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NMPA Announcement on Adding the Medication Information for Children to the Package Inserts of Haloperidol Tablets and Other Varieties

CCFDIE|Updated: 2021-05-31

In order to better meet the clinical medication needs of children, upon the study and demonstration, package inserts of Haloperidol Tablets and other varieties may be added with the children users and dosage and usage for children according to the requirements. On May 28, relevant issues are hereby announced as follows: 

I. The marketing authorization holders of relevant varieties may, based on the Provisions for Drug Registration and in accordance with corresponding revision suggestions, submit the supplementary application to the Center for Drug Evaluation of NMPA, revise the [Indications] and [Usage and Dosage] of the package insert, and simultaneously improve the safety information and other relevant contents in the package insert. If revision relates to the drug label, the latter shall be modified together. 

II. After the approval of corresponding supplementary application is obtained, the marketing authorization holders of relevant varieties shall collect and report the ADR information in time, and conduct risk control and pharmacovigilance for pediatric medication.