Ireland· IE-PA-EU/1/10/621/7-12
Ristaben 50 mg film-coated tablets
A blood glucose lowering drugs, excl. insulins product containing sitagliptin as monohydrate phosphate salt, registered in Ireland by Merck Sharp & Dohme BV,.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
The record
At a glance
HPRA (Ireland)- Active substance
- Sitagliptin as monohydrate phosphate salt
- Manufacturer
- Merck Sharp & Dohme BV,
- Country
- Ireland (IE)
- ATC code
- A10B
- ATC class
- BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/10/621/7-12
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Sitagliptin as monohydrate phosphate salt in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaANSIFORAVipharm S.A., Ożarów Mazowiecki
- SpainALTUXERIN 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFGBexal Farmaceutica S.A.
- NetherlandsAdimuplan 50 mg, filmomhulde tablettenSandoz B.V.
- PolandAdimuplanSandoz GmbH
- SwedenAxavel 50 mg Filmdragerad tablettGenepharm S.A.
- FinlandFineriaMedical Pharmaquality SA
- BelgiumJanumet 50 mg - 1000 mgMerck Sharp & Dohme
- ItalyADAGLIPADAMED S.R.L.
Authorised across Europe · EMA
The same active substance is authorised in 30 EEA countries. Names it is sold under:
- Austria · Jansitin, Jazeta
- Belgium · Sitagliptin Eg, Sitagliptin Grindeks
- Bulgaria · Sitagliptin Grindeks, Майсиглу
- Cyprus · Jidinum, Jimandin
- Czechia · Anau, Ansifora
- Germany · Frekidir, Jansitin
- Denmark · Frekidir, Meliglix
- Estonia · Adimuplan, Maysiglu
- Spain · Altuxerin, Disit
- Finland · Sitagliptin Apc Instytut, Sitagliptin Ashcure
- France · Sitagliptine Adamed, Sitagliptine Almus
- United Kingdom (Northern Ireland) · Sitagliptin, Sitagliptin Amarox
- Greece · Adimuplan, Axavel
- Croatia · Adimuplan, Condias
- Hungary · Ansifora, Jaglix
- Iceland · Januvia, Ristaben
- Italy · Adaglip, Andamane
- Liechtenstein · Januvia, Ristaben
- Lithuania · Adimuplan, Jimandin
- Luxembourg · Sitagliptin Eg
- Latvia · Adimuplan, Jimandin
- Malta · Anau, Jidinum
- Netherlands · Adimuplan, Anau
- Norway · Frekidir, Januvia
- Poland · Ansifora, Jansitin
- Portugal · Itam, Jidinum
- Romania · Adimuplan, Jansitin
- Sweden · Axavel, Frekidir
- Slovenia · Adimuplan, Maysiglu
- Slovakia · Adimuplan, Anau
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of HPRA (Ireland). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/b5dd67e9-f6d0-42c0-b060-fd5a7ea8b992 GET /v1/drugs/b5dd67e9-f6d0-42c0-b060-fd5a7ea8b992?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"form": "Film-coated tablet",
"routes": [
"Oral use"
],
"source": "hpra",
"atc_all": [
"A10B"
],
"strength": null,
"pa_number": "EU/1/10/621/7-12",
"substances": [
"Sitagliptin as monohydrate phosphate salt"
],
"legal_basis": "Informed consent application (Article 10c of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "15/03/2010",
"dispensing_status": "Product subject to prescription which may be renewed (B)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": "IC0131-023-003"
}See everything about sitagliptin as monohydrate phosphate salt.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.