ZARZIO

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Germany, Hong Kong SAR China, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.

Active ingredients

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

1	Filgrastim UNII PVI5M0M1GW - FILGRASTIM
	Filgrastim causes marked increases in peripheral blood neutrophil counts within 24 hours, with minor increases in monocytes.
	Read more about Filgrastim

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A6-100053	Injection	ZARZIO 30MU/0.5ML INJ 30MU/0.5ml 50.5ml	Filgrastim 30MU/0.5ml Filgrastim Filgrastim Vaccines & Biologicals Biologics Imported Products 50.5ml 16/06/2020 Novartis Nigeria Limited, Landmark Building 52-54 Isaac John Street Ikeja GRA, Lagos 2.34707E+12 arit.onwusah@novartis.com Sandoz GmbH, Biochemiestrasse 10, Langkampfen Austria , Sandoz GmbH, Biochemiestrasse 10, Langkampfen Austria , Austria	29/08/2022
A6-100055	Injection	ZARZIO 48MU/0.5ML INJ 48MU/0.5ML 5 0.5ml	Filgrastim 48MU/0.5ML Filgrastim Filgrastim Vaccines & Biologicals Biologics Imported Products 5 0.5ml 16/06/2020 Novartis Nigeria Limited, Landmark Building 52-54 Isaac John Street Ikeja GRA, Lagos 2.34707E+12 arit.onwusah@novartis.com Sandoz GmbH, Biochemiestrasse 10, Langkampfen Austria , Sandoz GmbH, Biochemiestrasse 10, Langkampfen Austria , Austria	29/08/2022

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
ZARZIO Solution for injection / infusion	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		Classification
L03AA02	Filgrastim	L Antineoplastic and immunomodulating agents → L03 Immunostimulants → L03A Immunostimulants → L03AA Colony stimulating factors
Discover more medicines within L03AA02

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
AU	Pharmaceutical Benefits Scheme	2733W, 2747N, 2758E, 2783L
BR	Câmara de Regulação do Mercado de Medicamentos	511518120069307
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	10271504, 10275956, 11013342, 11013359, 11138569, 11138575, 11218854, 11218860, 11367778, 11367784, 11657625, 11852999, 11856655, 11856661, 11878378, 12345460, 12366522, 12388251, 12536243, 12536266, 12554459, 12562499, 12562507, 12566936, 12566942, 12802785, 12802816, 12871622, 12871639, 14178233, 14417608, 15390113, 15390136, 15433762, 15433779, 16744027, 16744033, 17180420
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	68-MBE-0816, 85-MBE-0117
EE	Ravimiamet	1399204, 1399215, 1399226, 1399237, 1399248, 1399259, 1399260, 1399271
ES	Centro de información online de medicamentos de la AEMPS	08495001, 08495003, 08495005, 08495007
FI	Lääkealan turvallisuus- ja kehittämiskeskus	157756, 170672
FR	Base de données publique des médicaments	60514839, 60670037
GB	Medicines & Healthcare Products Regulatory Agency	199531, 199533
HK	Department of Health Drug Office	62169, 64300
IT	Agenzia del Farmaco	039125012, 039125024, 039125036, 039125048, 039125051, 039125063, 039125075, 039125087
LT	Valstybinė vaistų kontrolės tarnyba	1036013, 1036014, 1036015, 1036016, 1036017, 1036018, 1036019, 1036020, 1058043, 1058044, 1058045, 1058046, 1058047, 1058048, 1058049, 1058050
NG	Registered Drug Product Database	A6-100053, A6-100055
NL	Z-Index G-Standaard	14165082
NL	Z-Index G-Standaard, PRK	41831, 41858
NZ	Medicines and Medical Devices Safety Authority	14962, 14963
PL	Rejestru Produktów Leczniczych	100206431, 100206454
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W53892001, W53892002, W53892003, W53892004, W53893001, W53893002, W53893003, W53893004
SG	Health Sciences Authority	14764P
TN	Direction de la Pharmacie et du Médicament	11073011H, 11073012H
TR	İlaç ve Tıbbi Cihaz Kurumu	8681428951079, 8681428951086, 8681428951093, 8681428951109
ZA	Health Products Regulatory Authority	47/30.4/0603, 47/30.4/0604