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REKOVELLE (follitropin delta), ovulation stimulant
GYNAECOLOGY - New medicinal product
Opinions on drugs -
Posted on
Jun 28 2017
Reason for request
Inclusion
No clinical benefit demonstrated in comparison to GONAL-f to induce controlled ovarian stimulation for the development of multiple follicles in women undergoing an assisted reproductive technology program.
- REKOVELLE has Marketing Authorisation to induce controlled ovarian stimulation for the development of multiple follicles in women undergoing an assisted reproductive technology program, such as in-vitro fertilisation (IVF) or IVF with intracytoplasmic sperm injection (ICSI).
- The non-inferiority of REKOVELLE in comparison to GONAL-F was demonstrated in the ongoing pregnancy rate and the ongoing implantation rate 10-11 weeks after transfer.
Clinical Benefit
| Substantial |
- |
Clinical Added Value
| no clinical added value |
- |
Therapeutic use
|
- |
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