EMA
- Application: EMEA/H/C/001225
- Local brand name: Colobreathe
- Status: approved
Coly-Mycin M (COLISTIMETHATE SODIUM) regulatory status in European Union.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA has authorised it.
Ph Health is the originator. The local marketing authorisation holder may differ — check the official source linked above.