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Pharmaceuticals - Community Register

  

Register of not active Orphan Medicinal Products (by number)

EU Designation Product Designated Orphan Indication Sponsor Designation date Tradename
EU Centralised Nr
implemented by
EU/3/00/002 Alpha-Galactosidase A Treatment of Fabry disease Shire Human Genetic Therapies AB 08/08/2000 Replagal
EU/1/01/189
04/05/2001
EU/3/00/003 Alpha-Galactosidase A Treatment of Fabry disease Genzyme Europe B.V. 08/08/2000 Fabrazyme
EU/1/01/188
04/05/2001
EU/3/00/004 Fluorouracil Treatment of glioblastoma Ethypharm S.A. 18/10/2000
EU/3/00/006 1,5-(Butylimino)-1,5-dideoxy, D-glucitol Treatment of Gaucher Disease Actelion Registration Ltd 18/10/2000 Zavesca
EU/1/02/238
20/11/2002
EU/3/00/007 N-carbamyl-L-glutamic acid Treatment of N-acetylglutamate synthetase (NAGS) deficiency Orphan Europe S.A.R.L. 18/10/2000 Carbaglu
EU/1/02/246
24/01/2003
EU/3/00/008 Arsenic trioxide Treatment of acute promyelocytic leukaemia Cephalon Europe 18/10/2000 Trisenox
EU/1/02/204
05/03/2002
EU/3/00/009 Thalidomide Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions Pharmion France 29/12/2000
EU/3/00/011 Busulfan (Intravenous use) Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.
Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.
Pierre Fabre Médicament 29/12/2000 Busilvex
EU/1/03/254
09/07/2003
EU/3/00/014 Iloprost Treatment of primary and of the following forms of secondary pulmonary hypertension: connective tissue disease pulmonary hypertension, drug-induced pulmonary hypertension, portopulmonary hypertension, pulmonary hypertension associated with congenital heart disease, chronic thromboembolic pulmonary hypertension Bayer Schering Pharma AG 29/12/2000 Ventavis
EU/1/03/255
16/09/2003
EU/3/00/015 Xaliproden hydrochloride Treatment of amyotrophic lateral sclerosis Sanofi-Aventis 17/01/2001
EU/3/00/016 Lusupultide Treatment of acute respiratory distress syndrome Nycomed GmbH 17/01/2001
EU/3/00/017 Arsenic trioxide Treatment of acute promyelocytic leukaemia Agence générale des équipements et produits de santé - Etablissement pharmaceutique des hôpitaux de Paris (AGEPS-EPHP) 17/01/2001
EU/3/01/019 bosentan Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension Actelion Registration Ltd 14/02/2001 Tracleer
EU/1/02/220
15/05/2002
EU/3/01/020 Ibuprofen Treatment of patent ductus arteriosus Orphan Europe S.A.R.L. 14/02/2001 Pedea
EU/1/04/284
29/07/2004
EU/3/01/021 Imatinib mesylate Treatment of chronic myeloid leukaemia Novartis Europharm Limited 14/02/2001 Glivec
EU/1/01/198
27/08/2001
EU/3/01/022 Laronidase Treatment of Mucopolysaccharidosis, type I Genzyme Europe B.V. 14/02/2001 Aldurazyme
EU/1/03/253
10/06/2003
EU/3/01/023 Pegvisomant Treatment of acromegaly Pfizer Limited 14/02/2001 Somavert
EU/1/02/240
13/11/2002
EU/3/01/024 Ribavirin Treatment of haemorrhagic fever with renal syndrome ICN Pharmaceuticals Limited 14/02/2001
EU/3/01/027 Ibuprofen Prevention of patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age Orphan Europe S.A.R.L. 05/03/2001
EU/3/01/029 Ribavirin Treatment of adenovirus infection in immunocompromised patients Valeant Pharmaceuticals Limited 08/03/2001
EU/3/01/030 8-cyclopentlyl-1,3-dipropylxanthine Treatment of cystic fibrosis SciClone Pharmaceuticals Italy S.r.l 29/03/2001
EU/3/01/031 Arsenic trioxide Treatment of myelodysplastic syndromes Cephalon Europe 29/03/2001
EU/3/01/032 Arsenic trioxide Treatment of multiple myeloma Cephalon Europe 29/03/2001
EU/3/01/033 Ranpirnase Treatment of malignant mesothelioma MoRa Pharma GmbH 29/03/2001
EU/3/01/036 Recombinant human C1-inhibitor Treatment of angioedema caused by C1 inhibitor deficiency Pharming Group N.V. 11/05/2001
EU/3/01/037 Humanised Anti-HM1.24 Monoclonal Antibody Treatment of multiple myeloma Chugai Pharma Europe Ltd 10/05/2001
EU/3/01/040 Fomepizole Treatment of methanol poisoning IDIS Ltd 30/05/2001
EU/3/01/041 Recombinant human alpha-1-antitrypsin (respiratory use) Treatment of emphysema secondary to congenital alpha 1-antitrypsin deficiency Talecris Biotherapeutics GmbH 30/05/2001
EU/3/01/042 Human engineered monoclonal antibody specific for Transforming Growth Factor 2 Prevention of scarring in glaucoma filtration surgical procedures Cambridge Antibody Technology 30/05/2001
EU/3/01/043 Human Milk Fat Globule 1 / Human Milk Fat Globule 1 - S-p-isothiocyanatobenzyl-diethylenetriaminepentaacetic acid for use with 90Yttrium Treatment of ovarian cancer Antisoma Plc 30/05/2001
