Is Romosozumab 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 Romosozumab, including Evenity (105 mg, Solution for injection in pre-filled syringe, SAR 1809.00).

Is Romosozumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Romosozumab, including EVENITY (Prescription).

Is Romosozumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Romosozumab: Evenity.

Are there safety signals or safety updates for Romosozumab?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2021-05-06).

Active substance

Romosozumab

SFDA 1
US FDA 1
EMA 1
Health Canada 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Evenity	105 mg	Solution for injection in pre-filled syringe · Subcutaneous use	2 Pre-filled syringe	SAR 1809.00	Biological · Prescription	Amgen Inc.	Valid

Indications — CHI Daman Drug Formulary

OSTEOPOROSIS

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

Product	Strength	Form · route	Applicant	Status	First approved
EVENITY	105MG/1.17ML	injectable · injection	AMGEN INC	Prescription	9 Apr 2019

EMA European Union — centrally authorised medicines

Evenity UCB Pharma S.A. · Authorised · authorised 9 Dec 2019 · ATC M05BX

Therapeutic indication (EMA)

Evenity is indicated in treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EVENITY	02489597	105 MG / 1.17 ML	SOLUTION · SUBCUTANEOUS	AMGEN CANADA INC

Safety signals and safety-related labeling changes

EMA PRAC 6 May 2021 PRAC signal: Cardiac arrhythmia
Action for MAH: update of the product information: No
EMA PRAC 11 Feb 2021 PRAC signal: Renal impairment
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2021 PRAC signal: Cardiac arrhythmia
Action for MAH: update of the product information: No
US FDA 20 Dec 2019 EVENITY — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for romosozumab →

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.