10 SmPC mistakes

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10 SmPC mistakes

The following extract from a SmPC contains 10 deviations from the QRD template, version 8 (07/2011). Can you spot them?

3.       Pharmaceutical form

Tablets.
The tablets can be divided into equal doses.

4.3     Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

6.2     Incompatibilities

X must not be mixed with other medicinal products except those mentioned in section 6.6.

 6.3     Shelf life

The shelf life is 3 years.

6.4     Special precautions for storage

Keep in the original package.
Store below 25 °C.

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

Date of first authorisation:
Date of last renewal:

10.     DATE OF REVISION OF TEXT

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