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In order to better meet the needs of children's clinical medications, studies have demonstrated that the instructions for haloperidol tablets and other drugs (Annex 1) can increase the number of children used and the dosage as required
.
The relevant matters are hereby announced as follows: 1.
The holders of the marketing authorization of the relevant products may submit their proposals to the Drug Evaluation Center of the State Food and Drug Administration in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, and in accordance with the corresponding amendment recommendations (Annex 2-4) Supplement the application, revise the relevant content of the instructions [Indications] and [Usage and Dosage], and at the same time improve the safety information and other related content of the instructions
.
If the revised content involves drug labeling, it should be revised together
.
2.
After the corresponding supplementary application is approved, the marketing authorization holder of the relevant product shall collect and report the adverse reaction information in a timely manner, and do a good job in the risk control and pharmacovigilance of children's drug use
.
Hereby announce
.
Attachment: 1.
List of varieties 2.
Recommendations for revision of drug inserts for haloperidol tablets 3.
Recommendations for revisions of drug inserts for risperidone oral preparations 4.
Recommendations for revisions to drug inserts of fluoxetine oral preparations National Food and Drug Administration May 28, 2021 Announcement No.
75 of 2021 Announcement 1.
docx Announcement No.
75 of 2021 of the National Medical Products Administration Attachment 2.
doc Announcement No.
75 of 2021 of the National Medical Products Administration Attachment 3.
doc of 2021 Annex 4.
doc of Announcement No.
75
.
The relevant matters are hereby announced as follows: 1.
The holders of the marketing authorization of the relevant products may submit their proposals to the Drug Evaluation Center of the State Food and Drug Administration in accordance with the "Administrative Measures for Drug Registration" and other relevant regulations, and in accordance with the corresponding amendment recommendations (Annex 2-4) Supplement the application, revise the relevant content of the instructions [Indications] and [Usage and Dosage], and at the same time improve the safety information and other related content of the instructions
.
If the revised content involves drug labeling, it should be revised together
.
2.
After the corresponding supplementary application is approved, the marketing authorization holder of the relevant product shall collect and report the adverse reaction information in a timely manner, and do a good job in the risk control and pharmacovigilance of children's drug use
.
Hereby announce
.
Attachment: 1.
List of varieties 2.
Recommendations for revision of drug inserts for haloperidol tablets 3.
Recommendations for revisions of drug inserts for risperidone oral preparations 4.
Recommendations for revisions to drug inserts of fluoxetine oral preparations National Food and Drug Administration May 28, 2021 Announcement No.
75 of 2021 Announcement 1.
docx Announcement No.
75 of 2021 of the National Medical Products Administration Attachment 2.
doc Announcement No.
75 of 2021 of the National Medical Products Administration Attachment 3.
doc of 2021 Annex 4.
doc of Announcement No.
75
