Health Canada
- Status: approved
🇨🇦 Roflumilast 500 in Canada
Roflumilast 500 (Roflumilast 500) regulatory status in Canada.
Marketing authorisation
Roflumilast 500 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Roflumilast 500 approved in Canada?
Yes. Health Canada has authorised it.
Who is the marketing authorisation holder for Roflumilast 500 in Canada?
Spanish Research Center for Respiratory Diseases is the originator. The local marketing authorisation holder may differ — check the official source linked above.