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Pharmaceuticals - Community Register

  

Register of not active Orphan Medicinal Products (alphabetical)

Product EU Designation Designated Orphan Indication Sponsor Designation date Tradename
EU Centralised Nr
implemented by
1-[2-(Benzo[1,2,5]thiadiazol-5-ylamino)-6-(2,6-dichloro-phenyl)-pyrido[2,3-d]pyrimidin-7-yl]-3-tert-butyl-urea EU/3/10/770 Treatment of acute myeloid leukaemia Sanofi-Aventis groupe 20/09/2010
1,5-(Butylimino)-1,5-dideoxy, D-glucitol EU/3/00/006 Treatment of Gaucher Disease Actelion Registration Ltd 18/10/2000 Zavesca
EU/1/02/238
20/11/2002
17-allylamino-17-demethoxygeldanamycin EU/3/04/247 Treatment of multiple myeloma Bristol-Myers Squibb International Corporation 21/12/2004
17-allylamino-17-demethoxygeldanamycin EU/3/04/256 Treatment of chronic myeloid leukemia Bristol-Myers Squibb International Corporation 26/01/2005
17-(allylamino)-17-demethoxygeldanamycin hydroquinone hydrochloride EU/3/07/512 Treatment of malignant gastro intestinal stromal tumours Voisin Consulting S.A.R.L. 29/11/2007
(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 EU/3/05/321 Treatment of primary malignant bone tumours Merck Sharp & Dohme Limited 28/10/2005
(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 EU/3/05/312 Treatment of soft tissue sarcoma Merck Sharp & Dohme Limited 26/08/2005
(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 EU/3/10/729 Treatment of acute myeloid leukaemia Merck KGaA 23/03/2010
2-(4-(diethylamino) phenyl)-6-methyl-2H-benzo[d][1,2,3] triazol-5-amine EU/3/06/385 Treatment of Duchenne muscular dystrophy Vastox plc. 25/07/2006
26 base single stranded phosphodiester DNA oligonucleotide EU/3/06/352 Treatment of pancreatic cancer Antisoma Research Ltd 16/02/2006
26 base single stranded phosphodiester DNA oligonucleotide EU/3/09/662 Treatment of acute myeloid leukaemia Antisoma Research Ltd 08/10/2009
26 base single stranded phosphodiester DNA oligonucleotide EU/3/06/353 Treatment of renal cell carcinoma Antisoma Research Ltd 16/02/2006
2-chloro-9-[2-deoxy-2-fluoro--D-arabinofuranosyl]adenine. EU/3/03/141 Treatment of acute myeloid leukaemia Genzyme Europe B.V. 08/05/2003
2-O-methyl-phosphorothioate oligonucleotide EU/3/06/357 Treatment of Duchenne muscular dystrophy Prosensa B.V. 16/02/2006
4-[3,5-bis(trimethylsilyl)benzamido] benzoic acid EU/3/07/497 Treatment of hepatocellular carcinoma Quintiles Ireland Ltd 22/10/2007
4,5-dihydro-2-(2,4-dihydroxyphenyl)-4-methylthiazole-4(S)-carboxylic acid EU/3/03/180 Treatment of chronic iron overload requiring chelation therapy Genzyme Europe B.V. 12/12/2003
4,6,8-trihydroxy-10-(3,7,11-trimethyldodeca-2,6,10-trienyl)-5,10-dihydrodibenzo[b,e][1,4]diazepin-11-one EU/3/09/639 Treatment of glioma Albany Regulatory Consulting Limited 15/05/2009
4-benzyl-2-naphtalen-1-yl-1,2,4-thiadiazolidine-3,5-dione EU/3/09/679 Treatment of progressive supranuclear palsy NOSCIRA, S.A. 28/10/2009
5-10-Methylene-tetrahydrofolate EU/3/03/143 Treatment of pancreatic cancer in combination with 5-fluorouracil Interface International Consultancy Limited 11/06/2003
5,10-methylene-tetrahydrofolic acid EU/3/04/221 Treatment of pancreatic cancer in combination with 5-fluorouracil Interface International Consultancy Limited 02/09/2004
5'-O-(trans-9''-octadecenoyl)-1-beta-D-2'-deoxy-2',2'-difluorocytidine EU/3/09/680 Treatment of pancreatic cancer Clovis Oncology UK Limited 28/10/2009
8-cyclopentlyl-1,3-dipropylxanthine EU/3/01/030 Treatment of cystic fibrosis SciClone Pharmaceuticals Italy S.r.l 29/03/2001
a -1-acid glycoprotein EU/3/03/138 Treatment of tricyclic antidepressants poisoning Bio Products Laboratory 20/03/2003
a-1-acid glycoprotein EU/3/03/164 Treatment of cocaine poisoning Bio Products Laboratory 02/10/2003
Abarelix EU/3/10/771 Treatment of low-flow priapism Speciality European Pharma Ltd 20/09/2010
Abetimus sodium EU/3/01/064 Treatment of lupus nephritis La Jolla Limited 20/11/2001
Acetylcysteine EU/3/04/259 Treatment of idiopathic pulmonary fibrosis Zambon Group Spa 26/01/2005
Adeno associated viral vector containing the human calpain 3 gene EU/3/06/359 Treatment of calpainopathy Généthon 06/04/2006
Adeno-associated viral vector containing the human alpha-sarcoglycan gene EU/3/08/573 Treatment of alpha-sarcoglycanopathy Généthon 07/11/2008
