Should suspicions on drug abuse , misuse or medication error of MP or generally off-label use of MP be reported in the case that these do not lead to adverse effects?, State Institute for Drug Control

Should suspicions on drug abuse , misuse or medication error of MP or generally off-label use of MP be reported in the case that these do not lead to adverse effects?

Reports (ICSRs) of drug overdose, drug interaction, abuse of MP, medication error or off-label use of MP – if these are not linked to a simultaneous adverse drug reaction– should not be reported to the EV database. However, they should be monitored by the MAH and recorded for the purpose of potential evaluation of the specific product risk/benefit ratio.

State Institute for Drug Control

Should suspicions on drug abuse , misuse or medication error of MP or generally off-label use of MP be reported in the case that these do not lead to adverse effects?

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