Product Information

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