Pegvaliase
Enzymes
Sold as PALYNZIQ
- Drug class
- Enzymes
- Availability
- See label
- Routes
- Subcutaneous
- Markets covered
- 2
- Products on record
- 4
Overview
Pegvaliase 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 |
|---|---|---|---|
| CA Canada | Health Canada | 3 | July 30, 2025 |
| EU European Union | EMA | 1 | July 12, 2024 |
CACanada· Health Canada
3 products
Uses
Palynziq (pegvaliase injection) is indicated to reduce blood phenylalanine concentrations in patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/L) despite dietary management.
1 Pediatrics Pediatrics (16 to < 18 years of age): The data to support the efficacy and safety of Palynziq in adolescent patients aged 16 to < 18 years of age are limited (see 14 CLINICAL TRIALS).
Pediatrics (< 16 years of age):
No data are available to support the efficacy and safety of Palynziq in patients < 16 years of age. 2 Geriatrics Geriatrics: No data are available to support the efficacy and safety of Palynziq in geriatric patients.
EUEuropean Union· EMA
1 product
Uses
Palynziq is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control (blood phenylalanine levels greater than 600 micromol/l) despite prior management with available treatment options.
3
How to take
Drug interactions
Known interactions involving Pegvaliase. 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]Health Canada (DPD) · 02526247 · revised July 30, 2025
- [2]European Medicines Agency · EMEA/H/C/004744 · revised July 12, 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.