FDA — authorised 25 May 2004
- Application: BLA021684
- Marketing authorisation holder: EMD SERONO
- Local brand name: GONAL-F RFF REDI-JECT
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 GONAL f® prefilled pen in United States
FDA authorised GONAL f® prefilled pen on 25 May 2004
Marketing authorisations
FDA
- Status: approved
GONAL f® prefilled pen 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 GONAL f® prefilled pen approved in United States?
Yes. FDA authorised it on 25 May 2004; FDA has authorised it.
Who is the marketing authorisation holder for GONAL f® prefilled pen in United States?
EMD SERONO holds the US marketing authorisation.