Spain· ES:55857
ORUDIS 100 mg SOLUCION INYECTABLE
A medicinal product containing ketoprofeno, registered in Spain by Sanofi Aventis S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- ketoprofeno
- Manufacturer
- Sanofi Aventis S.A.
- 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_codigo9536616EUR 2.06
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Ketoprofeno in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaKETONALLek Pharmaceuticals d.d., Ljubljana
- BelgiumRofenid Ready Mix I.M. 100 mgSanofi Belgium
- United KingdomFenoket 200mg modified-release capsulesOpus Pharmaceuticals Ltd
- PolandBi-ProfenidSanofi Winthrop Industrie
- FinlandAktronQuimica Farmaceutica Bayer S.A.
- ItalyALKETS.F. GROUP S.R.L.
- FranceBI PROFENID LP 100 mg, comprimé sécable à libération prolongéePHOENIX LABS (IRLANDE)
- CanadaANAFENBOEHRINGER INGELHEIM ANIMAL HEALTH CANADA INC.
Authorised across Europe · EMA
The same active substance is authorised in 25 EEA countries. Names it is sold under:
- Austria · Fastum, Ketospray
- Belgium · Fastum
- Bulgaria · Ketospray, Артрокол
- Cyprus · Fastum
- Czechia · Fastum, Keplat
- Germany · Alrheumun, Effekton
- Estonia · Fastum, Keto
- Finland · Keto, Ketorin
- France · Bi Profenid Lp, Ketoprofene Aguettant
- United Kingdom (Northern Ireland) · Ketoprofen, Ketoprofen Ennogen Ip
- Greece · Drastirel
- Croatia · Fastum, Ketonal
- Hungary · Fastum, Keplat
- Ireland · Fastum
- Italy · Alket, Dolgosin
- Lithuania · Fastum, Ketonal
- Luxembourg · Fastum, Ketoprofene Aguettant
- Latvia · Fastum, Keto
- Malta · Fastum, Ketokaps Max
- Poland · Fastum, Febrofen
- Portugal · Kepin, Keplat
- Romania · Fastum, Ketomag
- Sweden · Siduro
- Slovenia · Ketonal, Ketonal 100 Mg
- Slovakia · Fastum, Ketonal
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/b6c942fe-cad9-4e13-9745-b369fb8744cf GET /v1/drugs/b6c942fe-cad9-4e13-9745-b369fb8744cf?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\":394322400000,\"rev\":1743592282000}",
"nregistro": "55857",
"substance": "ketoprofeno"
}See everything about ketoprofeno.
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.