Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1867800
Name of medicinal product: TRODELVY
Active substances:
Sacituzumab govitecan
Estonian, English, Latin
ATC code: L01FX17
Dosage form: powder for concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 200mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1). Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1).
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: June 14, 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: Gilead Sciences Ireland Unlimited Company 
Marketing authorization number: EU/1/21/1592 
Marketing authorization issued on: November 22, 2021 
Marketing authorization expires on: November 23, 2026 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: September 15, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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