4576 results
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Press release: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU
Last updated: 15/10/2018under increased supervision; Aurobindo Pharma stopped from supplying … Aurobindo Pharma stopped from supplying … -
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News: Update on investigation by Italian authorities into the supply of stolen medicines
Last updated: 03/06/2014Update on investigation by Italian authorities into the supply … authorities in Italy and Germany: Italian medicines agency (AIFA) Paul … announced investigation by Italian authorities into the supply … -
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Referral: Didanosine
didanosine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/09/2013, EC decision date: 20/11/2013, Last updated: 10/12/2013was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … was Didanosine reviewed? Aurobindo Pharma (Malta) Limited submitted … administration France Aurobindo Pharma (Malta) Limited … -
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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, Revision: 8, Withdrawn, Last updated: 17/10/2022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): Topotecan Eagle
topotecan (as hydrochloride), Carcinoma; Small Cell Lung Carcinoma
Date of authorisation: 22/12/2011,, Revision: 2, Withdrawn, Last updated: 14/11/2014
PDF/1016.43 KB) (PDF/1016.43 KB) Italian (PDF/960.03 KB) (PDF/960.03 … -
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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Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 06/03/2023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Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 27/02/2023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): Ceprotin
human protein C, Purpura Fulminans; Protein C Deficiency
Date of authorisation: 16/07/2001, Revision: 18, Authorised, Last updated: 02/02/2023PDF/159.82 KB) (PDF/159.82 KB) Italian (PDF/136.83 KB) (PDF/136.83 … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Accord
cabazitaxel, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 28/08/2020,, Revision: 3, Authorised, Last updated: 16/01/2023
PDF/164.45 KB) (PDF/164.45 KB) Italian (PDF/143.94 KB) (PDF/143.94 … -
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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): 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): Tenkasi (previously Orbactiv) (updated)
oritavancin diphosphate, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 19/03/2015, Revision: 12, Authorised, Last updated: 25/05/2023PDF/196.21 KB) (PDF/196.21 KB) Italian (PDF/175.99 KB) (PDF/175.99 … -
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Human medicine European public assessment report (EPAR): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,, Revision: 6, Authorised, Last updated: 22/05/2023
PDF/149.6 KB) (PDF/149.6 KB) Italian (PDF/126.58 KB) (PDF/126.58 … -
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Human medicine European public assessment report (EPAR): Ibrance (updated)
Palbociclib, Breast Neoplasms
Date of authorisation: 09/11/2016,, Revision: 15, Authorised, Last updated: 22/05/2023
PDF/167.23 KB) (PDF/167.23 KB) Italian (PDF/143.81 KB) (PDF/143.81 … -
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Human medicine European public assessment report (EPAR): Circadin (updated)
melatonin, Sleep Initiation and Maintenance Disorders
Date of authorisation: 29/06/2007, Revision: 34, Authorised, Last updated: 17/05/2023PDF/144.38 KB) (PDF/144.38 KB) Italian (PDF/127.02 KB) (PDF/127.02 … -
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Human medicine European public assessment report (EPAR): Neofordex (updated)
dexamethasone, Multiple Myeloma
Date of authorisation: 16/03/2016, Revision: 11, Authorised, Last updated: 17/05/2023PDF/92.86 KB) (PDF/92.86 KB) Italian (PDF/83.76 KB) (PDF/83.76 … -
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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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Human medicine European public assessment report (EPAR): Ronapreve
casirivimab, imdevimab, COVID-19 virus infection
Date of authorisation: 12/11/2021,, Revision: 4, Authorised, Last updated: 28/04/2023
PDF/145.82 KB) (PDF/145.82 KB) Italian (PDF/120.52 KB) (PDF/120.52 … -
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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
PDF/147.52 KB) (PDF/147.52 KB) Italian (PDF/44.7 KB) (PDF/44.7 KB … -
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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
PDF/91.79 KB) (PDF/91.79 KB) Italian (PDF/72 KB) (PDF/72 KB) Latvian … -
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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 …