EU/3/01/046 Thalidomide Treatment of Graft versus Host Disease Pharmion France 09/07/2001
EU/3/01/047 Thalidomide Treatment of multiple myeloma Pharmion France 09/07/2001
EU/3/01/052 Seocalcitol Treatment of hepatocellular carcinoma Leo Pharmaceutical Products 31/07/2001
EU/3/01/053 Beraprost sodium Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension Aventis Pharma S.A. 18/09/2001
EU/3/01/054 Sinapultide, dipalmitoylfosfatidylcholine, palmitoyloleoyl fosfatidylglycerol and palmitic acid Treatment of Meconium Aspiration Syndrome Discovery Laboratories Inc 19/09/2001
EU/3/01/055 Cladribine (subcutaneous use) Treatment of indolent non-Hodgkin´s lymphoma Lipomed GmbH 18/09/2001 Litak
EU/1/04/275
14/04/2004
EU/3/01/057 Porcine lung surfactant Treatment of acute lung injury Leo Pharmaceutical Products 19/09/2001
EU/3/01/060 Pemetrexed disodium Treatment of malignant mesothelioma Eli Lilly Nederland B.V. 17/09/2001
EU/3/01/061 Imatinib Treatment of malignant gastrointestinal stromal tumours Novartis Europharm Limited 20/11/2001 Glivec
EU/1/01/198
27/08/2001
EU/3/01/063 Deoxyribose phosphorothioate (5-tct-ccc-agc-gtg-cgc-cat-3) Treatment of chronic lymphocytic leukaemia Voisin Consulting S.A.R.L. 20/11/2001
EU/3/01/064 Abetimus sodium Treatment of lupus nephritis La Jolla Limited 20/11/2001
EU/3/01/065 Deoxyribose phosphorothioate (5-tct-ccc-agc-gtg-cgc-cat-3) Treatment of multiple myeloma Voisin Consulting S.A.R.L. 20/11/2001
EU/3/01/066 Thalidomide Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions Celgene Europe Limited 20/11/2001
EU/3/01/068 Thalidomide Treatment of multiple myeloma Kendle International Ltd 19/12/2001
EU/3/01/072 Apomorphine (oromucosal use) Treatment of off-periods in Parkinson´s disease not responding to other oral treatment Orion Corporation 05/12/2001
EU/3/01/073 Recombinant human monoclonal antibody to hsp90 Treatment of invasive fungal infections Novartis Europharm Limited 05/12/2001
EU/3/01/076 Octovalent Pseudomonas aeruginosa O-polysaccharie-toxin A conjugate vaccine Prevention of Pseudomonas aeruginosa infections in patients with cystic fibrosis Orphan Europe S.A.R.L. 11/12/2001
EU/3/01/080 Human engineered monoclonal antibody specific for Transforming Growth Factor 1 Treatment of systemic sclerosis Genzyme Europe B.V. 04/02/2002
EU/3/02/085 Carmustine (solution for intratumoral injection) Treatment of glioma Icon Clinical Research UK Ltd 05/03/2002
EU/3/02/086 Porfimer sodium (for use with photodynamic therapy) Treatment of high-grade dysplasia in Barrett’s Esophagus Pinnacle Biologics B.V. 06/03/2002 PhotoBarr
EU/1/04/272
25/03/2004
EU/3/02/087 Eflornithine hydrochloride Treatment of Familial Adenomatous Polyposis (FAP) ILEX Services Limited 19/02/2002
EU/3/02/088 Colistimethate sodium Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis Forest Laboratories UK Ltd 19/02/2002
EU/3/02/089 GM-CSF receptor antagonist Treatment of juvenile myelomonocytic leukaemia British Biotech Pharmaceuticals Ltd 18/03/2002
EU/3/02/090 Human transferrin conjugated to mutant diphtheria toxin Treatment of gliomas Xenova Biomedix Limited 19/03/2002
EU/3/02/095 Iodine (131I) chimeric IgG monoclonal antibody cG250 Treatment of renal cell carcinoma Wilex AG 19/03/2002
EU/3/02/097 Humanized anti-KSA monoclonal antibody - human interleukin-2 fusion protein Treatment of renal cell carcinoma Merck KGaA 22/03/2002
EU/3/02/098 Epothilone B Treatment of ovarian cancer Novartis Europharm Limited 22/03/2002
EU/3/02/099 Bryostatin-1 Treatment of oesophageal cancer GPC Biotech AG 30/04/2002
EU/3/02/100 Recombinant human alpha-1 antitrypsin Treatment of emphysema secondary to congenital alpha-1-antitrypsin deficiency Aptiv Solutions (UK) Ltd 30/04/2002
EU/3/02/102 Mitotane Treatment of adrenal cortical carcinoma Laboratoire HRA Pharma 12/06/2002 Lysodren
EU/1/04/273
28/04/2004
EU/3/02/105 Carbamic acid, [[4-[[3-[[4-[1-(4-hydroxyphenyl)-1-methyl-ethyl]phenoxy]methyl]phenyl]methoxy]-phenyl]iminomethyl]-,ethyl ester Treatment of cystic fibrosis Boehringer Ingelheim International GmbH 26/06/2002
EU/3/02/108 Myristoylated-peptidyl-recombinant SCR1-3 of human complement receptor type I Prevention of post transplantation graft dysfunction Orexo AB 30/07/2002
EU/3/02/112 Doxorubicin carbon / iron magnetically targeted microparticles Treatment of hepatocellular carcinoma Interface International Consultancy Limited 11/09/2002
