MedPath
HSA Product

UTROGESTAN CAPSULE 200mg

Product approved by Health Sciences Authority (SG)

Basic Information

UTROGESTAN CAPSULE 200mg

CAPSULE, LIQUID FILLED

Regulatory Information

SIN15475P

April 30, 2018

Prescription Only

Therapeutic

ORAL, VAGINAL

August 10, 2023

June 3, 2025

XG03DA04

Company Information

PHARMED IMPORT & EXPORT PTE LTD

PHARMED IMPORT & EXPORT PTE LTD

Active Ingredients

Detailed Information

Contraindications

**CONTRAINDICATIONS** Utrogestan should not be used in individuals with any of the following conditions: - Known allergy or hypersensitivity to progesterone or to any of the excipients. - Severe hepatic dysfunction. - Undiagnosed vaginal bleeding. - Known missed abortion or ectopic pregnancy - Mammary or genital tract carcinoma. - Thromboembolic or thrombophlebitis disorders. - Cerebral haemorrhage. - Porphyria.

Indication Information

**INDICATION** Utrogestan is indicated for: Disorders related to progesterone deficit in particular menstrual irregularities due to ovulation disorders or anovulation, premenstrual disorders, breast pain or by benign breast disorders (mastopathies), bleeding due to fibroma, therapy of menopause (adjunctive use with estrogen in post-menopausal women for prevention of endometrial hyperplasia, menace of preterm delivery and can be used up to 36 week of pregnancy, threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to the 12th week of pregnancy, treatment of subfertility or primary or secondary infertility related to progesterone insufficiency in particular in In Vitro Fertilization) cycles and/or oocyte donation. For all other progesterone indications, the vaginal route represents an alternative to the oral route, in case of adverse events due to Progesterone (somnolence, dizziness).

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