Medicinal product name Mysimba
Pharmaceutical form Prolonged-release tablet
Strength 8 mg/90 mg 
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
Risk minimisation measuresIzglītojošie materiāli ārstam Izglītojošie materiāli ārstam
ATC code A08AA62 Antiobesity preparations, excl. diet 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 N28
(8 mg/90 mg)
PVC/PCTFE/PVC/AL blister    EU/1/14/988/002  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/1/14/988/002
Date of authorisation Mar 26, 2015
Marketing authorisation holder, country Orexigen Therapeutics Ireland Limited, Ireland