Drug Database
Back to search

Belgium· BE-AMP-SAM118535-00

Lysotossil 3.54 mg/ml

A cloperastine product containing cloperastine fendizoate, registered in Belgium by Zambon. The same ATC class is registered in 3 of our 19 countries.

ATC R05DB21

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedLysotossil 3.54 mg/mlATCR05DB21REGISTER NO.BE-AMP-SAM118535-00PACKS LISTED1CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about cloperastine fendizoateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Cloperastine is registered in 3 of 19 countries.

Countries holding a registration under ATC R05DB21 (cloperastine), each read from that country’s own register.

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

Cloperastine · ATC R05DB21

3 / 19 countries

  • Belgiumprice
  • Japan
  • Spainprice
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
Cloperastine Fendizoate
Manufacturer
Zambon
Country
Belgium (BE)
ATC code
R05DB21
ATC class
Cloperastine
Defined daily dose
60 mg, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    1799915

Regulatory notes

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

Same class

Other records under R05DB21

Cloperastine, as other registers publish it.

All cloperastine products

Authorised across Europe · EMA

The same active substance is authorised in 4 EEA countries. Names it is sold under:

  • Spain · Alvitatós, Cinfatusina
  • Italy · Cloel, Seki
  • Luxembourg · Lysotossil
  • Portugal · Sekitocil

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/b7a86028-1f59-409c-bda3-5d780e6752cf
GET /v1/drugs/b7a86028-1f59-409c-bda3-5d780e6752cf?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": "Syrup",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Lysotossil 3.54 mg/ml",
  "name_fr": "Lysotossil 3.54 mg/ml",
  "name_nl": "Lysotossil 3.54 mg/ml",
  "amp_code": "SAM118535-00",
  "strengths": [
    "0.3540",
    "0.1220",
    "0.0180",
    "45.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Cloperastine Fendizoate",
    "Methyl Parahydroxybenzoate",
    "Propyl Parahydroxybenzoate",
    "Sucrose"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Cloperastine",
  "authorisation_numbers": [
    "BE118535"
  ]
}
API referenceMCP serverPlans

See everything about cloperastine.

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