EU/3/02/113 Mitotane Treatment of adrenal cortical carcinoma Agence générale des équipements et produits de santé - Etablissement pharmaceutique des hôpitaux de Paris (AGEPS-EPHP) 11/09/2002
EU/3/02/114 Myristoylated-peptidyl-recombinant Human CD59 Treatment of paroxysmal nocturnal haemoglubinuria Orexo AB 11/09/2002
EU/3/02/117 Boswellia serrata resin extract Treatment of peritumoral oedema derived from brain tumours Pharmasan GmbH 21/10/2002
EU/3/02/123 anti-CD147 murine monoclonal IgM Treatment of Graft versus Host Disease SangStat UK Limited 14/11/2002
EU/3/02/125 Monoclonal antibody to human interleukin-6 Treatment of post-transplant lymphoproliferative disorders EUSA Pharma SAS 18/12/2002
EU/3/02/126 Recombinant inhibitor of human plasma kallikrein treatment of angioedema Dyax s.a. 18/12/2002
EU/3/02/131 Sodium oxybate Treatment of narcolepsy UCB Pharma Ltd. 03/02/2003 Xyrem
EU/1/05/312
13/10/2005
EU/3/03/138 a -1-acid glycoprotein Treatment of tricyclic antidepressants poisoning Bio Products Laboratory 20/03/2003
EU/3/03/139 bosentan Treatment of systemic sclerosis Actelion Registration Ltd 17/03/2003 Tracleer
EU/1/02/220
15/05/2002
EU/3/03/141 2-chloro-9-[2-deoxy-2-fluoro--D-arabinofuranosyl]adenine. Treatment of acute myeloid leukaemia Genzyme Europe B.V. 08/05/2003
EU/3/03/142 Iodine (131I) anti-CEA sheep-human chimeric monoclonal antibody monoclonal antibody labeled with iodine-131 Treatment of pancreatic cancer Xenova Biomedix Limited 07/05/2003
EU/3/03/143 5-10-Methylene-tetrahydrofolate Treatment of pancreatic cancer in combination with 5-fluorouracil Interface International Consultancy Limited 11/06/2003
EU/3/03/146 Aldesleukin (inhalation use) Treatment of renal cell carcinoma Chiron Corporation Ltd 30/06/2003
EU/3/03/147 Amiloride hydrochloride dihydrate Treatment of cystic fibrosis Pulmo Tec GmbH 30/06/2003
EU/3/03/148 Chimeric-anti-interleukin-6 monoclonal antibody Treatment of renal cell carcinoma Janssen Biologics B.V. 30/06/2003
EU/3/03/150 Adenovirus-Interferon gamma coding DNA sequence Treatment of cutaneous T-cell lymphoma Transgene S.A. 09/07/2003
EU/3/03/151 Aplidine Treatment of acute lymphoblastic leukaemia Pharma Mar S.A. 09/07/2003
EU/3/03/152 Engineered protein inhibitor of human neutrophil elastase Treatment of cystic fibrosis Debioclinic SA 09/07/2003
EU/3/03/155 Murine anti-idiotypic antibody against OC125 antibody against CA125 antigen Treatment of ovarian cancer Menarini Ricerche S.p.A. 09/07/2003
EU/3/03/158 Recombinant human arylsulfatase A Treatment of metachromatic leukodystrophy Shire Pharmaceuticals Ireland Limited 09/07/2003
EU/3/03/159 Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 Treatment of primary growth hormone insensitivity syndrome (Laron Syndrome) Insmed Europe Ltd 09/07/2003
EU/3/03/164 a-1-acid glycoprotein Treatment of cocaine poisoning Bio Products Laboratory 02/10/2003
EU/3/03/165 Nolatrexed Treatment of hepatocellular carcinoma Scirex Ltd. 02/10/2003
EU/3/03/167 H-Tyrosine-Glycine-Phenylalanine-Glycine-Glycine-OH Treatment of chronic idiopathic myelofibrosis Abiogen Pharma S.p.A. 20/10/2003
EU/3/03/169 Human immunoglobulin Treatment of dermatomyositis Orfagen 20/10/2003
EU/3/03/170 Human immunoglobulin Treatment of polymyositis Orfagen 24/10/2003
EU/3/03/179 Recombinant human factor XIII (composed of two A subunits) Treatment of hereditary factor XIII deficiency Novo Nordisk A/S 12/12/2003
EU/3/03/180 4,5-dihydro-2-(2,4-dihydroxyphenyl)-4-methylthiazole-4(S)-carboxylic acid Treatment of chronic iron overload requiring chelation therapy Genzyme Europe B.V. 12/12/2003
EU/3/03/181 N-acetylsarcosyl-glycyl-L-valyl-D-allo-isoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-prolyl-N-ethylamide Treatment of soft tissue sarcoma Abbott International European Office 12/12/2003
EU/3/03/184 Cilengitide Treatment of glioma Merck KGaA 14/01/2004
EU/3/03/185 Tacrolimus hydrate Treatment of vernal keratoconjunctivitis Sucampo Pharma Europa Ltd 14/01/2004
EU/3/04/187 Human monoclonal hepatitis B immunoglobulins Prevention of hepatitis B re-infection following liver transplantation ICON Clinical Research (U.K.) Limited 23/02/2004
EU/3/04/196 Ciclosporin Treatment of atopic keratoconjunctivitis Allergan Pharmaceuticals Ireland 14/04/2004
EU/3/04/205 Suberoylanilide hydroxamic acid Treatment of cutaneous T-cell lymphoma Merck Sharp & Dohme Limited 21/06/2004
EU/3/04/215 Porfimer sodium (for use with photodynamic therapy) Treatment of cholangiocarcinoma Pinnacle Biologics B.V. 29/07/2004
EU/3/04/218 (R, S)-3-(bromomethyl)-3-butanol-1-yl-diphosphate Treatment of renal cell carcinoma Innate Pharma SAS 29/07/2004
