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France· FR:63017696

MITOMYCINE SUBSTIPHARM 20 mg, poudre pour solution injectable/perfusion ou voie intravésicale

A medicinal product containing mitomycine c, registered in France by SUBSTIPHARM.

Checked against Base de données publique des médicaments — BDPM (France) on

Informational only — not a medical device.

SOURCE REGISTER · FRBase de données publique des médicament…normalisedMITOMYCINE SUBSTIPHARM 20 mg, poudre …ATC—REGISTER NO.FR:63017696PACKS LISTED1CHECKEDSeptember 12, 2026

The record

At a glance

Base de données publique des médicaments — BDPM (France)
Active substance
MITOMYCINE C
Manufacturer
SUBSTIPHARM
Country
France (FR)
ATC code
—
Reimbursed
No
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 1

  • cip13
    3400930186510
    1 flacon en verre jaune(brun) de 50 ml avec 1 filtre stérile à usage unique poly(fluorure de vinylidène) (PVDF)

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Mitomycine c in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All mitomycine c products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

  • Austria · Mitomycin Medac
  • Belgium · Mitomycin Accord Healthcare, Mitomycin Medac
  • Bulgaria · Митомицин Акорд
  • Cyprus · Mitomycin Accord, Mitomycine Substipharm
  • Czechia · Mitomycin Accord, Mitomycin Medac
  • Germany · Mitem, Mito-Apogepha
  • Denmark · Mitomycin Medac
  • Estonia · Mitomycin Accord, Mitomycin Medac
  • Spain · Mitomicina Accord, Mitomicina Aurovitas
  • Finland · Mitomycin Accord, Mitomycin Medac
  • United Kingdom (Northern Ireland) · Mitocin, Mitomycin Accord Healthcare
  • Ireland · Mitomycin Medac
  • Iceland · Mitomycin Medac
  • Italy · Mitomicina Accord, Mitomicina Medac
  • Lithuania · Mitomycin Medac
  • Latvia · Mitomycin Medac
  • Malta · Mitomycine Substipharm
  • Netherlands · Mitomycine Accord, Mitomycine Medac
  • Norway · Mitomycin Medac, Mitomycin Substipharm
  • Poland · Mitomycin Accord
  • Portugal · Mitomicina Accord, Mitomicina Accord Healthcare
  • Romania · Mitomicină Accord
  • Sweden · Mitomycin Medac, Mitomycin Substipharm
  • Slovenia · Mitomicin Accord, Mitomicin Medac
  • Slovakia · Mitomycin Accord, Mitomycin Medac

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 Base de données publique des médicaments — BDPM (France). 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/93c5819d-c2ae-41d5-93c4-8e8dee15fb90
GET /v1/drugs/93c5819d-c2ae-41d5-93c4-8e8dee15fb90?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.

{
  "cis": "63017696",
  "date_amm": "2019-08-01",
  "type_amm": "Procédure nationale",
  "numero_ue": null,
  "substance": "MITOMYCINE C",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "poudre pour solution injectable pour perfusion ou",
  "voies_administration": "intraartérielle;intraséreuse;intraveineuse;intravésicale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}

See everything about mitomycine c.

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.