Agalsidase Beta
Enzymes
Sold as FABRAZYME
- Drug class
- Enzymes
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 7
Overview
Agalsidase Beta is an active pharmaceutical ingredient in the Enzymes group (A16AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 4 | April 17, 2026 |
| CA Canada | Health Canada | 2 | March 22, 2025 |
| EU European Union | EMA | 1 | September 4, 2024 |
GBUnited Kingdom· MHRA
4 products
Uses
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency). Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.
How to take
CACanada· Health Canada
2 products
Uses
FABRAZYME (agalsidase beta) is indicated for: • long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease. 1 Pediatrics Pediatrics (≥8 years of age): The safety and efficacy of Fabrazyme has been demonstrated in Fabry patients at least 8 years of age.
(see 7 WARNINGS AND PRECAUTIONS - Pediatrics and 14 CLINICAL TRIALS) Pediatrics (<8 years of age): The safety and efficacy of Fabrazyme have not been studied in children below the age of 8 years. 2 Geriatrics (≥ 65 years of age) Clinical studies of Fabrazyme did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects.
How to take
EUEuropean Union· EMA
1 product
Uses
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency). Fabrazyme is indicated in adults, children and adolescents aged 8 years and older.
How to take
Drug interactions
Known interactions involving Agalsidase Beta. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB044250767 · revised April 17, 2026
- [2]Health Canada (DPD) · 02248965 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/000370 · revised September 4, 2024
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.