Spain· ES:49002
GARDENAL 50 mg COMPRIMIDOS
A medicinal product containing fenobarbital, 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
- fenobarbital
- Manufacturer
- Sanofi Aventis S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 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
Fenobarbital in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandAphenylbarbit 50 mg, TablettenStreuli Pharma AG
- FinlandPhenoleptil vetDechra Regulatory B.V.
- FranceGARDENAL 50 mg, compriméATNAHS PHARMA FRANCE
- NetherlandsFenobarbital Teva 50 mg, tablettenTeva Nederland B.V.
- NorwayFenemalOrifarm Healthcare A/S
- United StatesPhenobarbitalChartwell Governmental & Specialty RX, LLC.
- United KingdomGardenal Sodium 200mg/1ml solution for injection ampoulesConcord Pharmaceuticals Ltd
- CanadaEPIPHEN 30MGVETOQUINOL N A INC
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Belgium · Gardenal, Phenobarbital Sodium Sterop
- Bulgaria · Фенобарбитал Софарма
- Czechia · Luminal, Phenaemal
- Germany · Luminal, Luminaletten
- Denmark · Fenemal
- Estonia · Phenaemal
- France · Gardenal
- United Kingdom (Northern Ireland) · Phenobarbital Accord, Phenobarbital Activase
- Greece · Gardenal
- Croatia · Phenobarbiton
- Hungary · Sevenal, Sevenaletta
- Ireland · Phenobarbital Clonmel Healthcare
- Italy · Fenobarbitale Sodico S.A.L.F, Gardenale
- Luxembourg · Gardenal
- Netherlands · Fenobarbital Teva
- Norway · Fenemal
- Poland · Luminalum, Luminalum Unia
- Portugal · Bialminal, Fenobarbital Labesfal
- Romania · Fenobarbital Arena, Fenobarbital Zentiva
- Slovakia · Luminal, Phenaemal 0,1
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/23c06cf6-ef19-4365-a522-fa781bd2d08b GET /v1/drugs/23c06cf6-ef19-4365-a522-fa781bd2d08b?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. Tratamiento De Larga Duración. Psicótropos",
"estado": "{\"aut\":-1491177600000,\"rev\":1635867592000}",
"nregistro": "49002",
"substance": "fenobarbital"
}See everything about fenobarbital.
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.