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Medicines
United States
Alfa1 antitrypsin

FDA 2019

Alfa1 antitrypsin

Zemaira

5000MG For InjectionUnited StatesMarketedAuthorised 16 Apr 2019

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On this page

In other countries
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

ZemairaCanada · 4000 MG / VIAL · Kit, Powder For Solution · CSL Behring Canada INCSame brand
ZemairaCanada · 1000 MG / VIAL · Kit, Powder For Solution · CSL Behring Canada INCSame brand
ZemairaCanada · 5000 MG / VIAL · Kit, Powder For Solution · CSL Behring Canada INCSame brand
PROLASTINA 1000 mg, POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN.Spain · 1000 mg · polvo y disolvente para solución para perfusión · Grifols Deutschland GmbhSame form
Prolastina 4.000 MG Polvo y Disolvente Para Solución Para PerfusiónSpain · 4.000 mg · polvo y disolvente para solución para perfusión · Grifols Deutschland GmbhSame form
Prolastina 5.000 MG Polvo y Disolvente Para Solución Para PerfusiónSpain · 5.000 mg · polvo y disolvente para solución para perfusión · Grifols Deutschland Gmbh

More with the same substance on this register

Aralast, Aralast NpAlfa1 antitrypsin · 0.5G · For InjectionUnited States
Aralast, Aralast NpAlfa1 antitrypsin · 1.0G · For InjectionUnited States

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Same form

🇮🇹PlitalfaItaly · Polvere e solvente per soluzione per infusione endovenosa · Grifols Italia S.P.A.Same form

🇮🇹ProlastinItaly · Polvere e solvente per soluzione per infusione endovenosa · Instituto Grifols S.A.Same form

🇮🇹RespreezaItaly · Polvere e solvente per soluzione per infusione endovenosa · CSL Behring GMBHSame form

🇳🇱Prolastin 1000 mg, poeder en oplosmiddel voor oplossing voor infusieNetherlands · Poeder en oplosmiddel voor oplossing voor infusie · Grifols Deutschland GmbHSame form

🇳🇱Prolastin 4000 mg, poeder en oplosmiddel voor oplossing voor infusieNetherlands · Poeder en oplosmiddel voor oplossing voor infusie · Grifols Deutschland GmbHSame form

🇳🇱Prolastin 5000 mg, poeder en oplosmiddel voor oplossing voor infusieNetherlands · Poeder en oplosmiddel voor oplossing voor infusie · Grifols Deutschland GmbHSame form

🇸🇦Prolastine C 50MG/ML VialSaudi Arabia · Grifols Therapeutics INCSame form

🇪🇺RespreezaEuropean Union · CSL Behring GmbHSame substance

🇪🇺InfiniaEuropean Union · Kamada BioPharma Limited at Fieldfisher LLPSame substance

🇭🇷Prolastina 1000 mg prašak i otapalo za otopinu za infuzijuCroatia · Prašak i otapalo za otopinu za infuziju · Grifols Deutschland GmbH, Colmarer Straße 22, Schwanheim, Frankfurt Am Main, Hessen, NjemačkaSame substance

🇭🇷Prolastina 4000 mg prašak i otapalo za otopinu za infuzijuCroatia · Prašak i otapalo za otopinu za infuziju · Grifols Deutschland GmbH, Colmarer Straße 22, Schwanheim, Frankfurt Am Main, Hessen, NjemačkaSame substance

🇭🇷Prolastina 5000 mg prašak i otapalo za otopinu za infuzijuCroatia · Prašak i otapalo za otopinu za infuziju · Grifols Deutschland GmbH, Colmarer Straße 22, Schwanheim, Frankfurt Am Main, Hessen, NjemačkaSame substance

🇷🇴RESPREEZA 1000 mgRomania · 1000mg · pulb+ solv. pt. sol. perf. · CSL Behring GMBHSame substance

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

U.S. Food and Drug Administration

FDA Purple Book, September 2026 release; acquired 2026-10-10T15:29:54.330165+00:00; exact source fields retained with source-key projections.

Licence: FDA-created structured factual administrative metadata; public-domain policy with third-party exceptions · Added 11 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Alfa1 antitrypsin
Strength: 5000MG
Dosage form: For Injection
Route: Intravenous
Register: United States (FDA)
Status: Marketed
Status in the register: Licensed / Rx
Authorised: 16 Apr 2019
Registration: BLA 125078
Marketing authorisation holder: CSL Behring LLC
Procedure: 351(a)
Supply: Rx

FDA

GlassiaAlfa1 antitrypsin · 5G · Injection🇺🇸United States

FDAGlassiaAlfa1 antitrypsin · 4G · Injection🇺🇸United States

FDAGlassiaAlfa1 antitrypsin · 1G · Injection🇺🇸United States

FDAprolastin,prolastin-c,prolastin-c liquidAlfa1 antitrypsin · 4000MG/80ML · Injection🇺🇸United States

FDAprolastin,prolastin-c,prolastin-c liquidAlfa1 antitrypsin · 1000MG/20ML · Injection🇺🇸United States

FDAprolastin,prolastin-c,prolastin-c liquidAlfa1 antitrypsin · 1000MG · For Injection🇺🇸United States

FDAprolastin,prolastin-c,prolastin-c liquidAlfa1 antitrypsin · 500MG/10ML · Injection🇺🇸United States

FDAZemairaAlfa1 antitrypsin · 4000MG · For Injection🇺🇸United States

FDAZemairaAlfa1 antitrypsin · 1000MG · For Injection🇺🇸United States

FDAprolastin,prolastin-c,prolastin-c liquidAlfa1 antitrypsin · 500MG · For Injection🇺🇸United States