EU/3/04/221 5,10-methylene-tetrahydrofolic acid Treatment of pancreatic cancer in combination with 5-fluorouracil Interface International Consultancy Limited 02/09/2004
EU/3/04/225 Sodium dichloroacetate Treatment of systemic monochloroacetate poisoning Dr. Anthony W. Fox 02/09/2004
EU/3/04/226 Recombinant human interleukin-21 Treatment of renal cell carcinoma Bristol-Myers Squibb International Corporation 02/09/2004
EU/3/04/231 Deferoxamine mesilate Treatment of traumatic spinal cord injury SCT Spinal Cord Therapeutics GmbH 20/10/2004
EU/3/04/233 Adeno-associated viral vector containing the human gamma-sarcoglycan gene Treatment of gamma-sarcoglycanopathy Généthon 21/10/2004
EU/3/04/234 Sitaxentan sodium Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension Pfizer Limited 21/10/2004 Thelin
EU/1/06/353
10/08/2006
EU/3/04/235 Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 Treatment of Type B extreme insulin resistance syndrome Insmed Europe Ltd 20/10/2004
EU/3/04/236 Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 Treatment of Type A extreme insulin resistance syndrome Insmed Europe Ltd 21/10/2004
EU/3/04/237 Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 Treatment of Rabson-Mendenhall syndrome Insmed Europe Ltd 21/10/2004
EU/3/04/238 Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 Treatment of Leprechaunism Insmed Europe Ltd 21/10/2004
EU/3/04/239 Deuterium oxide Treatment of pancreatic cancer BDD Berolina Drug Development GmbH 20/10/2004
EU/3/04/246 Valproic acid, sodium Treatment of Familial Adenomatous Polyposis TopoTarget Germany AG 30/11/2004
EU/3/04/247 17-allylamino-17-demethoxygeldanamycin Treatment of multiple myeloma Bristol-Myers Squibb International Corporation 21/12/2004
EU/3/04/252 Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) Treatment of chronic myeloid leukemia Accelsiors CRO & Consultancy Services GmbH 21/12/2004
EU/3/04/253 Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) Treatment of acute myeloid leukaemia Accelsiors CRO & Consultancy Services GmbH 21/12/2004
EU/3/04/254 Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) Treatment of myelodysplastic syndromes Accelsiors CRO & Consultancy Services GmbH 21/12/2004
EU/3/04/255 Sabarubicin Treatment of small cell lung cancer Menarini Ricerche S.p.A. 21/12/2004
EU/3/04/256 17-allylamino-17-demethoxygeldanamycin Treatment of chronic myeloid leukemia Bristol-Myers Squibb International Corporation 26/01/2005
EU/3/04/259 Acetylcysteine Treatment of idiopathic pulmonary fibrosis Zambon Group Spa 26/01/2005
EU/3/05/262 Titanium dioxide and bisoctrizole Treatment of UV-A and visible light-induced photosensitivity disorders (chronic actinic dermatitis, cutaneous porphyrias, actinic prurigo and solar urticaria) Orfagen 03/03/2005
EU/3/05/267 (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3Hindol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysuccinate Treatment of malignant gastrointestinal stromal tumours Pfizer Limited 10/03/2005 Sutent
EU/1/06/347
19/07/2006
EU/3/05/268 (Z)-N-[2-(Diethylamino)ethyl]-5-[(5-fluoro-2-oxo-1,2-dihydro-3Hindol-3-ylidene)methyl]-2,4-dimethyl-1H-pyrrole-3-carboxamide (S)-2-hydroxysuccinate Treatment of renal cell carcinoma Pfizer Limited 10/03/2005
EU/3/05/271 Paromomycin sulphate Treatment of visceral leishmaniasis Sestria Ltd 11/04/2005
EU/3/05/274 Melatonin Non-24-Hour Sleep-Wake Disorder in blind people with no light perception ICON Clinical Research (U.K.) Limited 11/04/2005
EU/3/05/281 Interferon gamma Treatment of idiopathic pulmonary fibrosis InterMune Europe Ltd 27/05/2005
EU/3/05/291 Human monoclonal antibody against HLA-DR Treatment of Hodgkin’s lymphoma GPC Biotech AG 16/06/2005
EU/3/05/304 Imatinib mesilate Treatment of acute lymphoblastic leukaemia Novartis Europharm Limited 26/08/2005 Glivec
EU/1/01/198
27/08/2001
EU/3/05/305 Imatinib mesilate Treatment of dermatofibrosarcoma protuberans Novartis Europharm Limited 26/08/2005 Glivec
EU/1/01/198
27/08/2001
EU/3/05/306 Imatinib mesilate Treatment of mastocytosis Novartis Europharm Limited 26/08/2005
EU/3/05/308 Sapropterin Treatment of hyperphenylalaninemia Dr. Gunter Schaub 26/08/2005
EU/3/05/309 Sodium valproate Treatement of 5q muscular atrophy The Jennifer Trust for Spinal Muscular Atrophy 26/08/2005
EU/3/05/311 Troxacitabine Treatment of acute myeloid leukaemia Pharm Research Associates (UK) Limited 26/08/2005
