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.
Learn more about the Orphan designation process in Europe
Recent marketing authorisations
Medicinal Product | Marketing Authorisation Holder | Therapeutic Indication | Date of Marketing Authorisation | |
Bavencio® (avelumab) | Merck Serono Europe Limited | Merkel cell carcinoma | 18/09/2017 | |
| Besponsa® (inotuzumab ozogamicin) | Pfizer Limited | Precursor Cell Lymphoblastic Leukemia-Lymphoma | 29/06/2017 | |
| Brineura® (cerliponase alfa) | Biomarin International Limited | Neuronal ceroid lipofuscinosis type 2 | 30/05/2017 | |
Cystadrops® (mercaptamine) | Orphan Europe S.A.R.L. | Cystinosis | 19/01/2017 | |
Dinutuximab beta Apeiron® (dinutuximab beta) | Apeiron Biologics AG | Neuroblastoma | 08/05/2017 | |
Ledaga® (chlormethine) | Actelion Registration Ltd. |
T-cell lymphoma | 03/03/2017 | |
(parathyroid hormone) | Shire Pharmaceuticals Ireland Ltd | Hypoparathyroidism | 24/04/2017 | |
| Oxervate® (cenegermin [recombinant human nerve growth factor]) | Dompe farmaceutici s.p.a. | Neurotrophic keratitis | 06/07/2017 | |
Spinraza® (nusinersen) | Biogen Idec Ltd | Spinal muscular atrophy | 30/05/2017 |
Removed from the Community register of orphan medicinal products upon request of the MAH at the time of marketing authorisation
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