Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1835995
Name of medicinal product: PHESGO
Active substances:
Pertuzumab+Trastuzumab
Estonian, English, Latin
ATC code: L01FY01
Dosage form: solution for injection
Route of administration: subcutaneous use
Strengh: 600mg+600mg 10ml
Amount in package: 10ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: 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 (see section 5.1) - • the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1) 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.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: March 31, 2024
: This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Patients and healthcare professionals are asked to report any suspected adverse reactions to State Agency of Medicines.State Agency of Medicines
Marketing authorization holder: Roche Registration GmbH 
Marketing authorization number: EU/1/20/1497 
Marketing authorization issued on: December 21, 2020 
Marketing authorization expires on: December 22, 2025 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 5, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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