Belgium· BE-AMP-SAM190285-00
Oculotect 50 mg/ml
A künstliche tränenflüssigkeit und sonstige indifferente präparate product containing povidone, registered in Belgium by Alcon. The same ATC class is registered in 11 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
Where it is registered
Künstliche tränenflüssigkeit und sonstige indifferente präparate is registered in 11 of 19 countries.
Countries holding a registration under ATC S01XA20 (künstliche tränenflüssigkeit und sonstige indifferente präparate), 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
Künstliche tränenflüssigkeit und sonstige indifferente präparate · ATC S01XA20
11 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Povidone
- Manufacturer
- Alcon
- Country
- Belgium (BE)
- ATC code
- S01XA20
- ATC class
- Künstliche Tränenflüssigkeit und sonstige indifferente Präparate
- Reimbursed
- Not published by this register
- Source register
- FAMHP / AFMPS (Belgium)
- Last checked
- September 26, 2026
Packs & prices · 1
- be_apb1412543
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Künstliche tränenflüssigkeit und sonstige indifferente präparate in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandOculacAlcon Nordic A/S
- NetherlandsOculotect unidose 50 mg/ml, oogdruppelsEuro Registratie Collectief B.V.
- FranceNUTRIVISC 5 POUR CENT (20 mg/0,4 ml), collyre en solution en récipient unidoseLABORATOIRES ALCON
- CzechiaARUFILBAUSCH + LOMB IRELAND LIMITED, Dublin
- United KingdomOculotect 5% eye drops 0.4ml unit doseDE Pharmaceuticals
- SwitzerlandProtagent SE, AugentropfenAlcon Switzerland SA
- United StatesiVIZIA Dry EyeThea Pharma Inc.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- France · Dulcilarmes, Fluidabak
- Netherlands · Duratears Free, Oculotect
- Norway · Oculac
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/03bef557-bbd9-46d0-aac6-355b17485567 GET /v1/drugs/03bef557-bbd9-46d0-aac6-355b17485567?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": "Oculotect 50 mg/ml",
"name_fr": "Oculotect 50 mg/ml",
"name_nl": "Oculotect 50 mg/ml",
"amp_code": "SAM190285-00",
"strengths": [
"50.0000",
"50.0000",
"0.0500",
"2.0000",
"1.5000",
"5.4000",
"0.2000"
],
"pack_count": 1,
"substances": [
"Povidone",
"Benzalkonium Chloride",
"Boric Acid",
"Potassium Chloride",
"Sodium Chloride",
"Sodium Hydroxide",
"Sodium Lactate"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Artificial Tears and Other Indifferent Preparations",
"authorisation_numbers": [
"BE190285"
]
}See everything about künstliche tränenflüssigkeit und sonstige indifferente präparate.
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.