Ireland· IE-PA-PA0074/016/001

Rowatanal Cream

A zinkzubereitungen product containing bismuth subgallate + zinc oxide + menthol, registered in Ireland by Rowa Pharmaceuticals Limited.

ATC C05AX04

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedRowatanal CreamATCC05AX04REGISTER NO.IE-PA-PA0074/016/001PACKS LISTED1CHECKEDSeptember 28, 2026

The record

At a glance

HPRA (Ireland)
Active substance
Bismuth subgallate + Zinc oxide + Menthol
Manufacturer
Rowa Pharmaceuticals Limited
Country
Ireland (IE)
ATC code
C05AX04
ATC class
Zinkzubereitungen
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    PA0074/016/001

Regulatory notes

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

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/b3e2fde7-43b8-455f-bd6c-43457b3a91d0
GET /v1/drugs/b3e2fde7-43b8-455f-bd6c-43457b3a91d0?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": "Cream",
  "routes": [
    "Rectal use"
  ],
  "source": "hpra",
  "atc_all": [
    "C05AX",
    "C05AX04"
  ],
  "strength": null,
  "pa_number": "PA0074/016/001",
  "substances": [
    "Bismuth subgallate",
    "Zinc oxide",
    "Menthol"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Marketed",
  "authorised_at": "09/05/1996",
  "dispensing_status": "Product not subject to medical prescription",
  "registration_status": "AU",
  "supply_legal_status": "Supply through pharmacies only",
  "interchangeable_code": null
}

See everything about zinkzubereitungen.

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.