16597 results
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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. … market exclusivity under pharmaceutical legislation (typically 10 … -
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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Date of authorisation: 01/07/2009,, Revision: 14, Withdrawn, Last updated: 09/07/2021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. … seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato … -
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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Date of authorisation: 16/06/2011,, Revision: 4, Withdrawn, Last updated: 03/02/2015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): Budesonide/Formoterol Teva Pharma B.V.
Budesonide, formoterol, Asthma
Date of authorisation: 19/11/2014, Revision: 1, Withdrawn, Last updated: 30/01/2017Budesonide/Formoterol Teva Pharma B.V. Asthma … Budesonide/Formoterol Teva Pharma B.V. … statement Budesonide/Formoterol Teva Pharma B.V. Withdrawal of the marketing … -
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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: 08/12/2021Budesonide/Formoterol Teva Pharma B.V. Lung Diseases, Obstructive Lung … Budesonide/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): 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 … Pharmacotherapeutic group Antineoplastic agents … Therapeutic indication Imatinib Teva B.V. is indicated for the treatment … -
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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Overview On 22 April 2009, Teva Pharma B.V. officially notified the Committee … authorisation for Clopidogrel Teva Pharma, for the prevention of atherothrombotic … -
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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 … details Name Clopidogrel Teva Generics B.V. Agency product number EMEA/H/C/002254 … Marketing-authorisation holder Teva Pharma B.V. Revision 3 Date of issue … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Date of authorisation: 21/01/2011,, Revision: 6, Withdrawn, Last updated: 21/01/2014
Docetaxel Teva Pharma Carcinoma, Non-Small-Cell … oduct details Name Docetaxel Teva Pharma Agency product number EMEA/H/C/002032 … Marketing-authorisation holder Teva Pharma B.V. Revision 6 Date of issue … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva Pharma
Telmisartan, Hypertension
Date of authorisation: 03/10/2011,, Revision: 10, Authorised, Last updated: 26/10/2021
Telmisartan Teva Pharma Cardiovascular Diseases Vascular … details Name Telmisartan Teva Pharma Agency product number EMEA/H/C/002511 … Marketing-authorisation holder Teva B.V. Revision 10 Date of issue … -
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Human medicine European public assessment report (EPAR): Pioglitazone Teva Pharma
pioglitazone hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 26/03/2012,, Revision: 13, Withdrawn, Last updated: 30/08/2022
Pioglitazone Teva Pharma Nutritional and Metabolic … details Name Pioglitazone Teva Pharma Agency product number EMEA/H/C/002410 … Marketing-authorisation holder Teva Pharma B.V. Revision 13 Date of issue … -
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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
Clopidogrel Teva Pharma (previously Clopidogrel HCS) Myocardial … details Name Clopidogrel Teva Pharma (previously Clopidogrel HCS … Marketing-authorisation holder Teva B.V. Revision 9 Date of issue … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
Zoledronic acid Teva Pharma Osteoporosis Osteitis Deformans Osteoporosis … authorisation for Zoledronic acid Teva Pharma has been withdrawn at the … documents Zoledronic acid Teva Pharma : EPAR - Summary for the … -
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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 … application for Clopidogrel Teva Pharma (clopidogrel hydrobromide … Teva Pharma B.V. withdraws its marketing authorisation … -
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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): Fluad Tetra (updated)
A/Victoria/2570/2019 (H1N1)pdm09 like strain (A/Victoria/2570/2019 IVR‐215) A/Darwin/9/2021 (H3N2) like strain (A/Darwin/6/2021 IVR-227) B/Austria/1359417/2021 like strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain (B/Phuket/3073/2013 BVR‐1B), Influenza, Human
Date of authorisation: 20/05/2020,
, Revision: 6, Authorised, Last updated: 22/05/2023
strain (B/Austria/1359417/2021 BVR-26) B/Phuket/3073/2013 like strain … strain (B/Phuket/3073/2013 BVR‐1B) International non-proprietary … holder Seqirus Netherlands B.V. Revision 6 Date of issue … -
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Human medicine European public assessment report (EPAR): Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 30/06/2015,, Revision: 15, Authorised, Last updated: 12/01/2023
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Schizophrenia Spectrum and … Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) … market exclusivity under pharmaceutical legislation (typically 10 … -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014recommendations made by the Agency’s Pharmacovigilance Risk Assessment Committee … Tolucombi Telmisartan Teva Telmisartan Teva Pharma Tolura Onduarp Twynsta Actelsar … Irbesartan Krka) Irbesartan Teva Irbesartan Zentiva (previously … -
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Orphan designation: lonapegsomatropin for: Treatment of growth hormone deficiency
Date of designation: 17/10/2019, Positive, Last updated: 17/02/2022European Commission to Ascendis Pharma Endocrinology Division A/S … Lonapegsomatropin Ascendis Pharma since 11 January 2022. Expand … Lonapegsomatropin Ascendis Pharma) Skytrofa (previously Lonapegsomatropin … -
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,, 
, Revision: 3, Authorised, Last updated: 31/01/2023
Lonapegsomatropin Ascendis Pharma) Growth and Development … Lonapegsomatropin Ascendis Pharma is a medicine that is used … Lonapegsomatropin Ascendis Pharma was designated an ‘ A medicine … -
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Human medicine European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma)
clopidogrel besilate, Peripheral Vascular Diseases; Stroke; Myocardial Infarction
Date of authorisation: 16/10/2009,, Revision: 26, Authorised, Last updated: 03/08/2022
previously Clopidogrel Taw Pharma) Vascular Diseases Cardiovascular … previously Clopidogrel Taw Pharma) … known as Clopidogrel Mylan Pharma and subsequently as Clopidogrel … -
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Withdrawn application: Lacosamide Pain UCB Pharma
lacosamide, date of withdrawal: 25/09/2008, Initial authorisation, Last updated: 26/09/2008Lacosamide Pain UCB Pharma: Withdrawn application … for Lacosamide Pain UCB Pharma International non-proprietary … On 25 September 2008, UCB Pharma S.A. officially notified … -
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Referral: Pregsure BVD
inactivated Bovine Viral Diarrhoea (BVD) type 1 virus, cytopathogenic strain 5960, Article 78
Status: European Commission final decision, opinion/position date: 15/07/2010, EC decision date: 07/10/2010, Last updated: 22/10/2010Pregsure BVD … Recommendation provided by Pharmacovigilance Risk Assessment Committee … decision Overview Pregsure BVD is an inactivated vaccine … -
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Withdrawn application: Oportuzumab monatox DLRC Pharma Services
oportuzumab monatox, date of withdrawal: 20/08/2021, Initial authorisation, Last updated: 20/10/2021Oportuzumab monatox DLRC Pharma Services: Withdrawn applicati … Oportuzumab monatox DLRC Pharma Services: Withdrawal of the … Oportuzumab monatox DLRC Pharma Services (oportuzumab monatox … -
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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn applicati … Overview On 26 January 2012, Teva Generics B.V. officially notified the Committee … authorisation for Pioglitazone Teva Generics, for the treatment …