321 results
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Human medicine European public assessment report (EPAR): Vectibix
panitumumab, Colorectal Neoplasms
Date of authorisation: 03/12/2007, Revision: 34, Authorised, Last updated: 06/07/2022FOLFOX (a combination of fluorouracil with folinic acid and the … oxaliplatin) or FOLFIRI (fluorouracil with folinic acid and a different … ‘fluoropyrimidine’ (such as 5-fluorouracil), oxaliplatin and irinotecan … -
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Direct healthcare professional communication (DHPC): Flucytosine: Updated recommendations for the use in patients with dihydropyrimidine dehydrogenase (DPD) deficiency
Active substance: Flucytosine, DHPC type: Referral - Article 31, Last updated: 04/06/2020FlucytosineEMEA/H/A-31/1481VariationReferral - Article 31Fluorouracil and fluorouracil related substances (capecitabine … professional communications Fluorouracil and … -
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Human medicine European public assessment report (EPAR): Zercepac
trastuzumab, Breast Neoplasms; Stomach Neoplasms
Date of authorisation: 27/07/2020,
, 
, Revision: 8, Authorised, Last updated: 09/02/2023
and either capecitabine or fluorouracil (other cancer medicines … combination with capecitabine or 5-fluorouracil and cisplatin is indicated … -
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Orphan designation: 5,10-Methylene-tetrahydrofolic acid for: Treatment of pancreatic cancer in combination with 5-fluorouracil
Date of designation: 02/09/2004, Withdrawn, Last updated: 15/10/2009cancer in combination with 5-fluorouracil … cancer in combination with 5-fluorouracil European Medicines … cancer in combination with 5-fluorouracil On 2 September 2004 … -
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Human medicine European public assessment report (EPAR): Ogivri
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 12/12/2018,, , Revision: 9, Authorised, Last updated: 30/09/2022
and either capecitabine or fluorouracil (other cancer medicines … combination with capecitabine or 5-fluorouracil and cisplatin is indicated … -
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Human medicine European public assessment report (EPAR): Ontruzant
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 15/11/2017,, Revision: 14, Authorised, Last updated: 20/09/2022
either capecitabine or 5‑fluorouracil (other cancer medicines … either capecitabine or 5‑fluorouracil (other cancer medicines … -
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Orphan designation: 5-10-Methylene-tetrahydrofolate for: Treatment pancreatic cancer in combination with 5-fluorouracil
Date of designation: 11/06/2003, Withdrawn, Last updated: 15/10/2009cancer in combination with 5-fluorouracil … cancer in combination with 5-fluorouracil European Medicines … cancer in combination with 5-fluorouracil On 11 June 2003, orphan … -
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Human medicine European public assessment report (EPAR): Zaltrap
aflibercept, Colorectal Neoplasms
Date of authorisation: 01/02/2013, Revision: 13, Authorised, Last updated: 21/12/2022the medicines irinotecan, 5-fluorouracil, and folinic acid. The medicine … the medicines irinotecan, 5-fluorouracil, and folinic acid. The … combination with irinotecan/ 5-fluorouracil/ folinic acid (FOLFIRI) chemotherapy … -
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Orphan designation: Flucytosine for: Treatment of glioma
Date of designation: 22/02/2018, Positive, Last updated: 18/09/2020that converts flucytosine to fluorouracil. Fluorouracil is a well-known chemotherapy … virus converts flucytosine to fluorouracil, which kills the cancer cell … that converts flucytosine to fluorouracil. Fluorouracil is a well-known chemotherapy … -
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Orphan designation: Vocimagene amiretrorepvec for: Treatment of glioma
Date of designation: 22/02/2018, Positive, Last updated: 18/09/2020that converts flucytosine to fluorouracil. Fluorouracil is a well-known chemotherapy … virus converts flucytosine to fluorouracil, which kills the cancer cell … that converts flucytosine to fluorouracil. Fluorouracil is a well-known chemotherapy … -
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 09/02/2018,, Revision: 19, Authorised, Last updated: 11/04/2023
and either capecitabine or fluorouracil (other cancer medicines … and either capecitabine or fluorouracil (other cancer medicines). Herzuma … -
