Poland· PL-100323243
Deltyba
A delamanid product containing delamanidum, registered in Poland by Otsuka Novel Products GmbH. The same ATC class is registered in 12 of our 19 countries.
Checked against URPL (Poland) 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: Poland, from URPL (Poland)
- 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
URPL (Poland)- Active substance
- Delamanidum
- Manufacturer
- Otsuka Novel Products GmbH
- Country
- Poland (PL)
- ATC code
- J04AK06
- ATC class
- Delamanid
- Defined daily dose
- 0.2 g, O
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 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.
- 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
- NetherlandsDeltyba 50 mg filmomhulde tablettenOtsuka Novel Products GmbH
- NorwayDeltybaOtsuka
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 URPL (Poland). 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/335d8113-fe9d-442b-b513-cd96deda16fe GET /v1/drugs/335d8113-fe9d-442b-b513-cd96deda16fe?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": "Tabletki powlekane",
"source": "urpl",
"strength": "50 mg",
"packaging": "Rpz ¦ Skasowane ¦ EU/1/13/875/003 ¦ 103097\n300 tabl.\nRpz ¦ Skasowane ¦ EU/1/13/875/002 ¦ 103098\n50 tabl.\nRpz ¦ Skasowane ¦ EU/1/13/875/001 ¦ 103099\n40 tabl.\nRpz ¦ EU/1/13/876/004 ¦ 119667\n48 tabl.\nRpz ¦ Skasowane ¦ EU/1/13/875/005 ¦ 144633\n48 tabl.",
"substance": "Delamanidum 50 mg",
"common_name": "Delamanidum",
"pl_product_id": "100323243",
"pozwolenie_nr": null,
"auth_procedure": "CEN",
"authorisation_validity": null
}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.