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Belgium· BE-AMP-SAM130042-00

Sterofrin 2.5 mg/ml - 1.2 mg/ml

A prednisolon und mydriatika product containing phenylephrine hydrochloride, registered in Belgium by Novartis Pharma.

ATC S01BB02

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedSterofrin 2.5 mg/ml - 1.2 mg/mlATCS01BB02REGISTER NO.BE-AMP-SAM130042-00PACKS LISTED0CHECKEDSeptember 26, 2026

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Phenylephrine Hydrochloride
Manufacturer
Novartis Pharma
Country
Belgium (BE)
ATC code
S01BB02
ATC class
Prednisolon und Mydriatika
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 0

No packs listed by the register for this record.

Regulatory notes

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

Same medicine, other countries

Prednisolon und mydriatika in 15 other countries

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

All prednisolon und mydriatika 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/d64d3e3f-00c4-4e1c-b163-54734c7bd749
GET /v1/drugs/d64d3e3f-00c4-4e1c-b163-54734c7bd749?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": "Eye drops, solution",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Sterofrin 2.5 mg/ml - 1.2 mg/ml",
  "name_fr": "Sterofrin 2.5 mg/ml - 1.2 mg/ml",
  "name_nl": "Sterofrin 2.5 mg/ml - 1.2 mg/ml",
  "amp_code": "SAM130042-00",
  "strengths": [
    "1.2000",
    "1.2000",
    "2.5000",
    "2.5000"
  ],
  "pack_count": 3,
  "substances": [
    "Phenylephrine Hydrochloride",
    "Prednisolone Acetate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Prednisolone and Mydriatics",
  "authorisation_numbers": [
    "BE130042"
  ]
}

See everything about prednisolon und mydriatika.

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.