315 results
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Human medicine European public assessment report (EPAR): Posaconazole AHCL
posaconazole, Mycoses
Date of authorisation: 25/07/2019,
, Revision: 5, Authorised, Last updated: 22/12/2022
Posaconazole AHCL Infections Bacterial Infections … Posaconazole AHCL … PRODUCT Posaconazole AHCL 40 mg/mL oral suspension … -
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Orphan designation: Fluorouracil for: Treatment of glioblastoma
Date of designation: 18/10/2000, Withdrawn, Last updated: 15/05/2009Fluorouracil Overview Please note that … Ethypharm S.A., France, for fluorouracil for the treatment of glioblastoma … medicine expected to work? Fluorouracil interrupts the action of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fluorouracil, salicylic acid
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: Fluorouracil / salicylic acid, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Solution
Decision date: 01/12/2009, Last updated: 25/01/2010, Compliance check: XFluorouracil / salicylic acid Dermatology … Key facts Fluorouracil salicylic acid DermatologyP/241/2009Fluorouracil … product specific waiver for fluorouracil / salicylic acid (EMEA-000650-PIP01-09 … -
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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: 23/07/2020Fluorouracil and fluorouracil related substances (capecitabine … Capecitabine Krka) capecitabine fluorouracil tegafur flucytosine capeci … -
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Press release: EMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and flucytosine
CHMP, Last updated: 30/04/2020testing prior to treatment with fluorouracil, capecitabine, tegafur and … starting cancer treatment with fluorouracil given by injection or infusion … another medicine related to fluorouracil) should not be delayed, testing … -
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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: 04/06/20205-Fluorouracil (i.v.), capecitabine and … 5-Fluorouracil (i.v.), capecitabine and … Krka) Teysuno capecitabine capecitabine capecitabine capecitabine capecitabine tegafur gimeracil oteracil Fluorouracil capecitabine tegafur capec … -
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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: 26/10/2022converted to the medicine fluorouracil in the body, but more is … cells than in normal tissues. Fluorouracil is very similar to pyrimidine … DNA and RNA). In the body, fluorouracil takes the place of pyrimidine … -
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Human medicine European public assessment report (EPAR): Teysuno
tegafur, gimeracil, oteracil, Stomach Neoplasms
Date of authorisation: 14/03/2011, Revision: 21, Authorised, Last updated: 04/04/2022converted to the medicine fluorouracil in the body, but more is … cells than in normal tissues. Fluorouracil is very similar to pyrimidine … DNA and RNA). In the body, fluorouracil takes the place of pyrimidine … -
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Human medicine European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde)
irinotecan anhydrous free-base, Pancreatic Neoplasms
Date of authorisation: 14/10/2016,
, Revision: 11, Authorised, Last updated: 13/12/2022
liposomal is used together with fluorouracil and leucovorin (also called … every 2 weeks together with fluorouracil and leucovorin. The doctor … Onivyde pegylated liposomal or fluorouracil plus leucovorin, or the three … -
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, Revision: 12, Authorised, Last updated: 25/04/2022
converted to the medicine fluorouracil in the body, but more is … cells than in normal tissues. Fluorouracil is very similar to pyrimidine … DNA and RNA). In the body, fluorouracil takes the place of pyrimidine … -
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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
converted to the medicine fluorouracil in the body, but more is … cells than in normal tissues. Fluorouracil is very similar to pyrimidine … DNA and RNA). In the body, fluorouracil takes the place of pyrimidine … -
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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
converted to the medicine fluorouracil in the body, but more is … cells than in normal tissues. Fluorouracil is an analogue of pyrimidine … DNA and RNA). In the body, fluorouracil takes the place of pyrimidine … -
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Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka) (updated)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 07/03/2023
converted to the medicine fluorouracil in the body, but more is … cells than in normal tissues. Fluorouracil is very similar to pyrimidine … DNA and RNA). In the body, fluorouracil takes the place of pyrimidine … -
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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
is used with cisplatin and fluorouracil (other cancer medicines … is used with cisplatin and fluorouracil. Docetaxel Kabi is a ‘generic … -
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Human medicine European public assessment report (EPAR): Cyramza
Ramucirumab, Stomach Neoplasms
Date of authorisation: 19/12/2014, Revision: 15, Authorised, Last updated: 13/12/2022FOLFIRI (a combination of fluorouracil, folinic acid and irinotecan … irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment … -
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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: 20/05/2022combination with cisplatin and 5-fluorouracil is indicated for the treatment … is used with cisplatin and fluorouracil (other cancer medicines … is used with cisplatin and fluorouracil. Docetaxel Zentiva contains … -
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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
combination with cisplatin and 5-fluorouracil is indicated for the treatment … -
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Human medicine European public assessment report (EPAR): Taxotere (updated)
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: 24/03/2023is used with cisplatin and fluorouracil (other cancer medicines … is used with cisplatin and fluorouracil. Taxotere contains the The … is used with cisplatin and fluorouracil (other cancer medicines … -
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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: 16, Authorised, Last updated: 20/03/2023
is used with cisplatin and fluorouracil (other cancer medicines … is used with cisplatin and fluorouracil. Docetaxel Accord is a ‘ … -
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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
combination with cisplatin and 5-fluorouracil is indicated for the treatment … -
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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
combination with cisplatin and 5-fluorouracil is indicated for the treatment … combination with cisplatin and 5-fluorouracil is indicated for the treatment … combination with cisplatin and 5-fluorouracil is indicated for the induction … -
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Human medicine European public assessment report (EPAR): Herceptin (updated)
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 28/08/2000, Revision: 42, Authorised, Last updated: 17/03/2023either capecitabine or 5‑fluorouracil (other anticancer medicines … either capecitabine or 5‑fluorouracil was compared with the same … either capecitabine or 5‑fluorouracil alone. When given by injection … -
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Human medicine European public assessment report (EPAR): Trazimera
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/07/2018,
, 
, Revision: 11, Authorised, Last updated: 17/10/2022
and either capecitabine or fluorouracil (other cancer medicines … and either capecitabine or fluorouracil (other cancer medicines … -
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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): 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 …