Strensiq
asfotase alfa
Table of contents
Overview
Strensiq is a medicine used long-term to treat patients with hypophosphatasia that started in childhood. Hypophosphatasia is a rare inherited disease of the bones which can lead to early loss of teeth, malformed bones, frequent bone fractures, and difficulty breathing.
Strensiq contains the active substance asfotase alfa.
Hypophosphatasia is rare, and Strensiq was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 3 December 2008.
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List item
Strensiq : EPAR - Medicine overview (PDF/102.9 KB)
First published: 28/09/2015
Last updated: 26/11/2018
EMA/716209/2018 -
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Strensiq : EPAR - Risk-management-plan summary (PDF/63.76 KB)
First published: 28/09/2015
Last updated: 28/09/2015
Authorisation details
Product details | |
---|---|
Name |
Strensiq
|
Agency product number |
EMEA/H/C/003794
|
Active substance |
asfotase alfa
|
International non-proprietary name (INN) or common name |
asfotase alfa
|
Therapeutic area (MeSH) |
Hypophosphatasia
|
Anatomical therapeutic chemical (ATC) code |
A16AB
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Exceptional circumstances |
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance. |
Orphan |
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation. |
Publication details | |
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Marketing-authorisation holder |
Alexion Europe SAS
|
Revision |
16
|
Date of issue of marketing authorisation valid throughout the European Union |
28/08/2015
|
Contact address |
103-105 rue Anatole France |
Product information
13/02/2023 Strensiq - EMEA/H/C/003794 - IAIN/0064/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Other alimentary tract and metabolism products
Therapeutic indication
Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.