Adeno-associated viral vector containing the human gamma-sarcoglycan gene EU/3/04/233 Treatment of gamma-sarcoglycanopathy Généthon 21/10/2004
Adeno-associated viral vector serotype 5 containing the human ABCA4 gene EU/3/08/609 Treatment of Stargardt’s disease Fondazione Telethon 06/02/2009
Adeno-associated viral vector serotype 8 containing the human AIPL1 gene EU/3/11/929 Treatment of Leber’s congenital amaurosis type 4 Fondazione Telethon 09/12/2011
Adenovirus-Interferon gamma coding DNA sequence EU/3/03/150 Treatment of cutaneous T-cell lymphoma Transgene S.A. 09/07/2003
Aldesleukin (inhalation use) EU/3/03/146 Treatment of renal cell carcinoma Chiron Corporation Ltd 30/06/2003
Alfimeprase EU/3/05/322 Treatment of acute peripheral arterial occlusion Quadramed Limited 28/10/2005
Allogeneic human umbilical cord tissue-derived cells EU/3/08/534 Treatment of retinitis pigmentosa Centocor B.V. 01/04/2008
Alpha-Galactosidase A EU/3/00/003 Treatment of Fabry disease Genzyme Europe B.V. 08/08/2000 Fabrazyme
EU/1/01/188
04/05/2001
Alpha-Galactosidase A EU/3/00/002 Treatment of Fabry disease Shire Human Genetic Therapies AB 08/08/2000 Replagal
EU/1/01/189
04/05/2001
Ambrisentan EU/3/10/790 Treatment of idiopathic pulmonary fibrosis Gilead Sciences International Ltd 01/10/2010
Amiloride hydrochloride dihydrate EU/3/03/147 Treatment of cystic fibrosis Pulmo Tec GmbH 30/06/2003
Amonafide L-malate EU/3/07/483 Treatment of acute myeloid leukaemia Antisoma Research Ltd 22/10/2007
anti-CD147 murine monoclonal IgM EU/3/02/123 Treatment of Graft versus Host Disease SangStat UK Limited 14/11/2002
Anti-EphA2 monoclonal antibody conjugated to maleimidocaproyl monomethylauristatin phenylalanine EU/3/09/682 Treatment of ovarian cancer MedImmune Ltd 28/10/2009
Anti-von Willebrand Aptamer EU/3/08/547 Treatment of thrombotic thrombocytopenic purpura FGK Representative Service GmbH 03/06/2008
Aplidine EU/3/03/151 Treatment of acute lymphoblastic leukaemia Pharma Mar S.A. 09/07/2003
Apomorphine (oromucosal use) EU/3/01/072 Treatment of off-periods in Parkinson's disease not responding to other oral treatment Orion Corporation 05/12/2001
Arsenic trioxide EU/3/01/032 Treatment of multiple myeloma Cephalon Europe 29/03/2001
Arsenic trioxide EU/3/00/017 Treatment of acute promyelocytic leukaemia Agence générale des équipements et produits de santé - Etablissement pharmaceutique des hôpitaux de Paris (AGEPS-EPHP) 17/01/2001
Arsenic trioxide EU/3/07/460 Treatment of acute myeloid leukaemia Cephalon Europe 02/08/2007
Arsenic trioxide EU/3/00/008 Treatment of acute promyelocytic leukaemia Cephalon Europe 18/10/2000 Trisenox
EU/1/02/204
05/03/2002
Arsenic trioxide EU/3/01/031 Treatment of myelodysplastic syndromes Cephalon Europe 29/03/2001
Autologous CD34+ cells transfected with retroviral vector containing the human gp91(phox) gene EU/3/06/393 Treatment of chronic granulomatous disease Vision 7 GmbH 28/08/2006
Autologous urothelial and smooth muscle cells EU/3/08/537 Treatment of spina bifida European Medical Advisory Services Limited 17/03/2008
Autologous urothelial and smooth muscle cells EU/3/08/574 Treatment of spinal cord injury European Medical Advisory Services Limited 07/11/2008
Axitinib EU/3/10/844 Treatment of renal cell carcinoma Pfizer Limited 23/02/2011
Bafetinib EU/3/10/731 Treatment of chronic myeloid leukaemia Eudax Srl 10/06/2010
Beraprost sodium EU/3/01/053 Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension Aventis Pharma S.A. 18/09/2001
bosentan EU/3/01/019 Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension Actelion Registration Ltd 14/02/2001 Tracleer
EU/1/02/220
15/05/2002
bosentan EU/3/03/139 Treatment of systemic sclerosis Actelion Registration Ltd 17/03/2003 Tracleer
EU/1/02/220
15/05/2002
bosentan EU/3/08/559 Treatment of idiopathic pulmonary fibrosis Actelion Registration Ltd 05/09/2008
Boswellia serrata resin extract EU/3/02/117 Treatment of peritumoral oedema derived from brain tumours Pharmasan GmbH 21/10/2002
Brivanib alaninate EU/3/11/918 Treatment of hepatocellular carcinoma Bristol-Myers Squibb Pharma EEIG 27/10/2011
Brostallicin EU/3/05/336 Treatment of soft tissue sarcoma Nuvisan Oncology SA 23/12/2005
Bryostatin-1 EU/3/02/099 Treatment of oesophageal cancer GPC Biotech AG 30/04/2002
Busulfan (Intravenous use) EU/3/00/011 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
