Regulatory PathRegulatory requirements compared

Active substances

Pertuzumab + Trastuzumab

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Phesgo80,40 mg/ml,mg/mlSolution for injection · Subcutaneous use1 VialSAR 25814.85Biological · PrescriptionF.Hoffmann-La Roche Ltd.Valid
Phesgo60,60 mg/ml,mg/mlSolution for injection · Subcutaneous use1 VialSAR 15636.80Biological · PrescriptionF.Hoffmann-La Roche Ltd.Valid
Indications — CHI Daman Drug Formulary

BILIARY TRACT CANCER; COLORECTAL CANCER-ADVANCED/ METASTATIC

EMA European Union — centrally authorised medicines

Phesgo Roche Registration GmbH · Authorised · authorised 21 Dec 2020 · ATC L01XY

Therapeutic indication (EMA)

Early breast cancer (EBC) Phesgo is indicated for use in combination with 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 recurrence Metastatic breast cancer (MBC) Phesgo is indicated for use in combination with 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.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PERJETA-HERCEPTIN02405024440 MG / VIAL; 420 MG / 14 MLSOLUTION; KIT; POWDER FOR SOLUTION · INTRAVENOUSHOFFMANN-LA ROCHE LIMITED
PHESGO0251291240 MG / ML; 80 MG / MLSOLUTION · SUBCUTANEOUSHOFFMANN-LA ROCHE LIMITED
PHESGO0251292060 MG / ML; 60 MG / MLSOLUTION · SUBCUTANEOUSHOFFMANN-LA ROCHE LIMITED

Components

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.