5302 results
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Referral: Renitec
Enalapril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 19/09/2002, EC decision date: 21/05/2003, Last updated: 02/12/2003Enalapril is a highly specific, competitive … the benefit/risk ratio of enalapril is considered to be favourable … Renitec, INN-Enalapril The European Agency … -
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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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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001706-PIP01-14-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form
Decision date: 07/12/2018, Last updated: 20/02/2019, Compliance check: XActive substance Enalapril (maleate) Therapeutic area … Enalapril (maleate … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001241-PIP02-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 03/09/2014, Last updated: 29/09/2014, Compliance check: XActive substance Enalapril (maleate) Therapeutic area … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … paediatric investigation plan for enalapril (maleate) (EMEA-001241-PIP02-13-M01 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enalapril (maleate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001516-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet for oral suspension, Orodispersible film
Decision date: 05/05/2014, Last updated: 06/06/2014, Compliance check: XActive substance Enalapril (maleate) Therapeutic area … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … the refusal of a waiver for enalapril (maleate) (EMEA-001516-PIP01-13 … -
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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 … authorisation) Pioglitazone Teva Generics pioglitazone On … medicinal product Pioglitazone Teva Generics 15, 30, 45 mg tablet … -
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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 … application for Clopidogrel Teva Pharma clopidogrel … clopidogrel On 22 April 2009, Teva Pharma B.V. officially notified … -
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Human medicine European public assessment report (EPAR): Ribavirin Teva
Ribavirin, Hepatitis C, Chronic
Date of authorisation: 31/03/2009,
, Revision: 14, Authorised, Last updated: 23/11/2020
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): Sildenafil Teva
sildenafil, Erectile Dysfunction
Date of authorisation: 30/11/2009,, Revision: 15, Authorised, Last updated: 13/10/2020
Sildenafil Teva Erectile Dysfunction … Sildenafil Teva … Sildenafil Teva, INN-sildenafil 7 … -
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Human medicine European public assessment report (EPAR): Irbesartan Teva
irbesartan, Hypertension
Date of authorisation: 30/10/2009,, Revision: 12, Authorised, Last updated: 10/12/2019
Irbesartan Teva Hypertension … Irbesartan Teva … formally requested by the Italian medicines agency, to examine … -
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Human medicine European public assessment report (EPAR): Telmisartan Teva
telmisartan, Hypertension
Date of authorisation: 25/01/2010,, Revision: 10, Authorised, Last updated: 05/09/2018
Telmisartan Teva Hypertension … Telmisartan Teva … formally requested by the Italian medicines agency, to examine … -
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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: 15, Authorised, Last updated: 16/09/2020
Desloratadine Teva Rhinitis, Allergic, Perennial Rhinitis … Desloratadine Teva … the public Desloratadine Teva desloratadine This is … -
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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): 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 … Rivastigmine Teva … Rivastigmine Teva, INN-rivastigmine 7 … -
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Human medicine European public assessment report (EPAR): Efavirenz Teva
efavirenz, HIV Infections
Date of authorisation: 09/01/2012,, Revision: 9, Authorised, Last updated: 17/10/2019
Efavirenz Teva HIV Infections … 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: 9, Authorised, Last updated: 22/08/2019
Nevirapine Teva HIV Infections … Nevirapine Teva … quot;Nevirapin Teva, INN-nevirapin" EMA/524629/2014 … -
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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): 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: 15, Authorised, Last updated: 29/01/2021
Imatinib Teva Leukemia, Myelogenous, Chronic … Imatinib Teva … Imatinib Teva, INN-imatinib 30 Churchill … -
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Human medicine European public assessment report (EPAR): Levetiracetam Teva (updated)
levetiracetam, Epilepsy
Date of authorisation: 25/08/2011,, Revision: 16, Authorised, Last updated: 02/02/2021
Levetiracetam Teva Epilepsy … PDF/15.8 KB) (PDF/15.8 KB) Italian (PDF/14.93 KB) (PDF/14.93 … indication Levetiracetam Teva is indicated as monotherapy … -
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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, Authorised, Last updated: 23/11/2020
Docetaxel Teva Head and Neck Neoplasms Carcinoma … Docetaxel Teva … EU/1/09/611/001 Docetaxel TEVA 20 mg /0.72 ml Concentrate … -
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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: 7, Authorised, Last updated: 04/10/2016
Repaglinide Teva Diabetes Mellitus, Type 2 … Repaglinide Teva … EMEA/H/C/ 1067 Repaglinide Teva repaglinide EPAR summary … -
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Human medicine European public assessment report (EPAR): Temozolomide Teva
temozolomide, Glioma, Glioblastoma
Date of authorisation: 28/01/2010,, Revision: 19, Authorised, Last updated: 10/07/2020
Temozolomide Teva Glioma Glioblastoma … Temozolomide Teva … Temozolomide Teva, INN: temozolomide EMA/523990/2014 … -
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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: 13, Authorised, Last updated: 29/07/2020
Capecitabine Teva Colonic Neoplasms Breast … Capecitabine Teva … Assessment report Capecitabine Teva International non-proprietary … -
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Human medicine European public assessment report (EPAR): Olanzapine Teva
olanzapine, Schizophrenia, Bipolar Disorder
Date of authorisation: 12/12/2007,, Revision: 27, Authorised, Last updated: 27/05/2020
Olanzapine Teva Schizophrenia Bipolar Disor … Olanzapine Teva … Olanzapine Teva, INN-olanzapine 7 … -
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Human medicine European public assessment report (EPAR): Entacapone Teva
entacapone, Parkinson Disease
Date of authorisation: 18/02/2011,, Revision: 8, Authorised, Last updated: 13/12/2018
Entacapone Teva Parkinson Disease … Entacapone Teva … Entacapone Teva-INN-Entacapone HCl 30 Churchill Place …