Germany· DE-A57-0d36a1dc36788535

Sativex

A medicinal product containing dronabinol, cannabidiol, registered in Germany by Cnx Therapeutics Ireland Limited.

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedSativexATC—REGISTER NO.DE-A57-0d36a1dc367885…PACKS LISTED0CHECKEDSeptember 30, 2026

The record

At a glance

EMA Article 57 (European Union)
Active substance
Dronabinol, Cannabidiol
Manufacturer
Cnx Therapeutics Ireland Limited
Country
Germany (DE)
ATC code
—
Reimbursed
Not published by this register
Source register
EMA Article 57 (European Union)
Last checked
September 30, 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

Dronabinol, cannabidiol in 8 other countries

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

All dronabinol, cannabidiol products

Authorised across Europe · EMA

The same active substance is authorised in 14 EEA countries. Names it is sold under:

  • Austria · Sativex
  • Belgium · Sativex
  • Czechia · Sativex
  • Denmark · Sativex
  • Spain · Sativex
  • Finland · Sativex
  • France · Sativex
  • United Kingdom (Northern Ireland) · Sativex
  • Greece · Avidekel/ Tikun, Capjera
  • Iceland · Sativex
  • Luxembourg · Sativex
  • Netherlands · Sativex
  • Norway · Sativex
  • Slovakia · Sativex

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 EMA Article 57 (European Union). 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/d77a0f4b-ecd6-4342-83c5-21f04b6c4b7c
GET /v1/drugs/d77a0f4b-ecd6-4342-83c5-21f04b6c4b7c?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.

{
  "pzn": null,
  "route": "Oromucosal Use",
  "source": "ema_art57_de",
  "ma_number": null,
  "substance": "Dronabinol, Cannabidiol",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}

See everything about dronabinol, cannabidiol.

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.