Is Marstacimab 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 Marstacimab, including HYMPAVZI (150 mg/ml, Solution for injection in pre-filled pen, SAR 29782.40).

Is Marstacimab approved by the US FDA?

Drugs@FDA lists 1 application product line for Marstacimab, including HYMPAVZI (Prescription).

Is Marstacimab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Marstacimab: Hympavzi.

Are there safety signals or safety updates for Marstacimab?

US FDA: 1 entry (latest 2026-06-05).

Active substance

Marstacimab

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
HYMPAVZI	150 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 29782.40	Biological · Prescription	PFIZER INC	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
HYMPAVZI	300MG	injectable · subcutaneous	PFIZER INC	Prescription	11 Oct 2024

EMA European Union — centrally authorised medicines

Hympavzi Pfizer Europe MA EEIG · Authorised · authorised 18 Nov 2024 · ATC B02BX11

Therapeutic indication (EMA)

Hympavzi is indicated for routine prophylaxis of bleeding episodes in patients 12 years of age and older, weighing at least 35 kg, with: Haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors who have severe disease (FVIII < 1%) with factor VIII inhibitors Haemophilia B (congenital factor IX deficiency) without factor IX inhibitors who have severe disease (FIX < 1%) with factor IX inhibitors.

Safety signals and safety-related labeling changes

US FDA 5 Jun 2026 HYMPAVZI — 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 marstacimab →

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.