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Human medicine European public assessment report (EPAR): Glustin
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 11/10/2000, Revision: 28, Withdrawn, Last updated: 17/10/2022PDF/696.95 KB) Czech (PDF/756.82 KB) (PDF 756.82 KB) Danish (PDF/676.89 KB … PDF/676.4 KB) Latvian (PDF/752.68 KB) (PDF 752.68 KB) Lithuanian (PDF/702.48 … -
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Human medicine European public assessment report (EPAR): Pandemic Influenza Vaccine H5N1 Baxter AG
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, Authorised, Last updated: 06/02/2023
looked at the ability of two 7.5 microgram doses of the vaccine … examined the effect of two 7.5 microgram doses of the vaccine … children, after the second 7.5-microgram dose, 85% of children … -
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Human medicine European public assessment report (EPAR): Aprovel
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 47, Authorised, Last updated: 16/02/2023is available as tablets (75, 150 and 300 mg). What is … hydrochlorothiazide. A starting dose of 75 mg can be used in patients … technique) or in patients over 75 years of age. In patients … -
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Human medicine European public assessment report (EPAR): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
, Revision: 25, Authorised, Last updated: 12/08/2022
PDF/102.13 KB) Danish (PDF/75.15 KB) (PDF 75.15 KB) Dutch (PDF 75.66 KB) (PDF 75.66 KB) Estonian (PDF/74.57 KB … -
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Human medicine European public assessment report (EPAR): Adynovi
rurioctocog alfa pegol, Hemophilia A
Date of authorisation: 08/01/2018,
, Revision: 8, Authorised, Last updated: 17/11/2022
PDF/102.37 KB) Danish (PDF/75.22 KB) (PDF 75.22 KB) Dutch (PDF 75.7 KB) (PDF 75.7 KB) Estonian (PDF/74.99 KB … -
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Human medicine European public assessment report (EPAR): Karvea
irbesartan, Hypertension
Date of authorisation: 26/08/1997, Revision: 45, Authorised, Last updated: 02/02/2023is available as tablets (75, 150 and 300 mg). What is … hydrochlorothiazide. A starting dose of 75 mg can be used in patients … technique) or in patients over 75 years of age. In patients … -
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Human medicine European public assessment report (EPAR): Xagrid
Anagrelide, Thrombocythemia, Essential
Date of authorisation: 15/11/2004, Revision: 40, Authorised, Last updated: 20/02/2023PDF/73.08 KB) French (PDF/75.65 KB) (PDF 75.65 KB) German (PDF/76.08 KB … PDF/103.24 KB) Hungarian (PDF/94.75 KB) (PDF/94 75 KB) Italian (PDF/73.58 KB … -
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Human medicine European public assessment report (EPAR): CoAprovel
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 14/10/1998, Revision: 46, Authorised, Last updated: 16/02/2023PDF/97.41 KB) Dutch (PDF/76.75 KB) (PDF/76 75 KB) Estonian (PDF 75.63 KB) (PDF 75.63 KB) Finnish (PDF/96.65 KB … -
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Human medicine European public assessment report (EPAR): Entresto
sacubitril, valsartan, Heart Failure
Date of authorisation: 19/11/2015, Revision: 15, Authorised, Last updated: 02/09/2022PDF/74.95 KB) Dutch (PDF/75.77 KB) (PDF 75.77 KB) Estonian (PDF/74.98 KB … PDF/74.98 KB) Finnish (PDF/75.58 KB) (PDF 75.58 KB) French (PDF/76.61 KB … -
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Human medicine European public assessment report (EPAR): Plenadren
hydrocortisone, Adrenal Insufficiency
Date of authorisation: 03/11/2011, Revision: 13, Authorised, Last updated: 06/12/2022PDF/76.55 KB) Estonian (PDF/75.02 KB) (PDF 75.02 KB) Finnish (PDF 75.63 KB) (PDF 75.63 KB) French (PDF/77.21 KB … -
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Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, Revision: 23, Authorised, Last updated: 16/02/2023PDF/100.43 KB) Danish (PDF/75.17 KB) (PDF 75.17 KB) Dutch (PDF 75.79 KB) (PDF 75.79 KB) Estonian (PDF/84.19 KB … -
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Human medicine European public assessment report (EPAR): Memantine Accord
memantine hydrochloride, Alzheimer Disease
Date of authorisation: 03/12/2013,
, Revision: 7, Authorised, Last updated: 13/01/2022
Summary for the public (PDF/75.62 KB … 8400 Facsimile +44 (0)20 7523 7129 E-mail info@ema.europa.eu … -
