Medicinal product name Suboxone
Pharmaceutical form Buccal film
Strength 4 mg/1 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.I, Pr.II nark.)
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 N07BC51 Other nervous system drugs

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 N7
(4 mg/1 mg)
PET/LBPE/Al/LBPE sachet    EU/1/06/359/010  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/1/06/359/010
Date of authorisation Sep 26, 2006
Marketing authorisation holder, country Indivior Europe Limited, Ireland