MAPAKNA LP (nifedipine) - Preterm delivery

The Committee deems that the clinical benefit of MAPAKNA LP 20 mg (nifedipine), prolonged-release tablet, is substantial in the MA indication.

In view of:

• the lack of clinical study conducted with the proprietary medicinal product MAPAKNA LP (nifedipine) in threatened preterm delivery;
• the clinical data available on nifedipine in TPD based on a literature review, with in particular 3 identified comparative studies with a low level of evidence as they are not free from limitations and bias, which do not allow an assessment of a potential difference in the effect size of nifedipine in relation to atosiban;
• the well-established and recommended use of nifedipine in threatened preterm delivery and the follow-up available from its off-label use in this indication;
• the known safety profile of nifedipine,
• the medical need for an alternative to intravenously administered atosiban, the oral administration of nifedipine being an advantage in this context of use among pregnant women with threatened preterm delivery;

the Committee deems that MAPAKNA LP 20 mg (nifedipine), prolonged-release tablet provides no clinical added value (CAV V) in the current therapeutic strategy including atosiban.