Belgium· BE-AMP-SAM268843-00

Protelos 2 g

A strontium ranelat product containing strontium ranelate, registered in Belgium by Les Laboratoires Servier. The same ATC class is registered in 3 of our 19 countries.

ATC M05BX03

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedProtelos 2 gATCM05BX03REGISTER NO.BE-AMP-SAM268843-00PACKS LISTED3CHECKEDSeptember 26, 2026

Where it is registered

Strontium ranelat is registered in 3 of 19 countries.

Countries holding a registration under ATC M05BX03 (strontium ranelat), each read from that country’s own register.

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

Strontium ranelat · ATC M05BX03

3 / 19 countries

  • Belgiumprice
  • Denmark
  • Finlandprice
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
Strontium Ranelate
Manufacturer
Les Laboratoires Servier
Country
Belgium (BE)
ATC code
M05BX03
ATC class
Strontium ranelat
Defined daily dose
2 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 3

  • be_apb
    2182657
  • be_apb
    2182665
  • be_apb
    0785873

Regulatory notes

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

Same medicine, other countries

Strontium ranelat in 1 other country

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

All strontium ranelat products

Authorised across Europe · EMA

The same active substance is authorised in 1 EEA country. Names it is sold under:

  • United Kingdom (Northern Ireland) · Strontium Ranelate Aristo

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/1e6c3209-168a-418d-98b8-cb5a6fbb97df
GET /v1/drugs/1e6c3209-168a-418d-98b8-cb5a6fbb97df?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": "Granules for oral suspension",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Protelos 2 g",
  "name_fr": "Protelos 2 g",
  "name_nl": "Protelos 2 g",
  "amp_code": "SAM268843-00",
  "strengths": [
    "2.0000",
    "2.0000"
  ],
  "pack_count": 6,
  "substances": [
    "Strontium Ranelate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Strontium Ranelate",
  "authorisation_numbers": [
    "EU/1/04/288/001",
    "EU/1/04/288/002",
    "EU/1/04/288/003",
    "EU/1/04/288/004",
    "EU/1/04/288/005",
    "EU/1/04/288/006"
  ]
}

See everything about strontium ranelat.

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.