Germany· DE-A57-6544840f6ea0085f
Pulmozyme
A dornase alfa product containing dornase alfa, registered in Germany by Roche Pharma Ag. The same ATC class is registered in 3 of our 19 countries.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
Where it is registered
Dornase alfa is registered in 3 of 19 countries.
Countries holding a registration under ATC DORNASE ALFA (dornase alfa), each read from that country’s own register.
- This record: Germany, from EMA Article 57 (European Union)
- 1 of them publish a price we can compare per daily dose
Dornase alfa · ATC DORNASE ALFA
3 / 19 countries
- Germany
- United Kingdom
- United Statesprice
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Dornase Alfa
- Manufacturer
- Roche Pharma Ag
- Country
- Germany (DE)
- ATC code
- DORNASE ALFA
- ATC class
- DORNASE ALFA
- 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
Dornase alfa in 15 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwedenPulmozyme 1 mg/ml Lösning för nebulisatorOrifarm AB
- NetherlandsPulmozyme 2500 E/2,5 ml, verneveloplossingBModesto B.V.
- United KingdomPulmozyme 2.5mg nebuliser liquid 2.5ml ampoulesWaymade Healthcare Plc
- IrelandPulmozyme 2500 U/ 2.5ml, nebuliser solutionRoche Products (Ireland) Limited
- CzechiaPULMOZYMEROCHE s.r.o., Praha
- IcelandPulmozymeRoche Pharmaceuticals A/S
- Japanドルナーゼ アルファ（遺伝子組換え）中外製薬
- NorwayPulmozymeRoche Norge AS
Authorised across Europe · EMA
The same active substance is authorised in 28 EEA countries. Names it is sold under:
- Austria · Pulmozyme
- Belgium · Pulmozyme
- Bulgaria · Пулмозим
- Cyprus · Pulmozyme
- Czechia · Pulmozyme
- Denmark · Pulmozyme
- Estonia · Pulmozyme
- Spain · Pulmozyme
- Finland · Pulmozyme
- France · Pulmozyme
- United Kingdom (Northern Ireland) · Pulmozyme
- Greece · Pulmozyme
- Croatia · Pulmozyme Otopina Za Atomizator
- Hungary · Pulmozyme
- Ireland · Pulmozyme
- Iceland · Pulmozyme
- Italy · Pulmozyme
- Lithuania · Pulmozyme
- Luxembourg · Pulmozyme
- Latvia · Pulmozyme
- Netherlands · Pulmozyme Verneveloplossing
- Norway · Pulmozyme
- Poland · Pulmozyme
- Portugal · Pulmozyme
- Romania · Pulmozyme
- Sweden · Pulmozyme
- Slovenia · Pulmozyme
- Slovakia · Pulmozyme
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/edc63353-5f54-43d4-9aaa-f6a67c5b03b8 GET /v1/drugs/edc63353-5f54-43d4-9aaa-f6a67c5b03b8?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": "Inhalation Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Dornase Alfa",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about dornase alfa.
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.