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Human medicine European public assessment report (EPAR): Docetaxel Zentiva (previously Docetaxel Winthrop)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 20/04/2007, Revision: 30, Withdrawn, Last updated: 20/05/2022Docetaxel Zentiva (previously Docetaxel Winthrop) Neoplasms Cancer Breast … Docetaxel Zentiva (previously Docetaxel Winthrop … EMEA/H/C/000808 Public statement Docetaxel Zentiva Withdrawal of the … -
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Human medicine European public assessment report (EPAR): Docetaxel Accord (updated)
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,
, Revision: 17, Authorised, Last updated: 14/09/2023
Docetaxel Accord Cancer Neoplasms Breast … Authorised docetaxel Overview Docetaxel Accord is a cancer medicine … of cancer: breast cancer. Docetaxel Accord can be used on its … -
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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Date of authorisation: 26/01/2010,, Revision: 18, Withdrawn, Last updated: 14/12/2021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 … EMEA/H/C/001107 Public statement Docetaxel Teva Withdrawal of the marketing … -
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Human medicine European public assessment report (EPAR): Docetaxel Kabi
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,, Revision: 14, Authorised, Last updated: 28/10/2020
Docetaxel Kabi Cancer Neoplasms Breast … Docetaxel Kabi … initial authorisation) Docetaxel Kabi docetaxel On 15 March 2012 the Committee … -
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Human medicine European public assessment report (EPAR): Docetaxel Mylan
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 31/01/2012,, Revision: 6, Withdrawn, Last updated: 12/03/2015
Docetaxel Mylan Head and Neck Neoplasms Carcinoma … Docetaxel Mylan … Rev. 1 Public statement Docetaxel Mylan Cessation of validity … -
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Human medicine European public assessment report (EPAR): Docefrez
docetaxel, Stomach Neoplasms; Adenoma; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Prostatic Neoplasms
Date of authorisation: 10/05/2010,, Revision: 1, Withdrawn, Last updated: 14/06/2012
Docefrez Stomach Neoplasms Adenoma Breast … Docefrez … Docefrez, INN docetaxel 7 Westferry Circus … -
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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 … Public statement on Docetaxel Teva Pharma 7 Westferry … -
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Human medicine European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel trihydrate, Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
Taxespira (previously Docetaxel Hospira UK Limited ) Stomach … Taxespira (previously Docetaxel Hospira UK Limited … Taxespira (previously Docetaxel Hospira UK Limited docetaxel docetaxel trihydrate … -
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Human medicine European public assessment report (EPAR): Taxotere
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 27/11/1995, Revision: 50, Authorised, Last updated: 24/03/2023docetaxel … EMEA/H/C/000073 Taxotere (docetaxel) An overview of Taxotere … contains the active substance docetaxel. How is Taxotere used … -
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Referral: Tritace
ramipril, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 24/04/2009active substance in Tritace, ramipril, is an angiotensin-converting … Protect Startset, Delix P, Ramipril Winthrop Ramipril Prevent, Loavel, Ramiwin Ramipril Medgenerics, Ramilich, Tritace … London, 18 March 2009 Doc. Ref. EMEA/CHMP/233264/2009 … -
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Referral: Tritazide
ramipril, hydrochlorothiazide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 18/12/2008, EC decision date: 06/03/2009, Last updated: 14/04/2009contains two active substances, ramipril and hydrochlorothiazide Ramipril is an angiotensin converting … adequately controlled with ramipril alone or hydrochlorothiazide … Tritace HCT, Triatec HCT, Ramipril e Idrocloritiazide, Ramicor … -
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Referral: Rambis and associated names
ramipril, bisoprolol fumarate, associated names: Ralbior, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/12/2022, EC decision date: 15/02/2023, Last updated: 08/03/2023authorisation of Rambis (ramipril / bisoprolol) in the EU On … combination of two medicines called ramipril and bisoprolol. Rambis contains … bisoprolol. Rambis contains both ramipril and bisoprolol and is intended … -
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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 … authorisation of the medicine Docetaxel Teva Generics. The Agency's … concluded that the benefits of Docetaxel Teva Generics outweigh its … -
