Germany· DE-A57-439ac2d0eeda1029
Efysmo
A medicinal product containing dronabinol, soft extract from cannabis flower (cannabis sativa l. dkj127 flos) corresponding to 19 mg delta-9-tetrahydrocannabinol (thc). extraction solvent: ethanol 96 (v/v), registered in Germany by Vertanical Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Dronabinol, Soft Extract From Cannabis Flower (Cannabis Sativa L. Dkj127 Flos) Corresponding To 19 Mg Delta-9-Tetrahydrocannabinol (Thc). Extraction Solvent: Ethanol 96 (V/V)
- Manufacturer
- Vertanical Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- August 5, 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, soft extract from cannabis flower (cannabis sativa l. dkj127 flos) corresponding to 19 mg delta-9-tetrahydrocannabinol (thc). extraction solvent: ethanol 96 (v/v) in 3 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesDronabinolAscend Laboratories, LLC
- NorwayDronabinol glostrupGlostrup Apotek
- United KingdomDronabinol 2.5mg capsulesImported (United States)
Authorised across Europe · EMA
The same active substance is authorised in 1 EEA country. Names it is sold under:
- Austria · Efysmo, Exilby
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/2f2ae84b-8d0e-47c9-874d-19d29463f938 GET /v1/drugs/2f2ae84b-8d0e-47c9-874d-19d29463f938?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": "Oral",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Dronabinol, Soft Extract From Cannabis Flower (Cannabis Sativa L. Dkj127 Flos) Corresponding To 19 Mg Delta-9-Tetrahydrocannabinol (Thc). Extraction Solvent: Ethanol 96 (V/V)",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dronabinol, soft extract from cannabis flower (cannabis sativa l. dkj127 flos) corresponding to 19 mg delta-9-tetrahydrocannabinol (thc). extraction solvent: ethanol 96 (v/v).
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.