Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
GEL
**Posology and method of administration** Intravaginal application - Treatment of infertility due to inadequate luteal phase: one application (1.125 g 8 % gel) every day, starting after documented ovulation or arbitrarily on the 18th–21st day of the cycle. - When used during in-vitro fertilisation, daily application of Crinone® 8 % gel should be continued for 30 days if there is laboratory evidence of pregnancy. Children: not applicable.
VAGINAL
Medical Information
**Therapeutic Indications** Treatment of disorders associated with progesterone deficiency, such as: - infertility due to inadequate luteal phase. - for use during in-vitro fertilisation, where infertility is mainly due to tubal, idiopathic or endometriosis linked sterility associated with normal ovulatory cycles.
**Contra-indications** - known sensitivity to Crinone® (progesterone or any of the other ingredient) - undiagnosed vaginal bleeding - known or suspected malignancy of the breast or genital organ - acute porphyria - thrombophlebitis, thromboembolic disorders, cerebral apoplexy or patients with a history of these conditions - missed abortion
G03DA04
progesterone
Manufacturer Information
MERCK PTE. LTD.
DENDRON BRANDS LTD
maropack ag
Active Ingredients
Documents
Package Inserts
Crinone PI.pdf
Approved: November 10, 2021