Spain· ES:71881
SALOFALK 4 g/60 ml SUSPENSION RECTAL
A medicinal product containing mesalazina, registered in Spain by Dr. Falk Pharma Gmbh.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- mesalazina
- Manufacturer
- Dr. Falk Pharma Gmbh
- 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_codigo6647707EUR 43.52
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Mesalazina in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesMesalamineBryant Ranch Prepack
- IrelandSalofalk 4g/60ml EnemaDr. Falk Pharma GmbH
- NorwaySalofalkDr. Falk Pharma GmbH (2)
- PolandSalofalkDr. Falk Pharma GmbH
- SwedenSalofalk 4 g/60 ml RektalsuspensionDr Falk Pharma GmbH
- United KingdomAsacol 1g/application foam enemaAllergan Ltd
- CzechiaASACOLTillotts Pharma GmbH, Rheinfelden
- NetherlandsAsacol 400 tablet, maagsapresistente tabletten 400 mgpharmaand GmbH
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Azzavix, Claversal
- Belgium · Asamovon, Claversal
- Bulgaria · Salofalk – Салофалк, Пентаза
- Cyprus · Asacol, Mecolzine
- Czechia · Asacol, Asacol Enema
- Germany · Asacol, Claversal
- Denmark · Asacol, Mesalazin Orion
- Estonia · Asacol, Pentasa
- Finland · Asacol, Asacol 1 G
- France · Fivasa, Mazalvix
- United Kingdom (Northern Ireland) · Asacol, Mesalazine
- Greece · Asacol, Asalazin
- Croatia · Pentasa, Salofalk
- Hungary · Pentasa, Salofalk
- Ireland · Asacolon, Galtasa
- Iceland · Asacol, Pentasa
- Italy · Argonal, Asacol
- Lithuania · Asacol, Pentasa
- Luxembourg · Claversal, Claversal Foam
- Latvia · Asacol, Pentasa
- Malta · Mecolzine, Mezavant Xl
- Netherlands · Asacol, Azzavix
- Norway · Asacol, Mesalazin Orion
- Poland · Crohnax, Granmesa
- Portugal · Asacol, Azzavix
- Romania · Mesalazina Alfasigma, Pentasa
- Sweden · Asacol, Mesalazin Orion
- Slovenia · Asacol, Asacol®
- Slovakia · Pentasa, Pentasa Sachet
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/3b4858c7-8e08-4732-b28c-c444cbe6b61c GET /v1/drugs/3b4858c7-8e08-4732-b28c-c444cbe6b61c?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\":1265670000000}",
"nregistro": "71881",
"substance": "mesalazina"
}See everything about mesalazina.
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.