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Belgium· BE-AMP-SAM135974-00

Silibinine Viatris 350 mg

A other therapeutic products product containing silibinin dihydrogen succinate disodium, registered in Belgium by Viatris Healthcare. The same ATC class is registered in 4 of our 19 countries.

ATC V03AX

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedSilibinine Viatris 350 mgATCV03AXREGISTER NO.BE-AMP-SAM135974-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Silibinin dihydrogen succinate disodium is registered in 4 of 19 countries.

Countries holding a registration under ATC V03AX (other therapeutic products), each read from that country’s own register.

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

Silibinin dihydrogen succinate disodium · ATC V03AX

4 / 19 countries

  • Belgiumprice
  • Ireland
  • Norwayprice
  • Polandprice
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
Silibinin Dihydrogen Succinate Disodium
Manufacturer
Viatris Healthcare
Country
Belgium (BE)
ATC code
V03AX
ATC class
Other therapeutic products
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    3349982
  • be_apb
    0685404

Regulatory notes

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

Same medicine, other countries

Silibinin dihydrogen succinate disodium in 3 other countries

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

All silibinin dihydrogen succinate disodium products

Authorised across Europe · EMA

The same active substance is authorised in 2 EEA countries. Names it is sold under:

  • Hungary · Legalon Sil
  • Romania · Silimarina Biofarm

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/43ac7464-c636-4b1a-bd12-5879a77910c4
GET /v1/drugs/43ac7464-c636-4b1a-bd12-5879a77910c4?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": "Powder for solution for injection",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Silibinine Viatris 350 mg",
  "name_fr": "Silibinine Viatris 350 mg",
  "name_nl": "Silibinine Viatris 350 mg",
  "amp_code": "SAM135974-00",
  "strengths": [
    "528.5000",
    "528.5000",
    "528.5000",
    "528.5000",
    "350.0000",
    "350.0000",
    "350.0000",
    "350.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Silibinin Dihydrogen Succinate Disodium",
    "Silibinin"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Other Therapeutic Products",
  "authorisation_numbers": [
    "BE135974"
  ]
}

See everything about silibinin dihydrogen succinate disodium.

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.