566 results
Keyword Everolimus Medac Remove keyword
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Orphan designation: everolimus for: Treatment of tuberous sclerosis
Date of designation: 04/08/2010, Positive, Last updated: 29/05/2018everolimus … opinion on orphan designation Everolimus for the treatment of tuberous … Limited, United Kingdom, for everolimus for the treatment of tuberous … -
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Human medicine European public assessment report (EPAR): Afinitor
everolimus, Carcinoma, Renal Cell; Breast Neoplasms; Pancreatic Neoplasms
Date of authorisation: 02/08/2009, Revision: 30, Authorised, Last updated: 27/06/2022everolimus … report Afinitor everolimus Procedure No.: EMEA/H/C/001038/II/0020 … Presentations: Afinitor everolimus See Annex A The following … -
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Human medicine European public assessment report (EPAR): Votubia
everolimus, Tuberous Sclerosis
Date of authorisation: 02/09/2011,
, Revision: 30, Authorised, Last updated: 27/06/2022
everolimus … EMEA/H/C/002311 Votubia (everolimus) An overview of Votubia … contains the active substance everolimus. Tuberous sclerosis is … -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP08-12-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 31/10/2017, Last updated: 13/02/2018, Compliance check: V, 01/06/2018Votubia Active substance everolimus Therapeutic area Neurology … paediatric investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … paediatric investigation plan for everolimus (Votubia), (EMEA-000019-PIP08-12-M03 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Afinitor, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000019-PIP06-09-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 05/05/2014, Last updated: 11/06/2014, Compliance check: Xassociated names Active substance everolimus Therapeutic area Immunology-Rheumatology-Transplantation … paediatric investigation plan for everolimus (Afinitor, Certican and associated … paediatric investigation plan for everolimus (Afinitor, Certican and … -
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Opinion/decision on a Paediatric investigation plan (PIP): Votubia, everolimus
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000019-PIP02-07-M05, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 22/01/2014, Last updated: 19/02/2014, Compliance check: V, 29/01/2016Votubia Active substance everolimus Therapeutic area Neurology … paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … paediatric investigation plan for everolimus (Votubia) (EMEA-000019-PIP02-07-M05 … -
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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 … -
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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 … -
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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): 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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Orphan designation: everolimus for: Treatment of gastric cancer
Date of designation: 30/08/2011, Withdrawn, Last updated: 09/02/2015everolimus … opinion on orphan designation Everolimus for the treatment of gastric … opinion on orphan designation Everolimus for the treatment of gastric … -
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Orphan designation: everolimus for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 14/11/2007, Withdrawn, Last updated: 09/02/2015everolimus … opinion on orphan designation Everolimus for the treatment of gastro-entero-pancreatic … opinion on orphan designation Everolimus for the treatment of gastro-entero-pancreatic … -
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Orphan designation: everolimus for: Treatment of renal-cell carcinoma
Date of designation: 05/06/2007, Withdrawn, Last updated: 06/09/2011everolimus … smop everolimus Rev.3 30 Churchill … opinion on orphan designation Everolimus for the treatment of renal … -
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Opinion/decision on a Paediatric investigation plan (PIP): everolimus
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000019-PIP11-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Dispersible tablet
Decision date: 30/01/2015, Last updated: 05/03/2015, Compliance check: XActive substance everolimus Therapeutic area Oncology … product specific waiver for everolimus (Certican and associated … product specific waiver for everolimus (Certican and associated … -
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Opinion/decision on a Paediatric investigation plan (PIP): everolimus
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000019-PIP03-08, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 15/08/2008, Last updated: 22/08/2014, Compliance check: XActive substance everolimus Therapeutic area Oncology … product specific waiver for everolimus (EMEA-000197-PIP01-08 … product specific waiver for everolimus (EMEA-000197-PIP01-08) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): everolimus
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-000019-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 11/12/2007, Last updated: 20/12/2007, Compliance check: XActive substance everolimus Therapeutic area Oncology … Microsoft Word - Decision Everolimus 000019-PIP01-07 European … product specific waiver for Everolimus (EMEA-000019-PIP01-07) in … -
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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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Everolimus product-specific bioequivalence guidance
Last updated: 03/01/2017Everolimus product-specific bioequivalence … of the bioequivalence of everolimus. … Everolimus - Overview of comments received …
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,
, Revision: 19, Authorised, Last updated: 25/05/2023
with the cancer medicine everolimus in patients who have been … treatment (20 mg) or with everolimus in previously treated patients … with the cancer medicine everolimus in patients who have been … -
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 16, Authorised, Last updated: 05/04/2023
with the cancer medicine everolimus. Patients treated with Cabometyx … in patients treated with everolimus. In addition, results indicated … than patients treated with everolimus (an average of 21.4 months … -
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Human medicine European public assessment report (EPAR): Trecondi
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019, Revision: 3, Authorised, Last updated: 25/01/2023Marketing-authorisation holder medac Gesellschaft für klinische … -
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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 …