CRED Managing Variations Effectively

Chapter C – 2 nd example

Proposal: Update of sections 4.1, 4.2, 4.4, 4.8, 5.1, 5.2 and 5.3 of the SmPC in order to extend the indication of Revolade in patients with chronic hepatitis C infection for the treatment of thrombocytopenia to enable the initiation of interferon- based therapy and during interferon-based therapy. The proposed starting dose is 25 mg once daily to be adjusted as necessary up to a maximum dose of 100 mg once daily. Therefore, two new tablet strengths (75 mg and 100 mg) are proposed to be introduced as well.  Extension application!!!!  Grouped with a variation (????)

72 Introduction to Classification of CMC (Quality) / Clinical / PhV Variations