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Belgium· BE-AMP-SAM001802-00

Rovamycine 1500000 IU

A spiramycin product containing spiramycin, registered in Belgium by The Simple Pharma Company. The same ATC class is registered in 9 of our 19 countries.

ATC J01FA02

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedRovamycine 1500000 IUATCJ01FA02REGISTER NO.BE-AMP-SAM001802-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Spiramycin is registered in 9 of 19 countries.

Countries holding a registration under ATC J01FA02 (spiramycin), each read from that country’s own register.

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

Spiramycin · ATC J01FA02

9 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Franceprice
  • Germany
  • Japan
  • Norwayprice
  • Polandprice
  • United Kingdom
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
Spiramycin
Manufacturer
The Simple Pharma Company
Country
Belgium (BE)
ATC code
J01FA02
ATC class
Spiramycin
Defined daily dose
3 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

1 priced
  • be_apb
    0128272
    EUR 11.79
  • be_apb
    0716662

Regulatory notes

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

Interactions

5 interactions on record for spiramycin.

Mechanism, severity and management for each pair, from a commercially licensed source — included 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

Spiramycin · interactions on record

5 records

5 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
Mechanism and what to do, in the interaction check
Interaction register. Grades as the source publishes them.

Same medicine, other countries

Spiramycin in 9 other countries

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

All spiramycin products

Authorised across Europe · EMA

The same active substance is authorised in 11 EEA countries. Names it is sold under:

  • Czechia · Rovamycine
  • Germany · Rovamycine, Selectomycin
  • Spain · Rovamycine
  • France · Rovamycine, Spiramycine Biogaran
  • Italy · Rovamicina
  • Luxembourg · Rovamycine
  • Latvia · Rovamycine
  • Poland · Rovamycine
  • Portugal · Rovamycine
  • Romania · Rovamycine
  • Slovakia · Rovamycine

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/ccbfb992-f22f-4105-8984-a7bddfd47217
GET /v1/drugs/ccbfb992-f22f-4105-8984-a7bddfd47217?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": "Film-coated tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Rovamycine 1500000 IU",
  "name_fr": "Rovamycine 1500000 IU",
  "name_nl": "Rovamycine 1500000 IU",
  "amp_code": "SAM001802-00",
  "strengths": [
    "1.5000",
    "1.5000"
  ],
  "pack_count": 1,
  "substances": [
    "Spiramycin"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Spiramycin",
  "authorisation_numbers": [
    "BE001802"
  ]
}

See everything about spiramycin.

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.