Carbamic acid, [[4-[[3-[[4-[1-(4-hydroxyphenyl)-1-methyl-ethyl]phenoxy]methyl]phenyl]methoxy]-phenyl]iminomethyl]-,ethyl ester EU/3/02/105 Treatment of cystic fibrosis Boehringer Ingelheim International GmbH 26/06/2002
Carmustine (solution for intratumoral injection) EU/3/02/085 Treatment of glioma Icon Clinical Research UK Ltd 05/03/2002
Chimeric-anti-interleukin-6 monoclonal antibody EU/3/03/148 Treatment of renal cell carcinoma Janssen Biologics B.V. 30/06/2003
Chimeric-anti-interleukin-6 monoclonal antibody EU/3/09/642 Treatment of multiple myeloma Janssen Biologics B.V. 12/06/2009
Cholest-4-en-3-one, oxime EU/3/06/397 Treatment of amyotrophic lateral sclerosis Trophos SA 28/08/2006
Ciclosporin EU/3/04/196 Treatment of atopic keratoconjunctivitis Allergan Pharmaceuticals Ireland 14/04/2004
Ciclosporin (implant) EU/3/06/415 Prevention of rejection of corneal transplant Lux Biosciences GmbH 03/11/2006
Cilengitide EU/3/03/184 Treatment of glioma Merck KGaA 14/01/2004
Cladribine (subcutaneous use) EU/3/01/055 Treatment of indolent non-Hodgkin's lymphoma Lipomed GmbH 18/09/2001 Litak
EU/1/04/275
14/04/2004
Colistimethate sodium EU/3/02/088 Treatment of Pseudomonas aeruginosa lung infection (including colonisation) in cystic fibrosis Forest Laboratories UK Ltd 19/02/2002
Complement factor H EU/3/06/425 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
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} EU/3/07/472 Treatment of chronic non-infectious uveitis Lux Biosciences GmbH 14/09/2007
Davunetide EU/3/10/728 Treatment of progressive supranuclear palsy FGK Representative Service GmbH 23/03/2010
Deferoxamine mesilate EU/3/04/231 Treatment of traumatic spinal cord injury SCT Spinal Cord Therapeutics GmbH 20/10/2004
Deoxyribose phosphorothioate (5-tct-ccc-agc-gtg-cgc-cat-3) EU/3/01/063 Treatment of chronic lymphocytic leukaemia Voisin Consulting S.A.R.L. 20/11/2001
Deoxyribose phosphorothioate (5-tct-ccc-agc-gtg-cgc-cat-3) EU/3/01/065 Treatment of multiple myeloma Voisin Consulting S.A.R.L. 20/11/2001
Deuterium oxide EU/3/04/239 Treatment of pancreatic cancer BDD Berolina Drug Development GmbH 20/10/2004
Dexamethasone (intravitreal implant) EU/3/10/763 Treatment of non-infectious uveitis affecting the posterior segment of the eye Allergan Pharmaceuticals Ireland 04/08/2010
Dihydroartemisinin, piperaquine EU/3/07/468 Treatment of malaria Sigma-Tau Industrie Farmaceutiche Riunite S.p.A 03/08/2007
Diphenylcyclopropenone EU/3/06/379 Treatment of alopecia totalis Orfagen 29/06/2006
Diphenylcyclopropenone EU/3/06/380 Treatment of alopecia universalis Orfagen 29/06/2006
Doxorubicin carbon / iron magnetically targeted microparticles EU/3/02/112 Treatment of hepatocellular carcinoma Interface International Consultancy Limited 11/09/2002
Eflornithine hydrochloride EU/3/02/087 Treatment of Familial Adenomatous Polyposis (FAP) ILEX Services Limited 19/02/2002
Eltrombopag olamine EU/3/07/467 Treatment of idiopathic thrombocytopenic purpura GlaxoSmithKline Trading Services Limited 03/08/2007 Revolade
EU/1/10/612
11/03/2010
Engineered protein inhibitor of human neutrophil elastase EU/3/03/152 Treatment of cystic fibrosis Debioclinic SA 09/07/2003
Epothilone B EU/3/02/098 Treatment of ovarian cancer Novartis Europharm Limited 22/03/2002
Eptacog alfa (activated) EU/3/07/436 Treatment of post-neonatal intracerebral haemorrhage Novo Nordisk A/S 20/03/2007
Everolimus EU/3/11/894 Treatment of gastric cancer Novartis Europharm Limited 30/08/2011
everolimus EU/3/07/449 Treatment of renal cell carcinoma Novartis Europharm Limited 05/06/2007 Afinitor
EU/1/09/538
03/08/2009
everolimus EU/3/07/488 Treatment of gastro-entero-pancreatic neuroendocrine tumours Novartis Europharm Limited 14/11/2007
Fenretinide EU/3/06/426 Treatment of primary malignant bone tumours Cancer Research UK 26/01/2007
Fenretinide EU/3/06/427 Treatment of soft tissue sarcoma Cancer Research UK 30/01/2007
Fluorouracil EU/3/00/004 Treatment of glioblastoma Ethypharm S.A. 18/10/2000
Fomepizole EU/3/01/040 Treatment of methanol poisoning IDIS Ltd 30/05/2001
Givinostat EU/3/09/704 Treatment of systemic-onset juvenile idiopathic arthritis Italfarmaco S.p.A. 28/01/2010
Glutathione EU/3/06/361 Treatment of cystic fibrosis Mukoviszidose e.V. 11/04/2006
GM-CSF receptor antagonist EU/3/02/089 Treatment of juvenile myelomonocytic leukaemia British Biotech Pharmaceuticals Ltd 18/03/2002
Heparin sodium (inhalation use) EU/3/05/337 Treatment of cystic fibrosis Vectura Group plc 23/12/2005
