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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,.

ATC A10B

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedRistaben 50 mg film-coated tabletsATCA10BREGISTER NO.IE-PA-EU/1/10/621/7-12PACKS LISTED1CHECKEDSeptember 28, 2026

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_number
    EU/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.

All sitagliptin as monohydrate phosphate salt products

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.