4968 results
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Opinion/decision on a Paediatric investigation plan (PIP): Perindopril (tosilate), 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-001320-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 22/10/2012, Last updated: 27/11/2012, Compliance check: XActive substance Perindopril (tosilate) Amlodipine besilate … Contact for public enquiries Teva Pharma B.V. Croatia lidija.brnic@pliva.com … product specific waiver for perindopril (tosilate) / amlodipine (besilate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Amlodipine besilate, indapamide, perindopril arginine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002849-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/12/2020, Last updated: 20/09/2021, Compliance check: XAmlodipine besilate indapamide perindopril arginine Therapeutic area … Contact for public enquiries Teva B.V. Email: MedAffGenTevaEurope@tevapharm.com … amlodipine (besilate)/ indapamide/ perindopril (arginine) (EMEA-002849-PIP01-20 … -
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Withdrawn application: Pioglitazone Teva Generics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date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012Pioglitazone Teva Generics: Withdrawn applicati … Pioglitazone Teva Generics: Withdrawal of the … authorisation) Pioglitazone Teva Generics pioglitazone On … -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Withdrawn application: Clopidogrel Teva Pharma
clopidogrel, date of withdrawal: 22/04/2009, Initial authorisation, Last updated: 23/04/2009Clopidogrel Teva Pharma: Withdrawn application … Clopidogrel Teva Pharma: Withdrawal of the … application for Clopidogrel Teva Pharma clopidogrel … -
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Referral: Coversyl
perindopril, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 27/07/2005, EC decision date: 07/11/2005, Last updated: 23/12/2005associated names contain perindopril, a well-known, potent angiotensin … the beneficial effect of perindopril beyond a mere reduction of … Coversyl, INN-perindopril European Medicines Agency … -
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Referral: Coversyl
perindopril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 24/07/2003, EC decision date: 04/12/2003, Last updated: 23/12/2003Commission final decision Overview Perindopril is a specific, competitive … renin-angiotensin-aldosteron system. Perindopril was initially approved in … the benefit/risk ratio of perindopril is considered favourable … -
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Human medicine European public assessment report (EPAR): Leflunomide Teva
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 10/03/2011,
, Revision: 6, Withdrawn, Last updated: 18/03/2014
Leflunomide Teva Arthritis, Rheumatoid … Leflunomide Teva … Public statement Leflunomide Teva Cessation of validity of … -
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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): 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): 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): 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): 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 … -
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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): 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): 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 … Efavirenz Teva … for the public Efavirenz Teva efavirenz This is a summary … -
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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 … Nevirapine Teva … quot;Nevirapin Teva, INN-nevirapin" EMA/524629/2014 … -
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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): Topotecan Teva
topotecan, Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 21/09/2009,, Revision: 8, Withdrawn, Last updated: 13/07/2018
Topotecan Teva Ovarian Neoplasms Uterine … Topotecan Teva … EMEA/H/C/1071 Topotecan Teva topotecan EPAR summary … -
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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): 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): Docetaxel Teva Pharma
docetaxel, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Prostatic Neoplasms
Date of authorisation: 21/01/2011,, Revision: 6, Withdrawn, Last updated: 21/01/2014
Docetaxel Teva Pharma Carcinoma, Non-Small-Cell … Docetaxel Teva Pharma … ublic statement on Docetaxel Teva Pharma 7 Westferry … -
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Human medicine European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva
irbesartan, hydrochlorothiazide, Hypertension
Date of authorisation: 26/11/2009,, Revision: 21, Authorised, Last updated: 31/08/2022
besartan/Hydrochlorothiazide Teva Cardiovascular Diseases Vascular … besartan/Hydrochlorothiazide Teva … formally requested by the Italian medicines agency, to examine … -
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Human medicine European public assessment report (EPAR): Ribavirin Teva Pharma B.V.
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 01/07/2009,, Revision: 14, Withdrawn, Last updated: 09/07/2021
Ribavirin Teva Pharma B.V. Hepatitis C … Ribavirin Teva Pharma B.V … seven medicines (Cilazapril Teva, Fenofibrato Pensa, Fenofibrato … -
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Opinion/decision on a Paediatric investigation plan (PIP): amlodipine, perindopril
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002091-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/04/2017, Last updated: 29/05/2017, Compliance check: XActive substance amlodipine perindopril Therapeutic area Cardiovascular … specific waiver for amlodipine / perindopril (EMEA-002091-PIP01-16 … specific waiver for amlodipine / perindopril (EMEA-002091-PIP01-16) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): perindopril, amlodipine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001968-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 04/11/2016, Last updated: 10/01/2017, Compliance check: XActive substance perindopril amlodipine Therapeutic area … product specific waiver for perindopril / amlodipine (EMEA-001968-PIP01-16) 30 … product specific waiver for perindopril / amlodipine (EMEA-001968-PIP01-16 …