235 results
-
List item
Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,
, Revision: 13, Authorised, Last updated: 31/03/2023
Capecitabine Medac Cancer Neoplasms Intestinal … Capecitabine Medac … EU/1/12/802/001 Capecitabine medac 150 mg … -
List item
Human medicine European public assessment report (EPAR): Leflunomide medac
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 18, Authorised, Last updated: 09/03/2023
Leflunomide medac Musculoskeletal Diseases Joint … report (EPAR) for Leflunomide medac. It explains how the The committee … conditions of use for Leflunomide medac. What is Leflunomide medac? Leflunomide medac is a medicine that contains … -
List item
Human medicine European public assessment report (EPAR): Pemetrexed medac
pemetrexed, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 26/11/2015,, Revision: 8, Authorised, Last updated: 09/08/2022
Pemetrexed medac Cancer Neoplasms Carcinoma … Pemetrexed medac … Pemetrexed medac, INN-pemetrexed 30 … -
List item
Human medicine European public assessment report (EPAR): Imatinib medac
imatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Dermatofibrosarcoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic-Myeloproliferative Diseases; Hypereosinophilic Syndrome
Date of authorisation: 25/09/2013,, Revision: 5, Withdrawn, Last updated: 16/10/2019
Imatinib medac Precursor Cell Lymphoblastic … authorisation for Imatinib Medac has been withdrawn at the … Summary documents Imatinib medac : EPAR - Summary for the … -
List item
Human medicine European public assessment report (EPAR): Carmustine medac (previously Carmustine Obvius) (updated)
carmustine, Hodgkin Disease; Lymphoma, Non-Hodgkin
Date of authorisation: 18/07/2018,, Revision: 8, Authorised, Last updated: 14/09/2023
Carmustine medac (previously Carmustine Obvius) Lymphoma Cancer Neoplasms Lymphoproliferative … Carmustine medac (previously Carmustine Obvius … Carmustine medac (previously Carmustine Obvius … -
List item
Human medicine European public assessment report (EPAR): Arsenic trioxide medac
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 17/09/2020,, Revision: 2, Authorised, Last updated: 26/04/2022
Arsenic trioxide medac Cancer Neoplasms Leukemia … Overview Arsenic trioxide medac is used to treat adults (aged … vitamin A). Arsenic trioxide medac is used in: patients with … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid medac
zoledronic acid monohydrate, Fractures, Bone; Cancer
Date of authorisation: 03/08/2012,, Revision: 13, Authorised, Last updated: 20/11/2020
Zoledronic acid medac Wounds and Injuries Cancer Neoplasms Fractures … Zoledronic acid medac … Zolderonic acid medac, INN-zoledronic acid … -
List item
Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020itabine Accord Capecitabine Medac Capecitabine Teva Ecansya … Krka) Xeloda Teysuno Capecitabine Accord Capecitabine Medac Capecitabine Teva Ecansya … -
List item
Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020Capecitabine Accord Capecitabine Medac Capecitabine Teva Ecansya … itabine Accord Capecitabine Medac Capecitabine Teva Ecansya … Krka) Teysuno Xeloda Capecitabine Accord Capecitabine Medac Capecitabine Teva Ecansya … -
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
Marketing-authorisation holder medac Gesellschaft für klinische … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 … -
List item
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 …