Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: Strensiq   
Auth. number : EU/1/15/1015
Active substance : asfotase alfa
Orphan market exclusivity for "Treatment of hypophosphatasia" (based on designation EU/3/08/594) started on 01/09/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 01/09/2025
ATC: Pending
Indication: Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.
Marketing Authorisation Holder: Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France
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 Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/09/2015 Centralised - Authorisation EMEA/H/C/3794 (2015)6114 of 28/08/2015
18/11/2015 Centralised - Variation EMEA/H/C/3794/IB/1/G
Updated with Decision(2016)7403 of 11/11/2016
12/01/2016 Centralised - Variation EMEA/H/C/3794/IAin/4
Updated with Decision(2016)7403 of 11/11/2016
15/11/2016 Centralised - Yearly update (2016)7403 of 11/11/2016
15/12/2016 Centralised - Annual reassessment EMEA/H/C/3794/S/11
15/12/2016 Centralised - Variation EMEA/H/C/3794/II/08
28/03/2017 Centralised - Variation EMEA/H/C/3794/IB/15
11/04/2017 Centralised - Variation EMEA/H/C/3794/IAin/17/G
20/04/2017 Centralised - Variation EMEA/H/C/3794/IB/0014
09/06/2017 Centralised - Variation EMEA/H/C/3794/II/18