Spain· ES:61079
ARTROTEC 50 mg/200 microgramos COMPRIMIDOS RECUBIERTOS
A medicinal product containing diclofenaco + misoprostol, registered in Spain by Pfizer S.L..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- diclofenaco + misoprostol
- Manufacturer
- Pfizer S.L.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 2026
Packs & prices · 1
1 priced- cima_codigo99988240EUR 12.89
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Diclofenaco + 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 tabletsMawdsley-Brooks & Company Ltd
- CanadaARTHROTEC 50PFIZER CANADA ULC
- PolandArthrotecPfizer Europe MA EEIG
- 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
- Germany · Arthotec Forte
- 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 AEMPS CIMA (Spain). 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/51d08f4d-0216-4ab7-b434-b2f52a5ad2b7 GET /v1/drugs/51d08f4d-0216-4ab7-b434-b2f52a5ad2b7?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.
{
"cpresc": "Medicamento Sujeto A Prescripción Médica",
"estado": "{\"aut\":852073200000}",
"nregistro": "61079",
"substance": "diclofenaco + misoprostol"
}See everything about diclofenaco + 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.