Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Zilbrysq 16.6 mg solution for injection in pre-filled syringe.
Zilbrysq 23 mg solution for injection in pre-filled syringe.
Zilbrysq 32.4 mg solution for injection in pre-filled syringe.
| Pharmaceutical Form |
|---|
|
Solution for injection (injection). The solution is clear to slightly opalescent and colourless, free of visible particles. The pH and osmolality of the solution are approximately 7.0 and 300 mOsm/kg respectively. |
Zilbrysq 16.6 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains zilucoplan sodium equivalent to 16.6 mg zilucoplan in 0.416 mL (40 mg/mL).
Zilbrysq 23 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains zilucoplan sodium equivalent to 23 mg zilucoplan in 0.574 mL (40 mg/mL).
Zilbrysq 32.4 mg solution for injection in pre-filled syringe: Each pre-filled syringe contains zilucoplan sodium equivalent to 32.4 mg zilucoplan in 0.810 mL (40 mg/mL).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Zilucoplan |
Zilucoplan is a 15 amino acid, synthetic macrocyclic peptide that inhibits the effects of the complement protein C5 through a dual mechanism of action. It specifically binds to C5, thereby inhibiting its cleavage by the C5 convertase to C5a and C5b, which results in a downregulation of the assembly and cytolytic activity of the membrane attack complex (MAC). Additionally, by binding to the C5b moiety of C5, zilucoplan sterically hinders binding of C5b to C6, which prevents the subsequent assembly and activity of the MAC, should any C5b be formed. |
| List of Excipients |
|---|
|
Sodium dihydrogen phosphate, monohydrate |
Pre-filled syringe (type I glass) with a 29G ½" thin wall needle closed with a grey fluoropolymer-laminated bromobutyl rubber plunger stopper. The needle is protected with a rigid needle shield consisting of a thermoplastic elastomer needle shield and a polypropylene rigid shield. Each pre-filled syringe is pre-assembled with a needle safety device, a finger grip and a coloured plunger:
Zilbrysq 16.6 mg solution for injection in pre-filled syringe: 0.416 mL solution for injection in pre-filled syringe with rubine red plunger.
Zilbrysq 23 mg solution for injection in pre-filled syringe: 0.574 mL solution for injection in pre-filled syringe with orange plunger.
Zilbrysq 32.4 mg solution for injection in pre-filled syringe: 0.810 mL solution for injection in pre-filled syringe with dark blue plunger.
Pack size of 7 pre-filled syringes for 16.6 mg, 23 mg and 32.4 mg solution for injection.
Multipack containing 28 (4 packs of 7) pre-filled syringes.
Not all pack sizes may be marketed.
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
Zilbrysq 16.6 mg solution for injection in pre-filled syringe:
EU/1/23/1764/001
EU/1/23/1764/002
Zilbrysq 23 mg solution for injection in pre-filled syringe:
EU/1/23/1764/003
EU/1/23/1764/004
Zilbrysq 32.4 mg solution for injection in pre-filled syringe:
EU/1/23/1764/005
EU/1/23/1764/006
| Drug | Countries | |
|---|---|---|
| ZILBRYSQ | Estonia, France, Croatia, Lithuania, Romania, United States |
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