EU/3/05/312 (1R, 2R, 4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R, 27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxy-cyclohexyldimethyl-phosphinate Treatment of soft tissue sarcoma Merck Sharp & Dohme Limited 26/08/2005
EU/3/05/320 Imatinib mesilate Treatment of chronic eosinophilic leukaemia and the hypereosinophilic syndrome Novartis Europharm Limited 28/10/2005 Glivec
EU/1/01/198
27/08/2001
EU/3/05/321 (1R, 2R, 4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R, 27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetra-cosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxy-cyclohexyldimethyl-phosphinate Treatment of primary malignant bone tumours Merck Sharp & Dohme Limited 28/10/2005
EU/3/05/322 Alfimeprase Treatment of acute peripheral arterial occlusion Quadramed Limited 28/10/2005
EU/3/05/330 Tilarginine acetate Treatment of cardiogenic shock Dr. Ulrich Granzer 18/10/2005
EU/3/05/331 Recombinant microbial lipase Treatment of malasbsorption due to exocrine pancreatic enzyme insufficiency Abbott Products GmbH 28/10/2005
EU/3/05/335 Human Staphylococcus aureus polyclonal immunoglobulin and human Staphylococcus epidermidis polyclonal immunoglobulin Prevention of late onset sepsis in premature infants of less or equal than 32 weeks gestational age Omnicare Clinical Research 14/12/2005
EU/3/05/336 Brostallicin Treatment of soft tissue sarcoma Nuvisan Oncology SA 23/12/2005
EU/3/05/337 Heparin sodium (inhalation use) Treatment of cystic fibrosis Vectura Group plc 23/12/2005
EU/3/05/340 Imatinib mesilate Treatment of myelodysplastic / myeloproliferative diseases Novartis Europharm Limited 23/12/2005 Glivec
EU/1/01/198
27/08/2001
EU/3/05/344 vandetanib Treatment of medullary thyroid carcinoma AstraZeneca UK Limited 24/01/2006
EU/3/05/345 Lentiviral vector containing the human Wiskott Aldrich syndrome protein gene Treatment of Wiskott-Aldrich syndrome Généthon 24/01/2006
EU/3/05/347 Human monoclonal antibody against HLA-DR Treatment of chronic lymphocytic leukaemia GPC Biotech AG 24/01/2006
EU/3/05/348 Purified inactivated Japanese encephalitis SA14-4-2 virus vaccine Prevention of Japanese encephalitis Intercell AG 24/01/2006 Ixiaro
EU/1/08/501
31/03/2009
EU/3/06/352 26 base single stranded phosphodiester DNA oligonucleotide Treatment of pancreatic cancer Antisoma Research Ltd 16/02/2006
EU/3/06/353 26 base single stranded phosphodiester DNA oligonucleotide Treatment of renal cell carcinoma Antisoma Research Ltd 16/02/2006
EU/3/06/357 2-O-methyl-phosphorothioate oligonucleotide Treatment of Duchenne muscular dystrophy Prosensa B.V. 16/02/2006
EU/3/06/358 Human monoclonal antibody against HLA-DR Treatment of multiple myeloma GPC Biotech AG 28/02/2006
EU/3/06/359 Adeno associated viral vector containing the human calpain 3 gene Treatment of calpainopathy Généthon 06/04/2006
EU/3/06/361 Glutathione Treatment of cystic fibrosis Mukoviszidose e.V. 11/04/2006
EU/3/06/366 Tobramycin (liposomal) Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis Axentis Pharma Limited 11/04/2006
EU/3/06/377 Mecasermin rinfabate Treatment of patients with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH Insmed Europe Ltd. 20/06/2006
EU/3/06/378 Mecasermin rinfabate Treatment of primary insulin-like growth factor-1 deficiency due to molecular or genetic defects Insmed Europe Ltd. 20/06/2006
EU/3/06/379 Diphenylcyclopropenone Treatment of alopecia totalis Orfagen 29/06/2006
EU/3/06/380 Diphenylcyclopropenone Treatment of alopecia universalis Orfagen 29/06/2006
EU/3/06/382 Pazopanib hydrochloride Treatment of renal cell carcinoma Glaxo Group Limited 29/06/2006
EU/3/06/383 Siplizumab Treatment of T-cell and NK-cell neoplasms MedImmune, LLC 29/06/2006
EU/3/06/385 2-(4-(diethylamino) phenyl)-6-methyl-2H-benzo[d][1,2,3] triazol-5-amine Treatment of Duchenne muscular dystrophy Vastox plc. 25/07/2006
EU/3/06/392 Human monoclonal antibody against inhibitory killer cell lg-like receptors Treatment of acute myeloid leukaemia Innate Pharma 28/08/2006
EU/3/06/393 Autologous CD34+ cells transfected with retroviral vector containing the human gp91(phox) gene Treatment of chronic granulomatous disease Vision 7 GmbH 28/08/2006
EU/3/06/397 Cholest-4-en-3-one, oxime Treatment of amyotrophic lateral sclerosis Trophos SA 28/08/2006
EU/3/06/398 H-Val-Ile-Val-Lys-Leu-Ile-Pro-Ser-Thr-Ser-Ser-Ala-Val-Asp-Thr-Pro-Tyr-Leu-Asp-Ile-Thr-Tyr-His-Phe-Val-Ala-Gln-Arg-Leu-Pro-Leu-OH Treatment of myasthenia gravis Debioclinic SA 28/08/2006
EU/3/06/402 Opebacan Treatment of meningococcal disease XOMA Ireland Ltd 28/08/2006
