904 results
Keyword Bosentan Teva Remove keyword
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Human medicine European public assessment report (EPAR): Tracleer
bosentan (as monohydrate), Scleroderma, Systemic; Hypertension, Pulmonary
Date of authorisation: 14/05/2002, Revision: 42, Authorised, Last updated: 13/02/2023bosentan … Tracleer, INN-bosentan 30 Churchill Place … authorisation(s) Active substance(s): bosentan Procedure No. EMEA/H/C/PSUSA/00000425/201511 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tracleer, Bosentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000425-PIP02-10-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 29/04/2013, Last updated: 31/05/2013, Compliance check: V, 21/03/2014Tracleer Active substance Bosentan Therapeutic area Pneumology-allergology … paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04 … paediatric investigation plan for bosentan (Tracleer) (EMEA-000425-PIP02-10-M04 … -
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Human medicine European public assessment report (EPAR): Stayveer
bosentan (as monohydrate), Hypertension, Pulmonary; Scleroderma, Systemic
Date of authorisation: 24/06/2013, Revision: 15, Authorised, Last updated: 13/02/2023Authorised bosentan monohydrate Overview Stayveer … medicine. active substance bosentan. This medicine is the same … active substance in Stayveer, bosentan, blocks a naturally occurring … -
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Orphan designation: Bosentan for: Treatment of systemic sclerosis (scleroderma)
Date of designation: 18/03/2003, Withdrawn, Last updated: 08/05/2014Bosentan … opinion on orphan designation Bosentan for treatment of systemic … Limited, United Kingdom, for bosentan for the treatment of systemic … -
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Orphan designation: Bosentan for: Treatment of idiopathic pulmonary fibrosis
Date of designation: 05/09/2008, Withdrawn, Last updated: 08/05/2014Bosentan … opinion on orphan designation Bosentan for the treatment of idiopathic … Limited, United Kingdom, for bosentan for the treatment of idiopathic … -
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Orphan designation: Bosentan for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 15/02/2001, Expired, Last updated: 27/02/2013Bosentan … opinion on orphan designation Bosentan for the treatment of pulmonary … opinion on orphan designation Bosentan for the treatment of pulmonary … -
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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 … Pioglitazone Teva Generics: Withdrawal of the … authorisation) Pioglitazone Teva Generics pioglitazone On … -
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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 … Clopidogrel Teva Pharma: Withdrawal of the … application for Clopidogrel Teva Pharma clopidogrel … -
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Human medicine European public assessment report (EPAR): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,
, Revision: 17, Authorised, Last updated: 04/07/2022
Sildenafil Teva Male Urogenital Diseases Genital … Sildenafil Teva … Sildenafil Teva, INN-sildenafil 7 … -
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Human medicine European public assessment report (EPAR): Tevagrastim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 17, Authorised, Last updated: 24/05/2023
Tevagrastim Agranulocytosis Leukopenia Leukocyte … part of the EPAR). What is Tevagrastim? Tevagrastim is a solution for injection … active substance filgrastim. Tevagrastim is a ‘ A medicine that … -
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Human medicine European public assessment report (EPAR): Nevirapine Teva
nevirapine, HIV Infections
Date of authorisation: 30/11/2009,, Revision: 11, Withdrawn, Last updated: 21/03/2023
Nevirapine Teva Blood-Borne Infections Communicable … Nevirapine Teva … Public statement Nevirapine Teva (nevirapine) Withdrawal … -
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Human medicine European public assessment report (EPAR): Efavirenz Teva
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 12, Authorised, Last updated: 03/03/2023
Efavirenz Teva Blood-Borne Infections Communicable … Efavirenz Teva … for the public Efavirenz Teva efavirenz This is a summary … -
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Human medicine European public assessment report (EPAR): Olanzapine Teva
olanzapine, Schizophrenia; Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 29, Authorised, Last updated: 22/11/2022
Olanzapine Teva Schizophrenia Spectrum and … Olanzapine Teva … Olanzapine Teva, INN-olanzapine 7 … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 13, Authorised, Last updated: 17/11/2022
Lamivudine Teva Infections Communicable … Lamivudine Teva … for the public Lamivudine Teva lamivudine This is a summary … -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 19, Authorised, Last updated: 06/07/2022
Levetiracetam Teva Nervous System Diseases Central … levetiracetam Overview Levetiracetam Teva is an epilepsy medicine … whole brain. Levetiracetam Teva can also be used as an add-on … -
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Human medicine European public assessment report (EPAR): Imatinib Teva
imatinib, Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome; Dermatofibrosarcoma
Date of authorisation: 07/01/2013,, Revision: 18, Authorised, Last updated: 09/06/2022
Imatinib Teva Leukemia, Myelogenous, Chronic … Imatinib Teva … Imatinib Teva, INN-imatinib 30 Churchill … -
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Human medicine European public assessment report (EPAR): Temozolomide Teva
temozolomide, Glioma; Glioblastoma
Date of authorisation: 28/01/2010,, Revision: 21, Authorised, Last updated: 18/02/2022
Temozolomide Teva Cancer Neuroectodermal … Temozolomide Teva … Temozolomide Teva, INN: temozolomide EMA/523990/2014 … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva
Telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Withdrawn, Last updated: 17/09/2021
Telmisartan Teva Hypertension … Telmisartan Teva … Public statement Telmisartan Teva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Irbesartan Teva
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 15, Authorised, Last updated: 06/09/2021
Irbesartan Teva Cardiovascular Diseases Vascular … EPAR). What is Irbesartan Teva? Irbesartan Teva is a medicine that contains … 150 and 300 mg). Irbesartan Teva is a ‘ A generic medicine … -
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Human medicine European public assessment report (EPAR): Repaglinide Teva
repaglinide, Diabetes Mellitus, Type 2
Date of authorisation: 28/06/2009,, Revision: 9, Authorised, Last updated: 17/12/2021
Repaglinide Teva Nutritional and Metabolic … Repaglinide Teva … EMEA/H/C/ 1067 Repaglinide Teva repaglinide EPAR summary … -
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Human medicine European public assessment report (EPAR): Ribavirin Teva
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009,, Revision: 15, Withdrawn, Last updated: 09/07/2021
Ribavirin Teva Hepatitis C, Chronic … Ribavirin Teva … seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato … -
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Human medicine European public assessment report (EPAR): Desloratadine Teva
desloratadine, Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Date of authorisation: 24/11/2011,, Revision: 18, Authorised, Last updated: 09/06/2022
Desloratadine Teva Respiratory Tract Diseases Nose … EPAR) for Desloratadine Teva. It explains how the The committee … of use for Desloratadine Teva. What is Desloratadine Teva? Desloratadine Teva is a medicine containing … -
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Human medicine European public assessment report (EPAR): Entacapone Teva
entacapone, Parkinson Disease
Date of authorisation: 18/02/2011,, Revision: 10, Authorised, Last updated: 28/09/2021
Entacapone Teva Nervous System Diseases Central … Entacapone Teva … Entacapone Teva-INN-Entacapone HCl 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Docetaxel Teva
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/01/2010,, Revision: 18, Withdrawn, Last updated: 14/12/2021
Docetaxel Teva Cancer Neoplasms Breast … Docetaxel Teva … Public statement Docetaxel Teva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Cabazitaxel Teva
cabazitaxel, Prostatic Neoplasms
Date of refusal: 11/07/2019, Refused, Last updated: 24/07/2019Cabazitaxel Teva Prostatic Neoplasms … Cabazitaxel Teva … Cabazitaxel Teva cabazitaxel cabazitaxel …