EMA — authorised 28 August 2015
- Marketing authorisation holder: Alexion Europe SAS
- Status: approved
🇪🇺 Strensiq in European Union
EMA authorised Strensiq on 28 August 2015
Marketing authorisations
EMA — authorised 28 August 2015
- Application: EMEA/H/C/003794
- Marketing authorisation holder: Alexion Europe SAS
- Local brand name: Strensiq
- Indication: Strensiq is indicated for long-term enzyme replacement therapy in patients with paediatric-onset hypophosphatasia to treat the bone manifestations of the disease.
- Pathway: exceptional circumstances, orphan
- Status: approved
Strensiq in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in European Union
Frequently asked questions
Is Strensiq approved in European Union?
Yes. EMA authorised it on 28 August 2015; EMA authorised it on 28 August 2015.
Who is the marketing authorisation holder for Strensiq in European Union?
Alexion Europe SAS holds the EU marketing authorisation.