EU/3/06/415 Ciclosporin (implant) Prevention of rejection of corneal transplant Lux Biosciences GmbH 03/11/2006
EU/3/06/425 Complement factor H Treatment of atypical Haemolytic Uraemic Syndrome (aHUS) associated with an inherited abnormality of the complement system Laboratoire français du Fractionnement et des Biotechnologies (LFB) S.A. 26/01/2007
EU/3/06/426 Fenretinide Treatment of primary malignant bone tumours Cancer Research UK 26/01/2007
EU/3/06/427 Fenretinide Treatment of soft tissue sarcoma Cancer Research UK 30/01/2007
EU/3/07/436 Eptacog alfa (activated) Treatment of post-neonatal intracerebral haemorrhage Novo Nordisk A/S 20/03/2007
EU/3/07/439 Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class Treatment of cryopirin-associated periodic syndromes (Familial Cold Urticaria Syndrome (FCUS), Muckle-Wells Syndrome (MWS), and Neonatal Onset Multisystem Inflammatory Disease (NOMID), also known as Chronic Infantile Neurological Cutaneous Novartis Europharm Limited 20/03/2007 Ilaris
EU/1/09/564
23/10/2009
EU/3/07/447 Nilotinib hydrochloride monohydrate Treatment of gastro intestinal stromal tumours Novartis Europharm Limited 13/04/2007
EU/3/07/449 everolimus Treatment of renal cell carcinoma Novartis Europharm Limited 05/06/2007 Afinitor
EU/1/09/538
03/08/2009
EU/3/07/454 Recombinant adeno-associated viral vector containing human acid alpha-glucosidase-gene Treatment of glycogen storage disease type II (Pompe's disease) TMC Pharma Services Ltd. 09/07/2007
EU/3/07/457 Lusupultide Treatment of aspiration pneumonitis requiring intubation and mechanical ventilation Nycomed GmbH 10/07/2007
EU/3/07/460 Arsenic trioxide Treatment of acute myeloid leukaemia Cephalon Europe 02/08/2007
EU/3/07/464 Panobinostat lactate Treatment of cutaneous T-cell lymphoma Novartis Europharm Limited 02/08/2007
EU/3/07/467 Eltrombopag olamine Treatment of idiopathic thrombocytopenic purpura GlaxoSmithKline Trading Services Limited 03/08/2007 Revolade
EU/1/10/612
11/03/2010
EU/3/07/468 Dihydroartemisinin, piperaquine Treatment of malaria Sigma-Tau Industrie Farmaceutiche Riunite S.p.A 03/08/2007
EU/3/07/472 Cyclo{{(E,Z)-(2s,3r,4r)-3-Hydroxy-4-Methyl-2-(Methylamino)Nona-6,8-Dienoyl}-L-2-Aminobutyryl-N-Methyl-Glycyl-N-Methyl-L-Leucyl-L-Valyl-N-Methyl-L-Leucyl-L-Alanyl-D-Alanyl-N-Methyl-L-Leucyl-N-Methyl-L-Leucyl-N-Methyl-L-Valyl} Treatment of chronic non-infectious uveitis Lux Biosciences GmbH 14/09/2007
EU/3/07/482 Sulfonated monophosphorylated mannose oligosaccharide Treatment of hepatocellular carcinoma Constella Group Ltd 14/09/2007
EU/3/07/483 Amonafide L-malate Treatment of acute myeloid leukaemia Antisoma Research Ltd 22/10/2007
EU/3/07/488 everolimus Treatment of gastro-entero-pancreatic neuroendocrine tumours Novartis Europharm Limited 14/11/2007
EU/3/07/497 4-[3,5-bis(trimethylsilyl)benzamido] benzoic acid Treatment of hepatocellular carcinoma Quintiles Ireland Ltd 22/10/2007
EU/3/07/500 Recombinant human rod-derived cone viability factor Treatment of retinitis pigmentosa Fovea Pharmaceuticals SA 29/11/2007
EU/3/07/502 Picoplatin Treatment of small cell lung cancer Kendle International Ltd 06/12/2007
EU/3/07/512 17-(allylamino)-17-demethoxygeldanamycin hydroquinone hydrochloride Treatment of malignant gastro intestinal stromal tumours Voisin Consulting S.A.R.L. 29/11/2007
EU/3/07/515 Tegafur / gimeracil / oteracil Treatment of gastric cancer Taiho Pharma Europe Limited 20/12/2007
EU/3/08/527 Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class Treatment of systemic-onset juvenile idiopathic arthritis Novartis Europharm Limited 04/02/2008
EU/3/08/528 Lumiliximab Treatment of chronic lymphocytic leukaemia Biogen Idec Limited 04/02/2008
EU/3/08/534 Allogeneic human umbilical cord tissue-derived cells Treatment of retinitis pigmentosa Centocor B.V. 01/04/2008
EU/3/08/537 Autologous urothelial and smooth muscle cells Treatment of spina bifida European Medical Advisory Services Limited 17/03/2008
EU/3/08/543 Sarsasapogenin Treatment of amyotrophic lateral sclerosis Phytopharm plc 08/05/2008
EU/3/08/547 Anti-von Willebrand Aptamer Treatment of thrombotic thrombocytopenic purpura FGK Representative Service GmbH 03/06/2008
EU/3/08/559 bosentan Treatment of idiopathic pulmonary fibrosis Actelion Registration Ltd 05/09/2008
EU/3/08/573 Adeno-associated viral vector containing the human alpha-sarcoglycan gene Treatment of alpha-sarcoglycanopathy Généthon 07/11/2008
