440 results
Keyword Pemetrexed Medac Remove keyword
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Human medicine European public assessment report (EPAR): Xalkori
crizotinib, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 23/10/2012, Revision: 33, Authorised, Last updated: 02/12/2022were treated with either pemetrexed or docetaxel. In another … patients who were treated with pemetrexed-containing therapy … were treated with either pemetrexed or docetaxel. In another … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015
Last updated: 20/11/2015Pemetrexed Accord … -
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Human medicine European public assessment report (EPAR): Temomedac
temozolomide, Glioma; Glioblastoma
Date of authorisation: 25/01/2010,
, Revision: 15, Authorised, Last updated: 28/03/2022
Marketing-authorisation holder medac Gesellschaft für klinische … -
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Human medicine European public assessment report (EPAR): Spectrila
asparaginase, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/01/2016, Revision: 5, Authorised, Last updated: 09/10/2020Marketing-authorisation holder Medac Gesellschaft fuer klinische … -
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Human medicine European public assessment report (EPAR): Trecondi
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019, Revision: 4, Authorised, Last updated: 08/08/2023Medac Gesellschaft für klinische … -
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Orphan designation: Treosulfan for: Conditioning treatment prior to haematopoietic-progenitor-cell transplantation
Date of designation: 22/02/2004, Positive, Last updated: 11/12/2020the European Commission to medac Gesellschaft fuer klinische … the European Commission to medac Gesellschaft fuer klinische … Sponsor’s contact details: medac Gesellschaft für klinische … -
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Human medicine European public assessment report (EPAR): Gliolan
5-aminolevulinic acid hydrochloride, Glioma
Date of authorisation: 07/09/2007, Revision: 8, Authorised, Last updated: 28/04/2023European Union for Gliolan to Medac Gesellschaft für klinische … -
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Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded (MC0518)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002706-PIP01-19-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 01/02/2022, Last updated: 17/04/2023, Compliance check: Xdisease (aGvHD) Intravenous use medac Gesellschaft für klinische … 410380060 E-mail: contact@medac.de PM: decision on the application … application submitted by medac Gesellschaft für klinische … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trecondi, Treosulfan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation; Oncology
PIP number: EMEA-000883-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution
Decision date: 09/09/2020, Last updated: 10/03/2023, Compliance check: V, 25/03/2022Contact for public enquiries medac Gesellschaft für klinische … 0) 401380060 E-mail: dra@medac.de Decision type PM: decision … application submitted by medac Gesellschaft für klinische … -
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Orphan designation: Terguride for: Treatment of systemic sclerosis
Date of designation: 24/01/2013, Withdrawn, Last updated: 22/03/2021sponsorship was transferred to medac Gesellschaft für klinische … -
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Orphan designation: 5-aminolevulinic acid hydrochloride for: Intra-operative photodynamic diagnosis of residual glioma
Date of designation: 14/11/2002, Expired, Last updated: 03/10/2017the European Commission to medac Gesellschaft für klinische … the European Commission to medac Gesellschaft für klinische … Sponsor’s contact details: medac Gesellschaft für klinische … -
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Orphan designation: Allogeneic bone marrow derived mesenchymal stromal cells, ex-vivo expanded for: Treatment of graft-versus-host disease
Date of designation: 31/07/2018, Positive, Last updated: 10/10/2018the European Commission to medac Gesellschaft für klinische … the European Commission to medac Gesellschaft für klinische … -
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Opinion/decision on a Paediatric investigation plan (PIP): Terguride (hydrogenmaleate)
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002015-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: XContact for public enquiries medac Gesellschaft für klinische … Spezialpräparate mbH Germany E-mail: dra@medac.de Tel.: +49 401380060 Fax … application submitted by medac Gesellschaft für klinische … -
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Opinion/decision on a Paediatric investigation plan (PIP): recombinant L-asparaginase
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-000013-PIP01-07-M03, Route(s) of administration: Intravenous use, Intramuscular use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 29/04/2013, Last updated: 31/05/2013, Compliance check: V, 14/06/2013Intravenous use Intramuscular use Medac Gesellschaft für klinische … Spezialpräparate mbH E-mail: j.kuehnel@medac.de Country: Germany Tel … application submitted by medac Gesellschaft für klinische … -
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Opinion/decision on a Paediatric investigation plan (PIP): Genetically modified Mycobacterium bovis BCG
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002461-PIP01-18, Route(s) of administration: Intravesical use, Pharmaceutical form(s): Powder for intravesical suspension
Decision date: 22/03/2019, Last updated: 24/06/2019, Compliance check: XContact for public enquiries medac Gesellschaft für klinische … 410380060 E-mail: contact@medac.de Decision type W: decision … -
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Orphan designation: L-Asparaginase for: Treatment of acute lymphoblastic leukaemia
Date of designation: 26/01/2005, Withdrawn, Last updated: 12/02/2018the European Commission to medac Gesellschaft fuer klinische … the European Commission to medac Gesellschaft fuer klinische … Sponsor’s contact details: medac Gesellschaft fuer klinische … -
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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: 15, Authorised, Last updated: 21/06/2023two other cancer medicines, pemetrexed and cisplatin. In a second … two other cancer medicines, pemetrexed and cisplatin. In a second … -
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Orphan designation: 5-[8-methyl-9-(1-methylethyl)-2-(4-morpholinyl)-9H-purin-6-yl]-2-pyrimidinamine for: Treatment of malignant mesothelioma
Date of designation: 16/12/2014, Withdrawn, Last updated: 10/02/2016used. Only one medicine, pemetrexed, was specifically authorised … compared with a combination of pemetrexed and cisplatin (another cancer … used. Only one medicine, pemetrexed, was specifically authorised … -
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National expert: Franz Schönfeld, Central Authority of the Länder for Health Protection on Medicinal Products and Medical Devices (updated)
- Declaration of interests - 39.44 KB | PDF
- Curriculum Vitae - 24.38 KB | PDF
Methotrexate, DDATHF and Pemetrexed. In: Heterocycles 55 (2001 … -
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Human medicine European public assessment report (EPAR): Keytruda (updated)
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: 52, Authorised, Last updated: 06/09/2023patients taking Keytruda with pemetrexed and platinum chemotherapy … of patients who had only pemetrexed and platinum chemotherapy … patients taking Keytruda with pemetrexed and platinum chemotherapy … -
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National expert: Francesco Onida, Italian Medicines Agency (updated)
- Declaration of interests - 41.98 KB | PDF
- Curriculum Vitae - 66.85 KB | PDF
di Sézary) _ 16_6_2022 MEDAC null Speaker in two webinars … transplantation" _ 20_5_2021 MEDAC Compensation/Fees/Honoraria/etc … -
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Orphan designation: Tazemetostat for: Treatment of malignant mesothelioma
Date of designation: 21/03/2018, Positive, Last updated: 28/04/2023alone was used. One medicine, pemetrexed, was authorised throughout … alone was used. One medicine, pemetrexed, was authorised throughout … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020
CHMP, Last updated: 24/07/2020Arsenic trioxide medac … -
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Orphan designation: Pegylated recombinant arginine deiminase (pegargiminase) for: Treatment of malignant mesothelioma
Date of designation: 15/01/2015, Positive, Last updated: 02/08/2022used. Only one medicine, pemetrexed, was specifically authorised … used. Only one medicine, pemetrexed, was specifically authorised … -
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Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for: Treatment of malignant mesothelioma
Date of designation: 16/12/2014, Positive, Last updated: 19/03/2021used. Only one medicine, pemetrexed, was specifically authorised … used. Only one medicine, pemetrexed, was specifically authorised …