4545 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, Revision: 8, Withdrawn, Last updated: 17/10/2022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): Kogenate Bayer (updated)
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Date of authorisation: 04/08/2000, Revision: 30, Withdrawn, Last updated: 02/03/2023PDF/704.25 KB) (PDF/704.25 KB) Italian (PDF/637.55 KB) (PDF/637.55 … -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): 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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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): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 33, Authorised, Last updated: 28/09/2022PDF/127.28 KB) (PDF/127.28 KB) Italian (PDF/107.56 KB) (PDF/107.56 … formally requested by the Italian medicines agency, to examine … -
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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): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 07/03/2023
PDF/201.21 KB) (PDF/201.21 KB) Italian (PDF/179.1 KB) (PDF/179.1 … -
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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/100.82 KB) (PDF/100.82 KB) Italian (PDF/81.9 KB) (PDF/81.9 KB … -
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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): Nyvepria (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 18/11/2020,, 
, Revision: 5, Authorised, Last updated: 29/03/2023
PDF/129.49 KB) (PDF/129.49 KB) Italian (PDF/108.75 KB) (PDF/108.75 … -
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Human medicine European public assessment report (EPAR): Ocrevus (updated)
ocrelizumab, Multiple Sclerosis
Date of authorisation: 08/01/2018, Revision: 16, Authorised, Last updated: 22/03/2023PDF/104.9 KB) (PDF/104.9 KB) Italian (PDF/82.68 KB) (PDF/82.68 … -
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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
PDF/146.91 KB) (PDF/146.91 KB) Italian (PDF/115.03 KB) (PDF/115.03 … -
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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
PDF/138.05 KB) (PDF/138.05 KB) Italian (PDF/117.4 KB) (PDF/117.4 … -
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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
PDF/155.15 KB) (PDF/155.15 KB) Italian (PDF/132.39 KB) (PDF/132.39 … -
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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/102.06 KB) (PDF/102.06 KB) Italian (PDF/81.47 KB) (PDF/81.47 … -
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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/154.46 KB) (PDF/154.46 KB) Italian (PDF/47.2 KB) (PDF/47.2 KB … -
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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
PDF/143.75 KB) (PDF/143.75 KB) Italian (PDF/120.07 KB) (PDF/120.07 …