Announcement of the State Food and Drug Administration on Revising the Instructions for Gefitinib Tablets (No. 17 of 2021)

In order to further protect the safety of public medication, the National Medical Products Administration has decided to revise the [Adverse Reactions] and [Precautions] items in the instructions for Gefitinib tablets

1.

If the revised content involves the label of a drug, it shall be revised together; the instructions and other content of the label shall be consistent with the original approved content

Gefitinib tablets manufacturers should conduct in-depth research on the mechanism of new adverse reactions, take effective measures to conduct publicity and training on use and safety issues, and promptly notify drug dealers and users of changes in the content of drug safety in an appropriate manner , Instruct physicians and pharmacists to use drugs rationally

2.

3.

Hereby announce

Attachment: Requirements for revision of the instructions for Gefitinib tablets

State Food and Drug Administration

January 21, 2021