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Belgium· BE-AMP-SAM212195-00

Therafixx-Tusso 0.15 %

A butamirate product containing butamirate citrate, registered in Belgium by Haleon Belgium. The same ATC class is registered in 6 of our 19 countries.

ATC R05DB13

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedTherafixx-Tusso 0.15 %ATCR05DB13REGISTER NO.BE-AMP-SAM212195-00PACKS LISTED1CHECKEDSeptember 26, 2026

Where it is registered

Butamirate is registered in 6 of 19 countries.

Countries holding a registration under ATC R05DB13 (butamirate), each read from that country’s own register.

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

Butamirate · ATC R05DB13

6 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Polandprice
  • Switzerlandprice
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
Butamirate Citrate
Manufacturer
Haleon Belgium
Country
Belgium (BE)
ATC code
R05DB13
ATC class
Butamirate
Defined daily dose
25 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    3903366

Regulatory notes

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

Same medicine, other countries

Butamirate in 4 other countries

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

All butamirate products

Authorised across Europe · EMA

The same active substance is authorised in 16 EEA countries. Names it is sold under:

  • Bulgaria · Антитусин, Бронхетамин
  • Cyprus · Butamed, Parmenol
  • Czechia · Sinecod, Tussical
  • Denmark · Tinguri
  • Estonia · Parmenol
  • Greece · Antis, Boytavixal
  • Croatia · Panatus, Panatus Akut
  • Hungary · Norigon, Sinecod
  • Italy · Froben Tosse Secca, Sinecod Tosse Sedativo
  • Luxembourg · Therafixx-Tusso
  • Latvia · Parmenol
  • Malta · Parmenol, Sinecod
  • Poland · Atussan, Maxipulmon
  • Romania · Sinecod, Stoptussin
  • Slovenia · Panatus, Panatus Forte
  • Slovakia · Sinecod, Tussical

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/484d15e8-0bcd-470e-b1e7-c18b0b6b59b2
GET /v1/drugs/484d15e8-0bcd-470e-b1e7-c18b0b6b59b2?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": "Syrup",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Therafixx-Tusso 0.15 %",
  "name_fr": "Therafixx-Tusso 0.15 %",
  "name_nl": "Therafixx-Tusso 0.15 %",
  "amp_code": "SAM212195-00",
  "strengths": [
    "0.1500",
    "0.1500",
    "0.1150",
    "0.2500",
    "29.0000",
    "0.0600",
    "0.0310",
    "40.5000"
  ],
  "pack_count": 1,
  "substances": [
    "Butamirate Citrate",
    "Benzoic Acid",
    "Ethanol",
    "Glycerol",
    "Saccharin Sodium",
    "Sodium Hydroxide",
    "Sorbitol Liquid"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Butamirate",
  "authorisation_numbers": [
    "BE212195"
  ]
}

See everything about butamirate.

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.