AMANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Orphan Europe SARL
Immeuble "Le Wilson"
70, avenue du Général de Gaulle
Orphan Europe SARL Eco River Parc
30, rue des Peupliers
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
B CONDITIONS OF THE MARKETING AUTHORISATION
•CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.