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Ireland· IE-PA-EU/1/18/1352/002

Besremi 500 microgram/0.5 ml Solution for injection in pre-filled pen

A ropeginterferon alfa-2b product containing ropeginterferon alfa-2b, registered in Ireland by Aop Orphan Pharmaceuticals GmbH. The same ATC class is registered in 12 of our 19 countries.

ATC L03AB15

Checked against HPRA (Ireland) on

Informational only — not a medical device.

SOURCE REGISTER · IEHPRA (Ireland)normalisedBesremi 500 microgram/0.5 ml Solution…ATCL03AB15REGISTER NO.IE-PA-EU/1/18/1352/002PACKS LISTED1CHECKEDSeptember 28, 2026

Where it is registered

Ropeginterferon alfa-2b is registered in 12 of 19 countries.

Countries holding a registration under ATC L03AB15 (ropeginterferon alfa-2b), 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

Ropeginterferon alfa-2b · ATC L03AB15

12 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

HPRA (Ireland)
Active substance
Ropeginterferon alfa-2b
Manufacturer
Aop Orphan Pharmaceuticals GmbH
Country
Ireland (IE)
ATC code
L03AB15
ATC class
Ropeginterferon alfa-2b
Defined daily dose
18 mcg, P
Reimbursed
Not published by this register
Source register
HPRA (Ireland)
Last checked
September 28, 2026

Packs & prices · 1

  • ie_pa_number
    EU/1/18/1352/002

Regulatory notes

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

Same medicine, other countries

Ropeginterferon alfa-2b in 12 other countries

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

All ropeginterferon alfa-2b products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Besremi
  • Liechtenstein · Besremi
  • Norway · Besremi

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/b094f5ee-6903-4064-ab3a-730187676d9b
GET /v1/drugs/b094f5ee-6903-4064-ab3a-730187676d9b?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 in pre-filled syringe",
  "routes": [
    "Subcutaneous use"
  ],
  "source": "hpra",
  "atc_all": [
    "L03AB15"
  ],
  "strength": null,
  "pa_number": "EU/1/18/1352/002",
  "substances": [
    "Ropeginterferon alfa-2b"
  ],
  "legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
  "market_info": "Unknown",
  "authorised_at": "15/02/2019",
  "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 ropeginterferon alfa-2b.

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.