FDA — authorised 23 February 2005
- Application: BLA103628
- Marketing authorisation holder: BIOGEN
- Indication: Labeling
- Status: approved
🇺🇸 Citomix in United States
FDA authorised Citomix on 23 February 2005
Marketing authorisations
FDA — authorised 28 July 2005
- Application: BLA103471
- Marketing authorisation holder: BAYER HEALTHCARE PHARMS
- Indication: Supplement
- Status: approved
FDA — authorised 27 August 2015
- Application: BLA103836
- Marketing authorisation holder: HORIZON THERAPEUTICS IRELAND DAC
- Indication: Labeling
- Status: approved
FDA — authorised 26 May 2020
- Application: BLA103780
- Marketing authorisation holder: SERONO INC
- Indication: Efficacy
- Status: approved
FDA
- Marketing authorisation holder: BAYER HEALTHCARE PHARMS
- Status: approved
Citomix in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Citomix approved in United States?
Yes. FDA authorised it on 23 February 2005; FDA authorised it on 28 July 2005; FDA authorised it on 27 August 2015.
Who is the marketing authorisation holder for Citomix in United States?
BIOGEN holds the US marketing authorisation.