129 results
-
List item
Human medicine European public assessment report (EPAR): Thalidomide Lipomed
Thalidomide, Multiple Myeloma
Date of authorisation: 19/09/2022, Authorised, Last updated: 20/10/2022Thalidomide Lipomed Neoplasms, Plasma Cell Cancer Neoplasms Hemostatic … Thalidomide Lipomed … EMEA/H/C/005715 Thalidomide Lipomed (thalidomide) An overview … -
List item
Human medicine European public assessment report (EPAR): Deferiprone Lipomed
Deferiprone, Iron Overload; beta-Thalassemia
Date of authorisation: 19/09/2018,
, Revision: 6, Authorised, Last updated: 08/06/2022
Deferiprone Lipomed Nutritional and Metabolic … Deferiprone Lipomed … authorisation) Deferiprone Lipomed deferiprone On 26 July … -
List item
Orphan designation: 4-hydroxyandrostenedione, Serenoa serrulata, alpha lipoic acid for: Treatment of multiple symmetric lipomatosis
Date of designation: 28/04/2016, Positive, Last updated: 02/09/2021treatment of multiple symmetric lipomatosis … treatment of multiple symmetric lipomatosis On 28 April 2016, orphan … treatment of multiple symmetric lipomatosis. What is multiple symmetric lipomatosis? Multiple symmetric … -
List item
Human medicine European public assessment report (EPAR): Litak
Cladribine, Leukemia, Hairy Cell
Date of authorisation: 14/04/2004, Revision: 7, Authorised, Last updated: 04/04/2018throughout the EU for Litak to Lipomed GmbH on 14 April 2004. The … throughout the EU for Litak to Lipomed GmbH on 14 April 2004. The … dossier The applicant Lipomed GmbH submitted on 4 July … -
List item
Orphan designation: Cladribine for: Treatment of mastocytosis
Date of designation: 05/08/2013, Positive, Last updated: 16/09/2013the European Commission to Lipomed GmbH, Germany, for cladribine … the European Commission to Lipomed GmbH, Germany, for cladribine … Sponsor’s contact details: Lipomed GmbH Hegenheimer Strasse … -
List item
Orphan designation: Cladribine for: Treatment of indolent non-Hodgkin's lymphoma
Date of designation: 18/09/2001, Expired, Last updated: 18/06/2014the European Commission to Lipomed GmbH, Germany, for cladribine … the European Commission to Lipomed GmbH, Germany, for cladribine … Sponsor’s contact details: Lipomed GmbH Hegenheimer Strasse … -
List item
National expert: Edyta Sapierzyńska, Chief Pharmaceutical Inspectorate (updated)
- Declaration of interests - 39.42 KB | PDF
- Curriculum Vitae - 26.39 KB | PDF
collagenous nevus, fibroma, lipoma, myxoma, neuroibroma, leiomyoma … neurofibrosarcoma, infiltrative lipoma, nodular fascilitis. Życie … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 July 2022
CHMP, Last updated: 22/07/2022Thalidomide Lipomed … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 July 2018
CHMP, Last updated: 27/07/2018Deferiprone Lipomed … -
List item
National expert: Gerardo Sarno, Italian Medicines Agency (updated)
- Declaration of interests - 40.13 KB | PDF
- Curriculum Vitae - 42.43 KB | PDF
-
List item
National expert: Dimitrios Filippou, National Organization For Medicines (updated)
- Declaration of interests - 39.32 KB | PDF
- Curriculum Vitae - 76.33 KB | PDF
secondary to a Submucosal Cecal Lipoma, Abdom. Imaging 2004, 29(4):426_8 … -
List item
National expert: Marinus Christianus van den Heuvel, European Medicines Agency (updated)
- Declaration of interests - 39.41 KB | PDF
- Curriculum Vitae - 35.46 KB | PDF
-
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
-
List item
Human medicine European public assessment report (EPAR): Farydak (updated)
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,
, Revision: 12, Authorised, Last updated: 16/05/2023
-
List item
Human medicine European public assessment report (EPAR): Ecansya (previously Capecitabine Krka)
capecitabine, Colonic Neoplasms; Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms
Date of authorisation: 20/04/2012,, Revision: 14, Authorised, Last updated: 07/03/2023
-
List item
Human medicine European public assessment report (EPAR): Bosulif (updated)
bosutinib (as monohydrate), Leukemia, Myeloid
Date of authorisation: 27/03/2013, Revision: 24, Authorised, Last updated: 17/05/2023 -
List item
Human medicine European public assessment report (EPAR): Byetta (updated)
exenatide, Diabetes Mellitus, Type 2
Date of authorisation: 20/11/2006, Revision: 28, Authorised, Last updated: 24/05/2023 -
List item
Human medicine European public assessment report (EPAR): Heplisav B (updated)
hepatitis B surface antigen, Hepatitis B
Date of authorisation: 18/02/2021,
, Revision: 3, Authorised, Last updated: 23/05/2023
-
List item
Human medicine European public assessment report (EPAR): Invirase
saquinavir, HIV Infections
Date of authorisation: 03/10/1996, Revision: 50, Authorised, Last updated: 13/03/2023 -
List item
Human medicine European public assessment report (EPAR): Xofigo (updated)
radium (223Ra) dichloride, Prostatic Neoplasms
Date of authorisation: 13/11/2013,, Revision: 13, Authorised, Last updated: 16/05/2023
-
List item
Human medicine European public assessment report (EPAR): Dzuveo
sufentanil citrate, Pain
Date of authorisation: 25/06/2018, Revision: 6, Authorised, Last updated: 31/03/2023 -
List item
Veterinary medicine European public assessment report (EPAR): Apoquel
oclacitinib maleate, Dogs
Date of authorisation: 12/09/2013, Revision: 8, Authorised, Last updated: 21/01/2022 -
List item
Human medicine European public assessment report (EPAR): Viread
tenofovir disoproxil fumarate, Hepatitis B, Chronic; HIV Infections
Date of authorisation: 04/02/2002, Revision: 58, Authorised, Last updated: 04/01/2023 -
List item
Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis
Date of authorisation: 26/09/2017, Revision: 26, Authorised, Last updated: 25/05/2023 -
List item
Human medicine European public assessment report (EPAR): Zessly
infliximab, Arthritis, Psoriatic; Psoriasis; Crohn Disease; Arthritis, Rheumatoid; Colitis, Ulcerative; Spondylitis, Ankylosing
Date of authorisation: 18/05/2018,
, Revision: 10, Authorised, Last updated: 12/12/2022