CRED Managing Variations Effectively

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Grouping of quality changes that affect the product information

Tablet 25 mg: Change in shelf life & storage conditions, finished product: • Type IB B.II.f.1. (b)1: shelf life extension 24  48 months • Type IB B.II.f.1. (d)1: storage conditions 25 ° C  none • Consequential change to label / PIL

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