50 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, Revision: 9, Withdrawn, Last updated: 24/10/2017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) … Pharma (previously Clopidogrel HCS) clopidogrel clopidogrel … -
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 Peripheral Vascular Diseases Acute … Clopidogrel HCS … Clopidogrel HCS, INN-clopidogrel 30 … -
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: XContact for public enquiries 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: Isabelle PARENT DU CHATELET, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 25.81 KB | PDF
-
List item
National expert: Ana Isabel Terleira Fernandez, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 86.19 KB | PDF
- Curriculum Vitae - 31.28 KB | PDF
-
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: 3, Authorised, Last updated: 25/02/2021
-
List item
Human medicine European public assessment report (EPAR): Neuraceq (updated)
florbetaben (18F), Radionuclide Imaging, Alzheimer Disease
Date of authorisation: 20/02/2014, Revision: 16, Authorised, Last updated: 25/02/2021 -
List item
Human medicine European public assessment report (EPAR): Busilvex
busulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 09/07/2003, Revision: 17, Authorised, Last updated: 20/11/2020 -
List item
Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, 
, , Revision: 1, Authorised, Last updated: 29/01/2021
-
List item
Human medicine European public assessment report (EPAR): Crysvita (updated)
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,, , , Revision: 7, Authorised, Last updated: 18/02/2021
-
List item
Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 15/11/2017,, 
, Revision: 8, Authorised, Last updated: 10/02/2021
-
List item
Human medicine European public assessment report (EPAR): Repatha
Evolocumab, Dyslipidemias, Hypercholesterolemia
Date of authorisation: 17/07/2015, Revision: 15, Authorised, Last updated: 11/12/2020 -
List item
Human medicine European public assessment report (EPAR): Verkazia
ciclosporin, Conjunctivitis, Keratitis
Date of authorisation: 06/07/2018,
, , Revision: 4, Authorised, Last updated: 10/07/2020
-
List item
Human medicine European public assessment report (EPAR): Evra
norelgestromin, ethinyl estradiol, Contraception
Date of authorisation: 21/08/2002, Revision: 21, Authorised, Last updated: 02/07/2020 -
List item
Human medicine European public assessment report (EPAR): Opdivo
nivolumab, Melanoma, Hodgkin Disease, Carcinoma, Renal Cell, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Urologic Neoplasms
Date of authorisation: 19/06/2015, Revision: 34, Authorised, Last updated: 14/12/2020 -
List item
Human medicine European public assessment report (EPAR): Zoely
Nomegestrol acetate, estradiol, Contraception
Date of authorisation: 26/07/2011,, Revision: 19, Authorised, Last updated: 03/07/2020
-
List item
National expert: Maria Baca-Estrada, European Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 29.75 KB | PDF
-
List item
Human medicine European public assessment report (EPAR): Stivarga
regorafenib, Colorectal Neoplasms
Date of authorisation: 26/08/2013, Revision: 15, Authorised, Last updated: 15/10/2019 -
List item
Human Medicines Highlights: Issue 19 - July 2010
Last updated: 02/08/2010Clopidogrel HCS (clopidogrel) - Prevention …
-
List item
Human medicine European public assessment report (EPAR): Phesgo
pertuzumab, trastuzumab, Breast Neoplasms
Date of authorisation: 21/12/2020,, Authorised, Last updated: 13/01/2021
-
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
National expert: Guruprasad Aithal, European Medicines Agency (updated)
- Declaration of interests - 82.13 KB | PDF
- Curriculum Vitae - 35.25 KB | PDF
-
List item
Withdrawn application: Ogivri
date of withdrawal: 03/08/2017, Initial authorisation, Last updated: 28/11/2017 -
List item
Withdrawn application: Qizenday
date of withdrawal: 13/11/2017, Initial authorisation, Last updated: 06/02/2018