EMA — authorised 1 August 2018
- Marketing authorisation holder: Dr. Falk Pharma GmbH
- Status: approved
EMA authorised Pulmicort Respules on 1 August 2018
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA authorised it on 1 August 2018.
Dr. Falk Pharma GmbH holds the EU marketing authorisation.