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3454 results
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Opinion on medicine for use outside EU: Mosquirix (updated)
RTS,S [Portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS), and combined with hepatitis B surface antigen (S)], , ATC code: J07 Opinion number: H-W-2300, Positive opinion Opinion date: 23/07/2015, Last updated: 01/08/2022 -
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Opinion on medicine for use outside EU: Fexinidazole Winthrop (updated)
fexinidazole, Trypanosomiasis, African, ATC code: P01CA03 Opinion number: H-W-2320, Positive opinion Opinion date: 15/11/2018, Last updated: 01/08/2022 -
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Opinion on medicine for use outside EU: Insulatard (updated)
Insulin human (RDNA), Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005780, Positive opinion Opinion date: 22/04/2022, Last updated: 28/07/2022 -
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Opinion on medicine for use outside EU: Actrapid (updated)
insulin human, Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005779, Positive opinion Opinion date: 22/04/2022, Last updated: 22/07/2022 -
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Opinion on medicine for use outside EU: Dapivirine Vaginal Ring 25 mg (updated)
dapivirine, Anti-HIV Agents, ATC code: G01AX17 Opinion number: H-W-2168, Positive opinion Opinion date: 23/07/2020, Last updated: 20/07/2022 -
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Opinion on medicine for use outside EU: Pyramax
artesunate, pyronaridine, Malaria, ATC code: P01BF06 Opinion number: H-W-2319, Positive opinion Opinion date: 16/02/2012, Last updated: 16/06/2022 -
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Opinion on medicine for use outside EU: Umbipro
chlorhexidine digluconate, Soft Tissue Infections, ATC code: D08AC02 Opinion number: H-W-3799, Withdrawn opinion Opinion date: 28/04/2016, Last updated: 08/04/2022 -
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Opinion on medicine for use outside EU: Globorix
Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis (inactivated), Haemophilus influenzae type b polysaccharide, Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid, Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid, hepatitis B surface antigen, Immunization; Hepatitis B; Diphtheria-Tetanus-Pertussis Vaccine; Bordetella pertussis; Haemophilus influenzae type b; Neisseria meningitidis, Serogroup A; Neisseria meningitidis, Serogroup C, ATC code: J07CA09 Opinion number: H/W/848, Withdrawn application , Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK)
lamivudine, zidovudine, HIV Infections, ATC code: J05AR01 Opinion number: H/W/672, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Lamivudine ViiV
lamivudine, HIV Infections, ATC code: J05AF05 Opinion number: H/W/673, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Tritanrix HB
Bordetella pertussis (inactivated), Diphtheria toxoid, hepatitis B surface antigen, tetanus toxoid, Hepatitis; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, ATC code: J07CA05 Opinion number: H-W-3838, Withdrawn opinion Opinion date: 19/12/2013, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Hemoprostol
misoprostol, Postpartum Hemorrhage, ATC code: G02AD06 Opinion number: H-W-2652, Withdrawn opinion Opinion date: 23/01/2014, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Aluvia
lopinavir, ritonavir, HIV Infections, ATC code: J05AR10 Opinion number: H-W-764, Positive opinion Opinion date: 21/09/2006, Last updated: 20/08/2020 -
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Opinion on medicine for use outside EU: Hexaxim
Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain), hepatitis B surface antigen, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, ATC code: J07CA09 Opinion number: H-W-2495, Withdrawn opinion Opinion date: 21/06/2012, Last updated: 06/07/2018 -
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Orphan designation: autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo for: Treatment of ovarian cancer (updated)
Date of designation: 16/04/2018, Withdrawn, Last updated: 17/08/2022 -
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Orphan designation: Recombinant truncated N-terminal fragment of human lens epithelium-derived growth factor for: Treatment of retinitis pigmentosa (updated)
Date of designation: 23/08/2017, Withdrawn, Last updated: 12/08/2022 -
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Orphan designation: allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2, dexamethasone for: Treatment in haematopoietic stem cell transplantation (updated)
Date of designation: 18/11/2016, Withdrawn, Last updated: 10/08/2022 -
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Orphan designation: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide (ivacaftor) for: Treatment of cystic fibrosis (updated)
Date of designation: 08/07/2008, Expired, Last updated: 10/08/2022 -
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Orphan designation: recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein, Eladocagene exuparvovec for: Treatment of aromatic L-amino acid decarboxylase deficiency (updated)
Date of designation: 18/11/2016, Positive, Last updated: 10/08/2022 -
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Orphan designation: 2-Chloro-N6-(3-iodobenzyl)adenosine-5'-N-methyluronamide (namodenoson) for: Treatment of hepatocellular carcinoma (updated)
Date of designation: 09/10/2015, Positive, Last updated: 10/08/2022 -
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Orphan designation: Adenovirus associated viral vector serotype 4 containing the human RPE65 gene for: Treatment of retinitis pigmentosa (updated)
Date of designation: 14/11/2007, Positive, Last updated: 09/08/2022 -
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Orphan designation: Adenovirus associated viral vector serotype 4 containing the human RPE65 gene for: Treatment of Leber's congenital amaurosis (updated)
Date of designation: 22/10/2007, Positive, Last updated: 09/08/2022 -
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Orphan designation: adenovirus associated viral vector serotype 5 containing the human pde6β gene for: Treatment of retinitis pigmentosa (updated)
Date of designation: 19/06/2013, Positive, Last updated: 09/08/2022 -
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Orphan designation: Adeno-associated viral vector serotype 5 containing the human RLBP1 gene for: Treatment of retinitis pigmentosa (updated)
Date of designation: 14/10/2016, Positive, Last updated: 09/08/2022 -
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Orphan designation: Mazindol for: Treatment of narcolepsy (updated)
Date of designation: 09/10/2015, Positive, Last updated: 03/08/2022