220 results
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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn application … Ambrisentan Zentiva Ambrisentan Zentiva ambrisentan ambrisentan … -
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Human medicine European public assessment report (EPAR): Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)
sevelamer carbonate, Hyperphosphatemia, Renal Dialysis
Date of authorisation: 15/01/2015, Revision: 17, Authorised, Last updated: 27/11/2020previously Sevelamer carbonate Zentiva) Hyperphosphatemia Renal … previously Sevelamer carbonate Zentiva)EMEA/H/C/003971sevelamer carbonatesevelamer carbonateHyperphosphatemiaRenal … authorisation) Sevelamer carbonate Zentiva sevelamer carbonate On … -
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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, date of withdrawal: 14/11/2008, Post-authorisation, Last updated: 17/11/2008Docetaxel Zentiva (previously Docetaxel Winthrop) Docetaxel … Docetaxel Winthrop) Docetaxel Zentiva (previously Docetaxel Winthro … -
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Human medicine European public assessment report (EPAR): Aripiprazole Zentiva
aripiprazole, Schizophrenia, Bipolar Disorder
Date of authorisation: 25/06/2015,
, Revision: 8, Authorised, Last updated: 19/03/2021
Aripiprazole Zentiva Schizophrenia Bipolar Disor … report (EPAR) for Aripiprazole Zentiva. It explains how the Agency … on how to use Aripiprazole Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva
pregabalin, Anxiety Disorders, Epilepsy
Date of authorisation: 17/07/2015,, Revision: 8, Authorised, Last updated: 12/03/2021
Pregabalin Zentiva Anxiety Disorders Epilepsy … report (EPAR) for Pregabalin Zentiva. It explains how the Agency … on how to use Pregabalin Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Duloxetine Zentiva
duloxetine, Anxiety Disorders, Depressive Disorder, Major, Neuralgia, Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 8, Authorised, Last updated: 10/02/2021
Duloxetine Zentiva Anxiety Disorders Depressive … report (EPAR) for Duloxetine Zentiva. It explains how the Agency … on how to use Duloxetine Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Riluzole Zentiva
Riluzole, Amyotrophic Lateral Sclerosis
Date of authorisation: 07/05/2012, Revision: 11, Authorised, Last updated: 01/10/2020Riluzole Zentiva Amyotrophic Lateral Sclerosi … report (EPAR) for Riluzole Zentiva. It explains how the Committee … conditions of use for Riluzole Zentiva. What is Riluzole Zentiva? Riluzole Zentiva is a medicine containing … -
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Human medicine European public assessment report (EPAR): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders, Neuralgia, Epilepsy
Date of authorisation: 27/02/2017,, Revision: 7, Authorised, Last updated: 17/03/2021
Pregabalin Zentiva k.s. Anxiety Disorders Neur … report (EPAR) for Pregabalin Zentiva k.s. It explains how the … on how to use Pregabalin Zentiva k.s. For practical information … -
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Human medicine European public assessment report (EPAR): Ivabradine Zentiva
ivabradine hydrochloride, Angina Pectoris, Heart Failure
Date of authorisation: 11/11/2016,, Revision: 2, Authorised, Last updated: 06/03/2020
Ivabradine Zentiva Angina Pectoris Heart Failu … report (EPAR) for Ivabradine Zentiva. It explains how the Agency … on how to use Ivabradine Zentiva. For practical information … -
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Opinion/decision on a Paediatric investigation plan (PIP): Clopidogrel Zentiva (previously Clopidogrel Winthrop), clopidogrel
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: Clopidogrel, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral formulation, Film-coated tablet
Decision date: 22/09/2009, Last updated: 07/12/2009, Compliance check: XKey facts Clopidogrel Zentiva (previously Clopidogrel Winthrop … EMEA/PDCO/583267 Generic Clopidogrel Zentiva (previously Clopidogrel Winthrop … Winthrop): EPAR Clopidogrel Zentiva (previously Clopidogrel Winthrop … -
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Human medicine European public assessment report (EPAR): Irbesartan Zentiva (previously Irbesartan Winthrop)
irbesartan, Hypertension
Date of authorisation: 19/01/2007, Revision: 24, Authorised, Last updated: 18/03/2021Irbesartan Zentiva (previously Irbesartan Winthr … report (EPAR) for Irbesartan Zentiva. It explains how the Committee … conditions of use for Irbesartan Zentiva. What is Irbesartan Zentiva? Irbesartan Zentiva is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Leflunomide Zentiva (previously Leflunomide Winthrop)
leflunomide, Arthritis, Rheumatoid, Arthritis, Psoriatic
Date of authorisation: 08/01/2010, Revision: 16, Authorised, Last updated: 23/03/2021Leflunomide Zentiva (previously Leflunomide Winthrop) Arthritis … leflunomide Overview Leflunomide Zentiva is a medicine used to treat … leflunomide. How is Leflunomide Zentiva used? Leflunomide Zentiva is available as tablets (10 … -
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Human medicine European public assessment report (EPAR): Clopidogrel Zentiva (previously Clopidogrel Winthrop)
