CRED Managing Variations Effectively

Acceptable grouping ??? Possible answers: Yes No Not sure/grey area

 Update in line with CCDS:

• Change 1 (Type II): significant update to s4.2 posology, as a result of a study

• Change 2 (Type II):Update to s4.4 (special warnings – unrelated) • Change 3 (Type II): Update to s4.8 (undesirable effects – unrelated)

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