Ireland· IE-PA-EU/1/99/124/001
Tractocile 6.75 mg/0.9 ml Solution for injection
A atosiban product containing atosiban acetate, registered in Ireland by Ferring AB. The same ATC class is registered in 14 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Atosiban is registered in 14 of 19 countries.
Countries holding a registration under ATC G02CX01 (atosiban), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 8 of them publish a price we can compare per daily dose
Atosiban · ATC G02CX01
14 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
The record
At a glance
HPRA (Ireland)- Active substance
- Atosiban acetate
- Manufacturer
- Ferring AB
- Country
- Ireland (IE)
- ATC code
- G02CX01
- ATC class
- Atosiban
- Defined daily dose
- 165 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/99/124/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Atosiban in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SpainATOSIBAN ACCORD 37,5 MG/5 ML CONCENTRADO PARA SOLUCION PARA PERFUSION EFGAccord Healthcare S.L.U.
- FinlandAtosiban Ever PharmaEVER Valinject GmbH
- United KingdomAtosiban 37.5mg/5ml concentrate for solution for infusion vialsSun Pharma UK Ltd
- FranceATOSIBAN ACCORD 37,5 mg/5 ml, solution à diluer pour perfusionACCORD HEALTHCARE FRANCE
- BelgiumAtosiban Altan 37.5 mg/5 mlAltan Pharma
- PolandAtosiban AccordAccord Healthcare Polska Sp. z o.o.
- SwedenAtosiban Accord 37,5 mg/5 ml Koncentrat till infusionsvätska, lösningAccord Healthcare B.V.
- NetherlandsAtosiban Accord 37,5 mg/5 ml concentraat voor oplossing voor infusieAccord Healthcare B.V.
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Atosiban Altan, Atosiban Ever Pharma
- Belgium · Atosiban Ever Pharma
- Bulgaria · Атозибан Ever Pharma
- Czechia · Atosiban Avmc, Atosiban Ever Pharma
- Germany · Atosiban Ever Pharma, Atosiban Ibisqus
- Denmark · Atosiban Ever Pharma
- Spain · Atosiban Altan Pharmaceuticals, S.A., Atosiban Ever Pharma
- Finland · Atosiban Ever Pharma
- France · Atosiban Altan, Atosiban Altan Pharmaceuticals, S.A.
- United Kingdom (Northern Ireland) · Atosiban Ibigen
- Greece · Atosiban Ever Pharma
- Croatia · Atosiban Ever Pharma, Atosiban Makpharm
- Iceland · Atosiban Sun, Tractocile
- Italy · Atosiban Ever Pharma, Atosiban Ibisqus
- Liechtenstein · Tractocile
- Luxembourg · Atosiban Ever Pharma
- Latvia · Atosiban Pharmidea
- Netherlands · Atosiban Accord, Atosiban Ever Pharma
- Norway · Atosiban Ever Pharma, Atosiban Sun
- Poland · Atosiban Ever Pharma
- Portugal · Atosiban Ever Pharma, Atosibano Altan
- Sweden · Atosiban Accord, Atosiban Ever Pharma
- Slovenia · Atoziban Ever Pharma
- Slovakia · Atosiban Ardez
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/fe729eb5-389b-48ca-9581-5bb016763cbb GET /v1/drugs/fe729eb5-389b-48ca-9581-5bb016763cbb?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": "Solution for injection",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"G02CX",
"G02CX01"
],
"strength": null,
"pa_number": "EU/1/99/124/001",
"substances": [
"Atosiban acetate"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "20/01/2000",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about atosiban.
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.