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France· FR:64639797

DELTYBA 50 mg, comprimé pelliculé

A delamanid product containing délamanid, registered in France by OTSUKA NOVEL PRODUCTS (ALLEMAGNE). The same ATC class is registered in 12 of our 19 countries.

ATC J04AK06

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…normalisedDELTYBA 50 mg, comprimé pelliculéATCJ04AK06REGISTER NO.FR:64639797PACKS LISTED1CHECKEDSeptember 12, 2026

Where it is registered

Delamanid is registered in 12 of 19 countries.

Countries holding a registration under ATC J04AK06 (delamanid), each read from that country’s own register.

  • This record: France, from Base de données publique des médicaments — BDPM (France)
  • 7 of them publish a price we can compare per daily dose

Delamanid · ATC J04AK06

12 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Icelandprice
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • United Kingdom
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

Base de données publique des médicaments — BDPM (France)
Active substance
DÉLAMANID
Manufacturer
OTSUKA NOVEL PRODUCTS (ALLEMAGNE)
Country
France (FR)
ATC code
J04AK06
ATC class
Delamanid
Defined daily dose
0.2 g, O
Reimbursed
No
Source register
Base de données publique des médicaments — BDPM (France)
Last checked
September 12, 2026

Packs & prices · 1

  • cip13
    3400930010570
    plaquette(s) aluminium de 48 comprimé(s)

Regulatory notes

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

Same medicine, other countries

Delamanid in 11 other countries

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

All delamanid products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Deltyba
  • Liechtenstein · Deltyba
  • Norway · Deltyba

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/3ff72f14-26bf-43de-99de-e43ce7c552bb
GET /v1/drugs/3ff72f14-26bf-43de-99de-e43ce7c552bb?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": "64639797",
  "date_amm": "2014-04-28",
  "type_amm": "Procédure centralisée",
  "numero_ue": "EU/1/13/875",
  "substance": "DÉLAMANID",
  "atc_source": "fr_atc_restore_2026-09-06",
  "statut_amm": "Autorisation active",
  "statut_bdm": null,
  "forme_pharmaceutique": "comprimé pelliculé",
  "voies_administration": "orale",
  "etat_commercialisation": "Commercialisée",
  "surveillance_renforcee": "Non"
}

See everything about delamanid.

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.