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Keyword Xeloda Remove keyword
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Human medicine European public assessment report (EPAR): Xeloda
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 02/02/2001, Revision: 30, Authorised, Last updated: 26/10/2022Xeloda Cancer Neoplasms Colorectal … Xeloda … alfa-2a), Tamiflu (oseltamivir), Xeloda (capecitabine) and Xenical … -
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020Xeloda Teysuno Capecitabine Accord Capecitabine … previously Capecitabine Krka) Xeloda Teysuno Capecitabine Accord Capecitabine … -
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Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020Medicine name Xeloda Capecitabine Accord Capecitabine … Xeloda Capecitabine Accord Capecitabine … Capecitabine Krka) Teysuno Xeloda Capecitabine Accord Capecitabine … -
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,
, Revision: 13, Authorised, Last updated: 31/03/2023
While the reference medicine, Xeloda, is available as 150 and 500 … with the reference medicine, Xeloda, and do not need to be repeated … and to be bioequivalent to Xeloda. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 07/03/2023
While the reference medicine, Xeloda, is available as 150 and 500 … with the reference medicine, Xeloda, and do not need to be repeated … and to be bioequivalent to Xeloda. Therefore, the Agency’s … -
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Human medicine European public assessment report (EPAR): Capecitabine Accord
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 16, Authorised, Last updated: 10/12/2021
While the reference medicine, Xeloda, is available as 150 and 500 … with the reference medicine, Xeloda, and do not need to be repeated … and to be bioequivalent to Xeloda. Therefore, the Agency’s … -
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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
authorised in the EU called Xeloda. Capecitabine Teva contains … with the reference medicine, Xeloda, and do not need to be repeated … and to be bioequivalent to Xeloda. Therefore, the Agency’s … -
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Press release: European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection
Last updated: 19/11/2013Tamiflu, Tarceva, Viracept, Xeloda, Xenical and Zelboraf. Nationally-authorised … Tamiflu, Tarceva, Viracept, Xeloda, Xenical and Zelboraf 3 … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 July 2012
CHMP, Last updated: 20/07/2012Mircera, Pegasys, Tamiflu, Xeloda, Xenical orlistat, methoxy … -
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Press release: European Medicines Agency starts infringement procedure to investigate Roche's alleged non-compliance with pharmacovigilance obligations
Last updated: 23/10/2012Tarceva: EPAR Viracept: EPAR Xeloda: EPAR Xenical: EPAR Zelboraf … Tamiflu, Tarceva, Viracept, Xeloda, Xenical and Zelboraf … -
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Press release: EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and flucytosine
CHMP, Last updated: 30/04/2020through EMA with the brand name Xeloda as well as various generic … Krka): EPAR Teysuno: EPAR Xeloda: EPAR Teysuno: Withdrawn application … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020
PRAC, Last updated: 13/03/2020Acetate Gedeon Richter: EPAR Xeloda: EPAR Teysuno: Withdrawn application … -
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Human medicine European public assessment report (EPAR): Xenical (updated)
orlistat, Obesity
Date of authorisation: 29/07/1998, Revision: 25, Authorised, Last updated: 10/05/2023alfa-2a), Tamiflu (oseltamivir), Xeloda (capecitabine) and Xenical … to work properly); • Xeloda, containing the active substance … -
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Human medicine European public assessment report (EPAR): Mircera
Methoxy polyethylene glycol-epoetin beta, Anemia; Kidney Failure, Chronic
Date of authorisation: 20/07/2007, Revision: 28, Authorised, Last updated: 20/03/2023alfa-2a), Tamiflu (oseltamivir), Xeloda (capecitabine) and Xenical … to work properly); • Xeloda, containing the active substance … -
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Human medicine European public assessment report (EPAR): Jevtana
cabazitaxel, Prostatic Neoplasms
Date of authorisation: 17/03/2011, Revision: 22, Authorised, Last updated: 25/04/2023 -
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Human medicine European public assessment report (EPAR): Tamiflu
oseltamivir, Influenza, Human
Date of authorisation: 20/06/2002, Revision: 42, Authorised, Last updated: 24/03/2023alfa-2a), Tamiflu (oseltamivir), Xeloda (capecitabine) and Xenical … to work properly); • Xeloda, containing the active substance … -
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Human medicine European public assessment report (EPAR): Javlor
vinflunine, Carcinoma, Transitional Cell; Urologic Neoplasms
Date of authorisation: 21/09/2009, Revision: 10, Authorised, Last updated: 23/11/2022 -
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Human medicine European public assessment report (EPAR): Pegasys
peginterferon alfa-2a, Hepatitis C, Chronic; Hepatitis B, Chronic
Date of authorisation: 20/06/2002, Revision: 45, Authorised, Last updated: 07/11/2022alfa-2a), Tamiflu (oseltamivir), Xeloda (capecitabine) and Xenical … to work properly); • Xeloda, containing the active substance … -
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Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023 -
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Human medicine European public assessment report (EPAR): Alli (previously Orlistat GSK)
orlistat, Obesity
Date of authorisation: 22/07/2007, Revision: 18, Authorised, Last updated: 06/01/2022alfa-2a), Tamiflu (oseltamivir), Xeloda (capecitabine) and Xenical … to work properly); • Xeloda, containing the active substance … -
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,
, 
, Revision: 10, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Herceptin
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 28/08/2000, Revision: 42, Authorised, Last updated: 17/03/2023 -
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,
, Revision: 9, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Capecitabine SUN
capecitabine, Stomach Neoplasms; Breast Neoplasms; Colonic Neoplasms; Colorectal Neoplasms
Date of authorisation: 21/06/2013,, Revision: 3, Withdrawn, Last updated: 22/12/2016
is a generic medicine of Xeloda. There are other generic medicinal … generic medicinal products of Xeloda authorised and marketed in … European Union (EU) called Xeloda. For more information on generic … -
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Human medicine European public assessment report (EPAR): Abraxane
paclitaxel, Breast Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 11/01/2008, Revision: 29, Authorised, Last updated: 13/05/2022