Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, Ireland, P43 R298
Palynziq 2.5 mg solution for injection in pre-filled syringe.
Palynziq 10 mg solution for injection in pre-filled syringe.
Palynziq 20 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). Colourless to pale yellow, clear to slightly opalescent solution with pH 6.6 – 7.4. 2.5 mg pre-filled syringe: Osmolality: 260 – 290 mOsm/kg. 10 mg and 20 mg pre-filled syringe: Osmolality: 285 – 315 mOsm/kg, viscous solution. |
Each 2.5 mg pre-filled syringe contains 2.5 mg pegvaliase in 0.5 ml solution.
Each 10 mg pre-filled syringe contains 10 mg pegvaliase in 0.5 ml solution.
Each 20 mg pre-filled syringe contains 20 mg pegvaliase in 1 ml solution.
The strength indicates the quantity of the phenylalanine ammonia lyase (rAvPAL) moiety of pegvaliase without consideration of the PEGylation.
The active substance is a covalent conjugate of the protein phenylalanine ammonia lyase (rAvPAL)* with NHS-methoxypolyethylene glycol (NHS-PEG).
* Anabaena variabilis rAvPAL produced by recombinant DNA technology in Escherichia coli.
The potency of this medicinal product should not be compared to any other PEGylated or non-PEGylated protein of the same therapeutic class. For more information, see section 5.1.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Pegvaliase |
Pegvaliase is a PEGylated recombinant phenylalanine ammonia lyase enzyme that converts phenylalanine to ammonia and trans-cinnamic acid that are primarily eliminated by liver metabolism. |
| List of Excipients |
|---|
|
Trometamol |
1 ml pre-filled syringe made of Type I borosilicate glass, equipped with a stainless steel 26 gauge needle, needle safety device, polypropylene plunger rod, and chlorobutyl or bromobutyl rubber syringe stopper with fluoropolymer coating. The automatic needle guard is composed of a polycarbonate transparent needle guard and a stainless steel spring inside the needle guard. After injection, the spring expands causing the needle to be covered by the needle guard.
Pre-filled syringe 2.5 mg (white plunger):
Each carton contains 1 pre-filled syringe.
Pre-filled syringe 10 mg (green plunger):
Each carton contains 1 pre-filled syringe.
Pre-filled syringe 20 mg (blue plunger):
Each carton contains 1 or 10 pre-filled syringes.
Not all pack sizes may be marketed.
BioMarin International Limited, Shanbally, Ringaskiddy, County Cork, Ireland, P43 R298
EU/1/19/1362/001 1 × 2.5 mg pre-filled syringe
EU/1/19/1362/002 1 × 10 mg pre-filled syringe
EU/1/19/1362/003 1 × 20 mg pre-filled syringe
EU/1/19/1362/004 10 × 20 mg pre-filled syringes
Date of first authorisation: 03 May 2019
| Drug | Countries | |
|---|---|---|
| PALYNZIQ | Austria, Estonia, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, United States |
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