Spain· ES:82049
FLUMAZENILO HIKMA 0,1 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION EFG
A medicinal product containing flumazenil, registered in Spain by Hikma Farmaceutica (Portugal) S.A..
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- flumazenil
- Manufacturer
- Hikma Farmaceutica (Portugal) S.A.
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- August 12, 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
Flumazenil in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United StatesFlumazenilProPharma Distribution
- FinlandFlumazenil B. BraunB. Braun Melsungen AG
- NorwayFlumazenil Aurora Medical2care4 ApS
- IrelandAnexate 500 micrograms/5ml, solution for injection or infusionCheplapharm Arzneimittel GmbH
- SwedenFlumazenil hameln 0,1 mg/ml Injektions-/infusionsvätska, lösningHameln Pharma gmbh
- United KingdomAnexate 500micrograms/5ml solution for injection ampoulesRoche Products Ltd
- GermanyAnexateCheplapharm Arzneimittel Gmbh
- CzechiaFLUMAZENIL PHARMASELECTPharmaselect International Beteiligungs GmbH, Vídeň
Authorised across Europe · EMA
The same active substance is authorised in 23 EEA countries. Names it is sold under:
- Austria · Anexate, Flumazenil B. Braun
- Belgium · Anexate, Flumazenil B. Braun
- Czechia · Flumazenil Pharmaselect
- Germany · Anexate, Flumazenil B. Braun
- Denmark · Flumazenil Fresenius Kabi, Flumazenil Hameln
- Finland · Flumazenil B. Braun, Flumazenil Fresenius Kabi
- France · Flumazenil Hikma, Flumazenil Viatris
- United Kingdom (Northern Ireland) · Flumazenil Hameln Pharma, Flumazenil Hikma Farmacêutica (Portugal)
- Greece · Anexate®, Demoxate
- Croatia · Anexate, Flumazenil B.Braun
- Hungary · Anexate, Flumazenil Kabi
- Ireland · Anexate
- Iceland · Flumazenil B. Braun
- Italy · Anexate, Flumazenil B. Braun
- Luxembourg · Flumazenil B. Braun
- Netherlands · Anexate, Flumazenil B. Braun
- Norway · Flumazenil Fresenius Kabi, Flumazenil Hameln
- Poland · Flumazenil B. Braun, Flumazenil Kabi
- Portugal · Flumazenilo Fresenius Kabi, Flumazenilo Generis
- Romania · Anexate, Flumazenil Pharmaselect
- Sweden · Flumazenil Fresenius Kabi, Flumazenil Hameln
- Slovenia · Anexate
- Slovakia · Flumazenil Pharmaselect
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/068ee917-a40a-4a8c-beb5-00049fd1869e GET /v1/drugs/068ee917-a40a-4a8c-beb5-00049fd1869e?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": "Uso Hospitalario",
"estado": "{\"aut\":1520463600000}",
"nregistro": "82049",
"substance": "flumazenil"
}See everything about flumazenil.
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.