Is Reslizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Reslizumab, including CINQAIR (Prescription).

Is Reslizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Reslizumab: Cinqaero.

Are there safety signals or safety updates for Reslizumab?

US FDA: 1 entry (latest 2019-01-09).

Active substance

Reslizumab

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
CINQAIR	100MG/10ML	injectable · injection	TEVA RESPIRATORY LLC	Prescription	23 Mar 2016

EMA European Union — centrally authorised medicines

Cinqaero Teva B.V. · Authorised · authorised 15 Aug 2016 · ATC R03DX08

Therapeutic indication (EMA)

Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CINQAIR	02456419	10 MG / ML	SOLUTION · INTRAVENOUS	TEVA CANADA LIMITED

Safety signals and safety-related labeling changes

US FDA 9 Jan 2019 CINQAIR — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for reslizumab →

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.