49 results
-
List item
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, Revision: 9, Withdrawn, Last updated: 24/10/2017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)EMEA/H/C/001133clopidogrel (as hydrochloride)clopidogrelMyocardial … Pharma (previously Clopidogrel HCS) - EMEA/H/C/001133 - IB/0027/G … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
National expert: Harald Hundsberger, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 80.13 KB | PDF
- Curriculum Vitae - 24.03 KB | PDF
drug discovery, HTS-Assays, HCS- Assays; 2005- Present Prof … -
List item
National expert: Jean Daniel Lelievre, European Medicines Agency (updated)
- Declaration of interests - 80.87 KB | PDF
- Curriculum Vitae - 20.7 KB | PDF
-
List item
National expert: Antonio Portolés, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 82.87 KB | PDF
- Curriculum Vitae - 42.56 KB | PDF
Biomedical Research Foundation of HCSC Antonio Portolés Pérez … -
List item
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
-
List item
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: 25, Authorised, Last updated: 17/06/2022
-
List item
Human medicine European public assessment report (EPAR): Gamifant
Emapalumab, Immune System Diseases
Date of refusal: 07/01/2021,
, Refused, Last updated: 23/03/2021
-
List item
Human medicine European public assessment report (EPAR): Evra (updated)
norelgestromin, ethinyl estradiol, Contraception
Date of authorisation: 22/08/2002, Revision: 24, Authorised, Last updated: 14/06/2022 -
List item
Human medicine European public assessment report (EPAR): Repatha (updated)
Evolocumab, Dyslipidemias; Hypercholesterolemia
Date of authorisation: 17/07/2015, Revision: 21, Authorised, Last updated: 16/06/2022 -
List item
Human medicine European public assessment report (EPAR): Neuraceq
florbetaben (18F), Radionuclide Imaging; Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 18, Authorised, Last updated: 01/09/2021 -
List item
Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 19, Authorised, Last updated: 09/02/2022 -
List item
Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 3, Authorised, Last updated: 01/04/2022
-
List item
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 -
List item
Human medicine European public assessment report (EPAR): Skysona
elivaldogene autotemcel, Adrenoleukodystrophy
Date of authorisation: 16/07/2021,, Withdrawn, Last updated: 04/04/2022
-
List item
Human medicine European public assessment report (EPAR): Stivarga
regorafenib, Colorectal Neoplasms
Date of authorisation: 26/08/2013, Revision: 17, Authorised, Last updated: 02/12/2021 -
List item
Human medicine European public assessment report (EPAR): Verkazia
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,
, , Revision: 6, Authorised, Last updated: 25/01/2022
-
List item
Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011, Revision: 21, Authorised, Last updated: 12/01/2022 -
List item
Human medicine European public assessment report (EPAR): Ontruzant
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 15/11/2017,, 
, Revision: 12, Authorised, Last updated: 16/11/2021
-
List item
Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 9, Authorised, Last updated: 10/12/2021
-
List item
Human medicine European public assessment report (EPAR): Opdivo
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: 49, Authorised, Last updated: 10/05/2022 -
List item
Human medicine European public assessment report (EPAR): Ioa
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 16/11/2011, Revision: 4, Withdrawn, Last updated: 26/08/2014 -
List item
Withdrawn application: Ogivri
date of withdrawal: 03/08/2017, Initial authorisation, Last updated: 28/11/2017