200 mg
Trade Name
Lutigest
Soft Capsule
Request Type
Registration
Drug Type
Generic(Multisource) Drug
Approval Date
SFDA Approved Use
PROGESTERONE indicated in adult women.
Oral Route:
Gynaecological:
- Disorders due to progesterone insufficiency, Particularly:
- premenstrual syndrome,
- menstrual irregularities with dysovulation or anovulation,
- benign breast disorders,
- peri-menopause.
- treatment of menopause (in addition to oestrogen therapy).
- sterility due to luteal failure.
Obstetric:
- Threatened miscarriage or prevention of repeated miscarriage due to proven luteal insufficiency.
- Threatened premature delivery.
Vaginal Route:
- Subfertility or primary/secondary infertility due to partial or total luteal phase deficiency (in particular: irregular ovulation, supplementation of the luteal phase during in vitro fertilisation, egg donations).
- Threat of miscarriage or prevention of recurrent miscarriages due to luteal phase deficiency.
- Prevention of a premature singleton birth in women at risk, with a short cervical length of [less or equal] 25 mm measured between weeks 16 and 24 of pregnancy (weeks 18 and 26 of amenorrhoea)
Oral Route:
Gynaecological:
- Disorders due to progesterone insufficiency, Particularly:
- premenstrual syndrome,
- menstrual irregularities with dysovulation or anovulation,
- benign breast disorders,
- peri-menopause.
- treatment of menopause (in addition to oestrogen therapy).
- sterility due to luteal failure.
Obstetric:
- Threatened miscarriage or prevention of repeated miscarriage due to proven luteal insufficiency.
- Threatened premature delivery.
Vaginal Route:
- Subfertility or primary/secondary infertility due to partial or total luteal phase deficiency (in particular: irregular ovulation, supplementation of the luteal phase during in vitro fertilisation, egg donations).
- Threat of miscarriage or prevention of recurrent miscarriages due to luteal phase deficiency.
- Prevention of a premature singleton birth in women at risk, with a short cervical length of [less or equal] 25 mm measured between weeks 16 and 24 of pregnancy (weeks 18 and 26 of amenorrhoea)