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Irish Medicines Database · HPRA register

Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injection

Authorisation PA1107/012/001 · Laboratoires Thea

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Fydrane 0.2 mg/ml + 3.1 mg/ml + 10 mg/ml, solution for injection
Licence PA1107/012/001 · Marketed
Licence holder
Laboratoires Thea (all products →)
Active substances
Tropicamide, Phenylephrine hydrochloride, Lidocaine Hydrochloride Monohydrate
Dosage form
Solution for injection
Route of administration
Intraocular use
ATC codes
S01FA, S01FA56
First authorised
28/08/2015
Prescription status
Product subject to prescription which may be renewed (B)
Supply
Supply through pharmacies only
Legal basis
Fixed combination application (Article 10b 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.