H-Tyrosine-Glycine-Phenylalanine-Glycine-Glycine-OH EU/3/03/167 Treatment of chronic idiopathic myelofibrosis Abiogen Pharma S.p.A. 20/10/2003
Human C1-inhibitor EU/3/09/668 Treatment of angioedema caused by C1-inhibitor deficiency ViroPharma SPRL-BVBA 08/10/2009
Human dermal fibroblasts cultured on a bioresorbable polyglactin mesh EU/3/11/873 Treatment of epidermolysis bullosa Shire Pharmaceuticals Ireland Limited 21/06/2011
Human engineered monoclonal antibody specific for Transforming Growth Factor 1 EU/3/01/080 Treatment of systemic sclerosis Genzyme Europe B.V. 04/02/2002
Human engineered monoclonal antibody specific for Transforming Growth Factor 2 EU/3/01/042 Prevention of scarring in glaucoma filtration surgical procedures Cambridge Antibody Technology 30/05/2001
Human immunoglobulin EU/3/03/170 Treatment of polymyositis Orfagen 24/10/2003
Human immunoglobulin EU/3/03/169 Treatment of dermatomyositis Orfagen 20/10/2003
Human Milk Fat Globule 1 / Human Milk Fat Globule 1 - S-p-isothiocyanatobenzyl-diethylenetriaminepentaacetic acid for use with 90Yttrium EU/3/01/043 Treatment of ovarian cancer Antisoma Plc 30/05/2001
Human monoclonal antibody against HLA-DR EU/3/05/291 Treatment of Hodgkin’s lymphoma GPC Biotech AG 16/06/2005
Human monoclonal antibody against HLA-DR EU/3/06/358 Treatment of multiple myeloma GPC Biotech AG 28/02/2006
Human monoclonal antibody against HLA-DR EU/3/05/347 Treatment of chronic lymphocytic leukaemia GPC Biotech AG 24/01/2006
Human monoclonal antibody against inhibitory killer cell lg-like receptors EU/3/06/392 Treatment of acute myeloid leukaemia Innate Pharma 28/08/2006
Human monoclonal hepatitis B immunoglobulins EU/3/04/187 Prevention of hepatitis B re-infection following liver transplantation ICON Clinical Research (U.K.) Limited 23/02/2004
Human Staphylococcus aureus polyclonal immunoglobulin and human Staphylococcus epidermidis polyclonal immunoglobulin EU/3/05/335 Prevention of late onset sepsis in premature infants of less or equal than 32 weeks gestational age Omnicare Clinical Research 14/12/2005
Human transferrin conjugated to mutant diphtheria toxin EU/3/02/090 Treatment of gliomas Xenova Biomedix Limited 19/03/2002
Humanised Anti-HM1.24 Monoclonal Antibody EU/3/01/037 Treatment of multiple myeloma Chugai Pharma Europe Ltd 10/05/2001
Humanised monoclonal antibody against epidermal growth factor receptor EU/3/12/1029 Treatment of glioma AbbVie Ltd 09/08/2012
Humanized anti-KSA monoclonal antibody - human interleukin-2 fusion protein EU/3/02/097 Treatment of renal cell carcinoma Merck KGaA 22/03/2002
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 EU/3/06/398 Treatment of myasthenia gravis Debioclinic SA 28/08/2006
Ibuprofen EU/3/01/027 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
Ibuprofen EU/3/01/020 Treatment of patent ductus arteriosus Orphan Europe S.A.R.L. 14/02/2001 Pedea
EU/1/04/284
29/07/2004
Idelalisib EU/3/13/1186 Treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) Gilead Sciences International Ltd 05/08/2013
Idelalisib EU/3/13/1159 Treatment of follicular lymphoma Gilead Sciences International Ltd 17/07/2013
Idelalisib EU/3/13/1160 Treatment of lymphoplasmacytic lymphoma Gilead Sciences International Ltd 17/07/2013
Idelalisib EU/3/13/1173 Treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma Gilead Sciences International Ltd 05/08/2013
Idelalisib EU/3/13/1187 Treatment of splenic marginal zone lymphoma Gilead Sciences International Ltd 05/08/2013
Idelalisib EU/3/13/1172 Treatment of nodal marginal zone lymphoma Gilead Sciences International Ltd 05/08/2013
Iloprost EU/3/00/014 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
Imatinib EU/3/01/061 Treatment of malignant gastrointestinal stromal tumours Novartis Europharm Limited 20/11/2001 Glivec
EU/1/01/198
27/08/2001
Imatinib mesilate EU/3/05/306 Treatment of mastocytosis Novartis Europharm Limited 26/08/2005
Imatinib mesilate EU/3/05/305 Treatment of dermatofibrosarcoma protuberans Novartis Europharm Limited 26/08/2005 Glivec
EU/1/01/198
27/08/2001
Imatinib mesilate EU/3/05/320 Treatment of chronic eosinophilic leukaemia and the hypereosinophilic syndrome Novartis Europharm Limited 28/10/2005 Glivec
EU/1/01/198
27/08/2001
Imatinib mesilate EU/3/05/340 Treatment of myelodysplastic / myeloproliferative diseases Novartis Europharm Limited 23/12/2005 Glivec
