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Registers Irish medicines Koselugo 7.5 mg granules in capsule for opening
Medicines register · Ireland

Koselugo 7.5 mg granules in capsule for opening

Authorisation EU/1/21/1552/004 · AstraZeneca AB

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 16 Sep 2026
Licence holder
AstraZeneca AB (all products →)
Active substance
Selumetinib Sulfate
Dosage form
Granules in capsule for opening
Route of administration
Oral use
ATC code
L01EE04
First authorised
09/01/2026
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.