359 results
Keyword Abiraterone Medac Remove keyword
-
List item
Human medicine European public assessment report (EPAR): Abiraterone Accord
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 26/04/2021,
, Revision: 1, Authorised, Last updated: 25/09/2023
Abiraterone Accord Cancer Neoplasms Genital … Abiraterone Accord … EMA/163793/2021 EMEA/H/C/005408 Abiraterone Accord abiraterone acetate) An overview of Abiraterone Accord and why it is authorised … -
List item
Human medicine European public assessment report (EPAR): Abiraterone Mylan
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 20/08/2021,, Revision: 4, Authorised, Last updated: 11/09/2023
Abiraterone Mylan Cancer Neoplasms Genital … Authorised abiraterone acetate Overview Abiraterone Mylan is a cancer medicine … of the body (metastatic). Abiraterone Mylan is used together with … -
List item
Human medicine European public assessment report (EPAR): Abiraterone Krka
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 24/06/2021,, Revision: 2, Authorised, Last updated: 08/03/2023
Abiraterone Krka Genital Neoplasms … Authorised abiraterone acetate Overview Abiraterone Krka is a cancer medicine … of the body (metastatic). Abiraterone Krka is used together with … -
List item
Human medicine European public assessment report (EPAR): Zytiga
abiraterone acetate, Prostatic Neoplasms
Date of authorisation: 05/09/2011,
, Revision: 26, Authorised, Last updated: 06/12/2022
abiraterone … Zytiga, INN-abiraterone acetate 30 Churchill … for the public Zytiga abiraterone acetate This is a summary … -
List item
Human medicine European public assessment report (EPAR): Akeega
abiraterone acetate, Niraparib tosilate monohydrate, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 19/04/2023, Authorised, Last updated: 02/06/2023niraparib / abiraterone acetate … EMEA/H/C/005932 Akeega (niraparib / abiraterone acetate) An overview of … substances: niraparib and abiraterone acetate. How is Akeega … -
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: 9, Authorised, Last updated: 24/11/2023
Carmustine medac (previously Carmustine Obvius) Lymphoma Cancer Neoplasms Lymphoproliferative … Carmustine medac (previously Carmustine Obvius … EMEA/H/C/004326 Carmustine medac1 (carmustine) An overview … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Niraparib (tosilate monohydrate), abiraterone acetate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002789-PIP01-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 15/07/2021, Last updated: 21/06/2021, Compliance check: XNiraparib (tosilate monohydrate) abiraterone acetate OncologyP/0244/2020EMEA-002789-PIP01-20 … tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20 … tosylate monohydrate) / abiraterone (acetate) (EMEA-002789-PIP01-20 … -
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
Abiraterone acetate product-specific bioequivalence guidance
Last updated: 23/11/2020Abiraterone acetate product-specific … conditions. bioequivalence of abiraterone acetate … Products for Human Use (CHMP) Abiraterone acetate tablets 250 mg and …
-
List item
Withdrawn application: Jivadco (updated)
date of withdrawal: 12/09/2023, Initial authorisation, Last updated: 23/11/2023Overview Medac Gesellschaft für klinische … trastuzumab duocarmazine) Medac Gesellschaft für klinische … -
List item
Human medicine European public assessment report (EPAR): Xofigo
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,
, Revision: 14, Authorised, Last updated: 30/10/2023
be used with the medicine abiraterone acetate and the corticosteroids … -
List item
Human medicine European public assessment report (EPAR): Lynparza
Olaparib, Ovarian Neoplasms
Date of authorisation: 16/12/2014, Revision: 23, Authorised, Last updated: 21/09/2023therapy in breast cancer and abiraterone together with prednisone … therapy in breast cancer and abiraterone together with prednisone … Lynparza in combination with abiraterone and prednisone or prednisolone … -
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
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
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 …