NPLATE

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Romiplostim UNII GN5XU2DXKV - ROMIPLOSTIM
	Romiplostim is an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor (also known as cMpl) to increase platelet production.
	Read more about Romiplostim

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
NPLATE Powder for solution for injection	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
B02BX04	Romiplostim	B Blood and blood forming organs → B02 Antihemorrhagics → B02B Vitamin K and other hemostatics → B02BX Other systemic hemostatics
Discover more medicines within B02BX04

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	9696H, 9697J, 9698K, 9699L
BR	Câmara de Regulação do Mercado de Medicamentos	544115070000517
CA	Health Products and Food Branch	02322854, 02322862
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	H6240813
EE	Ravimiamet	1399361, 1399372, 1459919, 1459931, 1459942, 1459953, 1459964, 1459975, 1764110, 1764121
ES	Centro de información online de medicamentos de la AEMPS	08497001, 08497005, 08497007
FI	Lääkealan turvallisuus- ja kehittämiskeskus	027807, 027818, 090149, 090161
FR	Base de données publique des médicaments	64313253, 68638461
GB	Medicines & Healthcare Products Regulatory Agency	172249, 358913
HK	Department of Health Drug Office	60582
IL	מִשְׂרַד הַבְּרִיאוּת	6683
IT	Agenzia del Farmaco	039002011, 039002023, 039002035, 039002047, 039002050, 039002062, 039002074, 039002086, 039002098, 039002100
LT	Valstybinė vaistų kontrolės tarnyba	1036005, 1036006, 1050900, 1050901, 1052875, 1052876, 1052877, 1052878, 1086607, 1086608
NL	Z-Index G-Standaard, PRK	151629, 92312, 92320
PL	Rejestru Produktów Leczniczych	100207979, 100207985, 100223493, 100223501, 100410427
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W53894001
TR	İlaç ve Tıbbi Cihaz Kurumu	8699862270045, 8699862270052
US	FDA, National Drug Code	55513-221, 55513-222, 55513-223
ZA	Health Products Regulatory Authority	45/8.2/0175, 45/8.2/0176