Back to search

Belgium· BE-AMP-SAM128807-00

Rhinospray Verstopte neus 1.18 mg/ml

A tramazoline product containing tramazoline hydrochloride monohydrate, registered in Belgium by Opella Healthcare Belgium. The same ATC class is registered in 6 of our 19 countries.

ATC R01AA09

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedRhinospray Verstopte neus 1.18 mg/mlATCR01AA09REGISTER NO.BE-AMP-SAM128807-00PACKS LISTED1CHECKEDSeptember 26, 2026

Where it is registered

Tramazoline is registered in 6 of 19 countries.

Countries holding a registration under ATC R01AA09 (tramazoline), 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

Tramazoline · ATC R01AA09

6 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Finlandprice
  • Germany
  • Japan
  • Netherlands
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
Tramazoline Hydrochloride Monohydrate
Manufacturer
Opella Healthcare Belgium
Country
Belgium (BE)
ATC code
R01AA09
ATC class
Tramazoline
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    4522835

Regulatory notes

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

Same medicine, other countries

Tramazoline in 5 other countries

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

All tramazoline products

Authorised across Europe · EMA

The same active substance is authorised in 15 EEA countries. Names it is sold under:

  • Austria · Rhinospray Plus Ätherische Öle
  • Bulgaria · Муконазал Плюс
  • Cyprus · Rhinact
  • Czechia · Muconasal Plus
  • Germany · Rhinospray Bei Schnupfen, Rhinospray Plus Bei Schnupfen
  • Spain · Rhinospray, Rhinospray Eucaliptus
  • Finland · Tramazoline Hydrochloride Opella
  • Greece · Rhinact
  • Hungary · Rhinospray
  • Italy · Rinogutt, Rinogutt, Soluzione Con Eucaliptolo
  • Luxembourg · Rhinospray Eucalyptus Nez Bouché, Rhinospray Nez Bouché
  • Netherlands · Bisolnasal Met Eucalyptus
  • Portugal · Rhinospray
  • Romania · Muconasal Spray
  • Slovakia · Muconasal Plus

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/b3257c2e-17ee-4452-a6e4-ad48fd308568
GET /v1/drugs/b3257c2e-17ee-4452-a6e4-ad48fd308568?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": "Nasal spray, solution",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Rhinospray Blocked nose 1.18 mg/ml",
  "name_fr": "Rhinospray Nez bouché 1.18 mg/ml",
  "name_nl": "Rhinospray Verstopte neus 1.18 mg/ml",
  "amp_code": "SAM128807-00",
  "strengths": [
    "0.1250",
    "0.1250",
    "0.1180",
    "0.1180",
    "0.0200",
    "0.3700",
    "0.5000",
    "2.0000"
  ],
  "pack_count": 2,
  "substances": [
    "Tramazoline Hydrochloride Monohydrate",
    "Tramazoline Hydrochloride",
    "Benzalkonium Chloride",
    "Disodium Hydrogen Phosphate",
    "Sodium Chloride",
    "Sorbitol Liquid"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Tramazoline",
  "authorisation_numbers": [
    "BE128807"
  ]
}

See everything about tramazoline.

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.