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Belgium· BE-AMP-SAM489680-00

Mydrane 0.2 mg/ml - 10 mg/ml

A tropicamid, kombinationen product containing phenylephrine hydrochloride, registered in Belgium by Laboratoires Théa. The same ATC class is registered in 10 of our 19 countries.

ATC S01FA56

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedMydrane 0.2 mg/ml - 10 mg/mlATCS01FA56REGISTER NO.BE-AMP-SAM489680-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about phenylephrine hydrochlorideAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Tropicamid, kombinationen is registered in 10 of 19 countries.

Countries holding a registration under ATC S01FA56 (tropicamid, kombinationen), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 7 of them publish a price we can compare per daily dose
Search tropicamid, kombinationen products by name

Tropicamid, kombinationen · ATC S01FA56

10 / 19 countries

  • Belgiumprice
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • 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
Phenylephrine Hydrochloride
Manufacturer
Laboratoires Théa
Country
Belgium (BE)
ATC code
S01FA56
ATC class
Tropicamid, Kombinationen
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    3433679
  • be_apb
    3433687

Regulatory notes

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

Same medicine, other countries

Tropicamid, kombinationen in 15 other countries

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

All tropicamid, kombinationen products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Biorphen, Phenylephrin Aguettant
  • Bulgaria · Фенилефрин Вижън, Фенилефрин Вижън Антибиотик-Разград Ад
  • Cyprus · Biorphen
  • Czechia · Neosynephrin-Pos, Phenylephrine Olikla
  • Germany · Biorphen, Neosynephrin-Pos
  • Denmark · Biorphen, Fenylefrin Abcur
  • Estonia · Biorphen
  • Spain · Colircusí, Disneumon Pernasal
  • Finland · Fenylefrin Abcur, Fenylefrin Aguettant
  • France · Neosynephrine, Phenylephrine Aguettant
  • United Kingdom (Northern Ireland) · Blocked Nose Relief, Flamingo Max Strength Congestion Relief
  • Greece · Biorphen, Phenylephrine Cooper
  • Croatia · Biorphen
  • Hungary · Biorphen
  • Ireland · Minims, Phenylephrine Hydrochloride Athlone Pharmaceuticals
  • Iceland · Biorphen, Fenylefrin Abcur
  • Italy · Fenilefrina Aguettant, Nasomixin C.M.
  • Luxembourg · Minims Phenylephrine Chlorhydrate Bausch + Lomb Ireland Limited, Minims Phenylephrinhydrochlorid Bausch + Lomb Ireland Limited
  • Latvia · Biorphen
  • Malta · Phenylephrine Laboratoire Aguettant
  • Netherlands · Fenylefrine Added Pharma, Fenylefrine Aguettant
  • Norway · Biorphen, Fenylefrin Abcur
  • Poland · Acatar Acti Form, Anosin
  • Portugal · Davinefrina, Fenilefrina Aguettant
  • Romania · Bioflu Nazal, Fenefrin
  • Sweden · Fenylefrin Abcur, Fenylefrin Aguettant
  • Slovenia · Fenilefrin Sintetica
  • Slovakia · Fenefrin, Phenylephrine Olikla

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/f2bb46b2-8567-4513-bbcb-e9624c83f3ac
GET /v1/drugs/f2bb46b2-8567-4513-bbcb-e9624c83f3ac?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": "Solution for injection",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Mydrane 0.2 mg/ml - 10 mg/ml",
  "name_fr": "Mydrane 0.2 mg/ml - 10 mg/ml",
  "name_nl": "Mydrane 0.2 mg/ml - 10 mg/ml",
  "amp_code": "SAM489680-00",
  "strengths": [
    "3.1000",
    "0.2000",
    "10.0000",
    "0.4000",
    "6.0000",
    "0.6700",
    "5.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Phenylephrine Hydrochloride",
    "Tropicamide",
    "Lidocaine Hydrochloride Monohydrate",
    "Disodium Edetate",
    "Disodium Hydrogen Phosphate Dodecahydrate",
    "Disodium Hydrogen Phosphate Dihydrate",
    "Sodium Chloride"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Tropicamide, Combinations",
  "authorisation_numbers": [
    "BE489680"
  ]
}
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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.

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