The marketing authorisation holder (MAH) is responsible to keep its product information updated in line with current scientific knowledge or recommendations. The MAH is responsible for regularly monitoring relevant sources of new information and recommendations On this website you will find links where to find recommendations and outcome resulting in amendment of the product information. Pharmacovigilance procedures outcome Referral Art. 30 and 31 (non-pharmacovigilance) CMDh Recommendations Core SmPC/PL Paediatric work sharing procedures MRI Product Index
