227 results
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Withdrawn application: Doxorubicin Hydrochloride Tillomed
doxorubicin, date of withdrawal: 02/03/2020, Initial authorisation, Last updated: 27/07/2020Doxorubicin Hydrochloride Tillomed: Withdrawn application … Doxorubicin Hydrochloride Tillomed: Withdrawal of the marketing … Doxorubicin hydrochloride Tillomed (doxorubicin hydrochloride … -
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Withdrawn application: Erlotinib Accord
erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020Erlotinib Accord: Withdrawn application … Erlotinib Accord Erlotinib Accord erlotinib … -
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Human medicine European public assessment report (EPAR): Tarceva
erlotinib, Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms
Date of authorisation: 19/09/2005, Revision: 30, Authorised, Last updated: 18/08/2021erlotinib … authorisation) Tarceva erlotinib On 18 March 2010 the Committee … Assessment report Tarceva erlotinib Procedure No.: EMEA/H/C/000618/II/0020 … -
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Orphan designation: erlotinib for: Treatment of patients with Olmsted syndrome
Date of designation: 09/12/2020, Positive, Last updated: 11/11/2022erlotinib Overview On 9 December 2020 … Génétiques, France, for erlotinib for the treatment of Olmsted … medicine expected to work? Erlotinib is a cancer medicine that … -
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Orphan designation: erlotinib for: Treatment of pachyonychia congenita
Date of designation: 18/07/2022, Positive, Last updated: 23/01/2023erlotinib Overview This medicine was … differentiation of keratinocytes. Erlotinib blocks the activity of a … erlotinib … -
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Referral: Carbamazepin Tillomed
carbamazepin, associated names: Carbamazepin Tillomed, Carbamazepina Tillomed, Karbamazepin Tillomed, Karbamazepina Tillomed, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 25/06/2020, Last updated: 21/07/2020Carbamazepin Tillomed … authorisation of Carbamazepin Tillomed (carbamazepine, 200 and 400 … -
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Erlotinib product-specific bioequivalence guidance
Last updated: 10/04/2015Erlotinib product-specific bioequivalence … conditions. bioequivalence of erlotinib. Please note that no comments … Draft Erlotinib Product-Specific Bioequivalence …
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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: 13/12/2022patients receiving Cyramza with erlotinib lived on average for 19 months … who received placebo with erlotinib. In another main study involving … Cyramza in combination with erlotinib is indicated for the first-line … -
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Human medicine European public assessment report (EPAR): Avastin (updated)
bevacizumab, Carcinoma, Non-Small-Cell Lung; Breast Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms; Carcinoma, Renal Cell
Date of authorisation: 12/01/2005, Revision: 63, Authorised, Last updated: 17/03/2023given in combination with erlotinib; advanced or metastatic kidney … -
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Human medicine European public assessment report (EPAR): Equidacent
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell
Date of authorisation: 24/09/2020,
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, Revision: 3, Withdrawn, Last updated: 25/11/2021
Bevacizumab, in combination with erlotinib, is indicated for first-line … -
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Human medicine European public assessment report (EPAR): Giotrif
afatinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 25/09/2013, Revision: 14, Authorised, Last updated: 21/04/2021another cancer medicine, erlotinib. What are the risks associated … another cancer medicine, erlotinib. What are the risks associated … -
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Human medicine European public assessment report (EPAR): Vegzelma (updated)
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 17/08/2022,, , Revision: 2, Authorised, Last updated: 22/03/2023
given in combination with erlotinib; advanced or metastatic kidney … given in combination with erlotinib; • advanced or metastatic … -
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Orphan designation: acetazolamide for: Treatment of periodic paralysis
Date of designation: 21/08/2019, Positive, Last updated: 14/01/2020Commission to Laboratorios Tillomed Spain, S.L.U, Spain, for … -
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Human medicine European public assessment report (EPAR): Onbevzi
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 11/01/2021,, , Revision: 3, Authorised, Last updated: 05/01/2023
Onbevzi, in combination with erlotinib, is indicated for first-line … -
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Human medicine European public assessment report (EPAR): Oyavas
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 4, Authorised, Last updated: 05/01/2023
Oyavas, in combination with erlotinib, is indicated for first line … -
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Human medicine European public assessment report (EPAR): Aybintio
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 19/08/2020,, , Revision: 6, Authorised, Last updated: 15/12/2022
Aybintio, in combination with erlotinib, is indicated for first-line … Aybintio, in combination with erlotinib, is indicated for first-line … -
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Human medicine European public assessment report (EPAR): Alymsys
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 26/03/2021,, , Revision: 4, Authorised, Last updated: 15/12/2022
Alymsys, in combination with erlotinib, is indicated for first line … -
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Human medicine European public assessment report (EPAR): Abevmy
bevacizumab, Colorectal Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Uterine Cervical Neoplasms
Date of authorisation: 21/04/2021,, , Revision: 5, Authorised, Last updated: 15/12/2022
Abevmy, in combination with erlotinib, is indicated for first-line … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020 (updated)
CHMP, Last updated: 27/03/2020Doxorubicin Hydrochloride Tillomed … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020
CHMP, Last updated: 30/04/2020Carbamazepin Tillomed … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
CHMP, Last updated: 29/05/2020Erlotinib Accord … -
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News: EMA promotes consistent development of bioequivalence studies through product-specific guidance
CHMP, Last updated: 15/11/2013emtricitabine/tenofovir disproxil; erlotinib; imatinib; memantine; miglustat … -
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
, Revision: 17, Authorised, Last updated: 29/11/2022
with other medicines (either erlotinib or gefitinib). Finally, in … with other medicines (either erlotinib or gefitinib). Finally … -
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National expert: Martin Bauer, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 82.23 KB | PDF
- Curriculum Vitae - 34.28 KB | PDF
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National expert: Fausto Roila, European Medicines Agency (updated)
- Declaration of interests - 86.05 KB | PDF
- Curriculum Vitae - 18.02 KB | PDF
Entrectinib (RO7102122) Erlotinib (RO508231) Ipatasertib (RO5532961 …