5. OTHER RELEVANT INFORMATION |
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8. EXPLANATORY NOTE |
An adverse event is defined as
a reaction which is harmful (noxious) and unintended, and which occurs
at doses normally used in man for prophylaxis, diagnosis,
or treatment of a disease, or for the modification of a physiological
function. |
Please report adverse event(s) which: |
1. |
a. Are life threatening or fatal.
b. Require in-patient hospitalisation or prolong existing hospitalisation.
c. Cause persistent incapacity or disability.
d. Cause birth defect.
e. Are medically significant.
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2. |
All adverse events to recently marketed products that have been introduced into
Singapore in the recent few years, regardless of their nature and severity.
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Please do not be deterred from reporting because some details are not known.
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Submission of follow-up reports
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Please indicate if this is a follow-up report as it is important that such reports are identified and linked to the original report.
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