Dear Kedsirin,
Please help amend and revise the discrepant information on the outer box labeling vs the PI as per highlighted in the respective remark columns on the attached files.
Apparently, there are some confusion and inconsistency on the prescribed dosage as well as on the age group currently appeared on the labeling and the PI.
The same information must also correlate to and consistent with the rest of the details being provided in the dossier earlier.
Please verify and finalize accordingly especially on the dosage and instruction on the dosage used and the correlated age group on the PI.
Please also provide the PI with already revised, corrected and finalized info in “MS WORDS” format or PDF format which can be edited, NOT in scanned copy please.
We appreciate very much your urgent attention on this as this is a compulsory part of the dossier that required to be submitted together to the MOH. Our timeline to submit this is by the 30th April.