5109 results
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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, Revision: 14, Withdrawn, Last updated: 09/07/2021
Ribavirin Teva Pharma B.V. Hepatitis C, Chronic … for Ribavirin Teva Pharma B. V. has been withdrawn at … documents Ribavirin Teva Pharma B.V. : EPAR - Medicine overview … -
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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: 15, Authorised, Last updated: 12/05/2021
Lamivudine Teva Pharma B.V. HIV Infections … is Lamivudine Teva Pharma B.V.? Lamivudine Teva Pharma B.V. is an antiviral medicine … mg). Lamivudine Teva Pharma B.V. is a ‘generic medicine’ … -
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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Date of authorisation: 15/11/2017,, Withdrawn, Last updated: 09/10/2018
Imatinib Teva B.V. Dermatofibrosarcoma Gastrointestinal … authorisation for Imatinib Teva B.V. has been withdrawn at the … Summary documents Imatinib Teva B.V. : EPAR - Summary for the … -
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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Date of authorisation: 16/06/2011,, Revision: 4, Withdrawn, Last updated: 03/02/2015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 … for Clopidogrel Teva Pharma B.V. has been withdrawn at the … documents Clopidogrel Teva Pharma B.V. : EPAR - Summary for the … -
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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. has lapsed because it has … Clopidogrel Teva Generics B.V. : EPAR - Summary for the … -
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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: 1, Authorised, Last updated: 13/07/2021onide/Formoterol Teva Pharma B.V. Asthma Pulmonary Disease … Budesonide/Formoterol Teva Pharma B.V. is a medicine used for the … Budesonide/Formoterol Teva Pharma B.V. is also used to relieve the … -
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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 … Budesonide/Formoterol Teva Pharma B.V. has been withdrawn at the … Budesonide/Formoterol Teva Pharma B.V.: EPAR - Summary for the public … -
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National expert: Louisa Braun Exner, Danish Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 17.58 KB | PDF
Louisa Braun Exner … Louisa Braun Exner … Vitae PERSONAL INFORMATION Louisa Braun Exner WORK EXPERIENCE March … -
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National expert: Christian B. (Kit) Roes, Medicines Evaluation Board (updated)
- Declaration of interests - 82.04 KB | PDF
- Curriculum Vitae - 110.22 KB | PDF
Christian B. (Kit) Roes … Christian B. (Kit) Roes … vitae PERSONAL INFORMATION Christian B. (Kit) Roes WORK EXPERIENCE March … -
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National expert: Sinan B. Sarac, Danish Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 17.06 KB | PDF
Sinan B. Sarac … Sinan B. Sarac … Vitae PERSONAL INFORMATION Sinan B. Sarac WORK EXPERIENCE September … -
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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. of its decision to withdraw … 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 … formally notified by Teva Pharma B.V. of its decision to withdraw … later stage. 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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Opinion/decision on a Paediatric investigation plan (PIP): Heparin (sodium)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002557-PIP01-19, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/07/2019, Last updated: 13/11/2019, Compliance check: Xthromboembolic events Subcutaneous use B. Braun Melsungen AG Tel. ++49 6172 … -
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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 … -
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National expert: Tamara Mandusic Nazor, Agency for Medicinal Products and Medical Devices of Croatia (updated)
- Declaration of interests - 79.96 KB | PDF
- Curriculum Vitae - 22.09 KB | PDF
Hospital Care Division of B. Braun Adria (sales representative … solutions for infusion for B. Braun in Croatia). 2.11 CAT member … -
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Human medicine European public assessment report (EPAR): Nyxoid
Naloxone hydrochloride dihydrate, Opioid-Related Disorders
Date of authorisation: 09/11/2017, Revision: 5, Authorised, Last updated: 26/02/2021reference medicine Naloxon HCl B. Braun is given by injection, Nyxoid … reference medicine Naloxon HCl B. Braun is given by injection, Nyxoid … -
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National expert: Eraldo Donnarumma, Italian Medicines Agency (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 17.73 KB | PDF
PANORAMI E PERCORSI) Doping: soluzione o inganno chimico? (BIF n.4/2006 … E PERCORSI) Il corretto uso delle erbe medicinali (BIF … -
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National expert: Michael Benning, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 80.31 KB | PDF
- Curriculum Vitae - 16.35 KB | PDF
Manager Pharmacovigilance B.Braun Melsungen AG (Germany) January … Indication 10/2010-07/2018 B.Braun Melsungen AG Cross product … -
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National expert: Thomas M RICHTER, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 81.17 KB | PDF
- Curriculum Vitae - 17.39 KB | PDF
Manager Clinical Development B. Braun Melsungen (Germany) EDUCATION … Indication 09/1993-09/1996 B. BRAUN MELSUNGEN (GERMANY) Lead …