Germany· DE-A57-5b65f8b7e9a57373
Arthotec Forte
A medicinal product containing diclofenac sodium, misoprostol, registered in Germany by Pfizer Pharma 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
- Diclofenac Sodium, Misoprostol
- Manufacturer
- Pfizer Pharma Gmbh
- 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
Diclofenac sodium, misoprostol in 11 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesARTHROTECPfizer Laboratories Div Pfizer Inc
- United KingdomArthrotec 50 gastro-resistant tabletsWaymade Healthcare Plc
- CanadaARTHROTEC 50PFIZER CANADA ULC
- PolandArthrotecDelfarma Sp. z o.o.
- NetherlandsArthrotec 50, tabletten met gereguleerde afgifteEuro Registratie Collectief B.V.
- IrelandArthrotec 50 modified-release tabletsPCO Manufacturing Ltd.
- NorwayArthrotecPfizer
- FinlandArthrotecPfizer Oy
Authorised across Europe · EMA
The same active substance is authorised in 14 EEA countries. Names it is sold under:
- Austria · Arthrotec, Arthrotec Forte
- Belgium · Arthrotec
- Spain · Artrotec
- Finland · Arthrotec Forte
- United Kingdom (Northern Ireland) · Arthrotec
- Ireland · Arthrotec
- Italy · Artrotec
- Luxembourg · Arthrotec
- Netherlands · Arthrotec
- Norway · Arthrotec
- Poland · Arthrotec, Arthrotec Forte
- Portugal · Arthrotec, Diclofenac + Misoprostol Aurovitas
- Romania · Arthrotec
- Slovakia · Arthrotec Forte
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/2388673d-6a49-4ce1-b13b-697b868a3c70 GET /v1/drugs/2388673d-6a49-4ce1-b13b-697b868a3c70?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": "Diclofenac Sodium, Misoprostol",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about diclofenac sodium, misoprostol.
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.