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374 results
Medicine
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG (updated)
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,
, Revision: 8, Withdrawn, Last updated: 13/09/2023
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Veterinary medicine European public assessment report (EPAR): Nobivac Myxo-RHD (updated)
live myxoma-vectored rabbit-haemorrhagic-disease virus strain 009, Rabbits
Date of authorisation: 07/09/2011, Revision: 4, Withdrawn, Last updated: 12/09/2023 -
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,
, 
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, Revision: 6, Withdrawn, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 19, Withdrawn, Last updated: 04/08/2023 -
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Human medicine European public assessment report (EPAR): Lenalidomide Krka d.d.
lenalidomide hydrochloride hydrate, Multiple Myeloma; Lymphoma, Follicular; Myelodysplastic Syndromes
Date of authorisation: 11/02/2021,
, Revision: 2, Withdrawn, Last updated: 10/07/2023
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Veterinary medicine European public assessment report (EPAR): Aftovaxpur DOE
Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063., Pigs; Cattle; Sheep
Date of authorisation: 15/07/2013,
Date of refusal: 16/05/2013, Revision: 8, Withdrawn, Last updated: 04/07/2023 -
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Veterinary medicine European public assessment report (EPAR): Comfortis
spinosad, Dogs; Cats
Date of authorisation: 11/02/2011, Revision: 12, Withdrawn, Last updated: 26/06/2023 -
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Human medicine European public assessment report (EPAR): Nitisinone MDK (previously Nitisinone MendeliKABS)
nitisinone, Tyrosinemias
Date of authorisation: 24/08/2017,, Revision: 6, Withdrawn, Last updated: 14/06/2023
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Human medicine European public assessment report (EPAR): Pioglitazone Teva
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 12, Withdrawn, Last updated: 04/05/2023
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Human medicine European public assessment report (EPAR): NeuroBloc
botulinum toxin type B, Torticollis
Date of authorisation: 22/01/2001, Revision: 33, Withdrawn, Last updated: 04/05/2023 -
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Human medicine European public assessment report (EPAR): Inpremzia
insulin human (rDNA), Diabetes Mellitus
Date of authorisation: 25/04/2022,, 
, Withdrawn, Last updated: 20/04/2023
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Human medicine European public assessment report (EPAR): DepoCyte
cytarabine, Meningeal Neoplasms
Date of authorisation: 11/07/2001, Revision: 15, Withdrawn, Last updated: 03/04/2023 -
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Human medicine European public assessment report (EPAR): Dasatinib Accord
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Withdrawn, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accordpharma
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Withdrawn, Last updated: 30/03/2023
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Human medicine European public assessment report (EPAR): Lamivudine/Zidovudine Teva
lamivudine, zidovudine, HIV Infections
Date of authorisation: 28/02/2011,, Revision: 16, Withdrawn, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 13, Withdrawn, Last updated: 20/03/2023
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Human medicine European public assessment report (EPAR): Temozolomide Sandoz
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 06/03/2023
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Human medicine European public assessment report (EPAR): Hepsera
adefovir dipivoxil, Hepatitis B, Chronic
Date of authorisation: 06/03/2003, Revision: 27, Withdrawn, Last updated: 06/03/2023 -
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Human medicine European public assessment report (EPAR): Kogenate Bayer
octocog alfa, Hemophilia A
Date of authorisation: 04/08/2000, Revision: 30, Withdrawn, Last updated: 02/03/2023 -
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Human medicine European public assessment report (EPAR): Temozolomide Hexal
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 27/02/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka d.d.
darunavir, HIV Infections
Date of authorisation: 18/01/2018,, Revision: 8, Withdrawn, Last updated: 03/02/2023
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Human medicine European public assessment report (EPAR): Trogarzo
Ibalizumab, HIV Infections
Date of authorisation: 26/09/2019,, Revision: 7, Withdrawn, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): IntronA
interferon alfa-2b, Carcinoid Tumor; Leukemia, Hairy Cell; Lymphoma, Follicular; Hepatitis B, Chronic; Hepatitis C, Chronic; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Melanoma; Multiple Myeloma
Date of authorisation: 09/03/2000, Revision: 34, Withdrawn, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Macugen
pegaptanib, Wet Macular Degeneration
Date of authorisation: 31/01/2006, Revision: 15, Withdrawn, Last updated: 02/12/2022