4678 results
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Human medicine European public assessment report (EPAR): Telmisartan Teva
Telmisartan, Hypertension
Date of authorisation: 25/01/2010,
, Revision: 11, Withdrawn, Last updated: 17/09/2021
PDF/1.27 MB) (PDF/1.27 MB) Italian (PDF/1.2 MB) (PDF/1.2 MB … formally requested by the Italian medicines agency, to examine … -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001343-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: XContact for public enquiries Zentiva, k.s. Czech Republic blanka.zoubkova@zentiva.com … application submitted by Zentiva, k.s. on 2 July 2012 under … decision is addressed to Zentiva, k.s., U kabelovny 130, 102 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: XContact for public enquiries Zentiva, k.s. Czech Republic blanka.zoubkova@zentiva.com … application submitted by Zentiva, k.s. on 2 July 2012 under … decision is addressed to Zentiva, k.s., U kabelovny 130, 102 … -
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Human medicine European public assessment report (EPAR): Dimethyl fumarate Mylan (updated)
dimethyl fumarate, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/05/2022,, Revision: 4, Authorised, Last updated: 08/09/2023
PDF/166.8 KB) (PDF/166.8 KB) Italian (PDF/145.47 KB) (PDF/145.47 … -
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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Date of authorisation: 28/02/2011,, Revision: 16, Withdrawn, Last updated: 21/03/2023
PDF/727.6 KB) (PDF/727.6 KB) Italian (PDF/662.83 KB) (PDF/662.83 … -
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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
PDF/705.31 KB) (PDF/705.31 KB) Italian (PDF/651.97 KB) (PDF/651.97 … -
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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/595.88 KB) (PDF/595.88 KB) Italian (PDF/515.38 KB) (PDF/515.38 … -
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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
PDF/701.4 KB) (PDF/701.4 KB) Italian (PDF/655.63 KB) (PDF/655.63 … -
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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
PDF/728.2 KB) (PDF/728.2 KB) Italian (PDF/661.4 KB) (PDF/661.4 … -
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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
PDF/706.14 KB) (PDF/706.14 KB) Italian (PDF/638.72 KB) (PDF/638.72 … -
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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: 02/03/2023PDF/704.25 KB) (PDF/704.25 KB) Italian (PDF/637.55 KB) (PDF/637.55 … -
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Human medicine European public assessment report (EPAR): Nimvastid
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 11/05/2009,, Revision: 10, Authorised, Last updated: 22/02/2023
PDF/210.32 KB) (PDF/210.32 KB) Italian (PDF/103.97 KB) (PDF/103.97 … -
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Human medicine European public assessment report (EPAR): Rasilez
aliskiren, Hypertension
Date of authorisation: 22/08/2007, Revision: 27, Authorised, Last updated: 23/02/2023PDF/100.04 KB) (PDF/100.04 KB) Italian (PDF/79.09 KB) (PDF/79.09 … -
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Human medicine European public assessment report (EPAR): Glidipion (previously Pioglitazone Actavis Group)
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/03/2012,, Revision: 8, Withdrawn, Last updated: 17/10/2022
PDF/767.3 KB) (PDF/767.3 KB) Italian (PDF/700.65 KB) (PDF/700.65 … -
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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
PDF/766.16 KB) (PDF/766.16 KB) Italian (PDF/696.38 KB) (PDF/696.38 … -
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Human medicine European public assessment report (EPAR): Sildenafil Actavis
sildenafil, Erectile Dysfunction
Date of authorisation: 10/12/2009,, Revision: 16, Authorised, Last updated: 01/06/2023
PDF/112.57 KB) (PDF/112.57 KB) Italian (PDF/89.98 KB) (PDF/89.98 … -
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Human medicine European public assessment report (EPAR): Gavreto (updated)
pralsetinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 18/11/2021,, 
, Revision: 6, Authorised, Last updated: 28/08/2023
PDF/141.5 KB) (PDF/141.5 KB) Italian (PDF/117.55 KB) (PDF/117.55 … -
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Human medicine European public assessment report (EPAR): Emadine
emedastine difumarate, Conjunctivitis, Allergic
Date of authorisation: 27/01/1999, Revision: 26, Authorised, Last updated: 10/07/2022PDF/91.16 KB) (PDF/91.16 KB) Italian (PDF/95.72 KB) (PDF/95.72 … -
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Human medicine European public assessment report (EPAR): Azilect
rasagiline, Parkinson Disease
Date of authorisation: 21/02/2005, Revision: 23, Authorised, Last updated: 18/08/2023PDF/96.68 KB) (PDF/96.68 KB) Italian (PDF/75.07 KB) (PDF/75.07 … -
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Human medicine European public assessment report (EPAR): Buvidal
buprenorphine, Opioid-Related Disorders
Date of authorisation: 20/11/2018, Revision: 8, Authorised, Last updated: 16/08/2023PDF/113.76 KB) (PDF/113.76 KB) Italian (PDF/93.18 KB) (PDF/93.18 … -
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Human medicine European public assessment report (EPAR): Fotivda
tivozanib, Carcinoma, Renal Cell
Date of authorisation: 24/08/2017,, Revision: 9, Authorised, Last updated: 17/07/2023
PDF/90.4 KB) (PDF/90.4 KB) Italian (PDF/72.18 KB) (PDF/72.18 … -
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Human medicine European public assessment report (EPAR): Pemetrexed Lilly
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 14/09/2015,, Revision: 7, Withdrawn, Last updated: 26/11/2021
PDF/723.57 KB) (PDF/723.57 KB) Italian (PDF/660.44 KB) (PDF/660.44 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001538-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: Xessential hypertension Oral use Zentiva k.s. Czech Republic E-mail … application submitted by Zentiva k.s. on 9 July 2013 under … decision is addressed to Zentiva k.s., U kabelovny 130, 102 … -
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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
PDF/722.62 KB) (PDF/722.62 KB) Italian (PDF/663.19 KB) (PDF/663.19 … -
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Human medicine European public assessment report (EPAR): Xeplion
paliperidone palmitate, Schizophrenia
Date of authorisation: 04/03/2011, Revision: 15, Authorised, Last updated: 22/06/2023PDF/99.01 KB) (PDF/99.01 KB) Italian (PDF/79.4 KB) (PDF/79.4 KB …