Fertavid
follitropin beta
Table of contents
Overview
The marketing authorisation for Fertavid has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Fertavid
|
| Agency product number |
EMEA/H/C/001042
|
| Active substance |
follitropin beta
|
| International non-proprietary name (INN) or common name |
follitropin beta
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
G03GA06
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Merck Sharp & Dohme B.V.
|
| Revision |
12
|
| Date of issue of marketing authorisation valid throughout the European Union |
19/03/2009
|
| Contact address |
Waarderweg 39 |
Product information
20/01/2020 Fertavid - EMEA/H/C/001042 - WS/1702
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Sex hormones and modulators of the genital system
Therapeutic 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.