo PL 20532/0039 Aurobindo Pharma Limited GB Furosemide Aurobindo PL 20532/0040 Aurobindo Pharma Limited GB Furosemide Bil Biologici Italia Laboratories S.R.L IT Furosemide Cf RVG Centrafarm B.V. NL Furosemide Cf RVG Centrafarm B.V. NL Furosemide Cf RVG Centrafarm B.V. NL Furosemide Claris UK/H/1241/01/DC RVG Claris Lifesciences (Uk) Limited NL Furosemide Claris UK/H/1241/01/DC 07/5406 Claris Lifesciences (Uk) Limited NO Furosemide Claris UK/H/1241/01/DC Claris Lifesciences (Uk) Limited SE Furosemide Clonmel Healthcare PA0126/008/001 Clonmel Healthcare Limited IE Furosemide Clonmel Healthcare PA0126/008/002 Clonmel Healthcare Limited IE Furosemide Crescent Pharma Limited PL 20416/0078 Crescent Pharma Limited GB Furosemide Crescent Pharma Limited PL 20416/0079 Crescent Pharma Limited GB EMA/729829/2015 Page 15/26
16 Furosemide Crescent Pharma Limited PL 20415/0384 Crescent Pharma Limited GB Furosemide Ct Abz-Pharma Gmbh, Graf-Arco- Str. 3 Furosemide Ct Abz-Pharma Gmbh, Graf-Arco- Str. 3 Furosemide Doc Generici Doc Generici S.R.L. IT Furosemide Evolugen NL Evolupharm FR Furosemide Focus Pharmaceuticals PL 20046/0037 Focus Pharmaceuticals Limited GB Furosemide Focus Pharmaceuticals PL 20046/0038 Focus Pharmaceuticals Limited GB Furosemide Focus Pharmaceuticals PL 20046/0039 Focus Pharmaceuticals Limited GB Furosemide Fresenius Kabi /H/0141/001 BE Fresenius Kabi N.V./S.A. Belgium BE Fresenius Kabi Ab Uppsala, Furosemide Fresenius Kabi /H/0141/ Sweden FI Furosemide Fresenius Kabi /H/0141/001 PL 08828/0179 Fresenius Kabi Limited Uk GB Furosemide Fresenius Kabi /H/0141/ / Fresenius Kabi Hellas A.E. GR Furosemide Fresenius Kabi /H/0141/001 PA 566/41/1 Fresenius Kabi Limited Uk IE Furosemide Fresenius Kabi /H/0141/001 RVG Fresenius Kabi Nederland B.V. NL Furosemide Hameln Pharmaceuticals PL 1502/0032 Hameln Pharmaceuticals Ltd GB Furosemide Hameln Pharmaceuticals Ltd S00503 Hameln Pharmaceuticals Ltd CY Furosemide Hexal Hexal S.P.A IT Furosemide Hexal Hexal S.P.A IT EMA/729829/2015 Page 16/26
17 Furosemide Hexal Hexal S.P.A IT Furosemide Injection Bp Minijet International Medication Systems PL 03265/0025 International Medication Systems, Limited GB Furosemide Injection Bp Minijet International Medication Systems PA 255/10/4 International Medication System (Slough Gb) Furosemide Italfarmaco Italfarmaco S.P.A IT Fresenius Kabi Pharma Portugal Furosemide Kabi /H/0141/ Lda. PL Furosémide Kabi /H/0141/001 NL Fresenius Kabi France S.A.S. FR Furosemide L.F.M Laboratorio Farmacologico Milanese S.R.L. IT Furosemide Laboratorio Reig Jofré PL 25174/0005 Laboratorio Reig Jofre, S.A. GB Furosemide Lavoisier NL Laboratoires Chaix Et Du Marais FR Furosemide Mylan BE Mylan Bvba/Sprl BE Furosemide Mylan NAT/H/1364/ Mylan Bvba/Sprl LU Furosemide Mylan RVG 27917=53385 Mylan B.V. NL Furosémide Mylan NL Mylan S.A.S FR Furosémide Mylan NL Mylan S.A.S FR Furosemide Mylan Generics Mylan S.P.A. IT Furosemide Mylan Generics Mylan S.P.A. IT Furosemide Mylan Generics Mylan S.P.A. IT IE EMA/729829/2015 Page 17/26
