Germany· DE-A57-8c737a39c094a5f7
Sanukehlklebs D6 Sanum-Kehlbeck
A medicinal product containing mycobacterium bovis (bcg) extractum cellulae (lyophil., steril.) d6, registered in Germany by Sanum-Kehlbeck Gmbh & Co.Kg.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Mycobacterium Bovis (Bcg) Extractum Cellulae (Lyophil., Steril.) D6
- Manufacturer
- Sanum-Kehlbeck Gmbh & Co.Kg
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mycobacterium bovis (bcg) extractum cellulae (lyophil., steril.) d6 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
- FinlandBcg VaccineChiron Vaccines Limited
- PolandBCG Szczepionka AJVaccinesAJ Vaccines A/S
- United KingdomBCG-medac 1,600million units powder and solvent for suspension for instillation vials with conical adapter and catheterImported (Germany)
- SwedenOncoTICE 12,5 mg Pulver till lösning för intravesikal användningMerck Sharp & Dohme BV
- FranceBCG MAJORELLE 100 mg, poudre et solvant pour suspension intravésicaleLABORATOIRES MAJORELLE
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 EMA Article 57 (European Union). 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/425768f5-e156-48b4-b880-730e2d17e2de GET /v1/drugs/425768f5-e156-48b4-b880-730e2d17e2de?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Mycobacterium Bovis (Bcg) Extractum Cellulae (Lyophil., Steril.) D6",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about mycobacterium bovis (bcg) extractum cellulae (lyophil., steril.) d6.
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.