Zolgensma

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Onasemnogene abeparvovec 20TVG/mL (TVG = Tera Vector Genomes; equivalent to 2 x 10^13 vector genomes per mL)

Available from:

Novartis New Zealand Ltd

Pharmaceutical form:

Solution for infusion

Composition:

Active: Onasemnogene abeparvovec 20TVG/mL (TVG = Tera Vector Genomes; equivalent to 2 x 10^13 vector genomes per mL) Excipient: Hydrochloric acid Magnesium chloride Poloxamer 188 Sodium chloride Trometamol Water for injection

Prescription type:

Prescription

Therapeutic indications:

Zolgensma is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of paediatric patients with spinal muscular atrophy (SMA) with a bi allelic mutation in the survival motor neuron 1 (SMN1) gene.

Product summary:

Package - Contents - Shelf Life: Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 2 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 3 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 4 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 5 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 6 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 7 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 8 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 9 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 10 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 11 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 12 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 13 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 14 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe

Authorization date:

2022-05-12