381 results
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Human medicine European public assessment report (EPAR): Abiraterone Accord
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,
, Authorised, Last updated: 05/05/2021
Abiraterone Accord Cancer Neoplasms Genital … Abiraterone Accord … EMA/163793/2021 EMEA/H/C/005408 Abiraterone Accord abiraterone acetate) An overview of Abiraterone Accord and why it is authorised … -
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Human medicine European public assessment report (EPAR): Abiraterone Krka
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 1, Authorised, Last updated: 06/07/2022
Abiraterone Krka Genital Neoplasms … Authorised abiraterone acetate Overview Abiraterone Krka is a cancer medicine … of the body (metastatic). Abiraterone Krka is used together with … -
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Human medicine European public assessment report (EPAR): Abiraterone Mylan
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 30/06/2022
Abiraterone Mylan Cancer Neoplasms Genital … Authorised abiraterone acetate Overview Abiraterone Mylan is a cancer medicine … of the body (metastatic). Abiraterone Mylan is used together with … -
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Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 26, Authorised, Last updated: 06/12/2022
Authorised abiraterone Overview This is a summary … medicine. active substance abiraterone acetate. How is Zytiga used … active substance in Zytiga, abiraterone acetate, is changed in the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Niraparib (tosilate monohydrate), abiraterone acetate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002789-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2021, Last updated: 21/06/2021, Compliance check: XNiraparib (tosilate monohydrate) abiraterone acetate OncologyP/0244/2020EMEA-002789-PIP01-20 … tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20 … tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20 … -
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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): 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): 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): 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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Abiraterone acetate product-specific bioequivalence guidance
Last updated: 23/11/2020Abiraterone acetate product-specific … conditions. bioequivalence of abiraterone acetate … Products for Human Use (CHMP) Abiraterone acetate tablets 250 mg and …