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Registers› Irish medicines ›Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
Medicines register · Ireland

Gemcitabine 38 mg/ml Concentrate for Solution for Infusion

Authorisation PA2059/039/005 · Fresenius Kabi Deutschland GmbH

Source: Health Products Regulatory Authority (HPRA), open dataset, CC BY 4.0. Published 08 Oct 2026
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from HPRA's official open dataset · Last verified · Editorial standards
Licence holder
Fresenius Kabi Deutschland GmbH (all products →)
Active substance
Gemcitabine hydrochloride
Clinical trials
386 clinical trials →
Dosage form
Concentrate for solution for infusion
Route of administration
Intravenous use
ATC codes
L01BC, L01BC05
First authorised
16/01/2015
Prescription status
Product subject to prescription which may not be renewed (A)
Supply
Supply through pharmacies only
Legal basis
Hybrid application (Article 10(3) of Directive No 2001/83/EC)

Gemcitabine hydrochloride: supply and approvals

9 authorised products on the HPRA list contain Gemcitabine hydrochloride. Shortage records below are for the substance in the EU, US and German markets and may not affect this Irish product; for Irish supply, check with the HPRA or a pharmacist.

EU shortage (EMA)
No entry in the EMA shortage catalogue (checked 9 Oct 2026)
US shortage (FDA)
No entry in the FDA drug shortage list (checked 8 Oct 2026)
Germany (BfArM)
3 supply notices, e.g. Bendacitabin 38 mg/ml (4 Dec 2023 to 31 Jan 2027)

Registers: EU shortages · US shortages · German shortages · EMA approvals

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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.

How this page is built

The facts on this page are pulled directly from the HPRA's (Health Products Regulatory Authority) official open dataset — they are not written from memory, and nothing here is summarised or edited. Each field below names the dataset it came from, so you can check it yourself.

This page is built automatically: a daily sync job downloads HPRA's published XML export and copies the licence number, holder, active substance(s), dosage form, route, ATC code(s), authorisation date and prescription status directly into this page — no AI drafting and no per-product editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The HPRA data on this page was last retrieved on 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.