Listen
OPTIKINZY (norgestimate/ethinylestradiol), hormone contraceptives for systemic use
GYNAECOLOGY - New medicinal product
Opinions on drugs -
Posted on
Jan 28 2019
Reason for request
Inclusion
Insufficient clinical benefit to justify reimbursement for contraception
-
OPTIKINZY has been granted an MA for oral contraception.
-
The data do not allow us to formally conclude that there is no difference in terms of risk of thromboembolism between oestroprogestative contraceptives containing levonorgestrel and those containing norgestimate (OPTIKINZY).
- No efficacy or tolerance advantage of OPTIKINZY over levonorgestrel-containing oestroprogestative oral contraceptives has been demonstrated
Clinical Benefit
| Insufficient |
le service médical rendu par OPTIKINZY est insuffisant pour justifier d’une prise en charge par la solidarité nationale dans l’indication de l’AMM. |
Clinical Added Value
| Not applicable |
- |
