CRED Managing Variations Effectively

Tablet 25 mg and Tablet 50 mg (same active substance) Change in shelf life & storage conditions, finished product: • Type IB B.II.f.1. (b)1: shelf life extension Grouping of similar (not identical) changes between different formulations, presentations of strengths 

 Tablet 25 mg : 24  48 months  Tablet 50 mg : 36  48 months

• Type IB B.II.f.1. (d)1: change storage conditions 25 ° C  none

 Tablet 25 mg and Tablet 50 mg • Consequential changes to the label/PIL

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