332 results
Keyword Ambrisentan Medac Remove keyword
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Human medicine European public assessment report (EPAR): Ambrisentan Mylan
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/06/2019,
, Revision: 3, Authorised, Last updated: 29/06/2022
Ambrisentan Mylan Lung Diseases Respiratory … Authorised ambrisentan Overview Ambrisentan Mylan is a medicine that … the arteries of the lungs. Ambrisentan Mylan is used in patients … -
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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn applicatio … Ambrisentan Zentiva Ambrisentan Zentiva ambrisentan ambrisentan … -
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Opinion/decision on a Paediatric investigation plan (PIP): Volibris, ambrisentan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000434-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Dispersible tablet
Decision date: 08/11/2019, Last updated: 27/03/2020, Compliance check: XVolibris Active substance ambrisentan Therapeutic area Cardiovascular … Volibris Volibris ambrisentan ambrisentan ambrisentan … -
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Human medicine European public assessment report (EPAR): Volibris
ambrisentan, Hypertension, Pulmonary
Date of authorisation: 20/04/2008, Revision: 22, Authorised, Last updated: 28/09/2021Authorised ambrisentan Overview Volibris is a medicine … medicine. active substance ambrisentan. How is Volibris used? Volibris … active substance in Volibris, ambrisentan, blocks the receptors for … -
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Orphan designation: ambrisentan for: Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Date of designation: 11/04/2005, Withdrawn, Last updated: 18/07/2018ambrisentan Overview … opinion on orphan designation Ambrisentan for the treatment of pulmonary … opinion on orphan designation Ambrisentan for the treatment of pulmonary … -
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Orphan designation: ambrisentan for: Treatment idiopathic pulmonary fibrosis
Date of designation: 01/10/2010, Withdrawn, Last updated: 05/09/2011ambrisentan Overview Please note that … Ltd, United Kingdom, for ambrisentan for the treatment idiopathic … medicine expected to work? Ambrisentan is expected to work by blocking … -
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Opinion/decision on a Paediatric investigation plan (PIP): ambrisentan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002030-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/01/2017, Last updated: 19/02/2021, Compliance check: XKey facts ambrisentan Cardiovascular diseasesP/0038/2017EMEA-002030-PIP01-16 … granting of a waiver for ambrisentan / tadalafil (EMEA-0020 … granting of a waiver for ambrisentan / tadalafil (EMEA-002030-PIP01-16 … -
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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 … -
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Human medicine European public assessment report (EPAR): Leflunomide medac
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 16, Authorised, Last updated: 16/05/2022
Leflunomide medac Musculoskeletal Diseases Joint … Leflunomide medac … Leflunomide medac, INN-leflunomide EMA/CHMP/328573/2014 … -
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Human medicine European public assessment report (EPAR): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,, Revision: 12, Authorised, Last updated: 25/04/2022
Capecitabine Medac Cancer Neoplasms Intestinal … Capecitabine Medac … EU/1/12/802/001 Capecitabine medac 150 mg … -
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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 … -
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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 … Arsenic trioxide medac … PRODUCT Arsenic trioxide medac 1 mg/ml concentrate for solution … -
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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 … -
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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 … -
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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 … -
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Human medicine European public assessment report (EPAR): Trecondi (updated)
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,
, Revision: 3, Authorised, Last updated: 25/01/2023
Marketing-authorisation holder medac Gesellschaft für klinische … -
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Summary of opinion: Trecondi (new)
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023action. medicinal product is medac Gesellschaft für klinische … this medicinal product is medac Gesellschaft für klinische … -
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Orphan designation: (S)-8-{2-amino-6-[1-(5-chloro-biphenyl-2-yl)-(R)-2,2,2-trifluoro-ethoxy]-pyrimidin-4-yl}-2,8-diaza-spiro[4.5]decane-3-carboxylic acid ethyl ester for: Treatment of pulmonary arterial hypertension
Date of designation: 20/04/2017, Positive, Last updated: 13/05/2019designation. They included ambrisentan, bosentan, epoprostenol, iloprost … another available treatment (ambrisentan) produced greater reduction … or than the combination of ambrisentan with tadalafil. This assumption … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-29 May 2019
CHMP, Last updated: 29/05/2019Ambrisentan Zentiva … -
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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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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): 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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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019
CHMP, Last updated: 26/04/2019Ambrisentan … -
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Orphan designation: N-(tert-butylcarbamoyl)-5-cyano-2-((4'-(difluoromethoxy)-[1,1'-biphenyl]-3-yl)oxy)benzenesulfonamide for: Treatment of pulmonary arterial hypertension
Date of designation: 22/02/2018, Positive, Last updated: 08/04/2020designation. They included ambrisentan, bosentan, epoprostenol, iloprost … designation. They included ambrisentan, bosentan, epoprostenol, iloprost … -
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National expert: Dennis Lex, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 81.05 KB | PDF
- Curriculum Vitae - 18.69 KB | PDF
Gilead Sciences) - Antivirals, Ambrisentan (Gilead Sciences) - Pulmonary … Gilead Sciences) - Antivirals, Ambrisentan (Gilead Sciences) - Pulmonary …