EU/1/01/198
27/08/2001
Imatinib mesilate EU/3/05/304 Treatment of acute lymphoblastic leukaemia Novartis Europharm Limited 26/08/2005 Glivec
EU/1/01/198
27/08/2001
Imatinib mesylate EU/3/01/021 Treatment of chronic myeloid leukaemia Novartis Europharm Limited 14/02/2001 Glivec
EU/1/01/198
27/08/2001
Interferon gamma EU/3/05/281 Treatment of idiopathic pulmonary fibrosis InterMune Europe Ltd 27/05/2005
Iodine (131I) anti-CEA sheep-human chimeric monoclonal antibody monoclonal antibody labeled with iodine-131 EU/3/03/142 Treatment of pancreatic cancer Xenova Biomedix Limited 07/05/2003
Iodine (131I) chimeric IgG monoclonal antibody cG250 EU/3/02/095 Treatment of renal cell carcinoma Wilex AG 19/03/2002
Kifunensine EU/3/11/905 Treatment of alpha-sarcoglycanopathy Généthon 27/09/2011
Kifunensine EU/3/11/907 Treatment of delta-sarcoglycanopathy Généthon 27/09/2011
Kifunensine EU/3/11/906 Treatment of beta-sarcoglycanopathy Généthon 27/09/2011
Kifunensine EU/3/11/908 Treatment of gamma-sarcoglycanopathy Généthon 27/09/2011
Laronidase EU/3/01/022 Treatment of Mucopolysaccharidosis, type I Genzyme Europe B.V. 14/02/2001 Aldurazyme
EU/1/03/253
10/06/2003
Lentiviral vector containing the human Wiskott Aldrich syndrome protein gene EU/3/05/345 Treatment of Wiskott-Aldrich syndrome Généthon 24/01/2006
Linsitinib EU/3/12/977 Treatment of adrenal cortical carcinoma Astellas Pharma Europe B.V. 02/04/2012
Lintuzumab EU/3/09/627 Treatment of acute myeloid leukaemia Seattle Genetics UK Limited 30/04/2009
Lintuzumab EU/3/09/626 Treatment of myelodysplastic syndromes Seattle Genetics UK Limited 29/04/2009
Lumiliximab EU/3/08/528 Treatment of chronic lymphocytic leukaemia Biogen Idec Limited 04/02/2008
Lusupultide EU/3/07/457 Treatment of aspiration pneumonitis requiring intubation and mechanical ventilation Nycomed GmbH 10/07/2007
Lusupultide EU/3/00/016 Treatment of acute respiratory distress syndrome Nycomed GmbH 17/01/2001
Maytansinoid-conjugated humanised monoclonal antibody against CD56 EU/3/10/746 Treatment of Merkel cell carcinoma ImmunoGen Europe Limited 09/06/2010
Maytansinoid-conjugated humanised monoclonal antibody against CD56 EU/3/10/835 Treatment of multiple myeloma ImmunoGen Europe Limited 23/02/2011
Maytansinoid-conjugated humanised monoclonal antibody against CD56 EU/3/10/792 Treatment of small cell lung cancer ImmunoGen Europe Limited 01/10/2010
Mecasermin rinfabate EU/3/06/377 Treatment of patients with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH Insmed Europe Ltd 20/06/2006
Mecasermin rinfabate EU/3/06/378 Treatment of primary insulin-like growth factor-1 deficiency due to molecular or genetic defects Insmed Europe Ltd 20/06/2006
Melatonin EU/3/05/274 Non-24-Hour Sleep-Wake Disorder in blind people with no light perception ICON Clinical Research (U.K.) Limited 11/04/2005
Mitotane EU/3/02/102 Treatment of adrenal cortical carcinoma Laboratoire HRA Pharma 12/06/2002 Lysodren
EU/1/04/273
28/04/2004
Mitotane EU/3/02/113 Treatment of adrenal cortical carcinoma Agence générale des équipements et produits de santé - Etablissement pharmaceutique des hôpitaux de Paris (AGEPS-EPHP) 11/09/2002
Monoclonal antibody to human interleukin-6 EU/3/02/125 Treatment of post-transplant lymphoproliferative disorders EUSA Pharma SAS 18/12/2002
Murine anti-idiotypic antibody against OC125 antibody against CA125 antigen EU/3/03/155 Treatment of ovarian cancer Menarini Ricerche S.p.A. 09/07/2003
Murine monoclonal antibody to GD2 EU/3/09/644 Treatment of neuroblastoma United Therapeutics Europe Ltd 12/06/2009
Myristoylated-peptidyl-recombinant Human CD59 EU/3/02/114 Treatment of paroxysmal nocturnal haemoglubinuria Orexo AB 11/09/2002
Myristoylated-peptidyl-recombinant SCR1-3 of human complement receptor type I EU/3/02/108 Prevention of post transplantation graft dysfunction Orexo AB 30/07/2002
[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] EU/3/11/859 Treatment of chondrosarcoma Voisin Consulting S.A.R.L. 13/05/2011
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 EU/3/12/958 Diagnosis of positive folate receptor status in ovarian cancer Endocyte Europe B.V. 09/02/2012
N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4'-(trifluoromethoxy)[1,1'-biphenyl]-3-carboxamide EU/3/09/697 Treatment of naevoid basal cell carcinoma syndrome (Gorlin syndrome) Novartis Europharm Limited 25/11/2009
