On this page

Keytruda Qlex

pembrolizumab and berahyaluronidase alfa-pmph

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Keytruda Qlex

Proper name

pembrolizumab and berahyaluronidase alfa-pmph

Licence type

351(a)

BLA number

761467

Applicant

Merck Sharp & Dohme LLC

Center

CDER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
395MG/2.4ML; 4,800UNITS/2.4ML (165MG/2,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	September 19, 2025
790MG/4.8ML; 9,600UNITS/4.8ML (165MG/2,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	September 19, 2025

Purple Book	FDA	Licence type, presentations, reference product, exclusivity