Register of Class 2 Cell, Tissue or Gene Therapy Products

Find information on currently registered cell, tissue or gene therapy products (CTGTP) in Singapore.

Product Name	Active Ingredient(s)	Product Registration Number	Registrant	Approval Date	Approved Package Insert (PI)/ Patient Information Leaflet (PIL)
KYMRIAH^® cells dispersion for infusion	Tisagenlecleucel	CTGT0001P	Novartis (Singapore) Pte Ltd	2021/03/03	Kymriah PI approved 4 January 2023
LUXTURNA^® 5x10¹² vector genomes/ml Concentrate and Solvent for Solution for Injection	Voretigene neparvovec	CTGT0002P	Novartis (Singapore) Pte Ltd	2022/01/20	Luxturna PI approved 20 January 2022 Luxturna PIL approved 20 January 2022
YESCARTA^® suspension for intravenous infusion	Axicabtagene ciloleucel	CTGT0003P	Gilead Sciences Singapore Pte Ltd	2023/03/01	Yescarta PI approved 01 March 2023 Yescarta PIL approved 01 March 2023

Product Name

Active Ingredient(s)

Product Registration Number

Registrant

Approval Date

Approved Package Insert (PI)/ Patient Information Leaflet (PIL)

KYMRIAH^® cells dispersion for infusion

Tisagenlecleucel

CTGT0001P

Novartis (Singapore) Pte Ltd

2021/03/03

LUXTURNA^® 5x10¹² vector genomes/ml Concentrate and Solvent for Solution for Injection

Voretigene neparvovec

CTGT0002P

Novartis (Singapore) Pte Ltd

2022/01/20

YESCARTA^® suspension for intravenous infusion

Axicabtagene ciloleucel

CTGT0003P

Gilead Sciences Singapore Pte Ltd

2023/03/01

Last updated: 31 Dec 2018