Is Ixazomib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Ixazomib, including NINLARO 2.3 mg Hard Capsule (2.3 mg, Capsule, hard, SAR 11947.40); NINLARO 3 mg Hard Capsule (3 mg, Capsule, hard, SAR 15269.30); NINLARO 4 mg Hard Capsule (4 mg, Capsule, hard, SAR 19914.95).

Is Ixazomib approved by the US FDA?

Drugs@FDA lists 1 application product line for Ixazomib, including NINLARO (Prescription).

Is Ixazomib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Ixazomib: Ninlaro.

Are there safety signals or safety updates for Ixazomib?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2024-07-01).

Active substance

Ixazomib

SFDA 3
US FDA 1
EMA 1
Health Canada 3
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NINLARO 2.3 mg Hard Capsule	2.3 mg	Capsule, hard · Oral use	3 Blister	SAR 11947.40	NCE · Prescription	TAKEDA PHARMA A/S	Valid
NINLARO 3 mg Hard Capsule	3 mg	Capsule, hard · Oral use	3 Blister	SAR 15269.30	NCE · Prescription	TAKEDA PHARMA A/S	Valid
NINLARO 4 mg Hard Capsule	4 mg	Capsule, hard · Oral use	3 Blister	SAR 19914.95	NCE · Prescription	TAKEDA PHARMA A/S	Valid

Indications — CHI Daman Drug Formulary

AMYLOIDOSIS - LIGHT CHAIN; LYMPHOPLASMACYTIC LYMPHOMA; MULTIPLE MYELOMA

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

Product	Strength	Form · route	Applicant	Status	First approved
NINLARO	EQ 2.3MG BASE; EQ 3MG BASE; EQ 4MG BASE	capsule · oral	TAKEDA PHARMS USA	Prescription	20 Nov 2015

EMA European Union — centrally authorised medicines

Ninlaro Takeda Pharma A/S · Authorised · authorised 21 Nov 2016 · ATC L01XG03

Therapeutic indication (EMA)

Ninlaro in combination with lenalidomide and dexamethasone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NINLARO	02456796	2.3 MG	CAPSULE · ORAL	TAKEDA CANADA INC
NINLARO	02456818	3 MG	CAPSULE · ORAL	TAKEDA CANADA INC
NINLARO	02456826	4 MG	CAPSULE · ORAL	TAKEDA CANADA INC

Safety signals and safety-related labeling changes

US FDA 1 Jul 2024 NINLARO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jan 2024 PRAC signal: Vasculitis
Action for MAH: update of the product information: No
EMA PRAC 6 Jul 2023 PRAC signal: Angioedema and anaphylactic reaction
Action for MAH: update of the product information: No

All safety entries for ixazomib →

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.