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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: 08/10/2014their medication with their doctor at their next regular appointment … Actavis captopril imidapril zofenopril candesartan delapril telmisartan aliskiren moexipril enalapril valsartan fosinopril irbesartan perindopril quinapril ramipril eprosartan olmesartan trandolapril losartan azilsartan lisinopril spirapril benazepril cilazapril telmisartan hydrochlorothiazide telmisartan telmisartan telmisartan telmisartan amlodipine telmisartan amlodipine telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide telmisartan hydrochlorothiazide amlodipine valsartan hydrochlorothiazide amlodipine … -
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Human medicine European public assessment report (EPAR): Micardis
Telmisartan, Hypertension
Date of authorisation: 16/12/1998, Revision: 27, Authorised, Last updated: 03/11/2022the EPAR) or contact your doctor or pharmacist. If you want … is 80 mg once a day. The doctor should monitor the patient’s … Micardis was compared with ramipril (another medicine to prevent … -
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Human medicine European public assessment report (EPAR): Pritor
Telmisartan, Hypertension
Date of authorisation: 11/12/1998, Revision: 29, Authorised, Last updated: 10/12/2020is 80 mg once a day. The doctor should monitor the patient’s … Pritor was compared with ramipril (another medicine to prevent … Pritor had a similar effect to ramipril, with around 17% of patients … -
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Human medicine European public assessment report (EPAR): Edarbi
Azilsartan medoxomil, Hypertension
Date of authorisation: 07/12/2011, Revision: 10, Authorised, Last updated: 17/03/2022antihypertensive medicines (ramipril, valsartan and olmesartan … also more effective than ramipril (10 mg). The studies also … the EPAR) or contact your doctor or pharmacist. Summary … -
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Human medicine European public assessment report (EPAR): Rasilez
aliskiren, Hypertension
Date of authorisation: 22/08/2007, Revision: 27, Authorised, Last updated: 23/02/2023used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker … the EPAR) or contact your doctor or pharmacist. List item … precautionary measure, that doctors should not prescribe aliskiren-containing … -
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Human medicine European public assessment report (EPAR): Dafiro HCT (updated)
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 03/11/2009, Revision: 25, Authorised, Last updated: 27/09/2023a summary of the A set of documents describing the evaluation … the EPAR) or contact your doctor or pharmacist. If you want … -
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Human medicine European public assessment report (EPAR): Copalia HCT (updated)
amlodipine, valsartan, hydrochlorothiazide, Hypertension
Date of authorisation: 03/11/2009, Revision: 24, Authorised, Last updated: 27/09/2023a summary of the A set of documents describing the evaluation … the EPAR) or contact your doctor or pharmacist. If you want … -
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Human medicine European public assessment report (EPAR): Tolucombi
Telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 13/03/2013,, Revision: 11, Authorised, Last updated: 24/08/2023
a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Tolucombi … has been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Glyxambi (updated)
empagliflozin, linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2016, Revision: 16, Authorised, Last updated: 27/09/2023a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Glyxambi … blood sugar levels). The doctor may need to reduce the dose … -
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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
a summary of the A set of documents describing the evaluation … the EPAR) or contact your doctor or pharmacist. If you want … 30 October 2009. Summary documents Irbesartan Teva : EPAR … -
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Human medicine European public assessment report (EPAR): Lyxumia
lixisenatide, Diabetes Mellitus, Type 2
Date of authorisation: 31/01/2013, Revision: 19, Authorised, Last updated: 18/07/2023a summary of the A set of documents describing the evaluation … medicine) or basal insulin, the doctor may need to reduce the dose … has been included in the A document describing the properties … -
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Human medicine European public assessment report (EPAR): Synjardy (updated)
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015, Revision: 26, Authorised, Last updated: 27/09/2023a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Synjardy … have been included in the A document describing the properties …