The Committee deems that the clinical benefit of MAPAKNA LP 20 mg (nifedipine), prolonged-release tablet, is substantial in the MA indication.
Clinical Added Value
no clinical added value
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.
Listen
