Germany· DE-A57-de99613784d6e6e2
Prolastin
A medicinal product containing human alpha1-proteinase inhibitor, registered in Germany by Grifols Deutschland 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
- Human Alpha1-Proteinase Inhibitor
- Manufacturer
- Grifols Deutschland Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- August 5, 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
Human alpha1-proteinase inhibitor in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FinlandProlastinaGrifols Deutschland GmbH
- CzechiaPROLASTINAGrifols Deutschland GmbH, Frankfurt
- FranceALFALASTIN 33,33 mg/mL, poudre et solvant pour solution injectableLFB-BIOMEDICAMENTS
- NorwayProlastinaGrifols Deutschland GmbH
- SwedenProlastina 1000 mg Pulver och vätska till infusionsvätska, lösningGrifols Deutschland GmbH
- IcelandRespreezaCSL Behring GmbH*
- IrelandProlastin 4000 mg, powder and solvent for solution for infusionGrifols Deutschland GmbH
- PolandRespreezaCSL Behring GmbH
Authorised across Europe · EMA
The same active substance is authorised in 20 EEA countries. Names it is sold under:
- Austria · Prolastin
- Belgium · Pulmolast
- Cyprus · Prolastina
- Czechia · Prolastina
- Denmark · Prolastina
- Spain · Prolasplan, Prolastina
- Finland · Prolastina
- France · Alfalastin, Prolastin
- Greece · Prolastin
- Croatia · Prolastina
- Ireland · Prolastin
- Iceland · Respreeza
- Italy · Plitalfa, Prolastin
- Liechtenstein · Respreeza
- Netherlands · Prolastin
- Norway · Prolastina, Respreeza
- Poland · Prolastin, Prolastin, 4000 Mg
- Portugal · Prolastin
- Sweden · Prolastina
- Slovakia · Prolastina
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/2937ce75-fddd-4347-b1ed-b2df2880d6d1 GET /v1/drugs/2937ce75-fddd-4347-b1ed-b2df2880d6d1?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": "Intravenous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Human Alpha1-Proteinase Inhibitor",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about human alpha1-proteinase inhibitor.
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.