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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

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