Spain· ES:61377
ONCOTICE 2-8 X 10(8) UFC POLVO PARA SUSPENSION INTRAVESICAL
A medicinal product containing bcg cultivo vivo desecado preparado irrigación vesical, registered in Spain by Merck Sharp & Dohme De Espana S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- BCG cultivo vivo desecado preparado irrigación vesical
- Manufacturer
- Merck Sharp & Dohme De Espana S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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
Bcg cultivo vivo desecado preparado irrigación vesical 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
- 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)
- CanadaVERITY-BCGVERITY PHARMACEUTICALS INC.
- 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 AEMPS CIMA (Spain). 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/f9e46a8a-7d1f-4b9a-a672-80f37baa007e GET /v1/drugs/f9e46a8a-7d1f-4b9a-a672-80f37baa007e?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":865116000000}",
"nregistro": "61377",
"substance": "BCG cultivo vivo desecado preparado irrigación vesical"
}See everything about bcg cultivo vivo desecado preparado irrigación vesical.
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.