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EMA Product

Orgalutran

Product approved by European Medicines Agency (EU)

Basic Information

Orgalutran

Regulatory Information

EMEA/H/C/000274

Authorised

May 16, 2000

May 17, 2000

25

May 30, 2024

Company Information

the netherlands

Kloosterstraat 6 5349 AB Oss

Organon NV

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic indication The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques. In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Orgalutran. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Orgalutran.

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