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Notification according to label change order _ [Prolia (Denosumab)]


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-3764, 2021.07.29) 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 October 29, 2021.

  • Product: Prolia (Denosumab)
  • Changes: Precautions for Use [3. Adverse Reactions 4] Results of Post-Market Research in Korea]
  • Label change date: October 29, 2021 (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: October 29, 2021) attached to the product, and you can also check the product information on our website (www.amgen.co.kr).