7736 results
-
List item
Opinion/decision on a Paediatric investigation plan (PIP): gallium (68Ga) chloride, germanium (68Ge) chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001102-PIP01-10, Route(s) of administration: Other use, Pharmaceutical form(s): Radionuclide generator
Decision date: 08/06/2011, Last updated: 14/07/2011, Compliance check: Xfacts gallium (68Ga) chloride germanium (68Ge) chloride OtherP/133/2011EMEA-001102-PIP01-10 … regaffairs.radiopharma@ezag.de Germany +49 30941084282 +49 30941084160 … Gallium [68 Ga] Chloride / Germanium [68 Ge] Chloride (EMEA-001102-PIP01-10 … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): germanium (68Ge) chloride, gallium (68Ga) chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002436-PIP01-18, Pharmaceutical form(s): Radionuclide generator
Decision date: 03/01/2019, Last updated: 24/04/2019, Compliance check: XKey facts germanium (68Ge) chloride gallium (68Ga … product specific waiver for Germanium (68Ge) chloride / Gallium … germanium (68Ge) chloride gallium … -
List item
Human medicine European public assessment report (EPAR): Bavencio
avelumab, Neuroendocrine Tumors
Date of authorisation: 18/09/2017,
, Revision: 14, Authorised, Last updated: 19/10/2022
ctodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms … -
List item
Human medicine European public assessment report (EPAR): Zelboraf (updated)
vemurafenib, Melanoma
Date of authorisation: 17/02/2012, Revision: 23, Authorised, Last updated: 17/03/2023Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … PDF/77.56 KB) (PDF/77.56 KB) German (PDF/57.24 KB) (PDF/57.24 … -
List item
Human medicine European public assessment report (EPAR): Temozolomide Hexal (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,
, Revision: 17, Withdrawn, Last updated: 27/02/2023
Hexal Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … Industriestrasse 25 D-83607 Holzkirchen Germany Product information 15/09/2022 … -
List item
Human medicine European public assessment report (EPAR): Temozolomide Sandoz (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 17, Withdrawn, Last updated: 06/03/2023
Sandoz Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … -
List item
Human medicine European public assessment report (EPAR): Tafinlar (updated)
dabrafenib mesilate, Melanoma
Date of authorisation: 26/08/2013, Revision: 28, Authorised, Last updated: 27/02/2023Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … -
List item
Human medicine European public assessment report (EPAR): Mekinist (updated)
trametinib, Melanoma
Date of authorisation: 30/06/2014, Revision: 29, Authorised, Last updated: 27/02/2023Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … -
List item
Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,
, Revision: 9, Authorised, Last updated: 13/02/2023
ancer Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal … PDF/82.82 KB) (PDF/82.82 KB) German (PDF/83.24 KB) (PDF/83.24 … -
List item
Human medicine European public assessment report (EPAR): Imlygic
talimogene laherparepvec, Melanoma
Date of authorisation: 16/12/2015, Revision: 13, Authorised, Last updated: 15/12/2022Tissue Neoplasms Cancer Neoplasms, Germ Cell and Embryonal Nevi … PDF/78.96 KB) (PDF/78.96 KB) German (PDF/79.47 KB) (PDF/79.47 … -
List item
Human medicine European public assessment report (EPAR): Opdualag
nivolumab, Relatlimab, Melanoma
Date of authorisation: 15/09/2022,, Authorised, Last updated: 17/10/2022
Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms … PDF/107.39 KB) (PDF/107.39 KB) German (PDF/108.77 KB) (PDF/108.77 … -
List item
Human medicine European public assessment report (EPAR): Gliolan
5-aminolevulinic acid hydrochloride, Glioma
Date of authorisation: 07/09/2007, Revision: 7, Authorised, Last updated: 10/08/2022Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms … PDF/46.94 KB) (PDF/46.94 KB) German (PDF/47.08 KB) (PDF/47.08 … -
List item
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
ctodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/86.89 KB) (PDF/86.89 KB) German (PDF/85.23 KB) (PDF/85.23 … -
List item
Human medicine European public assessment report (EPAR): Temozolomide Accord
temozolomide, Glioma; Glioblastoma
Date of authorisation: 15/03/2010,, Revision: 22, Authorised, Last updated: 21/03/2022
Accord Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/108.95 KB) (PDF/108.95 KB) German (PDF/86.56 KB) (PDF/86.56 … -
List item
Human medicine European public assessment report (EPAR): Temozolomide Sun
temozolomide, Glioma; Glioblastoma
Date of authorisation: 13/07/2011,, Revision: 19, Authorised, Last updated: 17/03/2022
Sun Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/131.27 KB) (PDF/131.27 KB) German (PDF/131.57 KB) (PDF/131.57 … -
List item
Human medicine European public assessment report (EPAR): Temozolomide Teva
temozolomide, Glioma; Glioblastoma
Date of authorisation: 28/01/2010,, Revision: 21, Authorised, Last updated: 18/02/2022
Teva Cancer Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms Neoplasms … PDF/102.5 KB) (PDF/102.5 KB) German (PDF/79.22 KB) (PDF/79.22 … -
List item
Human medicine European public assessment report (EPAR): Mektovi
binimetinib, Melanoma
Date of authorisation: 20/09/2018,, Revision: 6, Authorised, Last updated: 26/01/2022
ctodermal Tumors Neoplasms, Germ Cell and Embryonal Nevi … PDF/67.98 KB) (PDF/67.98 KB) German (PDF/68.01 KB) (PDF/68.01 … -
List item
Human medicine European public assessment report (EPAR): Temodal (updated)
temozolomide, Glioma; Glioblastoma
Date of authorisation: 26/01/1999, Revision: 36, Authorised, Last updated: 22/02/2023and Epithelial Neoplasms, Germ Cell and Embryonal Neoplasms … PDF/55.89 KB) (PDF/55.89 KB) German (PDF/56.82 KB) (PDF/56.82 … -
List item
Human medicine European public assessment report (EPAR): Xermelo
telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors
Date of authorisation: 17/09/2017,, Revision: 15, Authorised, Last updated: 12/12/2022
Xermelo Neoplasms, Germ Cell and Embryonal Neuroectodermal … -
List item
Non-clinical testing for inadvertent germline transmission of gene transfer vectors - Scientific guideline
Last updated: 17/11/2005ical testing for inadvertent germline transmission of gene transfer … ical testing for inadvertent germline transmission of gene transfer … NfG - nonclinical testing - germline transmission European …
-
List item
Human medicine European public assessment report (EPAR): SomaKit TOC (updated)
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 14, Authorised, Last updated: 07/03/2023
SomaKit TOC Neoplasms, Germ Cell and Embryonal Neuroectodermal … -
List item
Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, , 
, Revision: 13, Authorised, Last updated: 22/02/2023
Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms … -
List item
Human medicine European public assessment report (EPAR): Braftovi
Encorafenib, Melanoma; Colorectal Neoplasms
Date of authorisation: 19/09/2018,, Revision: 10, Authorised, Last updated: 05/08/2022
Nerve Tissue Neoplasms, Germ Cell and Embryonal Intestinal … PDF/115.97 KB) (PDF/115.97 KB) German (PDF/117.34 KB) (PDF/117.34 … -
List item
News: European Medicines Agency and German Society for Transfusion Medicine and Immunohaematology to co-organise workshop on advanced therapies
Last updated: 19/05/2014European Medicines Agency and German Society for Transfusion Medicine … Advanced Therapies (CAT) and the German Society for Transfusion Medicine … in collaboration with the German Stem Cell Network (GSCN … -
List item
ICH Considerations: general principles to address the risk of inadvertent germline integration of gene therapy vectors - Scientific guideline
Last updated: 01/11/2006address the risk of inadvertent germline integration of gene therapy … address the risk of inadvertent germline integration of gene therapy … address the risk of inadvertent germline integration of gene therapy …