Germany· DE-A57-f8e0fc494d7892ee
Dropizol
A medicinal product containing opium tincture, registered in Germany by Pharmanovia A/S.
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
- Opium Tincture
- Manufacturer
- Pharmanovia A/S
- 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
Opium tincture in 9 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumOpium Boiron 15CHBoiron
- United KingdomCamphorated opium tinctureA A H Pharmaceuticals Ltd
- Japanアヘン
- FinlandDropizolPharmanovia A/S
- IcelandDropizolPharmanovia A/S
- NorwayDropizolPharmanovia A/S
- SwedenDropizol 10 mg/ml Orala droppar, lösningPharmanovia A/S
- FranceDROPIZAL 10 mg/mL, solution buvable en gouttesPHARMANOVIA (DANEMARK)
Authorised across Europe · EMA
The same active substance is authorised in 15 EEA countries. Names it is sold under:
- Austria · Dropizol
- Czechia · Dropizol
- Denmark · Dropizol
- Spain · Dropizol
- Finland · Dropizol
- France · Dropizal
- United Kingdom (Northern Ireland) · Dropizol
- Hungary · Dropizol
- Ireland · Dropizol
- Iceland · Dropizol
- Netherlands · Dropizol
- Norway · Dropizol
- Portugal · Dropizale
- Sweden · Dropizol
- Slovakia · Dropizol
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/3388f0f2-c1d2-445d-847c-39fa7451052d GET /v1/drugs/3388f0f2-c1d2-445d-847c-39fa7451052d?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 Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Opium Tincture",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about opium tincture.
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.