EU/3/08/574 Autologous urothelial and smooth muscle cells Treatment of spinal cord injury European Medical Advisory Services Limited 07/11/2008
EU/3/08/606 Recombinant human residue 41 glutamic acid to glutamine variant of Interferon-alfa-2b Treatment of Behçet's disease Creabilis Therapeutics S.p.A. 19/01/2009
EU/3/08/609 Adeno-associated viral vector serotype 5 containing the human ABCA4 gene Treatment of Stargardt’s disease Fondazione Telethon 06/02/2009
EU/3/09/613 Tobramycin (inhalation use) Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis PARI Pharma GmbH 27/02/2009
EU/3/09/626 Lintuzumab Treatment of myelodysplastic syndromes Seattle Genetics UK Limited 29/04/2009
EU/3/09/627 Lintuzumab Treatment of acute myeloid leukaemia Seattle Genetics UK Limited 30/04/2009
EU/3/09/631 Talampanel Treatment of glioma Teva Pharma GmbH 29/04/2009
EU/3/09/639 4,6,8-trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo[b,e][1,4]diazepin-11-one Treatment of glioma Albany Regulatory Consulting Limited 15/05/2009
EU/3/09/642 Chimeric-anti-interleukin-6 monoclonal antibody Treatment of multiple myeloma Janssen Biologics B.V. 12/06/2009
EU/3/09/644 Murine monoclonal antibody to GD2 Treatment of neuroblastoma United Therapeutics Europe Ltd 12/06/2009
EU/3/09/646 Talampanel Treatment of amyotrophic lateral sclerosis Teva Pharma GmbH 12/06/2009
EU/3/09/655 Octocog alpha (liposomal) Treatment of haemophilia A Bayer Schering Pharma AG 24/07/2009
EU/3/09/658 Tamibarotene Treatment of acute promyelocytic leukaemia Eudax Srl 24/07/2009
EU/3/09/662 26 base single stranded phosphodiester DNA oligonucleotide Treatment of acute myeloid leukaemia Antisoma Research Ltd 08/10/2009
EU/3/09/668 Human C1-inhibitor Treatment of angioedema caused by C1-inhibitor deficiency ViroPharma SPRL-BVBA 08/10/2009
EU/3/09/674 Recombinant human serum amyloid P Prevention of scarring post glaucoma filtration surgery Appletree Europe S.à.r.l. 09/10/2009
EU/3/09/678 (-)-trans-3-(5,6-dihydro-4H-pyrrolo[3,2,1-ij]quinolin-1yl)-4-(1H-indol-3-yl) pyrrolidine-2, 5-dione Treatment of soft tissue sarcoma Gregory Fryer Associates Ltd 08/10/2009
EU/3/09/679 4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione Treatment of progressive supranuclear palsy NOSCIRA, S.A. 28/10/2009
EU/3/09/680 5'-O-(trans-9''-octadecenoyl)-1-beta-D-2'-deoxy-2',2'-difluorocytidine Treatment of pancreatic cancer Clovis Oncology UK Limited 28/10/2009
EU/3/09/682 Anti-EphA2 monoclonal antibody conjugated to maleimidocaproyl monomethylauristatin phenylalanine Treatment of ovarian cancer MedImmune Ltd 28/10/2009
EU/3/09/687 Patupilone Treatment of primary peritoneal cancer Novartis Europharm Limited 05/11/2009
EU/3/09/688 Patupilone Treatment of fallopian tube cancer Novartis Europharm Limited 05/11/2009
EU/3/09/697 N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide Treatment of naevoid basal cell carcinoma syndrome (Gorlin syndrome) Novartis Europharm Limited 25/11/2009
EU/3/09/704 Givinostat Treatment of systemic-onset juvenile idiopathic arthritis Italfarmaco S.p.A. 28/01/2010
EU/3/09/714 Streptococcus pyogenes Su strain cells treated with benzylpenicillin Treatment of congenital lymphatic malformations Theradex (Europe) Ltd. 29/01/2010
EU/3/09/721 Panobinostat Treatment of Hodgkin's lymphoma Novartis Europharm Limited 02/02/2010
EU/3/09/722 Pixantrone dimaleate Treatment of diffuse large B-cell lymphoma CTI Life Sciences Ltd 02/02/2010
EU/3/10/728 Davunetide Treatment of progressive supranuclear palsy FGK Representative Service GmbH 23/03/2010
EU/3/10/729 (1S, 2S, 3R, 4R)-3-(5-Fluoro-2-(3-methyl-4-(4-methylpiperazin-1-yl)-phenylamino)-pyrimidin-4-ylamino)-bicyclo[2.2.1]hept-5-ene-2-carboxamide benzoate Treatment of acute myeloid leukaemia Merck KGaA 23/03/2010
EU/3/10/731 Bafetinib Treatment of chronic myeloid leukaemia Eudax Srl 10/06/2010
EU/3/10/740 Perifosine Treatment of multiple myeloma Æterna Zentaris GmbH 10/06/2010
EU/3/10/743 Pagibaximab Prevention of sepsis caused by Gram positive pathogens in premature infants less than or equal to 34 weeks of gestational age Theorem Clinical Research GmbH 09/06/2010
EU/3/10/746 Maytansinoid-conjugated humanised monoclonal antibody against CD56 Treatment of Merkel cell carcinoma ImmunoGen Europe Limited 09/06/2010
EU/3/10/763 Dexamethasone (intravitreal implant) Treatment of non-infectious uveitis affecting the posterior segment of the eye Allergan Pharmaceuticals Ireland 04/08/2010
EU/3/10/771 Abarelix Treatment of low-flow priapism Speciality European Pharma Ltd 20/09/2010