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Orphan designation: 2',3',5'-Tri-O-acetyluridine for: Treatment of 5-fluorouracil overdose
Date of designation: 15/05/2009, Positive, Last updated: 09/06/2009designation for the treatment of 5-fluorouracil overdose … idine for the treatment of 5-fluorouracil overdose European … for the treatment of 5-fluorouracil overdose On 15 May 2009 … -
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Press release: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019
PRAC, Last updated: 15/03/2019patients before treatment with fluorouracil, capecitabine, tegafur and … review of medicines containing fluorouracil (also known as 5 fluorouracil or 5-FU) and the related … which can be converted to fluorouracil in the body … -
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Human medicine European public assessment report (EPAR): Keytruda
Pembrolizumab, Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
Date of authorisation: 17/07/2015, Revision: 50, Authorised, Last updated: 28/04/2023combination with platinum and 5-fluorouracil (5-FU) chemotherapy is effective … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 March 2020
PRAC, Last updated: 13/03/2020treatment recommendations for fluorouracil, capecitabine, tegafur and … recommended that patients receiving fluorouracil given by injection or infusion … tegafur, which are converted to fluorouracil in the body, should be tested … -
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Orphan designation: Patidegib for: Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome)
Date of designation: 21/03/2018, Positive, Last updated: 24/02/2023the time of designation, fluorouracil, imiquimod, sonidegib, tretinoin … the time of designation, fluorouracil, imiquimod, sonidegib, tretinoin … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
CHMP, Last updated: 30/04/2020below. Outcome of review on fluorouracil medicines The Committee recommended … starting cancer treatment with fluorouracil given by injection or infusion … another medicine related to fluorouracil) should not be delayed, testing … -
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Orphan designation: Zanidatamab for: Treatment of gastric cancer
Date of designation: 13/11/2020, Positive, Last updated: 13/10/2021doxorubicin, epirubicin, fluorouracil, mitomycin, ramucirumab and … doxorubicin, epirubicin, fluorouracil, mitomycin, ramucirumab and … -
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Orphan designation: N-(4-(1-cyanocyclopentyl)phenyl)-2-(4-pyridinylmethyl)amino-3-pyridinecarboxamide methanesulfonate for: Treatment of gastric cancer
Date of designation: 27/02/2017, Positive, Last updated: 02/03/2021doxorubicin, epirubicin, fluorouracil, mitomycin, ramucirumab and … doxorubicin, epirubicin, fluorouracil, mitomycin, ramucirumab and … -
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Orphan designation: avelumab for: Treatment of gastric cancer
Date of designation: 12/12/2016, Withdrawn, Last updated: 15/10/2019doxorubicin, epirubicin, fluorouracil, mitomycin, ramucirumab and … -
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Orphan designation: 4-[2-(6-Methylpyridin-2-yl)-5,6-dihydro-4H-pyrrolo[1,2-b]pyrazol-3-yl]-quinoline-6-carboxamide monohydrate for: Treatment of hepatocellular carcinoma
Date of designation: 12/03/2013, Withdrawn, Last updated: 17/06/2019doxorubicin, epirubicin, fluorouracil, mitomycin, mitoxantrone and … -
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Orphan designation: Ramucirumab for: Treatment of hepatocellular carcinoma
Date of designation: 04/07/2012, Withdrawn, Last updated: 11/08/2016mitoxantrone, mitomycin and fluorouracil. The sponsor has provided … mitoxantrone, mitomycin and fluorouracil. … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2020
PRAC, Last updated: 17/01/2020assessment. Article-20 procedure: Fluorouracil and fluorouracil related substances (capecitabine … use: Article 31 referrals Fluorouracil and fluorouracil related substances (capecitabine … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2020
PRAC, Last updated: 14/02/2020Update Article-20 procedure: Fluorouracil and fluorouracil related substances (capecitabine … products: Article 31 referrals Fluorouracil and fluorouracil related substances (capecitabine … -
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News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2019
PRAC, Last updated: 11/07/2019issues Article-31 procedure: Fluorouracil and fluorouracil related substances (capecitabine … use: Article 31 referrals Fluorouracil and fluorouracil related substances (capecitabine …