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Human medicine European public assessment report (EPAR): Apealea (updated)
paclitaxel, Ovarian Neoplasms
Date of authorisation: 20/11/2018, Revision: 0, Authorisedauthorisation) Apealea paclitaxel On 20 September 2018, the … substance of Apealea is paclitaxel, an antineoplastic agent … ‘taxanes’ (ATC code: L01CD01). Paclitaxel blocks a stage of cell division … -
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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: 10/01/2008, Revision: 23, AuthorisedAbraxane, INN-paclitaxel 30 Churchill Place … for the public Abraxane paclitaxel This document is a summary … contains the active substance paclitaxel attached to a human protein … -
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Human medicine European public assessment report (EPAR): Paxene
paclitaxel, Sarcoma, Kaposi Carcinoma, Non-Small-Cell Lung Ovarian Neoplasms Breast Neoplasms
Date of authorisation: 19/07/1999, Revision: 14, WithdrawnPublic statement on Paxene (paclitaxel) Withdrawal of the marketing … medicinal product Paxene, paclitaxel, which had been approved … EMEA/H/C/216 Paxene paclitaxel EPAR summary for the … -
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Human medicine European public assessment report (EPAR): Cyramza
ramucirumab, Stomach Neoplasms
Date of authorisation: 19/12/2014, Additional monitoring, Revision: 7, Authorisedcombination with another medicine, paclitaxel, or on its own if the combination … if the combination with paclitaxel is not appropriate, in patients … given in combination with paclitaxel, the recommended dose is … -
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Human medicine European public assessment report (EPAR): Avastin
bevacizumab, Carcinoma, Non-Small-Cell Lung Breast Neoplasms Ovarian Neoplasms Colorectal Neoplasms Carcinoma, Renal Cell
Date of authorisation: 12/01/2005, Revision: 50, Authorisedused in combination with paclitaxel (an anticancer medicine belonging … combination with the taxane paclitaxel. This follows a review1 of … used in combination with paclitaxel or docetaxel (anticancer … -
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Human medicine European public assessment report (EPAR): Herceptin
trastuzumab, Stomach Neoplasms Breast Neoplasms
Date of authorisation: 28/08/2000, Revision: 34, Authorisedanticancer medicines: with paclitaxel or docetaxel, or with an … Herceptin in combination with paclitaxel or docetaxel in a total of … used in combination with paclitaxel or docetaxel, around half … -
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Human medicine European public assessment report (EPAR): Mvasi (updated)
bevacizumab, Carcinoma, Renal Cell Peritoneal Neoplasms Ovarian Neoplasms Breast Neoplasms Carcinoma, Non-Small-Cell Lung Fallopian Tube Neoplasms
Date of authorisation: 14/01/2018, Additional monitoring, Biosimilar, Revision: 2, Authorisedmedicines carboplatin and paclitaxel. The cancer responded to … medicines carboplatin and paclitaxel. The cancer responded to … MVASI in combination with paclitaxel is indicated for first-line … -
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Human medicine European public assessment report (EPAR): Iressa
gefitinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 24/06/2009, Revision: 12, Authorisedcombination of carboplatin and paclitaxel (other anticancer medicines … combination of carboplatin and paclitaxel (other anticancer medicines … -
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Human medicine European public assessment report (EPAR): Trazimera
trastuzumab, Stomach Neoplasms Breast Neoplasms
Date of authorisation: 26/07/2018, Additional monitoring, Biosimilar, Revision: 1, Authorisedother cancer medicines: with paclitaxel or docetaxel, or with another … in combination with paclitaxel for the treatment of those … cyclophosphamide, in combination with paclitaxel or docetaxel. in combination … -
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms Breast Neoplasms
Date of authorisation: 16/05/2018, Additional monitoring, Biosimilar, Revision: 2, Authorisedother cancer medicines: with paclitaxel or docetaxel, or with another … treatments. - in combination with paclitaxel for the treatment of those … cyclophosphamide, in combination with paclitaxel or docetaxel. - in combination … -
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Human medicine European public assessment report (EPAR): Hycamtin
topotecan, Ovarian Neoplasms Uterine Cervical Neoplasms Small Cell Lung Carcinoma
