1898 results
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Human medicine European public assessment report (EPAR): Tadalafil Mylan
tadalafil, Erectile Dysfunction
Date of authorisation: 21/11/2014,
, Revision: 15, Authorised, Last updated: 01/06/2023
Tadalafil Mylan Mental Disorders Sexual … Authorised tadalafil Overview This is a summary … assessment report (EPAR) for Tadalafil Mylan. It explains how the … -
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Human medicine European public assessment report (EPAR): Tadalafil Lilly
tadalafil, Erectile Dysfunction
Date of authorisation: 22/03/2017, Revision: 5, Authorised, Last updated: 17/11/2021Tadalafil Lilly Mental Disorders Sexual … Authorised tadalafil Overview This is a summary … assessment report (EPAR) for Tadalafil Lilly. It explains how the … -
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Human medicine European public assessment report (EPAR): Adcirca (previously Tadalafil Lilly) (updated)
tadalafil, Hypertension, Pulmonary
Date of authorisation: 01/10/2008, Revision: 17, Authorised, Last updated: 20/09/2023Adcirca (previously Tadalafil Lilly) Hypertension Vascular … Authorised tadalafil Overview Adcirca is a medicine … medicine. active substance tadalafil. How is Adcirca used? Adcirca … -
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Opinion/decision on a Paediatric investigation plan (PIP): Cialis, tadalafil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000452-PIP02-10-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Oral suspension
Decision date: 11/09/2020, Last updated: 08/07/2021, Compliance check: XCialis Adcirca (previously Tadalafil Lilly) Adcirca Active substance … Adcirca Active substance tadalafil Therapeutic area Cardiovascular … paediatric investigation plan for tadalafil (Adcirca, Cialis), (EMEA-000452-PIP02-10-M06 … -
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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
Talmanco (previously Tadalafil Generics) Respiratory Tract … Talmanco (previously Tadalafil Generics … Talmanco, INN-tadalafil 30 Churchill Place … -
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Human medicine European public assessment report (EPAR): Cialis (updated)
tadalafil, Erectile Dysfunction
Date of authorisation: 12/11/2002, Revision: 31, Authorised, Last updated: 20/09/2023Authorised tadalafil Overview This is a summary … containing the active substance tadalafil. It is available as tablets … active substance of Cialis, tadalafil, belongs to a group of medicines … -
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Opinion/decision on a Paediatric investigation plan (PIP): Macitentan, tadalafil
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001961-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 09/09/2016, Last updated: 27/10/2016, Compliance check: XKey facts Macitentan tadalafil Cardiovascular diseasesP/0243/2016EMEA-001961-PIP01-16 … specific waiver for macitentan / tadalafil (EMEA-001961-PIP01-16) PDF … specific waiver for macitentan / tadalafil (EMEA-001961-PIP01-16 … -
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Human medicine European public assessment report (EPAR): Zoledronic acid Teva
zoledronic acid, Fractures, Bone; Cancer
Date of authorisation: 16/08/2012,, Revision: 14, Authorised, Last updated: 11/10/2021
Zoledronic acid Teva Wounds and Injuries Cancer Neoplasms Fractures … EPAR) for Zoledronic acid Teva. It explains how the Committee … of use for Zoledronic acid Teva. Expand section Collapse section … -
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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): Levetiracetam Teva
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 20, Authorised, Last updated: 21/06/2023
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): Irbesartan Teva (updated)
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 16, Authorised, Last updated: 05/09/2023
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): 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): 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): 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): 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): Tevagrastim
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,
, Revision: 18, Authorised, Last updated: 14/07/2023
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 … Repaglinide Teva … EMEA/H/C/ 1067 Repaglinide Teva repaglinide EPAR summary … -
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Human medicine European public assessment report (EPAR): Capecitabine Teva
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 15, Authorised, Last updated: 08/09/2021
Capecitabine Teva Cancer Neoplasms Colorectal … Capecitabine Teva … 6000 Capecitabine Teva Procedural steps taken and … -
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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): 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): 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): 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): 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 …