Medicinal product name Nitisinone MDK
Pharmaceutical form Capsule, hard
Strength 2 mg 
Information from the MAH on shortages 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) currently no information on availability from any wholesaler N60
(2 mg)
HDPE bottle    EU/1/17/1217/001  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/1/17/1217/001
Date of authorisation Aug 24, 2017
Marketing authorisation holder, country MendeliKABS Europe Limited, United Kingdom