Notice type: 3rd Party Publications
Problem Or Issue:
Important Safety Information from Ferring Ireland Limited and Pfizer Healthcare Ireland regarding Strengthening of wordings on dose recommendations, warnings and recommendations regarding the risks of uterine hyperstimulation, uterine rupture and foetal/neonatal death and inclusion of wordings on restriction of usage to qualified health care professionals and to hospitals and clinics as recommended by PRAC, CMDh and Health Products Regulatory Authority (HPRA)
Important Safety Information from Marketing Authorization Holders of products containing Dinoprostone