Ireland· IE-PA-PA0592/008/001
Megalotect 100 U/mL solution for infusion
A cytomegalovirus immunoglobulin product containing human cytomegalovirus immunoglobulin, registered in Ireland by Biotest Pharma GmbH. The same ATC class is registered in 9 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Cytomegalovirus immunoglobulin is registered in 9 of 19 countries.
Countries holding a registration under ATC J06BB09 (cytomegalovirus immunoglobulin), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 5 of them publish a price we can compare per daily dose
Cytomegalovirus immunoglobulin · ATC J06BB09
9 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Finlandprice
- Ireland
- Netherlands
- Polandprice
- Switzerlandprice
- United Kingdom
The record
At a glance
HPRA (Ireland)- Active substance
- Human Cytomegalovirus Immunoglobulin
- Manufacturer
- Biotest Pharma GmbH
- Country
- Ireland (IE)
- ATC code
- J06BB09
- ATC class
- Cytomegalovirus immunoglobulin
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberPA0592/008/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Cytomegalovirus immunoglobulin in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumIvegam-CMV 100 mg/mlCentrale Afdeling Voor Fractionering - Departement Central De Fractionnement
- United KingdomCytomegalovirus immunoglobulin human 3g powder for solution for infusion vialsScottish National Blood Transfusion Service
- GermanyCytotect CpBiotest Pharma Gmbh
- NetherlandsMegalotect 100 E/ml oplossing voor infusieBiotest Pharma GmbH
- PolandMegalotect CPBiotest Pharma GmbH
- SpainMEGALOTECT 100 U/ML SOLUCION PARA PERFUSIONBiotest Pharma Gmbh
- CanadaCYTOGAMKI BIOPHARMA LLC
Authorised across Europe · EMA
The same active substance is authorised in 17 EEA countries. Names it is sold under:
- Austria · Cytotect Cp
- Belgium · Megalotect
- Czechia · Cymvigo
- Germany · Cytotect Cp
- Spain · Megalotect
- United Kingdom (Northern Ireland) · Cytotect Cp
- Greece · Megalotect Cp
- Croatia · Cytotect Cp
- Hungary · Cytotect Cp
- Italy · Cytomegatect
- Lithuania · Cymvigo
- Netherlands · Megalotect
- Poland · Megalotect Cp
- Portugal · Megalotect Cp
- Romania · Cytotect Cp
- Slovenia · Megalotect
- Slovakia · Cytotect
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/b9598e9e-54e8-4a69-a184-1c62d9adc690 GET /v1/drugs/b9598e9e-54e8-4a69-a184-1c62d9adc690?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 infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"J06BB09"
],
"strength": null,
"pa_number": "PA0592/008/001",
"substances": [
"Human Cytomegalovirus Immunoglobulin"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Marketed",
"authorised_at": "14/10/2022",
"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 cytomegalovirus immunoglobulin.
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.