Medicinal product name Ameluz
Pharmaceutical form Gel
Strength 78 mg/g 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
Summary of product characteristics, package leaflet and labeling text  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 L01XD04 Antineoplastic agents

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 N1
(156 mg/2 g)
Aluminium tube    EU/1/11/740/001  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/1/11/740/001
Date of authorisation Dec 14, 2011
Marketing authorisation holder, country Biofrontera Bioscience GmbH, Germany