EMA — authorised 20 July 2012
- Status: approved
🇪🇺 Tudorza Pressair in European Union
EMA authorised Tudorza Pressair on 20 July 2012
Marketing authorisations
EMA — authorised 20 July 2012
- Application: EMEA/H/C/002211
- Marketing authorisation holder: Covis Pharma Europe B.V.
- Local brand name: Eklira Genuair
- Indication: Eklira Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
- Status: approved
EMA — authorised 20 July 2012
- Application: EMEA/H/C/002706
- Marketing authorisation holder: Covis Pharma Europe B.V.
- Local brand name: Bretaris Genuair
- Indication: Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
- Status: approved
Tudorza Pressair in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in European Union
Frequently asked questions
Is Tudorza Pressair approved in European Union?
Yes. EMA authorised it on 20 July 2012; EMA authorised it on 20 July 2012; EMA authorised it on 20 July 2012.
Who is the marketing authorisation holder for Tudorza Pressair in European Union?
Covis is the originator. The local marketing authorisation holder may differ — check the official source linked above.