Back to search

Belgium· BE-AMP-SAM531564-00

Fluoxetin AB 20 mg

A medicinal product containing fluoxetine hydrochloride, registered in Belgium by Aurobindo Pharma.

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedFluoxetin AB 20 mgATC—REGISTER NO.BE-AMP-SAM531564-00PACKS LISTED0CHECKEDSeptember 26, 2026

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Fluoxetine Hydrochloride
Manufacturer
Aurobindo Pharma
Country
Belgium (BE)
ATC code
—
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 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

Fluoxetine hydrochloride in 16 other countries

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

All fluoxetine hydrochloride products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Felicium, Fluctine
  • Bulgaria · Бифлокс
  • Cyprus · Afeksin, Fluoxetine Aurobindo
  • Czechia · Deprex, Fluoxetin Pharmconsul
  • Germany · Fluoxetin 1 A Pharma, Fluoxetin Abz
  • Denmark · Fluoxetin ”mylan”, Fluoxetin Hexal
  • Estonia · Fluoxetine Vitabalans, Flux
  • Spain · Fluoxetina Almus, Fluoxetina Aurovitas
  • Finland · Fluoxetine Vitabalans, Seromex
  • France · Fluoxetine Accord, Fluoxetine Almus
  • United Kingdom (Northern Ireland) · Fluoxetine, Fluoxetine Accord-Uk
  • Greece · Dagrilan, Exostrept
  • Croatia · Portal
  • Hungary · Floxet, Fluoxetin Zentiva
  • Ireland · Fluoxetine Activase Pharmaceuticals, Fluoxetine Brillpharma (Ireland)
  • Iceland · Fluoxetin Viatris, Fluoxetin Wh
  • Italy · Fluoxeren, Fluoxetina Accord
  • Lithuania · Fluoxetine Vitabalans, Flux
  • Luxembourg · Fluoxetin Ratiopharm, Fluoxetine Eg
  • Latvia · Fluoxetine Vitabalans, Flux
  • Malta · Fluoxetine Accord Healthcare, Fluoxetine Activase Pharmaceuticals
  • Netherlands · Fluoxetine Amdipharm, Fluoxetine Aurobindo
  • Norway · Fluoxetin Ratiopharm, Fluoxetin Sandoz
  • Poland · Andepin, Bioxetin
  • Portugal · Digassim, Fluoxetina Alter
  • Romania · Fluoxetină Arena, Fluoxin
  • Sweden · Fluoxetin Orifarm, Fluoxetin Ratiopharm
  • Slovenia · Fluoksetin Vitabalans, Fodiss
  • Slovakia · Fluoxetine Vitabalans, Magrilan

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 FAMHP / AFMPS (Belgium). 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/a776e798-4da2-4d36-9292-b2ce5883a6d3
GET /v1/drugs/a776e798-4da2-4d36-9292-b2ce5883a6d3?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.

{
  "form": "Capsule, hard",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Fluoxetin AB 20 mg",
  "name_fr": "Fluoxetin AB 20 mg",
  "name_nl": "Fluoxetin AB 20 mg",
  "amp_code": "SAM531564-00",
  "strengths": [
    "22.3570",
    "20.0000"
  ],
  "pack_count": 0,
  "substances": [
    "Fluoxetine Hydrochloride",
    "Fluoxetine"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": null,
  "authorisation_numbers": null
}

See everything about fluoxetine hydrochloride.

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.