UTROGESTAN (Besins Healthcare Australia Pty Ltd)
Product name
UTROGESTAN
Date registered
Evaluation commenced
Decision date
Approval time
215 (255 working days)
Active ingredients
progesterone
Registration type
EOI
Indication
UTROGESTAN (soft capsule) is now also indicated for treatment of unexplained threatened miscarriage in women with bleeding in the current pregnancy and a history of at least three or more previous miscarriages.
Use in women with less than three miscarriages may be warranted in those with reduced chances of future pregnancy such as those undergoing IVF treatment with limited viable egg and/or embryo availability or advanced fertility age. However, the benefit of treatment in clinical trials was limited to women with three or more miscarriages (see Section 5 Pharmacological properties; Clinical trials; Threatened Unexplained Miscarriage).