Is Romiplostim registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Romiplostim, including NPLATE 250 MCG POWDER FOR SOLUTION FOR INJECTION (250 µg, Powder and solvent for solution for injection, SAR 2701.95).

Is Romiplostim approved by the US FDA?

Drugs@FDA lists 1 application product line for Romiplostim, including NPLATE (Prescription).

Is Romiplostim authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Romiplostim: Nplate.

Are there safety signals or safety updates for Romiplostim?

US FDA: 1 entry (latest 2025-02-21).

Active substance

Romiplostim

SFDA 1
US FDA 1
EMA 1
Health Canada 2
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NPLATE 250 MCG POWDER FOR SOLUTION FOR INJECTION	250 µg	Powder and solvent for solution for injection · Subcutaneous use	1 Vial	SAR 2701.95	Biological · Prescription	AMGEN EUROPE B.V.	Valid

Indications — CHI Daman Drug Formulary

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); IMMUNE THROMBOCYPTOPENIC PUPURA; MYELODYSPLASTIC SYNDROMES- ANEMIA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
NPLATE	250MCG/0.5ML; 500MCG/1ML.	injectable · subcutaneous	AMGEN	Prescription	22 Aug 2008

EMA European Union — centrally authorised medicines

Nplate Amgen Europe B.V. · Authorised · authorised 4 Feb 2009 · ATC B02BX04

Therapeutic indication (EMA)

Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Paediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NPLATE	02322854	375 MCG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	AMGEN CANADA INC
NPLATE	02322862	625 MCG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	AMGEN CANADA INC

Safety signals and safety-related labeling changes

US FDA 21 Feb 2025 NPLATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for romiplostim →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.