Low clinical benefit in induction of labour in the absence of cervical ripening, only in the event of medically-justified induced labour, but no clinical benefit demonstrated in the therapeutic strategy

Insufficient clinical benefit in induction of labour with cervical ripening or in the event of non-medically-justified induced labour.

• ANGUSTA 25 µg, oral route, has MA in labour induction. The dosage is 25 µg every 2 h or 50 µg every 4 h. The maximum dose is 200 micrograms every 24 h.

• No studies on misoprostol have studied ANGUSTA 25 μg specifically. They were carried out on the proprietary medicinal product CYTOTEC at different doses (in the form of fractions of tablet oral solution made up from CYTOTEC). The bioequivalence between the two medicinal products has not been demonstrated.

• Data from literature suggest misoprostol administered by oral route to be effective on the reduction in the number of caesareans or on the reduction in the number of births by vaginal route not resulting in expulsion within 24 hours.

• However, the misoprostol administration regimens (some of which are off-label) used in the data from the relevant literature, among which none correspond to the dosages in the ANGUSTA MA cannot be used to position this medicinal product with respect to its comparators, in terms of efficacy and safety.