SYNAGIS

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug SYNAGIS contains one active pharmaceutical ingredient (API):

1 Palivizumab UNII DQ448MW7KS - PALIVIZUMAB

Palivizumab is a humanised IgG1κ monoclonal antibody directed to an epitope in the A antigenic site of the fusion protein of respiratory syncytial virus (RSV). This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences. It has potent neutralising and fusion-inhibitory activity against both RSV subtype A and B strains. Read about Palivizumab

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SYNAGIS Solution for injection	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
J06BD01	Palivizumab	J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BD Antiviral monoclonal antibodies
Discover more medicines within J06BD01

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 502321080034717, 502321080034817, 543714100000318, 543714100000418
Country: CA	Health Products and Food Branch	Identifier(s): 02438364, 02438372
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 44-MBE-0116
Country: EE	Ravimiamet	Identifier(s): 1141221, 1141232, 1662678, 1662689
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 199117003, 199117004
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 379856, 536087
Country: FR	Base de données publique des médicaments	Identifier(s): 67810869, 68932534
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 302514, 302517
Country: HK	Department of Health Drug Office	Identifier(s): 64445, 64446
Country: IE	Health Products Regulatory Authority	Identifier(s): 88557, 88563
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8947, 8948
Country: IT	Agenzia del Farmaco	Identifier(s): 034529014, 034529026, 034529038, 034529040
Country: JP	医薬品医療機器総合機構	Identifier(s): 6250404A1020, 6250404A2026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1030810, 1030812, 1059513, 1074856, 1089017
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 126012, 126020
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 17462, 17463
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100095807, 100095813, 100326840, 100461498
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67584001, W67585001
Country: SG	Health Sciences Authority	Identifier(s): 11256P, 15112P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699786770911, 8699786770928
Country: US	FDA, National Drug Code	Identifier(s): 60574-4113, 60574-4114
Country: ZA	Health Products Regulatory Authority	Identifier(s): 34/30.2/0240, 34/30.2/0241, 50/30.1/0148