6071 results
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Withdrawn application: Parsaclisib Incyte Biosciences Distribution B.V.
parsaclisib, date of withdrawal: 27/06/2022, Initial authorisation, Last updated: 08/11/2022Biosciences Distribution B.V.: Withdrawn application … Biosciences Distribution B.V.: Withdrawal of the marketing … Biosciences Distribution B.V. (parsaclisib) Incyte … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva Pharma B.V.
lamivudine, HIV Infections
Date of authorisation: 10/12/2009,
, Revision: 19, Authorised, Last updated: 21/04/2023
Lamivudine Teva Pharma B.V. Blood-Borne Infections Communicable … Lamivudine Teva Pharma B.V. … Lamivudine Teva Pharma B.V. lamivudine This is a summary … -
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Human medicine European public assessment report (EPAR): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,, Revision: 14, Withdrawn, Last updated: 09/07/2021
Ribavirin Teva Pharma B.V. Hepatitis C, Chronic … Ribavirin Teva Pharma B.V. … and Ribavirin Teva Pharma B.V.) some of the studies that … -
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Human medicine European public assessment report (EPAR): Imatinib Teva B.V.
imatinib mesilate, Dermatofibrosarcoma; Gastrointestinal Stromal Tumors; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 15/11/2017,, Withdrawn, Last updated: 09/10/2018
Imatinib Teva B.V. Dermatofibrosarcoma Gastrointestinal … Imatinib Teva B.V. … Imatinib Teva B.V. imatinib imatinib mesilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Live bacterium B. thetaiotaomicron
Decision type: RP: decision refers to a refusal on a proposed Paediatric Investigation Plan
Therapeutic area: Gastroentology-Hepatology
PIP number: Live bacterium B. thetaiotaomicron, Route(s) of administration: Oral use, Pharmaceutical form(s): Live Bacteria in an Enteric Coated Capsule
Decision date: 21/08/2009, Last updated: 22/10/2009, Compliance check: XLive bacterium B. thetaiotaomicron Gastroentol … Key facts Live bacterium B. thetaiotaomicron Gastroentology-HepatologyP/166/2009Live … Gastroentology-HepatologyP/166/2009Live bacterium B. thetaiotaomicron Live Bacteria … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Pharma B.V.
clopidogrel (as hydrobromide), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 16/06/2011,, Revision: 4, Withdrawn, Last updated: 03/02/2015
Clopidogrel Teva Pharma B.V. Peripheral Vascular Diseases Acute … Clopidogrel Teva Pharma B.V. … Clopidogrel Teva Pharma B.V. withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Clopidogrel Teva Generics B.V.
clopidogrel (as hydrochloride), Peripheral Vascular Diseases; Acute Coronary Syndrome; Myocardial Infarction; Stroke
Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014
Clopidogrel Teva Generics B.V. Peripheral Vascular Diseases Acute … Clopidogrel Teva Generics B.V. … Clopidogrel Teva Generics B.V., INN-clopidogrel 08 May … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
Budesonide, formoterol fumarate dihydrate, Asthma; Pulmonary Disease, Chronic Obstructive
Date of authorisation: 03/04/2020, Revision: 2, Authorised, Last updated: 08/12/2021onide/Formoterol Teva Pharma B.V. Lung Diseases, Obstructive Lung … onide/Formoterol Teva Pharma B.V. … Budesonide/Formoterol Teva Pharma B.V. 160 micrograms / 4.5 micrograms … -
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Human medicine European public assessment report (EPAR): Budesonide/Formoterol Teva Pharma B.V.
Budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017onide/Formoterol Teva Pharma B.V. Asthma … onide/Formoterol Teva Pharma B.V. … Budesonide/Formoterol Teva Pharma B.V. Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Bimervax (updated)
SARS-CoV-2 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains, COVID-19 virus infection
Date of authorisation: 30/03/2023,
, Revision: 2, Authorised, Last updated: 01/09/2023
RBD) fusion heterodimer – B.1.351-B.1.1.7 strains International non-proprietary … RBD) fusion heterodimer – B.1.351-B.1.1.7 strains … -
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National expert: Matthias Braun, Austrian Agency for Health and Food Safety (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 26.1 KB | PDF
Matthias Braun … Matthias Braun … Vitae Personal information Matthias Braun Work experience … -
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National expert: Armin Braun, Paul-Ehrlich-Institut (updated)
- Declaration of interests - 39.63 KB | PDF
- Curriculum Vitae - 26.05 KB | PDF
Armin Braun … Armin Braun … Vitae Personal information Armin Braun Work experience … -
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National expert: Louisa Braun Exner, Danish Medicines Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 26.73 KB | PDF
Louisa Braun Exner … Louisa Braun Exner … Vitae Personal information Louisa Braun Exner Work experience … -
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National expert: Christian B. (Kit) Roes, Medicines Evaluation Board (updated)
- Declaration of interests - 42.57 KB | PDF
- Curriculum Vitae - 62.38 KB | PDF
Christian B. (Kit) Roes … Christian B. (Kit) Roes … Vitae Personal information Christian B. (Kit) Roes Work experience … -
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Press release: Astellas Pharma Europe B.V. withdraws its application for an extension of the indication for Qutenza (capsaicin)
CHMP, Last updated: 20/03/2012Astellas Pharma Europe B.V. withdraws its application … by Astellas Pharma Europe B.V. of its decision to withdraw … 2011, Astellas Pharma Europe B.V. submitted an application … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Doxorubicin Sun (doxorubicin hydrochloride)
CHMP, Last updated: 21/07/2011Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation … Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation … Pharmaceutical Industries Europe B.V. withdraws its marketing … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Topotecan SUN (topotecan)
Last updated: 17/02/2011Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation … Pharmaceutical Industries B.V. of its decision to withdraw … Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation … -
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Press release: Teva Pharma B.V. withdraws its marketing authorisation application for Clopidogrel Teva Pharma (clopidogrel hydrobromide)
Last updated: 23/04/2009Teva Pharma B.V. withdraws its marketing authorisation … Teva Pharma B.V. withdraws its marketing authorisation … PRESS RELEASE Teva Pharma B.V. withdraws its marketing authorisation … -
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Press release: Sun Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation application for Repaglinide SUN (repaglinide)
Last updated: 25/03/2010Pharmaceutical Industries Europe B.V. withdraws its marketing authorisation … Pharmaceutical Industries B.V. of its decision to withdraw … Pharmaceutical Industries Europe B.V. withdraws its marketing … -
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Press release: Targanta Netherlands B.V. withdraws its marketing authorisation application for Ramvocid (oritavancin)
Last updated: 24/08/2009Targanta Netherlands B.V. withdraws its marketing authorisation … notified by Targanta Netherlands B.V. of its decision to withdraw … -
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, 
, 
, Revision: 8, Authorised, Last updated: 13/06/2023
together with bedaquiline and linezolid. Pretomanid FGK contains the … combination with bedaquiline and linezolid. For more information about … combination with bedaquiline and linezolid, in adults, for the treatment … -
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Human medicine European public assessment report (EPAR): Sivextro
tedizolid phosphate, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 23/03/2015, Revision: 21, Authorised, Last updated: 29/03/2023at least as effective as linezolid (another oxazolidinone antibiotic … of patients treated with linezolid. In a study involving 120 … is comparable to that of linezolid and was considered acceptable … -
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National expert: Tamara Mandusic Nazor, Agency For Medicinal Products And Medical Devices Of Croatia (updated)
- Declaration of interests - 40.13 KB | PDF
- Curriculum Vitae - 35.96 KB | PDF
Hospital Care Division of B. Braun Adria (sales representative … solutions for infusion for B. Braun in Croatia). 1.11 Committee … Hospital Care Division of B. … -
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Orphan designation: Triheptanoin for: Treatment of very-long-chain 3-hydroxyacyl-CoA-dehydrogenase deficiency
Date of designation: 06/12/2012, Withdrawn, Last updated: 12/08/2016the European Commission to B. Braun Melsungen AG, Germany, for … the European Commission to B. Braun Melsungen AG, Germany, for … Sponsor’s contact details: B. Braun Melsungen AG Carl Braun-Strasse 1 34212 Melsungen … -
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Orphan designation: Triheptanoin for: Treatment of long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency
Date of designation: 06/12/2012, Withdrawn, Last updated: 11/08/2016the European Commission to B. Braun Melsungen AG, Germany, for … the European Commission to B. Braun Melsungen AG, Germany, for … Sponsor’s contact details: B. Braun Melsungen AG Carl Braun-Strasse 1 34212 Melsungen …