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Spain· ES:57514

APOCARD 10 mg/ml SOLUCION INYECTABLE

A medicinal product containing flecainida, registered in Spain by Viatris Healthcare Limited.

Checked against AEMPS CIMA (Spain) on

Informational only — not a medical device.

SOURCE REGISTER · ESAEMPS CIMA (Spain)normalisedAPOCARD 10 mg/ml SOLUCION INYECTABLEATC—REGISTER NO.ES:57514PACKS LISTED0CHECKEDSeptember 12, 2026

The record

At a glance

AEMPS CIMA (Spain)
Active substance
flecainida
Manufacturer
Viatris Healthcare Limited
Country
Spain (ES)
ATC code
—
Reimbursed
Not published by this register
Source register
AEMPS CIMA (Spain)
Last checked
September 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

Flecainida in 16 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All flecainida products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

  • Austria · Aristocor
  • Belgium · Apocard Retard, Flecainide Retard Eg
  • Bulgaria · Амаритон, Фелкарид
  • Cyprus · Flecardia
  • Czechia · Amarhyton, Amarhyton 100 Mg
  • Germany · Flecadura, Flecainid
  • Denmark · Flecainid Sandoz, Flecainid Stada
  • Finland · Flecainide Orion, Tambocor
  • France · Flecaine, Flecaine L.P.
  • United Kingdom (Northern Ireland) · Flecainide Acetate Accord-Uk, Flecainide Acetate Brown & Burk Uk
  • Greece · Amarhyton, Flecainide/Flexmed
  • Croatia · Felkarid
  • Ireland · Flecainide Teva, Tambocor
  • Iceland · Flecainid Stada, Tambocor
  • Italy · Almarytm, Flecainide Aurobindo
  • Luxembourg · Apocard Retard, Flecainide Retard Eg
  • Malta · Flecainide Acetate Aurobindo Pharma (Malta), Tambocor
  • Netherlands · Flecainide Acetate Aurobindo, Flecainide Acetate Ratiopharm
  • Norway · Flecainid Sandoz, Tambocor
  • Poland · Flecainide Acetate Holsten
  • Portugal · Amarhyton, Apocard
  • Romania · Amarhyton, Tambocor
  • Sweden · Tambocor, Tambocor Retard
  • Slovenia · Felkarid
  • Slovakia · Amarhyton 100 Mg, Amarhyton 50 Mg

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/e2a4d68f-bcb2-4ff9-8d80-90446bad13c6
GET /v1/drugs/e2a4d68f-bcb2-4ff9-8d80-90446bad13c6?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\":567990000000}",
  "nregistro": "57514",
  "substance": "flecainida"
}

See everything about flecainida.

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.