279 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: 2, Authorised, Last updated: 23/03/2021
Ambrisentan Mylan Hypertension, Pulmonar … 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Withdrawn application: Ambrisentan Zentiva
ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019Ambrisentan Zentiva: Withdrawn applicatio … Ambrisentan Zentiva Ambrisentan Zentiva ambrisentan ambrisentan … -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: XKey facts Volibris ambrisentan Cardiovascular diseasesP/0370/2019EMEA-000434-PIP01-08-M06 … paediatric investigation plan for ambrisentan (Volibris), (EMEA-000434-PIP01-08-M06 … 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: 21, Authorised, Last updated: 07/05/2021Authorised ambrisentan Overview Volibris is a medicine … contains the active substance ambrisentan. How is Volibris used? Volibris … active substance in Volibris, ambrisentan, blocks the receptors for … -
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Summary of opinion: Volibris (new)
ambrisentan, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021authorisation) Volibris ambrisentan On 22 July 2021, the Committee … Volibris Volibris ambrisentan ambrisentan … -
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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Date of designation: 11/04/2005, Withdrawn, Last updated: 18/07/2018ambrisentan Overview … opinion on orphan designation Ambrisentan for the treatment of pulmonary … opinion on orphan designation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): Capecitabine Medac
capecitabine, Colorectal Neoplasms
Date of authorisation: 19/11/2012,
, , Revision: 11, Authorised, Last updated: 10/03/2021
Capecitabine Medac Colorectal Neoplasms … capecitabine Overview Capecitabine medac is a cancer medicine that … bowel) cancer. Capecitabine medac is used on its own or with … -
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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: 6, Authorised, Last updated: 21/09/2020
Pemetrexed medac Carcinoma, Non-Small-Cell … report (EPAR) for Pemetrexed medac. It explains how the Agency … on how to use Pemetrexed medac. For practical information … -
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Human medicine European public assessment report (EPAR): Leflunomide medac
leflunomide, Arthritis, Rheumatoid
Date of authorisation: 27/07/2010,, Revision: 15, Authorised, Last updated: 21/07/2020
Leflunomide medac Arthritis, Rheumatoid … report (EPAR) for Leflunomide medac. It explains how the Committee … conditions of use for Leflunomide medac. What is Leflunomide medac? Leflunomide medac is a medicine that contains … -
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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,, Authorised, Last updated: 01/10/2020
Arsenic trioxide medac Leukemia, Promyelocytic … Overview Arsenic trioxide medac is used to treat adults (aged … vitamin A). Arsenic trioxide medac is used in: patients with … -
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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 Fractures, Bone Cancer … EPAR) for Zoledronic acid medac. It explains how the Committee … of use for Zoledronic acid medac. What is Zoledronic acid medac? Zoledronic acid medac is a medicine that contains … -
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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: 23/07/2020Capecitabine Accord Capecitabine Medac Capecitabine Teva Ecansya … itabine 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: 04/06/2020XelodaCapecitabine AccordCapecitabine MedacCapecitabine TevaEcansya (previously Capecitabine … Capecitabine Teva Capecitabine Medac … itabine Accord Capecitabine Medac Capecitabine Teva Ecansya … -
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Human medicine European public assessment report (EPAR): Trecondi
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,
, Revision: 2, Authorised, Last updated: 07/09/2020
Medac Gesellschaft für klinische … EMEA/OD/075/03) Sponsor: medac Gesellschaft für klinische … of 23 September 2020 in Medac Gesellschaft für klinische … -
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Human medicine European public assessment report (EPAR): Temomedac
temozolomide, Glioma, Glioblastoma
Date of authorisation: 25/01/2010,, Revision: 14, Authorised, Last updated: 09/09/2020
medicines . Publication details >medac Gesellschaft für klinische … Spezialpräparate mbH14 25/01/2010 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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National expert: Dennis Lex, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 81.03 KB | PDF
- Curriculum Vitae - 18.81 KB | PDF
Gilead Sciences) - Antivirals, Ambrisentan (Gilead Sciences) - Pulmonary … Gilead Sciences) - Antivirals, Ambrisentan (Gilead Sciences) - Pulmonary … -
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Opinion/decision on a Paediatric investigation plan (PIP): Trecondi, Treosulfan (updated)
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: 08/07/2021, Compliance check: Xtransplantation Intravenous use medac Gesellschaft für klinische … 0) 401380060 E-mail: dra@medac.de PM: decision on the application … application submitted by medac Gesellschaft für klinische … -
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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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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: 5, Authorised, Last updated: 06/01/2021European Union for Gliolan 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: Xsystemic sclerosis Oral use medac Gesellschaft für klinische … Spezialpräparate mbH Germany E-mail: dra@medac.de Tel.: +49 401380060 Fax … application submitted by medac Gesellschaft für klinische …