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Human medicine European public assessment report (EPAR): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,, Revision: 14, Withdrawn, Last updated: 09/07/2021
PDF/698.34 KB) Czech (PDF/753.87 KB) (PDF 753.87 KB) Danish (PDF/677.04 KB … PDF/677.05 KB) Latvian (PDF/752.77 KB) (PDF 752.77 KB) Lithuanian (PDF/703.95 … -
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Human medicine European public assessment report (EPAR): Pelgraz
pegfilgrastim, Neutropenia
Date of authorisation: 21/09/2018,, 
, Revision: 8, Authorised, Last updated: 23/01/2023
PDF/73.85 KB) Dutch (PDF/75.71 KB) (PDF 75.71 KB) Estonian (PDF/73.48 KB … PDF/95.13 KB) Italian (PDF/75.07 KB) (PDF 75.07 KB) Latvian (PDF/95.47 KB … -
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Veterinary medicine European public assessment report (EPAR): Galliprant
grapiprant, Dogs
Date of authorisation: 09/01/2018, Revision: 5, Authorised, Last updated: 17/08/2021PDF/100.36 KB) Danish (PDF/75.3 KB) (PDF 75.3 KB) Dutch (PDF 75.89 KB) (PDF 75.89 KB) Estonian (PDF/74.81 KB … -
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Human medicine European public assessment report (EPAR): Lyxumia
lixisenatide, Diabetes Mellitus, Type 2
Date of authorisation: 31/01/2013, Revision: 17, Authorised, Last updated: 02/02/2023PDF/79 KB) Estonian (PDF/75.8 KB) (PDF 75.8 KB) Finnish (PDF 75.49 KB) (PDF 75.49 KB) French (PDF/101.58 KB … -
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Human medicine European public assessment report (EPAR): ReFacto AF
moroctocog alfa, Hemophilia A
Date of authorisation: 13/04/1999, Revision: 40, Authorised, Last updated: 08/11/2022PDF/76.67 KB) Estonian (PDF/75.21 KB) (PDF 75.21 KB) Finnish (PDF 75.79 KB) (PDF 75.79 KB) French (PDF/77.73 KB … -
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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: 25/07/2022Summary for the public (PDF/75.85 KB … is acknowledged. EMA/753310/2016 EMEA/H/C/004075 EPAR … readily. Afstyla EMA/753310/2016 Page 2/3 The active substance … -
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Human medicine European public assessment report (EPAR): Semglee
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,, , Revision: 6, Authorised, Last updated: 14/01/2022
PDF/73.11 KB) French (PDF/75.54 KB) (PDF 75.54 KB) German (PDF 75.82 KB) (PDF 75.82 KB) Greek (PDF/110.6 KB … -
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Human medicine European public assessment report (EPAR): Skilarence
dimethyl fumarate, Psoriasis
Date of authorisation: 23/06/2017, Revision: 11, Authorised, Last updated: 27/09/2022of patients who achieved a 75% reduction in their score … of patients who achieved a 75% reduction in their score … -
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Human medicine European public assessment report (EPAR): Kerendia
Finerenone, Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2
Date of authorisation: 16/02/2022,, Revision: 1, Authorised, Last updated: 20/02/2023
PDF/77.04 KB) Croatian (PDF/75.68 KB) (PDF 75.68 KB) Czech (PDF/64.25 KB … PDF/55.97 KB) Latvian (PDF/75.35 KB) (PDF 75.35 KB) Lithuanian (PDF/76.16 … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,, Revision: 18, Authorised, Last updated: 18/01/2022
Summary for the public (PDF/75.64 KB … 8400 Facsimile +44 (0)20 7523 7129 E-mail info@ema.europa.eu … -
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Human medicine European public assessment report (EPAR): Descovy
emtricitabine, tenofovir alafenamide, HIV Infections
Date of authorisation: 21/04/2016, Revision: 20, Authorised, Last updated: 17/02/2023Summary for the public (PDF/75.65 KB … -
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Human medicine European public assessment report (EPAR): Xadago
safinamide methanesulfonate, Parkinson Disease
Date of authorisation: 23/02/2015, Revision: 12, Authorised, Last updated: 26/10/2021PDF/79.76 KB) Finnish (PDF/75.02 KB) (PDF 75.02 KB) French (PDF 75.93 KB) (PDF 75.93 KB) German (PDF/77.89 KB … -
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Human medicine European public assessment report (EPAR): Dacogen
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,
, Revision: 16, Authorised, Last updated: 20/07/2021
PDF/102.41 KB) Danish (PDF/75.19 KB) (PDF 75.19 KB) Dutch (PDF 75.74 KB) (PDF 75.74 KB) Estonian (PDF/74.9 KB …