Date of authorisation: 12/11/1996, Revision: 29, Authorisedand compared Hycamtin with paclitaxel (another cancer medicine … compared with 14% of the paclitaxel patients (16 out of 114 … and compared Hycamtin with paclitaxel (another cancer medicine … -
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Human medicine European public assessment report (EPAR): Onzeald
etirinotecan pegol, Breast Neoplasms
Date of refusal: 08/01/2018, Refused -
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Human medicine European public assessment report (EPAR): Nexavar
sorafenib, Carcinoma, Hepatocellular Carcinoma, Renal Cell
Date of authorisation: 19/07/2006, Revision: 27, Authorisedsorafenib as add-on to paclitaxel/carboplatin, the HR for overall … a CYP2B6 substrate, or paclitaxel, a CYP2C8 substrate, did … Labelling Administration of paclitaxel (225 mg/m2) and carboplatin … -
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Human medicine European public assessment report (EPAR): Herzuma
trastuzumab, Stomach Neoplasms Breast Neoplasms
Date of authorisation: 08/02/2018, Additional monitoring, Biosimilar, Revision: 3, Authorisedother cancer medicines: with paclitaxel or docetaxel, or with another … treatments. - in combination with paclitaxel for the treatment of those … cyclophosphamide, in combination with paclitaxel or docetaxel. - in combination … -
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Human medicine European public assessment report (EPAR): Keytruda
pembrolizumab, Melanoma Hodgkin Disease Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/07/2015, Additional monitoring, Revision: 15, Authorisedmedicine chosen by the doctor (paclitaxel, docetaxel or vinflunine … -
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Human medicine European public assessment report (EPAR): Ontruzant (updated)
trastuzumab, Stomach Neoplasms Breast Neoplasms
Date of authorisation: 15/11/2017, Additional monitoring, Biosimilar, Revision: 2, Authorisedother cancer medicines: with paclitaxel or docetaxel, or with another … other cancer medicines: with paclitaxel or docetaxel, or with another … • in combination with paclitaxel for the treatment of those … -
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Human medicine European public assessment report (EPAR): Tyverb
lapatinib, Breast Neoplasms
Date of authorisation: 10/06/2008, Revision: 28, Authorised -
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Human medicine European public assessment report (EPAR): Alimta
pemetrexed, Mesothelioma Carcinoma, Non-Small-Cell Lung
Date of authorisation: 20/09/2004, Revision: 22, Authorisedfrom 0 to 21% [27], while paclitaxel showed a tumour response … 5-fluorouracil, irinotecan, and paclitaxel) and was not completely … 18% (3/17). Cisplatin and paclitaxel-resistant mesothelioma and … -
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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, Generic, Revision: 10, Authorised -
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Human medicine European public assessment report (EPAR): Portrazza
necitumumab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 15/02/2016, Additional monitoring, Revision: 2, Authorisednecitumumab in combination with paclitaxel and carboplatin chemotherapy … carboplatin chemotherapy versus paclitaxel and carboplatin chemotherapy … necitumumab in combination with paclitaxel and carboplatin versus … -
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Human medicine European public assessment report (EPAR): Perjeta
pertuzumab, Breast Neoplasms
Date of authorisation: 04/03/2013, Revision: 16, Authorisedthe recommended dose of paclitaxel is 80 mg/m2 once weekly for … cytotoxic agents, docetaxel, paclitaxel, gemcitabine, capecitabine … Perjeta plus trastuzumab and paclitaxel and none of the patients … -
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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: 23, Authorised -
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Human medicine European public assessment report (EPAR): Tecentriq
atezolizumab, Carcinoma, Transitional Cell Carcinoma, Non-Small-Cell Lung
Date of authorisation: 21/09/2017, Additional monitoring, Revision: 4, Authorisedplatinum-containing therapy. Taxanes (paclitaxel and docetaxel) are commonly … -
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Human medicine European public assessment report (EPAR): Caelyx
doxorubicin, Sarcoma, Kaposi Multiple Myeloma Ovarian Neoplasms Breast Neoplasms
Date of authorisation: 20/06/1996, Revision: 29, Authorised -
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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, Generic, Revision: 16, Authorised