jueves, 13 de septiembre de 2018

List of the latest marketing authorisations and orphan medicinal products designations | www.eurordis.org

List of the latest marketing authorisations and orphan medicinal products designations | www.eurordis.org

Eurordis, Rare Diseases Europe

The Voice of Rare Disease
Patients in Europe



List of the latest marketing authorisations and orphan medicinal products designations

Detailed information on European orphan medicinal products designation applications is available on the EMAwebsite. A full list of designated and authorised orphan medicinal products in Europe available at: ec.europa.eu.

Orphan drug regulatory processLearn more about the Orphan designation process in Europe





Recent marketing authorisations

Medicinal Product
Marketing Authorisation Holder
Therapeutic Indication
Date of Marketing Authorisation
Alofisel®
(darvadstrocel)
Tigenix, S.A.U.Complex anal fistulas in adults with Crohn’s disease23/03/2018
Amglidia®
(glibenclamide)
AmmtrekNeonatal diabetes24/05/2018
Crysvita®
(burosumab)
Kyowa Kirin Limited X-linked hypophosphataemia 19/02/2018
Jorveza®
(budesonide)
Dr. Falk Pharma GmbHEosinophilic oesophagitis08/01/2018
Lamzede®
(velmanase alfa)
Chiesi Farmaceutici S.p.A.Alpha-mannosidosis23/03/2018
Mepsevii®
(vestronidase alfametreleptin)
Ultragenyx Germany GmbHMucopolysaccharidosis type VII (MPS VII, also known as Sly syndrome)23/08/2018
Myalepta®
(metreleptin)
Aegerion Pharmaceuticals B.V.Lipodystrophy30/07/2018
Mylotarg®
(gemtuzumab ozogamicin)
Pfizer LimitedAcute myeloid leukemia19/04/2018
Premyvis®
(letermovir)
Merck Sharp & Dohme Limited
Cytomegalovirus infection prevention following haematopoietic stem cell transplant08/01/2018
Rubraca®
(rucaparib)
Clovis Oncology UK LimitedHigh-grade cancers of the ovary, fallopian tubes and peritoneum
24/05/2018

Teedgsi®
(inotersen sodium)
Ionis USA LtdHereditary transthyretin amyloidosis (hATTR)06/07/2018
Verkazia®
(ciclosporin)
Santen OyKeratoconjunctivitis (VKC) in children and adolescents from 4 to 18 years of age.06/07/2018


























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