Is Pertuzumab 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 Pertuzumab, including PERJETA 420 mg Concentrate for solution for infusion (420 mg, Concentrate for solution for infusion, SAR 10178.05).

Is Pertuzumab approved by the US FDA?

Drugs@FDA lists 2 application product lines for Pertuzumab, including PERJETA (Prescription); POHERDY (Prescription).

Is Pertuzumab authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Pertuzumab: Perjeta, Poherdy.

Are there safety signals or safety updates for Pertuzumab?

EMA PRAC: 3 entries; US FDA: 1 entry (latest 2026-04-23).

Active substance

Pertuzumab

SFDA 1
US FDA 2
EMA 3
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
PERJETA 420 mg Concentrate for solution for infusion	420 mg	Concentrate for solution for infusion · Intravenous use	1 Vial	SAR 10178.05	NCE · Prescription	ROCHE	Valid

Indications — CHI Daman Drug Formulary

BILIARY TRACT CANCER; BREAST CANCER HER-2 +VE; BREAST CANCER MET.HER-2 +VE; COLORECTAL CANCER-ADVANCED/ METASTATIC

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

Product	Strength	Form · route	Applicant	Status	First approved
PERJETA	420MG/14ML	vial · single-use	GENENTECH	Prescription	8 Jun 2012
POHERDY	420MG/14ML(30MG/ML)	injectable · intravenous	SHANGHAI HENLIUS BIOTECH	Prescription	13 Nov 2025

EMA European Union — centrally authorised medicines

Perjeta Roche Registration GmbH · Authorised · authorised 4 Mar 2013 · ATC L01FD02

Therapeutic indication (EMA)

Metastatic Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. Neoadjuvant Treatment of Breast Cancer: Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.

Poherdy Organon N.V. · Authorised · authorised 23 Apr 2026 · ATC L01FD02

Therapeutic indication (EMA)

Early breast cancerPoherdy is indicated for use in combination with trastuzumab and chemotherapy in:- the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence- the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrenceMetastatic breast cancerPoherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.

Pebrilzo Biosimilar Collaborations Ireland Limited · Opinion · ATC L01FD02

Therapeutic indication (EMA)

Treatment of breast cancer in adults

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PERJETA	02405016	420 MG / 14 ML	SOLUTION · INTRAVENOUS	HOFFMANN-LA ROCHE LIMITED

Safety signals and safety-related labeling changes

US FDA 23 Apr 2026 PERJETA — 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
EMA PRAC 4 Oct 2018 PRAC signal: Multiple sclerosis relapse
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Multiple sclerosis relapse
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2015 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No

All safety entries for pertuzumab →

Combinations containing Pertuzumab

Pertuzumab + trastuzumab

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.