Ireland· IE-PA-EU/1/07/400/13
Mircera 250 micrograms/0.3 ml solution for injection in pre-filled syringe
A methoxy polyethylene glycol-epoetin beta product containing methoxy peg-epoetin beta, registered in Ireland by Roche Registration GmbH. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Methoxy polyethylene glycol-epoetin beta is registered in 12 of 19 countries.
Countries holding a registration under ATC B03XA03 (methoxy polyethylene glycol-epoetin beta), 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
Methoxy polyethylene glycol-epoetin beta · ATC B03XA03
12 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of methoxy polyethylene glycol-epoetin beta costs, country by country.
Normalised to the WHO defined daily dose (4 mcg), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Methoxy polyethylene glycol-epoetin beta · price per daily dose (4 mcg)
USD · FX 28 Sept 2026
- CH Switzerland$10.18
The record
At a glance
HPRA (Ireland)- Active substance
- Methoxy peg-epoetin beta
- Manufacturer
- Roche Registration GmbH
- Country
- Ireland (IE)
- ATC code
- B03XA03
- ATC class
- Methoxy polyethylene glycol-epoetin beta
- Defined daily dose
- 4 mcg, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/07/400/13
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Methoxy polyethylene glycol-epoetin beta in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesMirceraVifor (International) Inc.
- FinlandMirceraAbacus Medicine A/S
- IcelandMirceraRoche Registration GmbH*
- NetherlandsMircera 100 µg / 0,3 ml, oplossing voor injectie (in voorgevulde spuit)Roche Registration GmbH
- SwedenMIRCERA 100 mikrogram/0,3 ml Injektionsvätska, lösning i förfylld sprutaRoche Registration GmbH
- FranceMIRCERA 100 microgrammes/0,3 ml, solution injectable en seringue préremplieROCHE REGISTRATION (ALLEMAGNE)
- United KingdomMircera 100micrograms/0.3ml solution for injection pre-filled syringesRoche Products Ltd
- SwitzerlandMircera 100 ug / 0.3 ml, Injektionslösung in einer FertigspritzeRoche Pharma (Schweiz) AG
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Mircera
- Liechtenstein · Mircera
- Norway · Mircera
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/69fc591e-c888-476e-ba67-195c59ee5c11 GET /v1/drugs/69fc591e-c888-476e-ba67-195c59ee5c11?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": [
"Intravenous use",
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"B03XA03"
],
"strength": null,
"pa_number": "EU/1/07/400/13",
"substances": [
"Methoxy peg-epoetin beta"
],
"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 methoxy polyethylene glycol-epoetin beta.
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.