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Pharmaceuticals - Community Register
Community register of medicinal products for human use
|Auth. number :||EU/1/13/871|
|Active substance :||Follitropin alfa|
|ATC:||Anatomical main group: G - Genito urinary system and sex hormones|
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03G - Gonadotropins and other ovulation stimulants
Chemical subgroup: G03GA - Gonadotropins
Chemical substance: G03GA05 - Follitropin alfa
(See WHO ATC Index)
|Indication:||In adult women|
• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate.
• Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra fallopian transfer.
• Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.
In adult men
• Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
|Marketing Authorisation Holder:||Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
|EPAR and active package presentations|
Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".|
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|01/10/2013||Centralised - Authorisation||EMEA/H/C/2608||(2013)6429 of 27/09/2013|
|12/05/2014||Centralised - Variation||EMEA/H/C/2608/IB/1|
|Updated with Decision(2014)6741 of 16/09/2014|
|18/09/2014||Centralised - Transfer Marketing Authorisation Holder||EMEA/H/C/2608/T/5||(2014)6741 of 16/09/2014|