Poland· PL-100388656
Flegatussin Caps
A r06cb02 product containing bromhexini hydrochloridum, registered in Poland by Zakłady Farmaceutyczne POLPHARMA S.A..
Checked against URPL (Poland) on
Informational only — not a medical device.
The record
At a glance
URPL (Poland)- Active substance
- Bromhexini hydrochloridum
- Manufacturer
- Zakłady Farmaceutyczne POLPHARMA S.A.
- Country
- Poland (PL)
- ATC code
- R06CB02
- ATC class
- R06CB02
- Reimbursed
- Not published by this register
- Source register
- URPL (Poland)
- Last checked
- September 27, 2026
Packs & prices · 2
- gtin05909991408398
- gtin05909991408404
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
R06cb02 in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- NetherlandsAlbert Heijn Broomhexine HCl hoesttabletten 8 mg, tablettenSameko Farma B.V.
- CzechiaBROMHEXIN BERLIN-CHEMIEBERLIN-CHEMIE AG, Berlín
- FinlandBisolvonOpella Healthcare France SAS
- SwedenBisolvon 0,8 mg/ml Oral lösningOpella Healthcare France SAS
- BelgiumBisolvon Citrus 8 mgSanofi Belgium
- GermanyBisolvonA. Nattermann & Cie. Gmbh
- NorwayBisolvonOpella Healthcare France SAS
- SpainBISOLVON MUCOLITICO 1,6 mg/ ml JARABEOpella Healthcare Spain S.L.
Authorised across Europe · EMA
The same active substance is authorised in 27 EEA countries. Names it is sold under:
- Belgium · Bisolvon Schleimiger Husten, Bisolvon Slijmhoest
- Bulgaria · Бромхексин Актавис, Бромхексин Дс
- Cyprus · Flecoxin
- Czechia · Bromhexin Berlin-Chemie, Bromhexin Egis
- Germany · Bisolvon, Bisolvon Hustentabletten
- Denmark · Bisolvon, Bromhexin "dak"
- Estonia · Bromhexine Grindeks
- Spain · Bisolvon Mucolítico, Bisolvon Mucolítico Infantil
- Finland · Bisolvon, Bisolvon Strong
- France · Bisolvon
- Greece · Bisolvon, Bron-Hal
- Croatia · Bisolex, Bisolex F
- Hungary · Paxirasol
- Ireland · Bisolvon
- Iceland · Sinex
- Italy · Bisolvon, Bisolvon Linctus Gusto Cioccolato-Ciliegia
- Lithuania · Bromhexin Berlin-Chemie, Bromhexine Grindeks
- Luxembourg · Bisolvon Toux Grasse, Toularynx Bromhexine
- Latvia · Bromhexin Sopharma, Bromhexine Grindeks
- Malta · Bisolvon, Bronchotussine
- Netherlands · Albert Heijn Hoestdrank Broomhexine Hcl Healthypharm, Bisolvon
- Norway · Bisolvon, Bromheksin Norfri
- Portugal · Basiflux, Bisolin Adulto
- Romania · Bromfluex, Bromhexin
- Sweden · Bisolvon, Bisolvon Citron
- Slovenia · Bisolvon
- Slovakia · Bromhexin Bc, Bromhexin Berlin-Chemie
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 URPL (Poland). 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/c6240bec-b422-4144-a72a-43ef3fc69bbe GET /v1/drugs/c6240bec-b422-4144-a72a-43ef3fc69bbe?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": "Kapsułki miękkie",
"source": "urpl",
"strength": "8 mg",
"packaging": "05909991408398 ¦ OTC ¦ 133273\n20 kaps.\n05909991408404 ¦ OTC ¦ 133274\n40 kaps.",
"substance": "Bromhexini hydrochloridum 8 mg",
"common_name": "Bromhexini hydrochloridum",
"pl_product_id": "100388656",
"pozwolenie_nr": "25441",
"auth_procedure": "NAR",
"authorisation_validity": "2023-11-24"
}See everything about r06cb02.
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.