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Registers Irish medicines FYLREVY 18.9 mg film-coated tablets
Medicines register · Ireland

FYLREVY 18.9 mg film-coated tablets

Authorisation EU/1/26/2020/004-006 · Gedeon Richter Plc

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 16 Sep 2026
Licence holder
Gedeon Richter Plc (all products →)
Active substance
Estetrol
Dosage form
Film-coated tablet
Route of administration
Oral use
ATC code
G03CA10
First authorised
26/03/2026
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Full application (Article 8(3) of Directive No 2001/83/EC)

This listing is regulatory information, not medical advice — consult the package leaflet, SPC, or a healthcare professional. For the authoritative record see the HPRA register.