Pharmaceuticals - Union Register

  

Union 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 1/09/2015
   10 years of market exclusivity
   This orphan market exclusivity will expire on 1/09/2025
ATC: Anatomical main group: A - Alimentary tract and metabolism
Therapeutic subgroup: A16 - Other alimentary tract and metabolism products
Pharmacological subgroup: A16A - Other alimentary tract and metabolism products
Chemical subgroup: A16AB - Enzymes
Chemical substance: A16AB13 - asfotase alfa
(See WHO ATC Index)
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 Union Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
1/09/2015 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 - Variation EMEA/H/C/3794/II/8
Updated with Decision(2017)8704 of 11/12/2017
15/12/2016 Centralised - Annual reassessment EMEA/H/C/3794/S/11
28/03/2017 Centralised - Variation EMEA/H/C/3794/IB/15
Updated with Decision(2017)8704 of 11/12/2017
11/04/2017 Centralised - Variation EMEA/H/C/3794/IAIN/17/G
Updated with Decision(2017)8704 of 11/12/2017
20/04/2017 Centralised - Variation EMEA/H/C/3794/IB/14
Updated with Decision(2017)8704 of 11/12/2017
9/06/2017 Centralised - Variation EMEA/H/C/3794/II/18
Updated with Decision(2017)8704 of 11/12/2017
13/12/2017 Centralised - Yearly update (2017)8704 of 11/12/2017
14/12/2017 Centralised - Annual reassessment EMEA/H/C/3794/S/24
25/01/2018 Centralised - Variation EMEA/H/C/3794/II/19/G
Updated with Decision(2019)69 of 07/01/2019
3/05/2018 Centralised - Variation EMEA/H/C/3794/II/27/G
Updated with Decision(2019)69 of 07/01/2019
13/09/2018 Centralised - Variation EMEA/H/C/3794/II/29
Updated with Decision(2019)69 of 07/01/2019
13/12/2018 Centralised - Annual reassessment EMEA/H/C/3794/S-32
10/01/2019 Centralised - Yearly update (2019)69 of 7/01/2019
1/04/2019 PSUSA - Modification EMEA/H/C/3794/PSUSA/10421/201807 (2019)2592 of 28/03/2019