7759 results
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Human medicine European public assessment report (EPAR): Topotecan Eagle
topotecan (as hydrochloride), Carcinoma; Small Cell Lung Carcinoma
Date of authorisation: 22/12/2011,
, Revision: 2, Withdrawn, Last updated: 14/11/2014
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Human medicine European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 33, Authorised, Last updated: 28/09/2022PDF/111.44 KB) (PDF/111.44 KB) German (PDF/109.33 KB) (PDF/109.33 … -
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Human medicine European public assessment report (EPAR): Pioglitazone Teva Pharma
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 13, Withdrawn, Last updated: 30/08/2022
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Human medicine European public assessment report (EPAR): Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
human IgG1 monoclonal antibody specific for human interleukin-1 alpha, Colorectal Neoplasms
Date of refusal: 08/12/2017, Refused, Last updated: 13/11/2017authorisation is XBiotech Germany GmbH. The company requested … -
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Human medicine European public assessment report (EPAR): Jylamvo
Methotrexate, Arthritis, Psoriatic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Psoriasis; Arthritis, Rheumatoid; Arthritis
Date of authorisation: 29/03/2017, Revision: 11, Authorised, Last updated: 30/01/2023PDF/94.73 KB) (PDF/94.73 KB) German (PDF/83.57 KB) (PDF/83.57 … -
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Human medicine European public assessment report (EPAR): Alecensa
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,
, Revision: 13, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Cresemba
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,
, Revision: 15, Authorised, Last updated: 17/01/2023
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Human medicine European public assessment report (EPAR): Picato
Ingenol mebutate, Keratosis, Actinic
Date of authorisation: 15/11/2012,, Revision: 10, Withdrawn, Last updated: 31/07/2020
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Human medicine European public assessment report (EPAR): Helixate NexGen
octocog alfa, Hemophilia A
Date of authorisation: 04/08/2000, Revision: 31, Withdrawn, Last updated: 02/06/2020PDF/652.41 KB) (PDF/652.41 KB) German (PDF/652.26 KB) (PDF/652.26 … -
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Human medicine European public assessment report (EPAR): Iblias
octocog alfa, Hemophilia A
Date of authorisation: 18/02/2016,, Revision: 4, Withdrawn, Last updated: 18/02/2020
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Human medicine European public assessment report (EPAR): Beyfortus (updated)
nirsevimab,
Date of authorisation: 31/10/2022,, Revision: 1, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Flucelvax Tetra (updated)
A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type), Influenza, Human
Date of authorisation: 12/12/2018,, Revision: 12, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Inrebic (updated)
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,, , Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Afstyla
lonoctocog alfa, Hemophilia A
Date of authorisation: 04/01/2017, Revision: 10, Authorised, Last updated: 25/07/2022PDF/76.8 KB) (PDF/76.8 KB) German (PDF/76.76 KB) (PDF/76.76 … -
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Human medicine European public assessment report (EPAR): Aldara (updated)
imiquimod, Condylomata Acuminata; Keratosis; Keratosis, Actinic; Carcinoma, Basal Cell
Date of authorisation: 18/09/1998, Revision: 30, Authorised, Last updated: 20/03/2023PDF/44.67 KB) (PDF/44.67 KB) German (PDF/47.51 KB) (PDF/47.51 … -
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Human medicine European public assessment report (EPAR): Vydura (updated)
Rimegepant, Migraine Disorders
Date of authorisation: 25/04/2022,, Revision: 4, Authorised, Last updated: 21/03/2023
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Human medicine European public assessment report (EPAR): Symtuza (updated)
darunavir, cobicistat, emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/09/2017, Revision: 17, Authorised, Last updated: 21/03/2023PDF/82.57 KB) (PDF/82.57 KB) German (PDF/82.93 KB) (PDF/82.93 … -
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Veterinary medicine European public assessment report (EPAR): Nobivac Piro
babesia canis, inactivated, babesia rossi, inactivated, Dogs
Date of authorisation: 02/09/2004, Revision: 4, Withdrawn, Last updated: 30/05/2013PDF/513.51 KB) (PDF/513.51 KB) German (PDF/520.41 KB) (PDF/520.41 … -
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Human medicine European public assessment report (EPAR): Enerzair Breezhaler (updated)
indacaterol, glycopyrronium bromide, mometasone, Asthma
Date of authorisation: 03/07/2020, Revision: 4, Authorised, Last updated: 17/03/2023PDF/115.16 KB) (PDF/115.16 KB) German (PDF/116.59 KB) (PDF/116.59 … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Teva
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Date of authorisation: 12/12/2022,, Authorised, Last updated: 21/12/2022
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Veterinary medicine European public assessment report (EPAR): Ingelvac PCV FLEX
porcine circovirus type 2 ORF2 protein, Pigs
Date of authorisation: 24/05/2017, Revision: 2, Withdrawn, Last updated: 28/06/2019PDF/356.76 KB) (PDF/356.76 KB) German (PDF/356.65 KB) (PDF/356.65 … -
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Human medicine European public assessment report (EPAR): Repaglinide Krka
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/11/2009,, Revision: 8, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Enyglid
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 13/10/2009,, Revision: 9, Authorised, Last updated: 14/12/2022
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Human medicine European public assessment report (EPAR): Senshio (updated)
ospemifene, Postmenopause
Date of authorisation: 14/01/2015,, Revision: 13, Authorised, Last updated: 08/03/2023
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Human medicine European public assessment report (EPAR): Fetcroja (updated)
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 5, Authorised, Last updated: 08/03/2023
PDF/108.32 KB) (PDF/108.32 KB) German (PDF/110.4 KB) (PDF/110.4 …