Depending on the seriousness of the side effects and the benefit / risk ratio observed or in the event that the conditions for granting MA are not respected, the ANSM may suspend, modify or withdraw a marketing authorization. .
The decision to suspend a Marketing Authorization is made in particular when it appears that the drug is harmful under normal conditions of use or that the therapeutic effect is lacking or that the drug does not have the declared quantitative and qualitative composition.
In some cases where the side effects are significant but the drug remains very useful, its distribution and administration may then be restricted, for example, in a hospital setting.
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