Germany· DE-A57-77e229a08ec8acda
Reactine Duo
A medicinal product containing pseudoephedrine hydrochloride, cetirizine dihydrochloride, registered in Germany by Kenvue Germany Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Pseudoephedrine Hydrochloride, Cetirizine Dihydrochloride
- Manufacturer
- Kenvue Germany Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
Pseudoephedrine hydrochloride, cetirizine dihydrochloride in 6 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United States12 hour allergy dMeijer Distribution Inc
- PolandCirrusVEDIM Sp. z o.o.
- SpainREACTINE CETIRIZINA/PSEUDOEFEDRINA 5mg/120mg COMPRIMIDOS DE LIBERACION PROLONGADAJntl Consumer Health (Spain) S.L.
- FinlandCirrusOrifarm Oy
- CanadaREACTINE COMPLETEMCNEIL CONSUMER HEALTHCARE DIVISION OF JOHNSON & JOHNSON INC
- IrelandZirtek Plus Decongestant 5mg/120mg Prolonged Release TabletUCB (Pharma) Ireland Limited,
Authorised across Europe · EMA
The same active substance is authorised in 12 EEA countries. Names it is sold under:
- Belgium · Cirrus, Rhinosinutab
- Bulgaria · Зиртек-D
- Estonia · Cirrus
- Spain · Reactine, Respidina Antialérgica
- Hungary · Zyrtec-D
- Ireland · Zirtek Plus Decongestant
- Italy · Reactine, Zirtec Decongestionante Antistaminico
- Lithuania · Cirrus
- Luxembourg · Cirrus, Rhinosinutab
- Latvia · Cirrus
- Malta · Cirrus
- Poland · Cirrus, Cirrus Duo
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 EMA Article 57 (European Union). 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/ece63932-9ed0-4b8c-823f-e2ba28689dc2 GET /v1/drugs/ece63932-9ed0-4b8c-823f-e2ba28689dc2?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.
{
"pzn": null,
"route": "Oral Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Pseudoephedrine Hydrochloride, Cetirizine Dihydrochloride",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about pseudoephedrine hydrochloride, cetirizine dihydrochloride.
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.