Iceland· IS-IS/1/15/116/01
BCG-medac
A bcg-impfstoff product containing bcg (bacillus calmette-guérin) bacteria, registered in Iceland by medac Gesellschaft für klinische Spezialpräparate GmbH. The same ATC class is registered in 11 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Bcg-impfstoff is registered in 11 of 19 countries.
Countries holding a registration under ATC L03AX03 (bcg-impfstoff), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 7 of them publish a price we can compare per daily dose
Bcg-impfstoff · ATC L03AX03
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- BCG (BACILLUS CALMETTE-GUÉRIN) BACTERIA
- Manufacturer
- medac Gesellschaft für klinische Spezialpräparate GmbH
- Country
- Iceland (IS)
- ATC code
- L03AX03
- ATC class
- BCG-Impfstoff
- Defined daily dose
- 0.033 Darreichungsform, intravesikal
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 2026
Packs & prices · 1
1 priced- ean5244113 hgl x1 pakkiISK 117044
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Bcg-impfstoff in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsBCG vaccin AJV, 0,75 mg per ml, poeder en oplosmiddel voor suspensie voor injectieAJ Vaccines A/S
- SpainONCOTICE 2-8 X 10(8) UFC POLVO PARA SUSPENSION INTRAVESICALMerck Sharp & Dohme De Espana S.A.
- SwitzerlandBCG-medac
- United KingdomBCG-medac 1,600million units powder and solvent for suspension for instillation vials with conical adapter and catheterImported (Germany)
- FinlandBcg VaccineChiron Vaccines Limited
- PolandBCG Szczepionka AJVaccinesAJ Vaccines A/S
- SwedenOncoTICE 12,5 mg Pulver till lösning för intravesikal användningMerck Sharp & Dohme BV
- GermanySanukehlklebs D6 Sanum-KehlbeckSanum-Kehlbeck Gmbh & Co.Kg
Authorised across Europe · EMA
The same active substance is authorised in 4 EEA countries. Names it is sold under:
- Austria · Bcg
- Bulgaria · Бцж Ваксина, Калгевакс
- Netherlands · Bm Onco Bcg
- Slovenia · Bcg
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 Icelandic Medicines Agency (Iceland). 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/98314486-34f2-4d85-86ed-329681c6a028 GET /v1/drugs/98314486-34f2-4d85-86ed-329681c6a028?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": "Duft og leysir fyrir þvagblöðrudreifu",
"source": "lyfjastofnun",
"atc_raw": "L03AX03",
"marketed": true,
"strength": null,
"ma_number": "IS/1/15/116/01",
"substance": "BCG (BACILLUS CALMETTE-GUÉRIN) BACTERIA",
"other_info": "Markaðssetning á Íslandi er háð því að Lyfjastofnun hafi staðfest að sérstök skilyrði er varða öryggi og verkun við notkun lyfsins séu uppfyllt.",
"legal_status": "(R) Lyfseðilsskylt\r\n(H) Sjúkrahúsmerkt",
"ma_issued_serial": "42277"
}See everything about bcg-impfstoff.
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.