Is Crizanlizumab registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Crizanlizumab.

Is Crizanlizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Crizanlizumab, including ADAKVEO (Prescription).

Is Crizanlizumab authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Crizanlizumab.

Are there safety signals or safety updates for Crizanlizumab?

US FDA: 1 entry (latest 2024-06-26).

Active substance

Crizanlizumab

SFDA 1
US FDA 1
EMA 1
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
Adakveo	10 mg/ml	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 6064.50	Biological · Prescription	Novartis Europharm Limited	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ADAKVEO	100MG/10ML	injectable · injection	NOVARTIS PHARMS CORP	Prescription	15 Nov 2019

EMA European Union — centrally authorised medicines

Adakveo Novartis Europharm Limited · Revoked · authorised 28 Oct 2020 · ATC B06AX01

Therapeutic indication (EMA)

Adakveo is indicated for the prevention of recurrent vaso occlusive crises (VOCs) in sickle cell disease patients aged 16 years and older. It can be given as an add on therapy to hydroxyurea/hydroxycarbamide (HU/HC) or as monotherapy in patients for whom HU/HC is inappropriate or inadequate.

Safety signals and safety-related labeling changes

US FDA 26 Jun 2024 ADAKVEO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for crizanlizumab →

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.