7695 results
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Withdrawn application: Pioglitazone Teva Generics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date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn application … Pioglitazone Teva Generics: Withdrawal of the marketing … authorisation) Pioglitazone Teva Generics pioglitazone On 22 September … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis; Osteitis Deformans
Date of authorisation: 27/03/2014,
, Revision: 2, Withdrawn, Last updated: 08/08/2016
Zoledronic acid Teva Generics Osteoporosis Osteitis Defor … authorisation for Zoledronic Acid Teva Generics has been withdrawn at the … documents Zoledronic acid Teva Generics : EPAR - Summary for the … -
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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Date of authorisation: 28/10/2010,, Revision: 3, Withdrawn, Last updated: 12/05/2014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 … Clopidogrel Teva Generics B.V … Clopidogrel Teva Generics B.V., INN-clopidogrel … -
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Human medicine European public assessment report (EPAR): Talmanco (previously Tadalafil Generics)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 09/01/2017,, Revision: 7, Authorised, Last updated: 09/06/2022
lmanco (previously Tadalafil Generics) Respiratory Tract Diseases Lung … lmanco (previously Tadalafil Generics) … Questions and answers on generic medicines What is a generic medicine? A generic medicine is a medicine that … -
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Opinion/decision on a Paediatric investigation plan (PIP): Furosemide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-000982-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Orodispersible tablet
Decision date: 21/10/2011, Last updated: 02/10/2018, Compliance check: XKey facts Furosemide Uro-nephrologyP/245/2011EMEA-000982-PIP01-10 … granting of a waiver for furosemide (EMEA-000982-PIP01-10) PDF … 28/11/2011 EMA/826074/2011 Generic Related content … -
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Referral: Furosemide Vitabalans
furosemide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/02/2013, EC decision date: 14/05/2013, Last updated: 30/07/2013Furosemide Vitabalans … Questions and answers on Furosemide Vitabalans (tablet, 40 mg … Questions and answers on Furosemide Vitabalans (tablet, 40 mg … -
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Opinion/decision on a Paediatric investigation plan (PIP): eplerenone, Furosemide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-003065-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/12/2021, Last updated: 13/03/2023, Compliance check: XKey facts eplerenone Furosemide Cardiovascular diseasesP/0488/2021EMEA-003065-PIP01-21 … specific waiver for eplerenone / furosemide (EMEA-003065-PIP01-21) PDF … 13/03/2023 EMA/632017/2021 Generic Topics: Paediatrics … -
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Referral: Docetaxel Teva Generics
docetaxel, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/02/2011, EC decision date: 07/07/2011, Last updated: 03/07/2012Docetaxel Teva Generics … of the medicine Docetaxel Teva Generics. The Agency's Committee for … the benefits of Docetaxel Teva Generics outweigh its risks, and that … -
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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 … authorisation for Clopidogrel Teva Pharma, for the prevention … -
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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 … details Name Telmisartan Teva Agency product number EMEA/H/C/001146 … chemical (ATC) code C09CA07 Generic Generic Generic This is a … -
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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): 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 … duct details Name Nevirapine Teva Agency product number EMEA/H/C/001119 … chemical (ATC) code J05AG01 Generic Generic Generic This is a … -
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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 … report (EPAR) for Efavirenz Teva. It explains how the Committee … conditions of use for Efavirenz Teva. Expand section Collapse section … -
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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): 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 is a medicine that … -
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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 … section What is Olanzapine Teva? Olanzapine Teva is a medicine containing … in the mouth. Olanzapine Teva is a ‘ generic medicine’. This means that … -
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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 … report (EPAR) for Sildenafil Teva. It explains how the Committee … conditions of use for Sildenafil Teva. Expand section Collapse section … -
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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 … report (EPAR) for Lamivudine Teva. It explains how the Committee … conditions of use for Lamivudine Teva. Expand section Collapse section … -
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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): 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 … section What is Repaglinide Teva? Repaglinide Teva is a medicine that contains … peach: 2 mg). Repaglinide Teva is a ‘ generic medicine’. This means that … -
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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 … report (EPAR) for Entacapone Teva. It explains how the Committee … conditions of use for Entacapone Teva. Expand section Collapse section … -
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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 … section What is Temozolomide Teva? Temozolomide Teva is a medicine that contains … and 250 mg). Temozolomide Teva is a ‘ generic medicine’. This means that … -
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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 … oduct details Name Ribavirin Teva Agency product number EMEA/H/C/001018 … chemical (ATC) code J05AB04 Generic Generic Generic This is a … -
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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 … report (EPAR) for Imatinib Teva. It explains how the Agency … advice on how to use Imatinib Teva. For practical information … -
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Human medicine European public assessment report (EPAR): Rivastigmine Teva
rivastigmine, Dementia; Alzheimer Disease; Parkinson Disease
Date of authorisation: 17/04/2009,, Revision: 4, Withdrawn, Last updated: 27/09/2012
Rivastigmine Teva Dementia Alzheimer Disease Parkinson … authorisation for Rivastigmine Teva has been withdrawn at the … Summary documents Rivastigmine Teva : EPAR - Summary for the …