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Irish Medicines Database · HPRA register

Spedra 200 mg tablets

Authorisation EU/1/13/841/008-010 · Menarini International Operations Luxembourg S.A.

← All medicines

Spedra 200 mg tablets

Licence EU/1/13/841/008-010 · Unknown

Licence holder: Menarini International Operations Luxembourg S.A. (all products →)
Active substance: Avanafil
Dosage form: Tablet
Route of administration: Oral use
ATC codes: G04BE, G04BE10
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 04 Jul 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.