Medicinal product name Zejula
Pharmaceutical form Capsule, hard
Strength 100 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.II onk. ķīm. ter.)
 Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
Conclusion on the therapeutic and cost effectiveness of medicines May 25, 2020 C56 C57 C48
 Oct 15, 2020 C56 C57 C48
 Oct 20, 2020 C56 C57 C48
ATC code L01XK02 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 N84: 84 × 1
(100 mg)
PVC/PCTFE/AL blister    EU/1/17/1235/001  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/1/17/1235/001
Date of authorisation Nov 16, 2017
Marketing authorisation holder, country GlaxoSmithKline (Ireland) Limited, Ireland