Iceland· IS-IS/1/23/097/01
Sínex
A bromhexine product containing bromhexinum inn hýdróklóríð, registered in Iceland by Laboratoria Qualiphar. The same ATC class is registered in 15 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) on
Informational only — not a medical device.
Where it is registered
Bromhexine is registered in 15 of 19 countries.
Countries holding a registration under ATC R05CB02 (bromhexine), each read from that country’s own register.
- This record: Iceland, from Icelandic Medicines Agency (Iceland)
- 8 of them publish a price we can compare per daily dose
Bromhexine · ATC R05CB02
15 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Germany
- Icelandprice
- Ireland
- Japan
- Netherlands
- Norwayprice
- Polandprice
- Sweden
- Switzerlandprice
- United Kingdom
The record
At a glance
Icelandic Medicines Agency (Iceland)- Active substance
- Bromhexinum INN hýdróklóríð
- Manufacturer
- Laboratoria Qualiphar
- Country
- Iceland (IS)
- ATC code
- R05CB02
- ATC class
- Bromhexine
- Defined daily dose
- 24 mg, O
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 29, 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
Bromhexine in 13 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumToularynx Bromhexine 5 mg/5 mlLaboratoria Qualiphar
- NetherlandsAlbert Heijn Broomhexine HCl hoesttabletten 8 mg, tablettenSameko Farma B.V.
- CzechiaBROMHEXIN BERLIN-CHEMIEBERLIN-CHEMIE AG, Berlín
- PolandFlegafortanAflofarm Farmacja Polska Sp. z o.o.
- FinlandBisolvonBoehringer Ingelheim International GmbH
- SwedenBisolvon 0,8 mg/ml Oral lösningOpella Healthcare France SAS
- GermanyBisolvonA. Nattermann & Cie. Gmbh
- NorwayBisolvonOpella Healthcare France SAS
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
- 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
- Poland · Flegafortan, Flegamina Baby
- 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 Icelandic Medicines Agency (Iceland). 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/364e6efe-97ef-49c7-a152-9f8b3e6a78dd GET /v1/drugs/364e6efe-97ef-49c7-a152-9f8b3e6a78dd?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": "Saft",
"source": "lyfjastofnun",
"atc_raw": "R05CB02",
"marketed": true,
"strength": "1 mg/ml",
"ma_number": "IS/1/23/097/01",
"substance": "Bromhexinum INN hýdróklóríð",
"other_info": null,
"legal_status": "(L) Ekki lyfseðilsskylt",
"ma_issued_serial": "45170"
}See everything about bromhexine.
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.