EMA — authorised 27 August 2018
- Marketing authorisation holder: ALNYLAM NETHERLANDS B.V.
- Status: approved
🇪🇺 Onpattro in European Union
EMA authorised Onpattro on 27 August 2018
Marketing authorisations
EMA — authorised 27 August 2018
- Application: EMEA/H/C/004699
- Marketing authorisation holder: Alnylam Netherlands B.V.
- Local brand name: Onpattro
- Indication: Onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.
- Pathway: accelerated assessment, orphan
- Status: approved
Onpattro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in European Union
Frequently asked questions
Is Onpattro approved in European Union?
Yes. EMA authorised it on 27 August 2018; EMA authorised it on 27 August 2018.
Who is the marketing authorisation holder for Onpattro in European Union?
ALNYLAM NETHERLANDS B.V. holds the EU marketing authorisation.