Drug Database
Back to search

Belgium· BE-AMP-SAM460915-00

Deltyba 50 mg

A delamanid product containing delamanid, registered in Belgium by Otsuka Novel Products. The same ATC class is registered in 12 of our 19 countries.

ATC J04AK06

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedDeltyba 50 mgATCJ04AK06REGISTER NO.BE-AMP-SAM460915-00PACKS LISTED0CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about delamanidAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Belgium, from FAMHP / AFMPS (Belgium)
  • 7 of them publish a price we can compare per daily dose
Search delamanid products by name

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

FAMHP / AFMPS (Belgium)
Active substance
Delamanid
Manufacturer
Otsuka Novel Products
Country
Belgium (BE)
ATC code
J04AK06
ATC class
Delamanid
Defined daily dose
0.2 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 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

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 FAMHP / AFMPS (Belgium). 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/f7d4f86e-b65f-42ce-bb2e-26f13c2b3664
GET /v1/drugs/f7d4f86e-b65f-42ce-bb2e-26f13c2b3664?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": "Film-coated tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Deltyba 50 mg",
  "name_fr": "Deltyba 50 mg",
  "name_nl": "Deltyba 50 mg",
  "amp_code": "SAM460915-00",
  "strengths": [
    "50.0000",
    "100.0000"
  ],
  "pack_count": 4,
  "substances": [
    "Delamanid",
    "Lactose",
    "Sodium Starch Glycolate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Delamanid",
  "authorisation_numbers": [
    "EU/1/13/875/003",
    "EU/1/13/875/004"
  ]
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console