Fertavid (follitropin beta)
- Region
- 🇪🇺 EU
- Active substance
- follitropin beta
- Company
- Merck Sharp & Dohme B.V.
- Status
- Withdrawn
- Therapeutic area
- Infertility; Hypogonadism
- EU approval
- Thu 19 Mar 2009
- Application
- EMEA/H/C/001042
- ATC
- G03GA06
- Official record
- www.ema.europa.eu
Indication
In the female: Fertavid is indicated for the treatment of female infertility in the following clinical situations: Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Puregon Authorised · Organon N.V.
Follow Fertavid
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.