EMA — authorised 15 November 2004
- Marketing authorisation holder: SHIRE PHARMACEUTICALS IRELAND LIMITED
- Status: approved
🇪🇺 Agrylin in European Union
EMA authorised Agrylin on 15 November 2004
Marketing authorisations
EMA — authorised 15 February 2018
- Application: EMEA/H/C/004585
- Marketing authorisation holder: Viatris Limited
- Local brand name: Anagrelide Viatris (previously Anagrelide Mylan)
- Indication: Anagrelide Viatris is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.An at-risk patient An at-risk essential thrombocythaemia patient is defined by one or more of the following features: >60 years of age or a platelet count >1,000 x 10⁹/l or a history of thrombo-haemorrhagic events.
- Status: approved
Agrylin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Agrylin approved in European Union?
Yes. EMA authorised it on 15 November 2004; EMA authorised it on 15 February 2018.
Who is the marketing authorisation holder for Agrylin in European Union?
SHIRE PHARMACEUTICALS IRELAND LIMITED holds the EU marketing authorisation.