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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 19 April 2023

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 1 March 2023

Yescarta PIL approved 1 March 2023

ZOLGENSMA® Suspension for intravenous infusion Onasemnogene abeparvovec CTGT0004P Novartis (Singapore) Pte Ltd 2023/04/21 Zolgensma PI approved 22 February 2024
SpheChon 10-70 spheroids/cm2 implantation suspension  Spheroids of human autologous matrix-associated chondrocytes

CTGT0005P CTGT0006P

Labcorp Development (Asia) Pte Ltd 2023/12/15 SpheChon PI approved 15 December 2023
           
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