56 results
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma (previously Clopidogrel HCS)
clopidogrel (as hydrochloride), Myocardial Infarction; Peripheral Vascular Diseases; Stroke
Date of authorisation: 21/09/2009,
, Revision: 9, Withdrawn, Last updated: 24/10/2017
Pharma (previously Clopidogrel HCS) Myocardial Infarction Peripheral … Pharma (previously Clopidogrel HCS) … Previously known as Clopidogrel HCS. Me dic ina l p ro du ct … -
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Human medicine European public assessment report (EPAR): Clopidogrel HCS
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 8, Authorised, Last updated: 01/08/2018
Clopidogrel HCS Vascular Diseases Cardiovascular … report (EPAR) for Clopidogrel HCS. It explains how the The committee … conditions of use for Clopidogrel HCS. What is Clopidogrel HCS? Clopidogrel HCS is a blood-thinning medicine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin calcium, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001364-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: Xand dyslipidaemia Oral use HCS bvba E-mail: info hcsbvba.be Country: Belgium Tel … application submitted by HCS bvba on 26 September 2012 … decision is addressed to HCS bvba, H Kennisstraat 53 … -
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Press release: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2010
CHMP, Last updated: 23/07/2010Clopidogrel HCS and Clopidogrel Teva Generics … Plavix. • Clopidogrel HCS and Clopidogrel Teva Generics … Teva Pharma B.V. and from HCS bvba, for the prevention … -
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National expert: Harald Hundsberger, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 79.91 KB | PDF
- Curriculum Vitae - 24.34 KB | PDF
drug discovery, HTS-Assays, HCS- Assays; 2005- Present Prof … -
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National expert: Antonio Portolés, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 83 KB | PDF
- Curriculum Vitae - 41.23 KB | PDF
Biomedical Research Foundation of HCSC Antonio Portolés Pérez … -
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Human medicine European public assessment report (EPAR): Livtencity (updated)
Maribavir, Cytomegalovirus Infections
Date of authorisation: 09/11/2022,
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, Revision: 3, Authorised, Last updated: 17/03/2023
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Human medicine European public assessment report (EPAR): Neuraceq
florbetaben (18F), Radionuclide Imaging; Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 19, Authorised, Last updated: 18/11/2022 -
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Human medicine European public assessment report (EPAR): Stivarga (updated)
regorafenib, Colorectal Neoplasms
Date of authorisation: 26/08/2013, Revision: 20, Authorised, Last updated: 08/03/2023 -
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Human medicine European public assessment report (EPAR): Spevigo
Spesolimab, Psoriasis
Date of authorisation: 09/12/2022,, 
, Authorised, Last updated: 08/02/2023
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Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, Revision: 23, Authorised, Last updated: 16/02/2023 -
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Human medicine European public assessment report (EPAR): Repatha
Evolocumab, Dyslipidemias; Hypercholesterolemia
Date of authorisation: 17/07/2015, Revision: 23, Authorised, Last updated: 23/01/2023 -
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Human medicine European public assessment report (EPAR): Phesgo
pertuzumab, trastuzumab, Breast Neoplasms
Date of authorisation: 21/12/2020,, Revision: 3, Authorised, Last updated: 02/03/2022
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,
, , Revision: 41, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Gamifant
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,, Refused, Last updated: 23/03/2021
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 4, Authorised, Last updated: 12/10/2022
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Human medicine European public assessment report (EPAR): Evra
norelgestromin, ethinyl estradiol, Contraception
Date of authorisation: 22/08/2002, Revision: 25, Authorised, Last updated: 09/11/2022 -
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Human medicine European public assessment report (EPAR): Ontruzant
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 15/11/2017,
, Revision: 14, Authorised, Last updated: 20/09/2022
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Human medicine European public assessment report (EPAR): Opdivo (updated)
nivolumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Mesothelioma; Colorectal Neoplasms
Date of authorisation: 19/06/2015, Revision: 52, Authorised, Last updated: 28/03/2023 -
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Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 19, Authorised, Last updated: 01/02/2022 -
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National expert: Maria Baca-Estrada, European Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 29.85 KB | PDF
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Human medicine European public assessment report (EPAR): Enjaymo
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,, , Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia
Date of authorisation: 19/02/2018,, , Revision: 10, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Hizentra
human normal immunoglobulin (SCIg), Immunologic Deficiency Syndromes
Date of authorisation: 14/04/2011, Revision: 21, Authorised, Last updated: 13/01/2022 -
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Human medicine European public assessment report (EPAR): VidPrevtyn Beta
SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain), COVID-19 virus infection
Date of authorisation: 10/11/2022,, Authorised, Last updated: 30/11/2022