715 results
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, rosuvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001914-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Olmesartan medoxomil rosuvastatin calcium Cardiovascular … product specific waiver for olmesartan medoxomil) / rosuvastatin (calcium … product specific waiver for olmesartan medoxomil) / rosuvastatin (calcium … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, 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-001538-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 19/12/2013, Last updated: 05/02/2014, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … for amlodipine (besilate) / olmesartan medoxomil) (EMEA-001538-PIP01-13) PDF … for amlodipine (besilate) / olmesartan medoxomil) (EMEA-001538-PIP01-13 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, 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-001852-PIP01-15, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/11/2015, Last updated: 07/01/2016, Compliance check: XKey facts Olmesartan medoxomil Amlodipine besilate Cardiovascular … product specific waiver for olmesartan medoxomil / amlodipine (besilate) (EMEA-001852-PIP01-15 … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/228/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/226/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, Amlodipine besilate, hydrochlorothiazide
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 04/11/2009, Last updated: 23/12/2009, Compliance check: XOlmesartan medoxomil / amlodipine besilate / hydrochlorothiazide Cardiovascular … Key facts Olmesartan medoxomil Amlodipine besilate hydrochlorothiazide … diseasesP/227/2009Olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Olmesartan medoxomil, hydrochlorothiazide, 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-002104-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/07/2017, Last updated: 24/07/2017, Compliance check: XKey facts Olmesartan medoxomil hydrochlorothiazide Amlodipine … product specific waiver for olmesartan medoxomil/amlodipine (besilate)/hydrochlorothiazide … product specific waiver for olmesartan medoxomil / amlodipine (besilate … -
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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: 08/10/2014Tolucombi Telmisartan Teva Telmisartan Teva Pharma Tolura Onduarp Twynsta Actelsar … Irbesartan Krka) Irbesartan Teva Irbesartan Zentiva (previously … Winthrop) Karvea Sabervel CoAprovel Ifirmacombi Irbesartan/Hydrochlorothiazide Teva Irbesartan Hydrochlorothiazide … -
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Human medicine European public assessment report (EPAR): Edarbi
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011, Revision: 9, Authorised, Last updated: 10/02/2021Authorised azilsartan medoxomil Overview This is a summary … active substance azilsartan medoxomil. It is available as tablets … substance in Edarbi, azilsartan medoxomil, is an ‘angiotensin-II-receptor … -
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Human medicine European public assessment report (EPAR): Ipreziv
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011,
, Revision: 4, Withdrawn, Last updated: 19/12/2014
Withdrawn azilsartan medoxomil Overview The marketing authorisation … gt;IprezivEMEA/H/C/002517Azilsartan medoxomilazilsartan medoxomilHypertensionC09CA09 This medicine is under additional … for Ipreziv (azilsartan medoxomil) in the European Union (EU … -
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Opinion/decision on a Paediatric investigation plan (PIP): Edarbi, Azilsartan medoxomil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000237-PIP01-08-M09, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Granules for oral suspension
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: XKey facts Edarbi Azilsartan medoxomil Cardiovascular diseasesP/0158/2021EMEA-000237-PIP01-08-M09 … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M09 … investigation plan for azilsartan medoxomil (Edarbi), (EMEA-000237-PIP01-08-M09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Azilsartan medoxomil, chlortalidone
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001294-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/10/2012, Last updated: 27/11/2012, Compliance check: XKey facts Azilsartan medoxomil chlortalidone Cardiovascular … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294 … specific waiver for azilsartan medoxomil / chlortalidone (EMEA-001294-PIP01-12 … -
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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): 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): Telmisartan Teva
telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 11, Withdrawn, Last updated: 17/09/2021
Telmisartan Teva Hypertension … authorisation for Telmisartan Teva has been withdrawn at the … Summary documents Telmisartan Teva : EPAR - Summary for the … -
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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): Efavirenz Teva
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 11, Authorised, Last updated: 10/02/2022
Efavirenz Teva Blood-Borne Infections Communicable … report (EPAR) for Efavirenz Teva. It explains how the The committee … conditions of use for Efavirenz Teva. What is Efavirenz Teva? Efavirenz Teva is a medicine that contains … -
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Human medicine European public assessment report (EPAR): Lamivudine Teva
lamivudine, Hepatitis B, Chronic
Date of authorisation: 23/10/2009,, Revision: 12, Authorised, Last updated: 06/01/2022
Lamivudine Teva Infections Communicable … report (EPAR) for Lamivudine Teva. It explains how the The committee … conditions of use for Lamivudine Teva. What is Lamivudine Teva? Lamivudine Teva is a medicine that contains … -
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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 … EPAR). What is Repaglinide Teva? Repaglinide Teva is a medicine that contains … peach: 2 mg). Repaglinide Teva is a ‘generic medicine’ … -
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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: 16, Authorised, Last updated: 10/11/2021
Imatinib Teva Leukemia, Myelogenous, Chronic … Imatinib Teva … Imatinib Teva, INN-imatinib 30 Churchill … -
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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: 28/10/2021
Olanzapine Teva Schizophrenia Spectrum and … EPAR). What is Olanzapine Teva? Olanzapine Teva is a medicine containing … in the mouth. Olanzapine 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, Authorised, Last updated: 09/12/2021
Nevirapine Teva Blood-Borne Infections Communicable … EPAR). What is Nevirapine Teva? Nevirapine Teva is a medicine that contains … tablets (200 mg). Nevirapine Teva is a ‘ A generic medicine … -
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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: 15, Authorised, Last updated: 08/12/2021
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): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,, Revision: 16, Authorised, Last updated: 26/10/2021
Sildenafil Teva Male Urogenital Diseases Genital … report (EPAR) for Sildenafil Teva. It explains how the The committee … conditions of use for Sildenafil Teva. What is Sildenafil Teva? Sildenafil Teva is a medicine that contains …