4532 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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Human medicine European public assessment report (EPAR): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,
, 
, Revision: 2, Authorised, Last updated: 30/11/2023
PDF/133.64 KB) (PDF/133.64 KB) Italian (PDF/107.54 KB) (PDF/107.54 … -
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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): Ceprotin (updated)
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, Revision: 2, Withdrawn, Last updated: 14/11/2014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Date of authorisation: 02/09/2004, Revision: 4, Withdrawn, Last updated: 30/05/2013PDF/595.88 KB) (PDF/595.88 KB) Italian (PDF/515.38 KB) (PDF/515.38 … -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): Jylamvo (updated)
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): DuoPlavin (updated)
clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome; Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 27, Authorised, Last updated: 02/02/2023PDF/108.17 KB) (PDF/108.17 KB) Italian (PDF/88.03 KB) (PDF/88.03 … -
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Human medicine European public assessment report (EPAR): Mycamine
micafungin, Candidiasis
Date of authorisation: 25/04/2008, Revision: 16, Authorised, Last updated: 04/01/2022PDF/149.7 KB) (PDF/149.7 KB) Italian (PDF/148.46 KB) (PDF/148.46 … -
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Human medicine European public assessment report (EPAR): Segluromet (updated)
ertugliflozin l-pyroglutamic acid, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/03/2018, Revision: 6, Authorised, Last updated: 02/02/2023PDF/166.96 KB) (PDF/166.96 KB) Italian (PDF/144.5 KB) (PDF/144.5 … -
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Human medicine European public assessment report (EPAR): Juluca (updated)
dolutegravir sodium, rilpivirine hydrochloride, HIV Infections
Date of authorisation: 16/05/2018, Revision: 14, Authorised, Last updated: 02/02/2023PDF/168.23 KB) (PDF/168.23 KB) Italian (PDF/146.38 KB) (PDF/146.38 … -
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Human medicine European public assessment report (EPAR): Locametz (updated)
gozetotide, Radionuclide Imaging
Date of authorisation: 09/12/2022, Revision: 1, Authorised, Last updated: 02/02/2023PDF/163.57 KB) (PDF/163.57 KB) Italian (PDF/141.23 KB) (PDF/141.23 … -
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Human medicine European public assessment report (EPAR): Qdenga (updated)
Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated, Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated, Dengue virus, serotype 2, live, attenuated, Dengue
Date of authorisation: 05/12/2022,, Authorised, Last updated: 30/01/2023
PDF/151.05 KB) (PDF/151.05 KB) Italian (PDF/120.08 KB) (PDF/120.08 … -
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Human medicine European public assessment report (EPAR): Lacosamide UCB (updated)
lacosamide, Epilepsies, Partial
Date of authorisation: 26/08/2019, Revision: 5, Authorised, Last updated: 25/01/2023PDF/151.49 KB) (PDF/151.49 KB) Italian (PDF/125.94 KB) (PDF/125.94 … -
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Human medicine European public assessment report (EPAR): Bexsero (updated)
outer membrane vesicles from neisseria meningitidis group b (strain nz 98/254), recombinant Neisseria meningitidis group B fHbp fusion protein, recombinant Neisseria meningitidis group B NadA protein, recombinant Neisseria meningitidis group B NHBA fusion protein, Meningitis, Meningococcal
Date of authorisation: 13/01/2013, Revision: 30, Authorised, Last updated: 25/01/2023PDF/96.25 KB) (PDF/96.25 KB) Italian (PDF/77.37 KB) (PDF/77.37 … -
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Human medicine European public assessment report (EPAR): Metalyse (updated)
tenecteplase, Myocardial Infarction
Date of authorisation: 23/02/2001, Revision: 22, Authorised, Last updated: 23/01/2023PDF/99.29 KB) (PDF/99.29 KB) Italian (PDF/102.59 KB) (PDF/102.59 … -
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Human medicine European public assessment report (EPAR): Biktarvy (updated)
bictegravir, emtricitabine, tenofovir alafenamide, fumarate, HIV Infections
Date of authorisation: 21/06/2018, Revision: 15, Authorised, Last updated: 23/01/2023PDF/161.1 KB) (PDF/161.1 KB) Italian (PDF/135.34 KB) (PDF/135.34 … -
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Human medicine European public assessment report (EPAR): Avonex (updated)
interferon beta-1a, Multiple Sclerosis
Date of authorisation: 13/03/1997, Revision: 36, Authorised, Last updated: 18/01/2023PDF/168.62 KB) (PDF/168.62 KB) Italian (PDF/145.22 KB) (PDF/145.22 … -
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Human medicine European public assessment report (EPAR): Kesimpta (updated)
ofatumumab, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 16/01/2023
PDF/142.87 KB) (PDF/142.87 KB) Italian (PDF/117.57 KB) (PDF/117.57 … -
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Human medicine European public assessment report (EPAR): Relvar Ellipta (updated)
fluticasone furoate, vilanterol, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 13/11/2013, Revision: 24, Authorised, Last updated: 02/02/2023PDF/95.48 KB) (PDF/95.48 KB) Italian (PDF/74.85 KB) (PDF/74.85 … -
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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): Cabazitaxel Accord (updated)
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 …