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Ireland· IE-PA-PPA0465/463/001

Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution

A tiotropium bromid, kombinationen product containing tiotropium + olodaterol, registered in Ireland by PCO Manufacturing Ltd..

ATC R03BB54

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedSpiolto Respimat 2.5 microgram/2.5 mi…ATCR03BB54REGISTER NO.IE-PA-PPA0465/463/001PACKS LISTED1CHECKEDSeptember 28, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about tiotropium + olodaterolAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

HPRA (Ireland)
Active substance
Tiotropium + Olodaterol
Manufacturer
PCO Manufacturing Ltd.
Country
Ireland (IE)
ATC code
R03BB54
ATC class
Tiotropium bromid, Kombinationen
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PPA0465/463/001

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Tiotropium bromid, kombinationen in 14 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All tiotropium bromid, kombinationen products

Authorised across Europe · EMA

The same active substance is authorised in 30 EEA countries. Names it is sold under:

  • Austria · Spiolto Respimat, Yanimo Respimat
  • Belgium · Spiolto Respimat, Yanimo Respimat
  • Bulgaria · Спиолто Респимат, Янимо Респимат
  • Cyprus · Spiolto Respimat, Yanimo Respimat
  • Czechia · Spiolto Respimat
  • Germany · Spiolto Respimat, Yanimo Respimat
  • Denmark · Spiolto Respimat
  • Estonia · Spiolto Respimat
  • Spain · Spiolto Respimat, Yanimo Respimat
  • Finland · Inspiolto Respimat, Yanimo Respimat
  • France · Spiolto Respimat
  • United Kingdom (Northern Ireland) · Spiolto Respimat
  • Greece · Spiolto Respimat, Yanimo Respimat
  • Croatia · Spiolto Respimat
  • Hungary · Spiolto Respimat
  • Iceland · Spiolto Respimat
  • Italy · Spiolto Respimat
  • Liechtenstein · Spiolto Respimat, Yanimo Respimat
  • Lithuania · Spiolto Respimat
  • Luxembourg · Spiolto Respimat, Yanimo Respimat
  • Latvia · Spiolto Respimat
  • Malta · Spiolto Respimat
  • Netherlands · Spiolto Respimat, Yanimo Respimat
  • Norway · Spiolto Respimat
  • Poland · Spiolto Respimat, Yanimo Respimat
  • Portugal · Spiolto Respimat, Yanimo Respimat
  • Romania · Spiolto Respimat
  • Sweden · Spiolto Respimat, Yanimo Respimat
  • Slovenia · Spiolto Respimat
  • Slovakia · Spiolto Respimat

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/5411fa82-fe04-4cfe-a9db-4254629baade
GET /v1/drugs/5411fa82-fe04-4cfe-a9db-4254629baade?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": "Inhalation solution",
  "routes": [
    "Inhalation use"
  ],
  "source": "hpra",
  "atc_all": [
    "R03BB",
    "R03BB54"
  ],
  "strength": null,
  "pa_number": "PPA0465/463/001",
  "substances": [
    "Tiotropium",
    "Olodaterol"
  ],
  "legal_basis": "Parallel importation notified in accordance with Article 76(3) of Directive 2001/83/EC",
  "market_info": "Unknown",
  "authorised_at": "05/03/2021",
  "dispensing_status": "Product subject to prescription which may be renewed (B)",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}
API referenceMCP serverPlans

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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.

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