EMA — authorised 14 May 2002
- Marketing authorisation holder: Janssen-Cilag International N.V.
- Status: approved
EMA authorised Tracleer on 14 May 2002
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 14 May 2002.
Janssen-Cilag International N.V. holds the EU marketing authorisation.