Vaccines, Blood & Biologics
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GLASSIA
STN: 125325
Proper Name: Alpha1-Proteinase Inhibitor (Human)
Tradename: GLASSIA
Manufacturer: Kamada Ltd.
Indication:
- Treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin.
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Supporting Documents
July 1, 2010 Approval Letter - GLASSIA
STN 125325/0, Treatment of chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha-1-proteinase inhibitor (Alpha1-PI), also known as alpha1-antitrypsin.Summary Basis for Regulatory Action - GLASSIA, June 14, 2010 (PDF - 237KB)Approval History, Letters, Reviews, and Related Documents - GLASSIA
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Related Information
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
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