282 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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn application … Ambrisentan Zentiva Ambrisentan Zentiva ambrisentan ambrisentan … -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) (updated)
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 15/01/2015, Revision: 19, Authorised, Last updated: 11/01/2023previously Sevelamer carbonate Zentiva) Nutritional and Metabolic … authorisation) Sevelamer carbonate Zentiva sevelamer carbonate On … product Sevelamer carbonate Zentiva. The marketing authorisation … -
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Withdrawn application: Docetaxel Zentiva (previously Docetaxel Winthrop)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): Pregabalin Zentiva
pregabalin, Anxiety Disorders; Epilepsy
Date of authorisation: 17/07/2015,
, Revision: 14, Authorised, Last updated: 21/11/2022
Pregabalin Zentiva Mental Disorders Nervous … 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): Riluzole Zentiva
Riluzole, Amyotrophic Lateral Sclerosis
Date of authorisation: 07/05/2012, Revision: 13, Authorised, Last updated: 22/11/2022Riluzole Zentiva Nervous System Diseases Central … report (EPAR) for Riluzole Zentiva. It explains how the 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): Aripiprazole Zentiva
aripiprazole, Schizophrenia; Bipolar Disorder
Date of authorisation: 25/06/2015,, Revision: 9, Authorised, Last updated: 26/08/2022
Aripiprazole Zentiva Schizophrenia Spectrum and … 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): Duloxetine Zentiva
duloxetine, Neuralgia; Depressive Disorder, Major; Anxiety Disorders; Diabetes Mellitus
Date of authorisation: 20/08/2015,, Revision: 11, Authorised, Last updated: 16/08/2022
Duloxetine Zentiva Nervous System Diseases Neuromuscular … 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): Pregabalin Zentiva k.s.
pregabalin, Anxiety Disorders; Neuralgia; Epilepsy
Date of authorisation: 27/02/2017,, Revision: 13, Authorised, Last updated: 18/11/2022
Pregabalin Zentiva k.s. Mental Disorders Nervous … 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: 5, Authorised, Last updated: 22/08/2022
Ivabradine Zentiva Pathological Conditions … 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: XInvented name Clopidogrel Zentiva (previously Clopidogrel Winthrop … Clopidogrel Zentiva (previously Clopidogrel Winthrop) Clopidogrel … Clopidogrel Winthrop) Clopidogrel Zentiva (previously Clopidogrel Winth … -
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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: 28, Authorised, Last updated: 28/09/2022Irbesartan Zentiva (previously Irbesartan Winthrop) Cardiovascular … report (EPAR) for Irbesartan Zentiva. It explains how the 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): Clopidogrel Zentiva (previously Clopidogrel Winthrop)
clopidogrel, Stroke; Peripheral Vascular Diseases; Myocardial Infarction; Acute Coronary Syndrome
Date of authorisation: 15/07/2008, Revision: 31, Authorised, Last updated: 23/06/2022Clopidogrel Zentiva (previously Clopidogrel Winthrop) Cardiovascular … report (EPAR) for Clopidogrel Zentiva. It explains how the 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): Leflunomide Zentiva (previously Leflunomide Winthrop)
leflunomide, Arthritis, Rheumatoid; Arthritis, Psoriatic
Date of authorisation: 08/01/2010, Revision: 18, Authorised, Last updated: 17/05/2022Leflunomide Zentiva (previously Leflunomide Winthrop) Musculoskeletal … Leflunomide Zentiva (previously Leflunomide Winth … MEDICINAL PRODUCT Leflunomide Zentiva 10 mg film-coated tablets … -
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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, Withdrawn, Last updated: 20/05/2022Docetaxel Zentiva (previously Docetaxel Winthrop) Neoplasms Cancer Breast … Docetaxel Zentiva (previously Docetaxel Winthro … Public statement Docetaxel Zentiva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Tenofovir disoproxil Zentiva
tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 15/09/2016,, Revision: 12, Authorised, Last updated: 15/09/2022
Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … Tenofovir disoproxil Zentiva … public Tenofovir disoproxil Zentiva tenofovir disoproxil This … -
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Human medicine European public assessment report (EPAR): Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 18/01/2007, Revision: 33, Authorised, Last updated: 28/09/2022besartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … besartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide … Irbesartan Hydrochlorothiazide Zentiva1 irbesartan / hydrochlorothiazide … -
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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: 8, Authorised, Last updated: 18/05/2022
itabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Zentiva … Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, INN-Efavirenz/Emtricitabine/Tenofovir … -
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Zentiva
emtricitabine, tenofovir disoproxil phosphate, HIV Infections
Date of authorisation: 09/11/2016,, Revision: 6, Authorised, Last updated: 21/07/2021
itabine/Tenofovir disoproxil Zentiva Blood-Borne Infections Communicable … itabine/Tenofovir disoproxil Zentiva … Emtricitabine/Tenofovir disoproxil Zentiva , INN-emtricitabine/tenofovir … -
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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) Cardiovascular … Clopidogrel/Acetylsalicylic acid Zentiva. It explains how the 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 (updated)
- Declaration of interests - 80.34 KB | PDF
- Curriculum Vitae - 16.54 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: Jan Smolka, State Institute for Drug Control (updated)
- Declaration of interests - 80.51 KB | PDF
- Curriculum Vitae - 17.7 KB | PDF
2016 Trainee Technologist Zentiva k.s. (Czechia) • … Indication 12/2015-10/2018 Zentiva, k.s. Cross product responsibility … -
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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: XContact for public enquiries 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): 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: XContact for public enquiries 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 …