Germany· DE-A57-ce5500d9026adae9

Azur Compositum

A medicinal product containing paracetamol, caffeine, codeine phosphate hemihydrate, registered in Germany by Aristo Pharma Gmbh (Art 57).

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedAzur CompositumATC—REGISTER NO.DE-A57-ce5500d9026ada…PACKS LISTED0CHECKEDSeptember 30, 2026

The record

At a glance

EMA Article 57 (European Union)
Active substance
Paracetamol, Caffeine, Codeine Phosphate Hemihydrate
Manufacturer
Aristo Pharma Gmbh (Art 57)
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

Paracetamol, caffeine, codeine phosphate hemihydrate in 5 other countries

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

All paracetamol, caffeine, codeine phosphate hemihydrate products

Authorised across Europe · EMA

The same active substance is authorised in 15 EEA countries. Names it is sold under:

  • Bulgaria · Солпадеин
  • Cyprus · Lonarid N, Solpadeine
  • Estonia · Solpadeine, Solpadeine Soluble
  • Spain · Analgilasa
  • France · Paracetamol / Cafeine / Codeine Biogaran, Paracetamol/Cafeine/Codeine Arrow
  • United Kingdom (Northern Ireland) · Co-Codamol Plus, Codasolve
  • Greece · Lonarid N
  • Ireland · Maxeeze, Paracetamol/Codeine Phosphate Hemihydrate/Caffeine Accord
  • Lithuania · Solpadeine
  • Latvia · Solpadeine, Solpadeine Soluble
  • Malta · Paracetamol/Caffeine/Codeine Phosphate Frilab, Solpadeine
  • Netherlands · Paracetamol/Codeïnefosfaat/Coffeïne Accord
  • Poland · Solpadeine, Solpadeine Max
  • Romania · Codamin P, N – Calmant Iii
  • Slovakia · Cetafen Rapid, Panadol Ultra

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/40d51d33-74e8-43a3-843e-ee26015efaa7
GET /v1/drugs/40d51d33-74e8-43a3-843e-ee26015efaa7?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": "Rectal Use",
  "source": "ema_art57_de",
  "ma_number": null,
  "substance": "Paracetamol, Caffeine, Codeine Phosphate Hemihydrate",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}

See everything about paracetamol, caffeine, codeine phosphate hemihydrate.

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.