Drug Database
Back to search

Belgium· BE-AMP-SAM478933-00

Omidria 10 mg/ml - 3 mg/ml

A phenylephrine and ketorolac product containing phenylephrine hydrochloride, registered in Belgium by Rayner Surgical (Ireland). The same ATC class is registered in 6 of our 19 countries.

ATC S01FB51

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedOmidria 10 mg/ml - 3 mg/mlATCS01FB51REGISTER NO.BE-AMP-SAM478933-00PACKS LISTED0CHECKEDSeptember 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

Phenylephrine and ketorolac is registered in 6 of 19 countries.

Countries holding a registration under ATC S01FB51 (phenylephrine and ketorolac), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 4 of them publish a price we can compare per daily dose
Search phenylephrine and ketorolac products by name

Phenylephrine and ketorolac · ATC S01FB51

6 / 19 countries

  • Belgiumprice
  • Denmark
  • Finlandprice
  • Polandprice
  • United Kingdom
  • United Statesprice
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
Rayner Surgical (Ireland)
Country
Belgium (BE)
ATC code
S01FB51
ATC class
Phenylephrine and ketorolac
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

Phenylephrine and ketorolac in 15 other countries

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

All phenylephrine and ketorolac 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/80c265d9-a308-4a72-9cf9-bf073a1334e3
GET /v1/drugs/80c265d9-a308-4a72-9cf9-bf073a1334e3?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": "Concentrate for solution for intraocular irrigation",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "Omidria 10 mg/ml - 3 mg/ml",
  "name_fr": "Omidria 10 mg/ml - 3 mg/ml",
  "name_nl": "Omidria 10 mg/ml - 3 mg/ml",
  "amp_code": "SAM478933-00",
  "strengths": [
    "10.2000",
    "10.2000",
    "10.2000",
    "2.8800",
    "2.8800",
    "2.8800"
  ],
  "pack_count": 1,
  "substances": [
    "Phenylephrine Hydrochloride",
    "Phenylephrine",
    "Ketorolac Trometamol",
    "Ketorolac",
    "Mannitol",
    "Sodium Chloride",
    "Sodium Hydroxide",
    "Polysorbate 80"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Phenylephrine and Ketorolac",
  "authorisation_numbers": [
    "EU/1/15/1018/001"
  ]
}
API referenceMCP serverPlans

See everything about phenylephrine and ketorolac.

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.

Try it freeOpen in the console