asfotase alfa

This medicine is authorised for use in the European Union.


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. 

This EPAR was last updated on 15/02/2023

Authorisation details

Product details
Agency product number
Active substance
asfotase alfa
International non-proprietary name (INN) or common name
asfotase alfa
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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 circumstancesExceptional 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.


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
Marketing-authorisation holder
Alexion Europe SAS
Date of issue of marketing authorisation valid throughout the European Union
Contact address

103-105 rue Anatole France
92300 Levallois-Perret

Product information

13/02/2023 Strensiq - EMEA/H/C/003794 - IAIN/0064/G

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Product information documents contain:

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.

Assessment history

Changes since initial authorisation of medicine

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