4608 results
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Opinion/decision on a Paediatric investigation plan (PIP): alprazolam
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-003043-PIP01-21, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder
Decision date: 10/06/2022, Last updated: 13/06/2023, Compliance check: XKey facts alprazolam NeurologyP/0220/2022EMEA-003043-PIP01-21 … granting of a waiver for alprazolam (EMEA-003043-PIP01-21) PDF … granting of a waiver for alprazolam (EMEA-003043-PIP01-21) in … -
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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, Revision: 8, Withdrawn, Last updated: 17/10/2022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): Exviera
dasabuvir sodium, Hepatitis C, Chronic
Date of authorisation: 14/01/2015,
, Revision: 26, Authorised, Last updated: 13/04/2023
PDF/96.14 KB) (PDF/96.14 KB) Italian (PDF/75.56 KB) (PDF/75.56 … -
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Human medicine European public assessment report (EPAR): Ritonavir Mylan
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 14, Authorised, Last updated: 17/05/2023
PDF/113.97 KB) (PDF/113.97 KB) Italian (PDF/91.84 KB) (PDF/91.84 … -
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Human medicine European public assessment report (EPAR): Posaconazole AHCL
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 5, Authorised, Last updated: 22/12/2022
PDF/167.44 KB) (PDF/167.44 KB) Italian (PDF/145.1 KB) (PDF/145.1 … -
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Revision: 7, Authorised, Last updated: 19/12/2022
PDF/164.14 KB) (PDF/164.14 KB) Italian (PDF/142.51 KB) (PDF/142.51 … -
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Human medicine European public assessment report (EPAR): Voriconazole Accord
voriconazole, Aspergillosis; Candidiasis; Mycoses
Date of authorisation: 16/05/2013,, Revision: 17, Authorised, Last updated: 14/06/2023
PDF/101.09 KB) (PDF/101.09 KB) Italian (PDF/80.2 KB) (PDF/80.2 KB … -
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Human medicine European public assessment report (EPAR): Zubsolv
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 10/11/2017, Revision: 9, Authorised, Last updated: 29/07/2022PDF/93.52 KB) (PDF/93.52 KB) Italian (PDF/75.13 KB) (PDF/75.13 … -
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Human medicine European public assessment report (EPAR): Crixivan
indinavir sulfate ethanolate, HIV Infections
Date of authorisation: 04/10/1996, Revision: 39, Withdrawn, Last updated: 12/07/2022PDF/697.74 KB) (PDF/697.74 KB) Italian (PDF/630.9 KB) (PDF/630.9 … -
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Human medicine European public assessment report (EPAR): Ivemend
fosaprepitant, Vomiting; Cancer
Date of authorisation: 11/01/2008, Revision: 24, Authorised, Last updated: 26/08/2022PDF/113.64 KB) (PDF/113.64 KB) Italian (PDF/95.56 KB) (PDF/95.56 … -
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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): 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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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): 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): 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): 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): Tezspire (updated)
tezepelumab, Asthma
Date of authorisation: 19/09/2022,, Revision: 7, Authorised, Last updated: 22/09/2023
PDF/126.85 KB) (PDF/126.85 KB) Italian (PDF/106.94 KB) (PDF/106.94 … -
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, 
, Revision: 10, Authorised, Last updated: 22/09/2023
PDF/91.91 KB) (PDF/91.91 KB) Italian (PDF/72.68 KB) (PDF/72.68 … -
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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 …