Belgium· BE-AMP-SAM665947-00

Ondibta 100 U/ml

A insulin glargine product containing insulin glargine, registered in Belgium by Sandoz. The same ATC class is registered in 13 of our 19 countries.

ATC A10AE04

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOndibta 100 U/mlATCA10AE04REGISTER NO.BE-AMP-SAM665947-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Insulin glargine is registered in 13 of 19 countries.

Countries holding a registration under ATC A10AE04 (insulin glargine), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 8 of them publish a price we can compare per daily dose

Insulin glargine · ATC A10AE04

13 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Insulin Glargine
Manufacturer
Sandoz
Country
Belgium (BE)
ATC code
A10AE04
ATC class
Insulin glargine
Defined daily dose
40 E, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

1 priced
  • be_apb
    5848460
    EUR 43.81
  • be_apb
    7750409

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

433 interactions on record for insulin glargine.

Graded by severity as the source publishes them — 15 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Insulin glargine · interactions on record

433 records

  • 15 severe
  • 367 moderate
  • 50 minor

Most severe, free to view

  • SucralfateA02BX02moderate
  • ThiethylperazinA04AB03moderate
  • TriflupromazinA04AD06moderate
  • PrednisoloneA07EA01moderate

1 more interaction with mechanism and management, from a commercially licensed source.

Sign in to check
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Insulin glargine in 16 other countries

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

All insulin glargine products

Authorised across Europe · EMA

The same active substance is authorised in 3 EEA countries. Names it is sold under:

  • Iceland · Abasaglar, Abasaglar Kwikpen
  • Liechtenstein · Abasaglar, Abasaglar Kwikpen
  • Norway · Lantus, Lantus Solostar

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/efc2ad0f-44c0-4671-9e8b-7fa82a482f9f
GET /v1/drugs/efc2ad0f-44c0-4671-9e8b-7fa82a482f9f?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": "Solution for injection in pre-filled pen",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Ondibta 100 U/ml",
  "name_fr": "Ondibta 100 U/ml",
  "name_nl": "Ondibta 100 U/ml",
  "amp_code": "SAM665947-00",
  "strengths": [
    "100.0000",
    "100.0000",
    "100.0000",
    "100.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Insulin Glargine",
    "Glycerol",
    "Sodium Hydroxide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Insulin Glargine",
  "authorisation_numbers": [
    "EU/1/25/2000/002",
    "EU/1/25/2000/001",
    "EU/1/25/2000/003"
  ]
}

See everything about insulin glargine.

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.