18 Furosemide Mylan Generics Mylan S.P.A. IT Furosemide Ratiopharm Ratiopharm Gmbh Furosemide Ratiopharm Ratiopharm Gmbh Furosemide Ratiopharm Ratiopharm Gmbh Furosemide Ratiopharm Ratiopharm Gmbh Furosemide Ratiopharm Ratiopharm Gmbh Furosemide Ratiopharm Ratiopharm Gmbh Ratiopharm Nederland B.V. Furosemide Ratiopharm RVG Swensweg 5 NL Furosemide Ratiopharm Teva Sweden Ab SE Furosemide Sandoz NAT/H/5190/001 BE Sandoz N.V. BE Furosemide Sandoz NL Sandoz FR Furosemide Sandoz NL Sandoz FR Furosemide Sandoz NL Sandoz FR Furosemide Sandoz NL Sandoz FR Furosemide Sandoz NL Sandoz FR Furosemide Sandoz NL Sandoz FR Furosemide Sandoz NL Sandoz FR Furosemide Sandoz NL Sandoz FR EMA/729829/2015 Page 18/26
19 Furosemide Sandoz RVG RVG Sandoz B.V. NL Furosemide Sandoz RVG RVG Sandoz B.V. NL Furosemide Sandoz RVG RVG Sandoz B.V. NL Furosemide Sandoz RVG RVG Sandoz B.V. NL Furosemide Sodium Ratiopharm Ratiopharm Gmbh Furosemide Sodium Ratiopharm Ratiopharm Gmbh Furosemide Tablets UK/H/754/01 PL 17907/0018 Bristol Laboratories Ltd (Berkhamsted) GB Furosemide Tablets UK/H/754/02 PL 17907/0019 Bristol Laboratories Ltd (Berkhamsted) GB Furosemide Tablets PL 04569/0113 Generics (UK) Ltd t/a Mylan GB Furosemide Tablets PL 04569/0114 Generics (UK) Ltd t/a Mylan GB Furosemide Tablets PL 04569/0115 Generics (UK) Ltd t/a Mylan GB Furosemide Tablets UK/H/754/01 PA 1240/001/001 Bristol Laboratories Ltd (Berkhamsted) IE Furosemide Tablets UK/H/754/02 PA 1240/001/002 Bristol Laboratories Ltd (Berkhamsted) IE Furosemide Tablets UK/H/754/01 RVG Bristol Laboratories Ltd (Berkhamsted) NL Furosemide Tablets UK/H/754/02 RVG Bristol Laboratories Ltd (Berkhamsted) NL Furosemide Tablets 40 Mg 04556/0003 Pharmvit Limited GB Teva Pharma B.V. Computerweg Furosemide Teva EE-H DC EE Furosemide Teva EE-H DC /M Teva Italia S.R.L. IT EMA/729829/2015 Page 19/26
20 Furosemide Teva EE-H DC /M Teva Italia S.R.L. IT Furosemide Teva EE-H DC /M Teva Italia S.R.L. IT Furosemide Teva EE-H DC /M Teva Italia S.R.L. IT Furosemide Teva EE-H DC /M Teva Italia S.R.L. IT Furosemide Teva EE-H DC /M Teva Italia S.R.L. IT Furosemide Teva EE-H DC /M Teva Italia S.R.L. IT Furosémide Teva NL26851 Teva Santé FR Furosémide Teva NL39628 Teva Santé FR Furosemide Teva Generics Pharmacare Srl IT Furosemide Teva Generics Pharmacare Srl IT Furosemide Unifarma Sia Unifarma LV Furosemide Wockhardt Uk Ltd 29831/0098 Wockhardt Uk Ltd GB Furosemide Wockhardt Uk Ltd 29831/0201 Wockhardt Uk Ltd GB Furosemide Wockhardt Uk Ltd AA154/05001 Wockhardt Uk Ltd MT Furosemide Wockhardt Uk Ltd AA154/05002 Wockhardt Uk Ltd MT Furosemide Zentiva NL Sanofi-Aventis France FR Furosemide Zentiva NL Sanofi-Aventis France FR Furosemide Zentiva NL Sanofi-Aventis France FR EMA/729829/2015 Page 20/26
21 Furosemid-Ratiopharm OGYI-T-8857/01 Teva Gyógyszergyár Zrt HU Furosemid-Ratiopharm OGYI-T-8857/02 Teva Gyógyszergyár Zrt HU Furosemīds Olainfarm Jsc Olainfarm LV Furosemidum R/1350 Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna PL Furosemidum Polpharma R/0451 Zaklady Farmaceutyczne "polpharma" Spolka Akcyjna PL Furoser II-1764 Tchaikapharma High Quality Medicines, Inc. BG Fursemid Belupo, Lijekovi I Kozmetika UP/I /09-02/249 Belupo D.D. HR Fursemid Belupo, Lijekovi I Kozmetika UP/I /09-02/253 Belupo D.D. HR Fursemid Forte UP/I /09-02/252 Belupo D.D. HR Fusid Teva Gmbh Fusid Teva Gmbh Hydroflux 45715/ Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. GR Hydroflux 78957/ Ioulia And Irene Tseti Pharmaceutical Laboratories S.A. GR Impugan SE/H/1341/001 IS/1/13/039/03 Actavis Group Hf. IS Impugan SE/H/1341/002 IS/1/13/039/01 Actavis Group Hf. IS Impugan SE/H/1341/003 IS/1/13/039/02 Actavis Group Hf. IS Impugan Actavis Group Hf. SE Impugan SE/H/1341/ Actavis Group Hf. SE EMA/729829/2015 Page 21/26
