Is Caplacizumab 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 Caplacizumab, including Cablivi (10 mg, Powder and solvent for solution for injection, SAR 16906.90).

Is Caplacizumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Caplacizumab, including CABLIVI (Prescription).

Is Caplacizumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Caplacizumab: Cablivi.

Are there safety signals or safety updates for Caplacizumab?

US FDA: 1 entry (latest 2025-12-23).

Active substance

Caplacizumab

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
Cablivi	10 mg	Powder and solvent for solution for injection · Intravenous, Subcutaneous	1 Vial	SAR 16906.90	Biological · Prescription	Ablynx NV	Valid

Indications — CHI Daman Drug Formulary

THROMBOTIC THROMBOCYTOPENIC PURPURA

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

Product	Strength	Form · route	Applicant	Status	First approved
CABLIVI	11MG/VIAL	injectable · injection	ABLYNX NV	Prescription	6 Feb 2019

EMA European Union — centrally authorised medicines

Cablivi Ablynx NV · Authorised · authorised 30 Aug 2018 · ATC B01A

Therapeutic indication (EMA)

Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

Safety signals and safety-related labeling changes

US FDA 23 Dec 2025 CABLIVI — 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 caplacizumab →

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.