398 results
Keyword trastuzumab Remove keyword
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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
Authorised trastuzumab Overview This is a summary … medicine. active substance trastuzumab. How is Herzuma used? Herzuma … active substance in Herzuma, trastuzumab, is a monoclonal antibody … -
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,, Revision: 10, Authorised, Last updated: 24/03/2023
trastuzumab … EMEA/H/C/004361 Kanjinti (trastuzumab) An overview of Kanjinti … contains the active substance trastuzumab. How is Kanjinti used? Kanjinti … -
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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: 17/03/2023trastuzumab … Herceptin, INN-trastuzumab EMA/981900/2011 EMEA/H/C/000278 … for the public Herceptin trastuzumab This document is a summary … -
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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
trastuzumab … One vial contains 60 mg of trastuzumab, a humanised IgG1 monoclonal … One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal … -
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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
trastuzumab … Trazimera, INN-TRASTUZUMAB 30 Churchill Place … EMEA/H/C/004463 Trazimera (trastuzumab) An overview of Trazimera … -
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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
trastuzumab … One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal … One vial contains 420 mg of trastuzumab, a humanised IgG1 monoclonal … -
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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
trastuzumab … for the public Ontruzant trastuzumab This is a summary of the … contains the active substance trastuzumab. How is Ontruzant used … -
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Human medicine European public assessment report (EPAR): Kadcyla
trastuzumab emtansine, Breast Neoplasms
Date of authorisation: 15/11/2013, Revision: 15, Authorised, Last updated: 22/03/2023trastuzumab emtansine … for the public Kadcyla trastuzumab emtansine This is a summary … contains the active substance trastuzumab emtansine. It is used to … -
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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
trastuzumab deruxtecan … EMEA/H/C/005124 Enhertu (trastuzumab deruxtecan) An overview … have previously received trastuzumab, another HER2-targeted treatment … -
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Human medicine European public assessment report (EPAR): Phesgo
pertuzumab, trastuzumab, Breast Neoplasms
Date of authorisation: 21/12/2020,, Revision: 3, Authorised, Last updated: 02/03/2022
pertuzumab / trastuzumab … EMEA/H/C/005386 Phesgo (pertuzumab / trastuzumab) An overview of Phesgo and … substances pertuzumab and trastuzumab. For more information about … -
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Withdrawn application: Hervelous
trastuzumab, date of withdrawal: 14/09/2022, Initial authorisation, Last updated: 13/12/2022trastuzumab Overview Prestige Biopharma … medicine. active substance trastuzumab and was to be available as … active substance in Hervelous, trastuzumab, is a monoclonal antibody … -
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Withdrawn application: Tuznue
trastuzumab, date of withdrawal: 14/09/2022, Initial authorisation, Last updated: 13/12/2022trastuzumab Overview Prestige Biopharma … medicine. active substance trastuzumab and was to be available as … active substance in Tuznue, trastuzumab, is a monoclonal antibody … -
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Opinion/decision on a Paediatric investigation plan (PIP): Enhertu, trastuzumab deruxtecan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002978-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 08/07/2021, Last updated: 19/07/2022, Compliance check: XEnhertu Active substance trastuzumab deruxtecan Therapeutic area … product specific waiver for trastuzumab deruxtecan (Enhertu), (EMEA-002978- PIP01-21 … product specific waiver for trastuzumab deruxtecan (Enhertu), (EMEA-002978- PIP01-21 … -
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Opinion/decision on a Paediatric investigation plan (PIP): trastuzumab deruxtecan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002976-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 09/07/2021, Last updated: 19/07/2022, Compliance check: XKey facts trastuzumab deruxtecan OncologyP/0259/2021EMEA-002976-PIP01-21 … trastuzumab deruxtecan … -
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Opinion/decision on a Paediatric investigation plan (PIP): trastuzumab deruxtecan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002976-PIP02-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 16/07/2021, Last updated: 19/07/2022, Compliance check: XKey facts trastuzumab deruxtecan OncologyP/0279/2021EMEA-002976-PIP02-21 … trastuzumab deruxtecan … -
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News: Public Statement on HerceptinN(Trastuzumab): New Pharmacokinetic Data
Last updated: 19/06/2001pharmacokinetics of Herceptin (trastuzumab) and would like to advise … risk of cardiac toxicity. Trastuzumab is is a humanised monoclonal … website. Public Statement on Trastuzumab (Herceptin)- New pharmacokinetic … -
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Press release: Re-analysis of data on use of breast cancer medicine Tyverb following treatment with trastuzumab
CHMP, Last updated: 30/04/2019following treatment with trastuzumab … despite previous treatment with trastuzumab. The results had indicated … a benefit of Tyverb over trastuzumab when each medicine was used … -
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Human medicine European public assessment report (EPAR): Perjeta
pertuzumab, Breast Neoplasms
Date of authorisation: 04/03/2013, Revision: 22, Authorised, Last updated: 09/12/2021cases, Perjeta is used with trastuzumab and docetaxel (other cancer … back, in combination with trastuzumab and chemotherapy, before … back, in combination with trastuzumab and chemotherapy, after the … -
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Human medicine European public assessment report (EPAR): Tyverb (updated)
lapatinib, Breast Neoplasms
Date of authorisation: 10/06/2008, Revision: 35, Authorised, Last updated: 10/05/2023patient’s metastatic disease with trastuzumab (another cancer medicine … body; in combination with trastuzumab for metastatic cancer that … treated with a combination of trastuzumab and other cancer medicines … -
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Human medicine European public assessment report (EPAR): Nerlynx
neratinib, Breast Neoplasms
Date of authorisation: 31/08/2018,, Revision: 12, Authorised, Last updated: 05/12/2022
following treatment with trastuzumab (another medicine used for … finishing treatment with trastuzumab, and is given for 1 year … who had already received trastuzumab. Around 94% of the women given … -
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Human medicine European public assessment report (EPAR): Tukysa
Tucatinib, Breast Neoplasms; Neoplasm Metastasis
Date of authorisation: 11/02/2021,, Revision: 4, Authorised, Last updated: 29/03/2023
medicines, capecitabine and trastuzumab, and is used after at least … treated with capecitabine and trastuzumab on certain days of a 21-day … two other cancer medicines, trastuzumab and capecitabine. When 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: 16, Authorised, Last updated: 20/03/2023
cyclophosphamide, doxorubicin or trastuzumab) in patients who have not … -
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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: 50, Authorised, Last updated: 24/03/2023doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients … doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients … -
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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
cyclophosphamide, doxorubicin or trastuzumab) in patients who have not … -
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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: 20/05/2022Winthrop in combination with trastuzumab is indicated for the treatment … doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients …