Idiomas

Lista de las últimas designaciones de medicamentos huérfanos y/o autorizaciones de mercado

En la web de la EMA se encuentra disponible información detallada sobre las aplicaciones de la designación europea de medicamentos huérfanos.
Hay disponible una lista completa de medicamentos designados y autorizados en Europa en: ec.europa.eu

Learn more about the Orphan designation process in Europe

Autorizaciones de comercialización
Designaciones de medicamentos huérfanos

Medicamentos recientemente autorizados

Consulte una lista de medicamentos huérfanos autorizados actualmente en la UE.

Elzonris® (tagraxofusp)	Stemline Therapeutics B.V.	Adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN)	07/01/2021
Inrebic® (fedratinib)	Celgene Europe BV	Adults with myelofibrosis (a rare form of blood cancer)	08/02/2021
Lumoxiti® (moxetumomab pasudotox)	AstraZeneca AB	Adults with hairy cell leukaemia, a cancer of the white blood cells	08/02/2021
Sogroya® (somapacitan)	Novo Nordisk A/S	Growth hormone deficiency	31/03/2021
Enspryng® (satralizumab)	Roche Registration GmbH	Neuromyelitis Optica Spectrum disorders (NMOSD)	24/06/2021
Bylvay® (odevixibat)	Albireo	+6 months with progressive familial intrahepatic cholestasis (PFIC)	16/07/2021
Skysona® (elivaldogene autotemcel)	bluebird bio (Netherlands) B.V.	Under 18 years of age with early cerebral adrenoleukodystrophy (CALD)	16/07/2021
Imcivree® (setmelanotide)	Rhythm Pharmaceuticals Limited	+6 years who have pro-opiomelanocortin (POMC) deficiency or leptin receptor (LEPR) deficiency	16/07/2021
Abecma® (idecabtagene vicleucel)	Celgene Europe BV	Adults with multiple myeloma (a cancer of the bone marrow)	18/08/2021
Voxzogo® (vosoritide)	BioMarin International Limited	Achondroplasia in patients aged +2 years	26/08/2021
Minjuvi® (tafasitamab)	Incyte Biosciences Distribution B.V.	Adults with diffuse large B-cell lymphoma (DLBCL)	26/08/2021

Lista de las últimas designaciones de medicamentos huérfanos

2021

Jan - Feb - Mar - Apr - May - Jun - Jul - Aug - Sep

2020

Jan - Feb - Mar - Apr - May - Jun - Jul - Aug - Sep - Oct - Nov - Dec

2019

Jan - Feb - Mar - Apr - May - June - July - Sep - Oct - Nov - Dec

2018

Jan - Feb - Mar - Apr - May - June - July - Sep - Oct - Nov - Dec

2017

Jan - Feb - Mar - Apr - May - Jun - July- Sep - Oct - Nov - Dec

Overview of Orphan Medicinal Product Designation Procedure since 2000

Including and prior to 2018 the EMA also published the detailed information summarised below:

Year	Applications submitted	Positive COMP opinions	Applications withdrawn	Negative COMP opinions	Designations granted by the Commission	Orphan medicinal products authorised	Orphan designations included in authorised therapeutic indication
2018	203	152	79	3	126	12	15
2017	260	144	96	2	138	14	15
2016	330	220	82	2	209	14	14
2015	258	177	94	1	190	14	21
2014	329	196	61	2	187	15	16
2013	201	136	60	1	136	7	8
2012	197	139	52	1	148	10	12
2011	166	111	45	2	107	5	5
2010	174	123	51	2	128	4	4
2009	164	113	23	0	106	9	9
2008	119	86	31	1	73	6	7
2007	125	97	19	1	98	13	13
2006	104	81	20	2	80	9	11
2005	118	88	30	0	88	4	4
2004	108	75	22	4	73	6	6
2003	87	54	41	1	55	5	5
2002	80	43	30	2	49	4	4
2001	83	62	27	1	64	3	3
2000	72	26	6	0	14	0	0
Total	3211	2134	881	28	2121	164	185