22 Impugan SE/H/1341/ Actavis Group Hf. SE Impugan SE/H/1341/ Actavis Group Hf. SE Jufurix Juta Pharma Gmbh Lasilix NL Sanofi Aventis France FR Lasilix V Sanofi Aventis France FR Lasilix V Sanofi Aventis France FR Lasilix NL Sanofi Aventis France FR Lasilix NL Sanofi Aventis France FR Lasilix VNL Sanofi Aventis France FR Lasilix VNL Sanofi Aventis France FR Lasilix 082/01402 Sanofi Malta Ltd MT Lasix Sanofi-Aventis Gmbh Osterreich AT Lasix Sanofi-Aventis Gmbh Osterreich AT Lasix Sanofi-Aventis Gmbh Osterreich AT Lasix Sanofi-Aventis Gmbh Osterreich AT Lasix Sanofi-Aventis Gmbh Osterreich AT Lasix Sanofi-Aventis Gmbh Osterreich AT Lasix BE Sanofi Belgium BE EMA/729829/2015 Page 22/26
23 Lasix BE Sanofi Belgium BE Lasix BE Sanofi Belgium BE Lasix BE Sanofi Belgium BE Lasix BE Sanofi Belgium BE Lasix Sanofi-Aventis Cyprus Ltd CY Lasix Sanofi-Aventis Cyprus Ltd CY Lasix Sanofi-Aventis Deutschland Gmbh Lasix Sanofi-Aventis Deutschland Gmbh Lasix Sanofi-Aventis Deutschland Gmbh Lasix Sanofi-Aventis Deutschland Gmbh Lasix Sanofi-Aventis Deutschland Gmbh Lasix Sanofi-Aventis Deutschland Gmbh Lasix Sanofi-Aventis Deutschland Gmbh Lasix Sanofi-Aventis Denmark A/S DK Lasix Sanofi-Aventis Denmark A/S DK Lasix 9635 Sanofi Oy FI Lasix 9636 Sanofi Oy FI Lasix 15380/ Sanofi-Aventis Aebe GR EMA/729829/2015 Page 23/26
24 Lasix 15542/ Sanofi-Aventis Aebe GR Lasix UP/I /12-01/681 Sanofi-Aventis Croatia D.O.O. HR Lasix PA 540/52/2 Sanofi-Aventis Ireland Ltd IE Lasix PA 540/52/5 Sanofi-Aventis Ireland Ltd IE Lasix PA 540/52/4 Sanofi-Aventis Ireland Ltd IE Lasix IS Sanofi-Aventis Norge As IS Lasix IS Sanofi-Aventis Norge As IS Lasix Sanofi Spa IT Lasix Sanofi Spa IT Lasix Sanofi Spa IT Lasix Sanofi Spa IT Lasix LT/1/99/1059/001 Uab Sanofi-Aventis Lietuva LT Lasix LT/1/99/1059/002 Uab Sanofi-Aventis Lietuva LT Lasix 2006/ Sanofi Belgium LU Lasix 2006/ Sanofi Belgium LU Lasix 02006/ Sanofi Belgium LU Lasix 02006/ Sanofi Belgium LU Lasix 02006/ Sanofi Belgium LU EMA/729829/2015 Page 24/26
25 Lasix RVG Sanofi-Aventis Netherlands B.V. NL Lasix RVG Sanofi-Aventis Netherlands B.V. NL Lasix RVG Sanofi-Aventis Netherlands B.V. NL Lasix 6895 Sanofi-Aventis Norge As NO Lasix 6896 Sanofi-Aventis Norge As NO Lasix Sanofi - Produtos Farmaceuticos Lda Lasix Sanofi - Produtos Farmaceuticos Lda Lasix Sanofi - Produtos Farmaceuticos Lda Lasix Sanofi - Produtos Farmaceuticos Lda Lasix Sanofi - Produtos Farmaceuticos Lda Lasix Sanofi - Produtos Farmaceuticos Lda Lasix Sanofi - Produtos Farmaceuticos Lda Lasix 9803 Sanofi Ab SE Lasix 9804 Sanofi Ab SE Lasix 5363-I-180/11 Sanofi-Aventis D.O.O. SI Lasix Retard Sanofi-Aventis Gmbh Osterreich AT Lasix Retard Sanofi-Aventis Gmbh Osterreich AT Lasix Retard Sanofi-Aventis Estonia Oü EE EMA/729829/2015 Page 25/26
26 Riomid 40964/ Medicus A.E GR Riomid 40965/ Medicus A.E GR Salurex Remedica Ltd CY Salurex 7733 Remedica Ltd CY Salurex AA084/05301 Remedica Ltd MT Seguril Sanofi-Aventis Sa ES Seguril Sanofi-Aventis Sa ES Seguril Sanofi-Aventis Sa ES Vesix Takeda Oy FI Vesix Special Takeda Oy FI EMA/729829/2015 Page 26/26
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