Medicinal product name Orfadin
Pharmaceutical form Capsule, hard
Strength 10 mg 
Information from the MAH on shortages Not available
predicted availability date: not notified
Legal status Rx Prescription (Pr.)
 Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code A16AX04 Other alimentary tract and metabolism products

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers)
predicted availability date: not notified
currently no information on availability from any wholesaler N60
(10 mg)
HDPE bottle 5408.84  EU/1/04/303/003  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/04/303/003
Date of authorisation Feb 21, 2005
Marketing authorisation holder, country Swedish Orphan Biovitrum International AB, Sweden