Anagrelide Viatris (previously Anagrelide Mylan) (anagrelide)
- Region
- 🇪🇺 EU
- Active substance
- anagrelide
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Thrombocythemia, Essential
- CHMP opinion
- Thu 14 Dec 2017
- EU approval
- Thu 15 Feb 2018
- Designations
- Generic
- Application
- EMEA/H/C/004585
- ATC
- L01XX35
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Xagrid Authorised · Takeda Pharmaceuticals International AG Ireland
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.