Ireland· IE-PA-EU/1/12/787/003
Revestive 1.25 mg powder and solvent for solution for injection
A teduglutide product containing teduglutide, registered in Ireland by Takeda Pharmaceuticals International AG Ireland Branch. The same ATC class is registered in 15 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Teduglutide is registered in 15 of 19 countries.
Countries holding a registration under ATC A16AX08 (teduglutide), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 9 of them publish a price we can compare per daily dose
Teduglutide · ATC A16AX08
15 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
- United Statesprice
The record
At a glance
HPRA (Ireland)- Active substance
- Teduglutide
- Manufacturer
- Takeda Pharmaceuticals International AG Ireland Branch
- Country
- Ireland (IE)
- ATC code
- A16AX08
- ATC class
- Teduglutide
- Defined daily dose
- 5 mg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/12/787/003
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Interactions
18 interactions on record for teduglutide.
Graded by severity as the source publishes them — 2 severe. Severity grades are free for everyone; mechanism and management come with Growth.
- Severity for every pair — free, no plan needed
- The source, licence and sync date on every record
- Mechanism and what to do for each pair — Growth plan
Teduglutide · interactions on record
18 records
- 2 severe
- 16 moderate
Most severe, free to view
- BexaroteneL01XF03severe
- BexarotenL01XX25severe
- ClonazepamN03AE01moderate
- MidazolamN03AE02moderate
- Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Same medicine, other countries
Teduglutide in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceREVESTIVE 1,25 mg, poudre et solvant pour solution injectableTAKEDA PHARMACEUTICALS INTERNATIONAL (IRLANDE)
- NetherlandsRevestive 1.25 mg, poeder en oplossing voor injectieTakeda Pharmaceuticals International AG Ireland Branch
- SwedenNilleto 5 mg Pulver och vätska till injektionsvätska, lösningFresenius Kabi AB
- FinlandRevestiveTakeda Pharmaceuticals International AG Ireland Branch
- CzechiaREVESTIVETakeda Pharmaceuticals International AG Ireland Branch, Dublin
- SpainREVESTIVE 5 MG POLVO Y DISOLVENTE PARA SOLUCION INYECTABLETakeda Pharmaceuticals International Ag Ireland Branch
- BelgiumRevestive 1.25 mgTakeda Pharmaceuticals International Ireland Branch
- PolandRevestiveTakeda Pharmaceuticals International AG Ireland Branch
Authorised across Europe · EMA
The same active substance is authorised in 7 EEA countries. Names it is sold under:
- Austria · Tidonalle
- Spain · Teduglutida Cipla
- France · Téduglutide, Teduglutide Adalvo
- Iceland · Revestive, Teduglutide Viatris
- Liechtenstein · Revestive, Teduglutide Viatris
- Norway · Niletto, Revestive
- Sweden · Nilleto, Teduglutid Cipla
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/00d3cadb-3ca0-4a7c-8780-e88e05829937 GET /v1/drugs/00d3cadb-3ca0-4a7c-8780-e88e05829937?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": "Powder and solvent for solution for injection",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"A16AX",
"A16AX08"
],
"strength": null,
"pa_number": "EU/1/12/787/003",
"substances": [
"Teduglutide"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "23/06/2017",
"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 teduglutide.
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.