Medicinal product name Rekovelle
Pharmaceutical form Solution for injection
Strength 12 µg/0.36 ml 
Information from the MAH on shortages No information on expected shortages
Legal status Rx Prescription (Pr.II gin.)
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 G03GA10 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
(12 µg/0,36 ml)
Glass pre-filled pen 74.95  EU/1/16/1150/004  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/1/16/1150/004
Date of authorisation Dec 12, 2016
Marketing authorisation holder, country Ferring Pharmaceuticals A/S, Denmark