EU/3/10/785 Vorinostat Treatment of malignant mesothelioma Merck Sharp & Dohme Limited 20/09/2010
EU/3/10/790 Ambrisentan Treatment of idiopathic pulmonary fibrosis Gilead Sciences International Ltd 01/10/2010
EU/3/10/792 Maytansinoid-conjugated humanised monoclonal antibody against CD56 Treatment of small cell lung cancer ImmunoGen Europe Limited 01/10/2010
EU/3/10/799 Tecovirimat Treatment of cowpox infection SIGA Pharmaceuticals (Europe) Ltd 01/10/2010
EU/3/10/809 Nanoparticle albumin-bound paclitaxel Treatment of pancreatic cancer Celgene Europe Limited 26/11/2010
EU/3/10/835 Maytansinoid-conjugated humanised monoclonal antibody against CD56 Treatment of multiple myeloma ImmunoGen Europe Limited 23/02/2011
EU/3/10/837 Plitidepsin Treatment of primary myelofibrosis Pharma Mar S.A. 23/02/2011
EU/3/10/838 Plitidepsin Treatment of post-essential thrombocythaemia myelofibrosis Pharma Mar S.A. 23/02/2011
EU/3/10/839 Plitidepsin Treatment of post-polycythaemia vera myelofibrosis Pharma Mar S.A. 23/02/2011
EU/3/10/844 Axitinib Treatment of renal cell carcinoma Pfizer Limited 23/02/2011
EU/3/11/853 Ombrabulin Treatment of soft tissue sarcoma Sanofi-Aventis groupe 15/04/2011
EU/3/11/854 Vorinostat Treatment of multiple myeloma Merck Sharp & Dohme Limited 15/04/2011
EU/3/11/859 [N-((2S,3R,3aS,3R,4aR,6S,6aR,6bS,7aR,12aS,12bS,Z)-3,6,11,12b-tetramethyl-2,3a,3,4,4,4a,5,5,6,6,6a,6b,7,7a,7,8,10,12,12a,12b-icosahydro-1H,3H-spiro[furo[3,2-b]pyridine-2,9-naphtho[2,1-a]azulene]-3-yl)methanesulfonamide hydrochloride] Treatment of chondrosarcoma Voisin Consulting S.A.R.L. 13/05/2011
EU/3/11/873 Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh Treatment of epidermolysis bullosa Shire Pharmaceuticals Ireland Limited 21/06/2011
EU/3/11/894 Everolimus Treatment of gastric cancer Novartis Europharm Limited 30/08/2011
EU/3/11/905 Kifunensine Treatment of alpha-sarcoglycanopathy Généthon 27/09/2011
EU/3/11/906 Kifunensine Treatment of beta-sarcoglycanopathy Généthon 27/09/2011
EU/3/11/907 Kifunensine Treatment of delta-sarcoglycanopathy Généthon 27/09/2011
EU/3/11/908 Kifunensine Treatment of gamma-sarcoglycanopathy Généthon 27/09/2011
EU/3/11/918 Brivanib alaninate Treatment of hepatocellular carcinoma Bristol-Myers Squibb Pharma EEIG 27/10/2011
EU/3/11/946 Recombinant homodimer of the human annexin V Prevention of ischaemia/reperfusion injury associated with solid organ transplantation Astellas Pharma Europe B.V. 11/01/2012
EU/3/12/949 Sodium phenylbutyrate Treatment of citrullinaemia type 1 Lucane Pharma SA 09/02/2012
EU/3/12/950 Sodium phenylbutyrate Treatment of ornithine transcarbamylase deficiency Lucane Pharma SA 09/02/2012
EU/3/12/951 Sodium phenylbutyrate Treatment of carbamoyl-phosphate synthase-1 deficiency Lucane Pharma SA 09/02/2012
EU/3/12/958 N-[4-[[(2-amino-3,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-D-gamma-glutamyl-(2S)-2-amino-beta-alanyl-L-alpha-aspartyl-L-cysteine and folic acid Diagnosis of positive folate receptor status in ovarian cancer Endocyte Europe B.V. 09/02/2012
EU/3/12/977 Linsitinib Treatment of adrenal cortical carcinoma Astellas Pharma Europe B.V. 02/04/2012
EU/3/12/1000 Polyinosine-polycytidylic acid coupled with the polycationic polyethyleneimine Treatment of pancreatic cancer Bioncotech Therapeutics S.L. 06/06/2012
EU/3/12/1029 Humanised monoclonal antibody against epidermal growth factor receptor Treatment of glioma AbbVie Ltd 09/08/2012
EU/3/12/1090 Recombinant human monoclonal antibody of the IgG1 kappa class against prostate stem cell antigen Treatment of pancreatic cancer Astellas Pharma Europe B.V. 24/01/2013
EU/3/13/1101 Progesterone Treatment of moderate and severe traumatic brain injury BHR Pharma Belgium 08/02/2013
EU/3/13/1104 Terguride Treatment of systemic sclerosis High Tech Participations GmbH 08/02/2013
EU/3/13/1159 Idelalisib Treatment of follicular lymphoma Gilead Sciences International Ltd 17/07/2013
EU/3/13/1160 Idelalisib Treatment of lymphoplasmacytic lymphoma Gilead Sciences International Ltd 17/07/2013
EU/3/13/1172 Idelalisib Treatment of nodal marginal zone lymphoma Gilead Sciences International Ltd 05/08/2013
EU/3/13/1173 Idelalisib Treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma Gilead Sciences International Ltd 05/08/2013
EU/3/13/1186 Idelalisib Treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) Gilead Sciences International Ltd 05/08/2013
EU/3/13/1187 Idelalisib Treatment of splenic marginal zone lymphoma Gilead Sciences International Ltd 05/08/2013