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Netherlands· NL-a53d869b5d02

Ongentys 25 mg harde capsules

A cytisinicline product containing opicapon, registered in Netherlands by BIAL - Portela & C, S.A.. The same ATC class is registered in 9 of our 19 countries.

ATC N07BA04

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedOngentys 25 mg harde capsulesATCN07BA04REGISTER NO.NL-a53d869b5d02PACKS LISTED1CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about opicaponAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Cytisinicline is registered in 9 of 19 countries.

Countries holding a registration under ATC N07BA04 (cytisinicline), each read from that country’s own register.

  • This record: Netherlands, from CBG-MEB (Netherlands)
  • 4 of them publish a price we can compare per daily dose
Search cytisinicline products by name

Cytisinicline · ATC N07BA04

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Germany
  • Ireland
  • Netherlands
  • 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

CBG-MEB (Netherlands)
Active substance
OPICAPON
Manufacturer
BIAL - Portela & C, S.A.
Country
Netherlands (NL)
ATC code
N07BA04
ATC class
Cytisinicline
Defined daily dose
6 mg, O
Reimbursed
Not published by this register
Source register
CBG-MEB (Netherlands)
Last checked
September 29, 2026

Packs & prices · 1

  • cbg_meb_id
    EU/1/15/1066

Regulatory notes

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

Same medicine, other countries

Cytisinicline in 14 other countries

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

All cytisinicline products

Authorised across Europe · EMA

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

  • Iceland · Ongentys
  • Liechtenstein · Ongentys
  • Norway · Ongentys

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/d8a246a3-6b43-46d5-8ef3-19f3009d8588
GET /v1/drugs/d8a246a3-6b43-46d5-8ef3-19f3009d8588?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": "Capsule, hard",
  "route": "Oraal gebruik",
  "soort": null,
  "source": "cbg_meb",
  "smpc_url": "https://www.ema.europa.eu/en/documents/product-information/ongentys-epar-product-information_nl.pdf",
  "strength": null,
  "atc_label": "Cytisinicline",
  "detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp116747",
  "excipients": [
    "AMMONIA (E 527)",
    "BLAUWE INKT",
    "ERYTHROSINE (E 127)",
    "GELATINE (E 441)",
    "INDIGOKARMIJN ALUMINIUMLAK (E 132)",
    "INDIGOKARMIJN ALUMINIUMLAK (E 132)",
    "LACTOSE 1-WATER",
    "MAGNESIUMSTEARAAT (E 470b)",
    "MAÏSZETMEEL, GEPREGELATINEERD",
    "NATRIUMZETMEELGLYCOLAAT",
    "PROPYLEENGLYCOL (E 1520)",
    "SCHELLAK (E 904)",
    "TITAANDIOXIDE (E 171)"
  ],
  "substances": [
    "OPICAPON"
  ],
  "leaflet_url": null,
  "authorised_at": "2016/06/24",
  "procedure_number": "EMEA/H/C/002790",
  "dispensing_status": "Uitsluitend recept",
  "registration_number": "EU/1/15/1066",
  "additional_monitoring": "Y"
}
API referenceMCP serverPlans

See everything about cytisinicline.

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.

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