Important note regarding WHO public assessment reports (WHOPARs)

The product information is an essential part of the medicinal product.  The SmPC and PIL published with the WHOPAR have been quality assured by WHO experts and reflect the situation at the time of publication of the WHOPAR.  These texts, i.e. the SmPC and the PIL are prequalified and should be adhered to.  Generally, a deviation from the prequalified product information (especially as to contents) means the product can no longer be considered to be prequalified.

For more information, see the complete Note below:

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• Important note regarding WHOPARs