EMA — authorised 18 July 2022
- Marketing authorisation holder: EIGERBIO EUROPE LIMITED
- Status: approved
🇪🇺 Zokinvy in European Union
EMA authorised Zokinvy on 18 July 2022
Marketing authorisations
EMA — authorised 18 July 2022
- Application: EMEA/H/C/005271
- Marketing authorisation holder: TMC Pharma (EU) Limited
- Local brand name: Zokinvy
- Indication: Zokinvy is indicated for the treatment of patients 12 months of age and older with a genetically confirmed diagnosis of Hutchinson-Gilford progeria syndrome or a processing-deficient progeroid laminopathy associated with either a heterozygous LMNA mutation with progerin-like protein accumulation or a homozygous or compound heterozygous ZMPSTE24 mutation.
- Pathway: exceptional circumstances, orphan
- Status: approved
Zokinvy 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 Zokinvy approved in European Union?
Yes. EMA authorised it on 18 July 2022; EMA authorised it on 18 July 2022.
Who is the marketing authorisation holder for Zokinvy in European Union?
EIGERBIO EUROPE LIMITED holds the EU marketing authorisation.