N-acetylsarcosyl-glycyl-L-valyl-D-allo-isoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-prolyl-N-ethylamide EU/3/03/181 Treatment of soft tissue sarcoma Abbott International European Office 12/12/2003
Nanoparticle albumin-bound paclitaxel EU/3/10/809 Treatment of pancreatic cancer Celgene Europe Limited 26/11/2010
N-carbamyl-L-glutamic acid EU/3/00/007 Treatment of N-acetylglutamate synthetase (NAGS) deficiency Orphan Europe S.A.R.L. 18/10/2000 Carbaglu
EU/1/02/246
24/01/2003
Nilotinib hydrochloride monohydrate EU/3/07/447 Treatment of gastro intestinal stromal tumours Novartis Europharm Limited 13/04/2007
Nolatrexed EU/3/03/165 Treatment of hepatocellular carcinoma Scirex Ltd 02/10/2003
Octocog alpha (liposomal) EU/3/09/655 Treatment of haemophilia A Bayer Schering Pharma AG 24/07/2009
Octovalent Pseudomonas aeruginosa O-polysaccharie-toxin A conjugate vaccine EU/3/01/076 Prevention of Pseudomonas aeruginosa infections in patients with cystic fibrosis Orphan Europe S.A.R.L. 11/12/2001
Ombrabulin EU/3/11/853 Treatment of soft tissue sarcoma Sanofi-Aventis groupe 15/04/2011
Opebacan EU/3/06/402 Treatment of meningococcal disease XOMA Ireland Ltd 28/08/2006
Pagibaximab EU/3/10/743 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
Panobinostat EU/3/09/721 Treatment of Hodgkin's lymphoma Novartis Europharm Limited 02/02/2010
Panobinostat lactate EU/3/07/464 Treatment of cutaneous T-cell lymphoma Novartis Europharm Limited 02/08/2007
Paromomycin sulphate EU/3/05/271 Treatment of visceral leishmaniasis Sestria Ltd 11/04/2005
Patupilone EU/3/09/688 Treatment of fallopian tube cancer Novartis Europharm Limited 05/11/2009
Patupilone EU/3/09/687 Treatment of primary peritoneal cancer Novartis Europharm Limited 05/11/2009
Pazopanib hydrochloride EU/3/06/382 Treatment of renal cell carcinoma Glaxo Group Limited 29/06/2006
Pegvisomant EU/3/01/023 Treatment of acromegaly Pfizer Limited 14/02/2001 Somavert
EU/1/02/240
13/11/2002
Pegylated recombinant factor VIIa EU/3/08/552 Treatment of haemophilia B Novo Nordisk A/S 03/06/2008
Pegylated recombinant factor VIIa EU/3/08/551 Treatment of haemophilia A Novo Nordisk A/S 04/06/2008
Pemetrexed disodium EU/3/01/060 Treatment of malignant mesothelioma Eli Lilly Nederland B.V. 17/09/2001
Perifosine EU/3/10/740 Treatment of multiple myeloma Æterna Zentaris GmbH 10/06/2010
Picoplatin EU/3/07/502 Treatment of small cell lung cancer Kendle International Ltd 06/12/2007
Pixantrone dimaleate EU/3/09/722 Treatment of diffuse large B-cell lymphoma CTI Life Sciences Ltd 02/02/2010
Plerixafor EU/3/11/931 Adjunctive treatment to cytotoxic therapy in acute myeloid leukaemia Genzyme Europe B.V. 09/12/2011
Plitidepsin EU/3/10/837 Treatment of primary myelofibrosis Pharma Mar S.A. 23/02/2011
Plitidepsin EU/3/10/838 Treatment of post-essential thrombocythaemia myelofibrosis Pharma Mar S.A. 23/02/2011
Plitidepsin EU/3/10/839 Treatment of post-polycythaemia vera myelofibrosis Pharma Mar S.A. 23/02/2011
Polyinosine-polycytidylic acid coupled with the polycationic polyethyleneimine EU/3/12/1000 Treatment of pancreatic cancer Bioncotech Therapeutics S.L. 06/06/2012
Porcine lung surfactant EU/3/01/057 Treatment of acute lung injury Leo Pharmaceutical Products 19/09/2001
Porfimer sodium (for use with photodynamic therapy) EU/3/02/086 Treatment of high-grade dysplasia in Barrett’s Esophagus Pinnacle Biologics B.V. 06/03/2002 PhotoBarr
EU/1/04/272
25/03/2004
Porfimer sodium (for use with photodynamic therapy) EU/3/04/215 Treatment of cholangiocarcinoma Pinnacle Biologics B.V. 29/07/2004
Progesterone EU/3/13/1101 Treatment of moderate and severe traumatic brain injury BHR Pharma Belgium 08/02/2013
Purified inactivated Japanese encephalitis SA14-4-2 virus vaccine EU/3/05/348 Prevention of Japanese encephalitis Intercell AG 24/01/2006 Ixiaro
EU/1/08/501
31/03/2009
(R, S)-3-(bromomethyl)-3-butanol-1-yl-diphosphate EU/3/04/218 Treatment of renal cell carcinoma Innate Pharma SAS 29/07/2004
Ranpirnase EU/3/01/033 Treatment of malignant mesothelioma MoRa Pharma GmbH 29/03/2001
Recombinant adeno-associated viral vector containing human acid alpha-glucosidase-gene EU/3/07/454 Treatment of glycogen storage disease type II (Pompe's disease) TMC Pharma Services Ltd 09/07/2007
Recombinant homodimer of the human annexin V EU/3/11/946 Prevention of ischaemia/reperfusion injury associated with solid organ transplantation Astellas Pharma Europe B.V. 11/01/2012
