Medicinal product name Ovaleap
Biosimilar medicine
Pharmaceutical form Solution for injection
Strength 450 IU/0.75 ml 
Information from the MAH on shortages No information on expected shortages
Legal status Rx Prescription (Pr.)
KZSR Reimbursed medicines reference product
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 G03GA05 Sex hormones and modulators of the genital system

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
(450 IU/0,75 ml)
Glass cartridge 152.70 
KZSR*
EU/1/13/871/002  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
* Indication about medicine on the List of state reimbursed medicines is just informative. Source of the information is the National Health Service. For details please visit the NHS website.

Registration information

Marketing authorisation No. EU/1/13/871/002
Date of authorisation Sep 27, 2013
Marketing authorisation holder, country Theramex Ireland Limited, Ireland