Notification according to label change order _[Repatha Inj. Pre-filled syringe (evolocumab) and 1 other]

In accordance with the results of the drug re-examination, the Ministry of Food and Drug Safety’s Label Change Order (Biopharmaceutical Quality Management Division-155, 2024.02.16) has changed the precautions for the use of the following products.

As a result, we would like to inform you that the product information for this product has been changed as of May 16, 2024.

• Product: Repatha Inj. Pre-filled syringe (evolocumab) and Repatha Inj. Pre-filled pen (evolocumab)
• Changes: Precautions for Use [3. Adverse Reactions, Post-marketing surveillance results in Korea]
• Label change date: May 16, 2024 (3 months after MFDS’s instruction date)
• Attachments: Ministry of Food and Drug Safety Label Change Order official letter, Changes, and comparative table [Please refer to our Korean website(www.amgen.co.kr) ]  

For more information, please refer to the revised product information (date of revision: May 16, 2024) attached to the product, and you can also check the product information on our website (www.amgen.co.kr).