Recombinant human alpha-1 antitrypsin EU/3/02/100 Treatment of emphysema secondary to congenital alpha-1-antitrypsin deficiency Aptiv Solutions (UK) Ltd 30/04/2002
Recombinant human alpha-1-antitrypsin (respiratory use) EU/3/01/041 Treatment of emphysema secondary to congenital alpha 1-antitrypsin deficiency Talecris Biotherapeutics GmbH 30/05/2001
Recombinant human arylsulfatase A EU/3/03/158 Treatment of metachromatic leukodystrophy Shire Pharmaceuticals Ireland Limited 09/07/2003
Recombinant human C1-inhibitor EU/3/01/036 Treatment of angioedema caused by C1 inhibitor deficiency Pharming Group N.V. 11/05/2001
Recombinant human factor XIII (composed of two A subunits) EU/3/03/179 Treatment of hereditary factor XIII deficiency Novo Nordisk A/S 12/12/2003
Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 EU/3/04/236 Treatment of Type A extreme insulin resistance syndrome Insmed Europe Ltd 21/10/2004
Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 EU/3/04/235 Treatment of Type B extreme insulin resistance syndrome Insmed Europe Ltd 20/10/2004
Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 EU/3/03/159 Treatment of primary growth hormone insensitivity syndrome (Laron Syndrome) Insmed Europe Ltd 09/07/2003
Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 EU/3/04/237 Treatment of Rabson-Mendenhall syndrome Insmed Europe Ltd 21/10/2004
Recombinant human insulin-like growth factor-I / recombinant human insulin-like growth factor binding protein-3 EU/3/04/238 Treatment of Leprechaunism Insmed Europe Ltd 21/10/2004
Recombinant human interleukin-21 EU/3/04/226 Treatment of renal cell carcinoma Bristol-Myers Squibb International Corporation 02/09/2004
Recombinant human monoclonal antibody of the IgG1 kappa class against prostate stem cell antigen EU/3/12/1090 Treatment of pancreatic cancer Astellas Pharma Europe B.V. 24/01/2013
Recombinant human monoclonal antibody to hsp90 EU/3/01/073 Treatment of invasive fungal infections Novartis Europharm Limited 05/12/2001
Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class EU/3/07/439 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
Recombinant human monoclonal antibody to human IL-1beta of the IgG1/K class EU/3/08/527 Treatment of systemic-onset juvenile idiopathic arthritis Novartis Europharm Limited 04/02/2008
Recombinant human residue 41 glutamic acid to glutamine variant of Interferon-alfa-2b EU/3/08/606 Treatment of Behçet's disease Creabilis Therapeutics S.p.A. 19/01/2009
Recombinant human rod-derived cone viability factor EU/3/07/500 Treatment of retinitis pigmentosa Fovea Pharmaceuticals SA 29/11/2007
Recombinant human serum amyloid P EU/3/09/674 Prevention of scarring post glaucoma filtration surgery Appletree Europe S.à.r.l. 09/10/2009
Recombinant inhibitor of human plasma kallikrein EU/3/02/126 treatment of angioedema Dyax s.a. 18/12/2002
Recombinant microbial lipase EU/3/05/331 Treatment of malasbsorption due to exocrine pancreatic enzyme insufficiency Abbott Products GmbH 28/10/2005
Ribavirin EU/3/01/024 Treatment of haemorrhagic fever with renal syndrome ICN Pharmaceuticals Limited 14/02/2001
Ribavirin EU/3/01/029 Treatment of adenovirus infection in immunocompromised patients Valeant Pharmaceuticals Limited 08/03/2001
Sabarubicin EU/3/04/255 Treatment of small cell lung cancer Menarini Ricerche S.p.A. 21/12/2004
Sapropterin EU/3/05/308 Treatment of hyperphenylalaninemia Dr Gunter Schaub 26/08/2005
Sarsasapogenin EU/3/08/543 Treatment of amyotrophic lateral sclerosis Phytopharm plc 08/05/2008
Seocalcitol EU/3/01/052 Treatment of hepatocellular carcinoma Leo Pharmaceutical Products 31/07/2001
Sinapultide, dipalmitoylfosfatidylcholine, palmitoyloleoyl fosfatidylglycerol and palmitic acid EU/3/01/054 Treatment of Meconium Aspiration Syndrome Discovery Laboratories Inc 19/09/2001
Siplizumab EU/3/06/383 Treatment of T-cell and NK-cell neoplasms MedImmune, LLC 29/06/2006
Sitaxentan sodium EU/3/04/234 Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension Pfizer Limited 21/10/2004 Thelin
EU/1/06/353
10/08/2006
Sodium dichloroacetate EU/3/04/225 Treatment of systemic monochloroacetate poisoning Dr Anthony W. Fox 02/09/2004
Sodium oxybate EU/3/02/131 Treatment of narcolepsy UCB Pharma Ltd 03/02/2003 Xyrem
EU/1/05/312
13/10/2005
Sodium phenylbutyrate EU/3/12/949 Treatment of citrullinaemia type 1 Lucane Pharma SA 09/02/2012
