NPLATE

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

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 about Romiplostim

Medication package inserts

Below package inserts are available for further reading:

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