clopidogrel, Stroke, Peripheral Vascular Diseases, Myocardial Infarction, Acute Coronary Syndrome
Date of authorisation: 15/07/2008, Revision: 27, Authorised, Last updated: 02/02/2021Clopidogrel Zentiva (previously Clopidogrel Winthrop) Stroke Peripheral … report (EPAR) for Clopidogrel Zentiva. It explains how the Committee … conditions of use for Clopidogrel Zentiva. What is Clopidogrel Zentiva? Clopidogrel Zentiva is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Prostatic Neoplasms, Stomach Neoplasms, Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Authorised, Last updated: 20/12/2019Docetaxel Zentiva (previously Docetaxel Winthrop) Head … Docetaxel Zentiva (previously Docetaxel Winthro … Docetaxel Zentiva (previously Docetaxel Winthro … -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva (updated)
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 9, Authorised, Last updated: 14/04/2021
Tenofovir disoproxil Zentiva HIV Infections … for Tenofovir disoproxil Zentiva. It explains how the Agency … use Tenofovir disoproxil Zentiva. For practical information … -
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Human medicine European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop) (updated)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 27, Authorised, Last updated: 04/05/2021besartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Irbesartan Hydrochlorothiazide Zentiva. It explains how the The committee … Irbesartan Hydrochlorothiazide Zentiva. What is Irbesartan Hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva (updated)
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 5, Authorised, Last updated: 22/04/2021
itabine/Tenofovir disoproxil Zentiva HIV Infections … Emtricitabine/Tenofovir disoproxil Zentiva is used in combination with … Emtricitabine/Tenofovir disoproxil Zentiva is also used to help prevent … -
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Human medicine European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
efavirenz, emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 17/07/2017,, Revision: 6, Authorised, Last updated: 22/02/2021
itabine/Tenofovir disoproxil Zentiva HIV Infections … Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva. It explains how the Agency … Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, patients should read the … -
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Human medicine European public assessment report (EPAR): Clopidogrel/Acetylsalicylic acid Zentiva (previously DuoCover)
clopidogrel, acetylsalicylic acid, Acute Coronary Syndrome, Myocardial Infarction
Date of authorisation: 14/03/2010, Revision: 22, Authorised, Last updated: 13/11/2019idogrel/Acetylsalicylic acid Zentiva (previously DuoCover) Acute … Clopidogrel/Acetylsalicylic acid Zentiva. It explains how the Committee … Clopidogrel/Acetylsalicylic acid Zentiva. What is Clopidogrel/Acetylsalicylic … -
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021orothiazide Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Irbesartan … Teva Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … CoAprovel Karvezide Karvea Irbesartan/Hydrochlorothiazide Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Irbesartan … -
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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: 08/10/2014Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … Teva Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Krka) Irbesartan Teva Irbesartan Zentiva (previously Irbesartan Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide … -
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National expert: Dana Machutkova, State Institute for Drug Control
- Declaration of interests - 80.19 KB | PDF
- Curriculum Vitae - 16.37 KB | PDF
amp;amp; Technology Director Zentiva, k.s. (Czechia) August 2009-August … Pharmaceutical Production Director Zentiva, k.s. (Czechia) EDUCATION … Indication 06/1983-02/2015 Zentiva, k.s. Cross product responsibility … -
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National expert: Georgescu Doina, National Agency for Medicines and Medical Devices of Romania (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 18.71 KB | PDF
Specialist SICOMED S.A. /ZENTIVA S.A. (Romania) April 2006-March … Engineer - Validation Specialist ZENTIVA S.A. (Romania) March 2009-November … Engineer- Validation Specialist Zentiva S.A. part of sanofi Aventis … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ezetimibe, Rosuvastatin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001344-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: Xhypercholesterolaemia Oral use Zentiva, k.s. Czech Republic blanka.zoubkova@zentiva.com … application submitted by Zentiva, k.s. on 2 July 2012 under … decision is addressed to Zentiva, k.s., U kabelovny 130, 102 … -
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Opinion/decision on a Paediatric investigation plan (PIP): valsartan, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001343-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 20/11/2012, Last updated: 04/01/2013, Compliance check: Xof hypertension Oral use Zentiva, k.s. Czech Republic blanka.zoubkova@zentiva.com … application submitted by Zentiva, k.s. on 2 July 2012 under … decision is addressed to Zentiva, k.s., U kabelovny 130, 102 …