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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Date of authorisation: 20/04/2007, Revision: 30, Withdrawn, Last updated: 20/05/2022Docetaxel Zentiva (previously Docetaxel Winthrop) Neoplasms Cancer Breast … Docetaxel Zentiva (previously Docetaxel Winthrop …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
docetaxel, Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Prostatic Neoplasms; Breast Neoplasms
Date of authorisation: 22/05/2012,
, Revision: 15, Authorised, Last updated: 21/12/2021
Docetaxel Accord Cancer Neoplasms Breast … Docetaxel Accord … Package size EU/1/12/769/001 Docetaxel Accord 20 mg/1 ml Concentrate … -
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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Date of authorisation: 26/01/2010,, Revision: 18, Withdrawn, Last updated: 14/12/2021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Date of authorisation: 31/01/2012,, Revision: 6, Withdrawn, Last updated: 12/03/2015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: 49, Authorised, Last updated: 14/12/2021docetaxel … EMEA/H/C/000073 Taxotere (docetaxel) An overview of Taxotere … contains the active substance docetaxel. How is Taxotere used … -
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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): Micardis
telmisartan, Hypertension
Date of authorisation: 16/12/1998, Revision: 26, Authorised, Last updated: 25/02/2022a summary of the A set of documents describing the evaluation … the EPAR) or contact your doctor or pharmacist. If you want … is 80 mg once a day. The doctor should monitor the patient’s … -
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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: 10/02/2021antihypertensive 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: 25, Authorised, Last updated: 09/02/2022used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker … the EPAR) or contact your doctor or pharmacist. Summary documents Rasilez : EPAR - Summary … precautionary measure, that doctors should not prescribe aliskiren-containing … -
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Human medicine European public assessment report (EPAR): Rapamune (updated)
Sirolimus, Graft Rejection; Kidney Transplantation
Date of authorisation: 13/03/2001, Revision: 46, Authorised, Last updated: 25/07/2022remain under the guidance of a doctor who is a qualified specialist … followed by 2 mg once a day. The doctor will adjust the dose to achieve … and after 10 to 20 days the doctor will adjust the dose to achieve … -
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Human medicine European public assessment report (EPAR): Rasilez HCT
aliskiren, hydrochlorothiazide, Hypertension
Date of authorisation: 16/01/2009, Revision: 17, Withdrawn, Last updated: 20/05/2022marketing-authorisation holder. Summary documents Rasilez HCT : EPAR - Medicine … precautionary measure, that doctors should not prescribe aliskiren-containing … will be distributed to doctors at national level to inform … -
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Human medicine European public assessment report (EPAR): Libtayo (updated)
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,
, 
, Revision: 12, Authorised, Last updated: 28/07/2022
started and supervised by a doctor experienced in treating cancer … unacceptable side effects. The doctor may need to delay doses if … package leaflet or contact your doctor or pharmacist. How does Libtayo … -
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Human medicine European public assessment report (EPAR): Thymanax (updated)
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009,
Date of refusal: 18/11/2006, Revision: 24, Authorised, Last updated: 08/08/2022a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Thymanax … symptoms after two weeks, the doctor may increase the dose to … -
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Human medicine European public assessment report (EPAR): Valdoxan (updated)
Agomelatine, Depressive Disorder, Major
Date of authorisation: 19/02/2009, Revision: 24, Authorised, Last updated: 08/08/2022a summary of the A set of documents describing the evaluation … leaflet or contact their doctor or pharmacist. What is Valdoxan … symptoms after two weeks, the doctor may increase the dose to … -
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Human medicine European public assessment report (EPAR): Torisel
Temsirolimus, Carcinoma, Renal Cell; Lymphoma, Mantle-Cell
Date of authorisation: 19/11/2007, Revision: 33, Authorised, Last updated: 21/06/2022under the supervision of a doctor who has experience in the … package leaflet or contact your doctor or pharmacist. How does Torisel … -
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Human medicine European public assessment report (EPAR): Dafiro HCT
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 03/11/2009, Revision: 23, Authorised, Last updated: 04/04/2022the EPAR) or contact your doctor or pharmacist. If you want … -
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Human medicine European public assessment report (EPAR): Copalia HCT
amlodipine, valsartan, hydrochlorothiazide, Hypertension
Date of authorisation: 03/11/2009, Revision: 21, Authorised, Last updated: 04/04/2022the EPAR) or contact your doctor or pharmacist. If you want … -
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Human medicine European public assessment report (EPAR): Glyxambi
empagliflozin, linagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 11/11/2016, Revision: 15, Authorised, Last updated: 25/05/2022leaflet or contact their doctor or pharmacist. Expand section … blood sugar levels). The doctor may need to reduce the dose … the EPAR) or contact your doctor or pharmacist. List item … -
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Human medicine European public assessment report (EPAR): Exforge HCT
valsartan, hydrochlorothiazide, Amlodipine besilate, Hypertension
Date of authorisation: 15/10/2009, Revision: 21, Authorised, Last updated: 01/04/2022the EPAR) or contact your doctor or pharmacist. List item … -
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Human medicine European public assessment report (EPAR): Tolucombi
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 13/03/2013,, Revision: 10, Authorised, Last updated: 25/02/2022
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): MicardisPlus
telmisartan, hydrochlorothiazide, Hypertension
Date of authorisation: 19/04/2002, Revision: 31, Authorised, Last updated: 25/02/2022a summary of the A set of documents describing the evaluation … has been included in the A document describing the properties … the EPAR) or contact your doctor or pharmacist. Summary …