Pharmaceuticals - Union Register


Union Register of medicinal products for human use


Product information

Invented name: Spinraza   
Auth. number : EU/1/17/1188
Active substance : nusinersen
Orphan market exclusivity for "Treatment of 5q spinal muscular atrophy" (based on designation EU/3/12/976) started on 1/06/2017
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/06/2027
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M09 - Other drugs for disorders of the musculo-skeletal system
Pharmacological subgroup: M09A - Other drugs for disorders of the musculo-skeletal system
Chemical subgroup: M09AX - Other drugs for disorders of the musculo-skeletal system
Chemical substance: M09AX07 - nusinersen
(See WHO ATC Index)
Indication: Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
Marketing Authorisation Holder: Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/06/2017 Centralised - Authorisation EMEA/H/C/4312 (2017)3851 of 30/05/2017
21/09/2017 Centralised - Variation EMEA/H/C/4312/II/1
Updated with Decision(2018)5862 of 31/08/2018
2/11/2017 Centralised - Variation EMEA/H/C/4312/II/2/G
Updated with Decision(2018)5862 of 31/08/2018
18/05/2018 Centralised - Notification EMEA/H/C/4312/N/7
Updated with Decision(2018)5862 of 31/08/2018
4/09/2018 Centralised - 2-Monthly update EMEA/H/C/4312/II/4 (2018)5862 of 31/08/2018
12/11/2018 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/4312/T/10 (2018)7550 of 8/11/2018
30/11/2018 Centralised - 2-Monthly update EMEA/H/C/4312/IB/9 (2018)8161 of 28/11/2018
27/03/2019 PSUSA - Modification EMEA/H/C/PSUSA/10595/201805 (2019)2395 of 25/03/2019