Irish Medicines Database · HPRA register

KEYTRUDA 25 mg/mL concentrate for solution for infusion

Authorisation EU/1/15/1024/002-003 · Merck Sharp & Dohme BV,

Licence EU/1/15/1024/002-003 · Unknown

Licence holder: Merck Sharp & Dohme BV, (all products →)
Active substance: Pembrolizumab
Dosage form: Concentrate for solution for infusion
Route of administration: Intravenous use
ATC code: L01FF02
First authorised: 18/08/2016
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)

Data: Health Products Regulatory Authority (HPRA) open dataset, licensed CC BY 4.0, published 16 Sep 2026. 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.