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Belgium· BE-AMP-SAM126287-00

Septopal 7,5 mg - 20 mg

A medicinal product containing gentamicin sulfate, registered in Belgium by Biomet Belgium.

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedSeptopal 7,5 mg - 20 mgATC—REGISTER NO.BE-AMP-SAM126287-00PACKS LISTED0CHECKEDSeptember 26, 2026

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Gentamicin Sulfate
Manufacturer
Biomet Belgium
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

Gentamicin sulfate in 9 other countries

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

All gentamicin sulfate products

Authorised across Europe · EMA

The same active substance is authorised in 18 EEA countries. Names it is sold under:

  • Austria · Gentax, Refobacin
  • Bulgaria · Гентамицин Актавис, Гентамицин Софарма
  • Czechia · Gentamicin Polpharma
  • Germany · Gent-Ophtal, Gent-Ophtal®
  • Denmark · Gentamicin Panpharma
  • Estonia · Gentamicin Medochemie
  • United Kingdom (Northern Ireland) · Gentamicin Amdipharm Uk, Gentamicin Intrathecal Zentiva Pharma Uk Limited
  • Hungary · Gentamicin Wagner
  • Ireland · Gentamicin Pinewood Laboratories, Genticin
  • Italy · Ciclozinil, Gentalyn
  • Lithuania · Gentamicin Pph
  • Malta · Gentamicin Medochemie
  • Netherlands · Garacol, Gentamicine-Pos
  • Norway · Gentamicin Panpharma
  • Poland · Garamycin, Gentamicin Wzf
  • Portugal · Cronocol, Gentamicina Basi
  • Sweden · Gentamicin Panpharma
  • Slovakia · Garamycin Schwamm

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/cec294dd-1c05-4601-849e-909a98d0bde8
GET /v1/drugs/cec294dd-1c05-4601-849e-909a98d0bde8?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": "Implantation chain",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Septopal 7,5 mg - 20 mg",
  "name_fr": "Septopal 7,5 mg - 20 mg",
  "name_nl": "Septopal 7,5 mg - 20 mg",
  "amp_code": "SAM126287-00",
  "strengths": [
    "7.5000",
    "20.0000"
  ],
  "pack_count": 0,
  "substances": [
    "Gentamicin Sulfate",
    "Zirconium Dioxide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": null,
  "authorisation_numbers": null
}

See everything about gentamicin sulfate.

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.