Belgium· BE-AMP-SAM117494-00
Sekin 3.54 mg/ml
A cloperastine product containing cloperastine fendizoate, registered in Belgium by Almirall. The same ATC class is registered in 3 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
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
Cloperastine · ATC R05DB21
3 / 19 countries
- Belgiumprice
- Japan
- Spainprice
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Cloperastine Fendizoate
- Manufacturer
- Almirall
- 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_apb0867663
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.
- SpainCLOPERASTINA KERN PHARMA 3,54 mg/ml JARABEKern Pharma S.L.
- SpainCLOPERASTINA NORMON 3,54 mg/ml SUSPENSION ORALLaboratorios Normon S.A.
- BelgiumLysotossil 10 mgZambon
- BelgiumLysotossil 3.54 mg/mlZambon
- BelgiumSekin 10 mgAlmirall
- Japanクロペラスチンフェンジゾ酸塩ニプロ
- Japanクロペラスチンフェンジゾ酸塩ニプロ
- Japanクロペラスチン塩酸塩ニプロ
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/ff0b52a5-610a-4fc0-a61c-6f3e245678e7 GET /v1/drugs/ff0b52a5-610a-4fc0-a61c-6f3e245678e7?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": "Sekin 3.54 mg/ml",
"name_fr": "Sekin 3.54 mg/ml",
"name_nl": "Sekin 3.54 mg/ml",
"amp_code": "SAM117494-00",
"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": [
"BE117494"
]
}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.