Ireland· IE-PA-EU/1/05/330/5-11
Rotarix oral suspension in pre-filled oral applicator
A rotavirus, lebend abgeschwächt product containing human rotavirus, live attenuated, registered in Ireland by GlaxoSmithKline Biologicals S.A.. The same ATC class is registered in 11 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Rotavirus, lebend abgeschwächt is registered in 11 of 19 countries.
Countries holding a registration under ATC J07BH01 (rotavirus, lebend abgeschwächt), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Rotavirus, lebend abgeschwächt · ATC J07BH01
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Human rotavirus, live attenuated
- Manufacturer
- GlaxoSmithKline Biologicals S.A.
- Country
- Ireland (IE)
- ATC code
- J07BH01
- ATC class
- Rotavirus, lebend abgeschwächt
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/05/330/5-11
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under J07BH01
Rotavirus, lebend abgeschwächt, as other registers publish it.
- NorwayRotarixGlaxoSmithKline Biologicals Services S.A
- FinlandRotarixGlaxoSmithKline Biologicals SA
- DenmarkRotarixGlaxoSmithKline Biologicals S.A.
- BelgiumRotarixGlaxoSmithKline Biologicals
- FinlandRotarixGlaxoSmithKline Biologicals SA
- PolandRotarixGlaxoSmithKline Biologicals S.A.
- PolandRotarixGlaxoSmithKline Biologicals S.A.
- DenmarkRotarixGlaxoSmithKline Biologicals
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/c4e3dbbb-395e-47fa-a026-70051b85cb4f GET /v1/drugs/c4e3dbbb-395e-47fa-a026-70051b85cb4f?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 oral suspension",
"routes": null,
"source": "hpra",
"atc_all": [
"J07BH",
"J07BH01"
],
"strength": null,
"pa_number": "EU/1/05/330/5-11",
"substances": [
"Human rotavirus, live attenuated"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": null,
"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 rotavirus, lebend abgeschwächt.
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.