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EMA Product

Strensiq

Product approved by European Medicines Agency (EU)

Basic Information

Strensiq

Regulatory Information

EMEA/H/C/003794

Authorised

August 28, 2015

June 24, 2015

17

February 7, 2024

Company Information

France

103-105 rue Anatole France 92300 Levallois-Perret

Alexion Europe SAS

Drug Classification

Orphan MedicineAdditional MonitoringExceptional Circumstances

Active Substances Detail

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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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