Netherlands· NL-c61a178d3884
Deltyba 50 mg filmomhulde tabletten
A delamanid product containing delamanid, registered in Netherlands by Otsuka Novel Products GmbH. The same ATC class is registered in 12 of our 19 countries.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
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: Netherlands, from CBG-MEB (Netherlands)
- 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
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- DELAMANID
- Manufacturer
- Otsuka Novel Products GmbH
- Country
- Netherlands (NL)
- ATC code
- J04AK06
- ATC class
- Delamanid
- Defined daily dose
- 0.2 g, O
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/13/875
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.
- BelgiumDeltyba 50 mgOtsuka Novel Products
- CzechiaDELTYBAOtsuka Novel Product GmbH, München
- SpainDELTYBA 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULAOtsuka Novel Products Gmbh
- FinlandDeltybaOtsuka Novel Products GmbH
- FranceDELTYBA 50 mg, comprimé pelliculéOTSUKA NOVEL PRODUCTS (ALLEMAGNE)
- IcelandDeltybaOtsuka Novel Products GmbH
- NorwayDeltybaOtsuka
- PolandDeltybaOtsuka Novel Products GmbH
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 CBG-MEB (Netherlands). 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/820f8b67-84eb-4edb-a9f3-859c9fae8338 GET /v1/drugs/820f8b67-84eb-4edb-a9f3-859c9fae8338?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": "Filmomhulde tablet",
"route": "Oraal gebruik",
"soort": null,
"source": "cbg_meb",
"smpc_url": "https://www.ema.europa.eu/en/documents/product-information/deltyba-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Delamanid",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp111288",
"excipients": [
"CARMELLOSE CALCIUM (E 466)",
"CELLULOSE, MICROKRISTALLIJN (E 460(i))",
"HYPROMELLOSE 2910 (3 - 15 mPa.s) (E 464)",
"HYPROMELLOSEFTALAAT",
"IJZEROXIDE GEEL (E 172)",
"LACTOSE 1-WATER",
"MACROGOL 8000",
"MAGNESIUMSTEARAAT (E 470b)",
"NATRIUMZETMEELGLYCOLAAT",
"POVIDON (E 1201)",
"SILICIUMDIOXIDE, GEHYDRATEERD (E 551)",
"TALK (E 553b)",
"TITAANDIOXIDE (E 171)",
"TOCOFEROL, DL-ALFA (E 307)"
],
"substances": [
"DELAMANID"
],
"leaflet_url": null,
"authorised_at": "2014/04/28",
"procedure_number": "EMEA/H/C/002552",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/13/875",
"additional_monitoring": "N"
}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.