Sodium phenylbutyrate EU/3/12/950 Treatment of ornithine transcarbamylase deficiency Lucane Pharma SA 09/02/2012
Sodium phenylbutyrate EU/3/12/951 Treatment of carbamoyl-phosphate synthase-1 deficiency Lucane Pharma SA 09/02/2012
Sodium valproate EU/3/05/309 Treatement of 5q muscular atrophy The Jennifer Trust for Spinal Muscular Atrophy 26/08/2005
Streptococcus pyogenes Su strain cells treated with benzylpenicillin EU/3/09/714 Treatment of congenital lymphatic malformations Theradex (Europe) Ltd 29/01/2010
Suberoylanilide hydroxamic acid EU/3/04/205 Treatment of cutaneous T-cell lymphoma Merck Sharp & Dohme Limited 21/06/2004
Sulfonated monophosphorylated mannose oligosaccharide EU/3/07/482 Treatment of hepatocellular carcinoma Constella Group Ltd 14/09/2007
Tacrolimus hydrate EU/3/03/185 Treatment of vernal keratoconjunctivitis Sucampo Pharma Europa Ltd 14/01/2004
Talampanel EU/3/09/631 Treatment of glioma Teva Pharma GmbH 29/04/2009
Talampanel EU/3/09/646 Treatment of amyotrophic lateral sclerosis Teva Pharma GmbH 12/06/2009
Tamibarotene EU/3/09/658 Treatment of acute promyelocytic leukaemia Eudax Srl 24/07/2009
Tecovirimat EU/3/10/799 Treatment of cowpox infection SIGA Pharmaceuticals (Europe) Ltd 01/10/2010
Tegafur / gimeracil / oteracil EU/3/07/515 Treatment of gastric cancer Taiho Pharma Europe Limited 20/12/2007
Terguride EU/3/13/1104 Treatment of systemic sclerosis High Tech Participations GmbH 08/02/2013
Thalidomide EU/3/01/047 Treatment of multiple myeloma Pharmion France 09/07/2001
Thalidomide EU/3/01/068 Treatment of multiple myeloma Kendle International Ltd 19/12/2001
Thalidomide EU/3/01/066 Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions Celgene Europe Limited 20/11/2001
Thalidomide EU/3/01/046 Treatment of Graft versus Host Disease Pharmion France 09/07/2001
Thalidomide EU/3/00/009 Treatment of erythema nodosum leprosum (ENL) or type II lepra reactions Pharmion France 29/12/2000
Tilarginine acetate EU/3/05/330 Treatment of cardiogenic shock Dr Ulrich Granzer 18/10/2005
Titanium dioxide and bisoctrizole EU/3/05/262 Treatment of UV-A and visible light-induced photosensitivity disorders (chronic actinic dermatitis, cutaneous porphyrias, actinic prurigo and solar urticaria) Orfagen 03/03/2005
Tobramycin (inhalation use) EU/3/09/613 Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis PARI Pharma GmbH 27/02/2009
Tobramycin (liposomal) EU/3/06/366 Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis Axentis Pharma Limited 11/04/2006
(-)-trans-3-(5,6-dihydro-4H-pyrrolo[3,2,1-ij]quinolin-1yl)-4-(1H-indol-3-yl) pyrrolidine-2, 5-dione EU/3/09/678 Treatment of soft tissue sarcoma Gregory Fryer Associates Ltd 08/10/2009
Troxacitabine EU/3/05/311 Treatment of acute myeloid leukaemia Pharm Research Associates (UK) Limited 26/08/2005
Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) EU/3/04/252 Treatment of chronic myeloid leukemia Accelsiors CRO & Consultancy Services GmbH 21/12/2004
Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) EU/3/04/254 Treatment of myelodysplastic syndromes Accelsiors CRO & Consultancy Services GmbH 21/12/2004
Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) EU/3/04/253 Treatment of acute myeloid leukaemia Accelsiors CRO & Consultancy Services GmbH 21/12/2004
Valproic acid, sodium EU/3/04/246 Treatment of Familial Adenomatous Polyposis TopoTarget Germany AG 30/11/2004
vandetanib EU/3/05/344 Treatment of medullary thyroid carcinoma AstraZeneca UK Limited 24/01/2006
Vatreptacog alfa (activated) EU/3/12/1030 Treatment of haemophilia A Novo Nordisk A/S 09/08/2012
Vatreptacog alfa (activated) EU/3/12/1032 Treatment of haemophilia B Novo Nordisk A/S 09/08/2012
Vorinostat EU/3/11/854 Treatment of multiple myeloma Merck Sharp & Dohme Limited 15/04/2011
Vorinostat EU/3/10/785 Treatment of malignant mesothelioma Merck Sharp & Dohme Limited 20/09/2010
Xaliproden hydrochloride EU/3/00/015 Treatment of amyotrophic lateral sclerosis Sanofi-Aventis 17/01/2001
Zinc acetate dihydrate EU/3/01/050 Treatment of Wilson's disease Orphan Europe S.A.R.L. 31/07/2001 Wilzin
EU/1/04/286
13/10/2004
(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 EU/3/05/267 Treatment of malignant gastrointestinal stromal tumours Pfizer Limited 10/03/2005 Sutent
EU/1/06/347
19/07/2006
(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 EU/3/05/268 Treatment of renal cell carcinoma Pfizer Limited 10/03/2005