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Rosuvastatin (Crestor) and risk of gynaecomastia Final SmPC and PL wording agreed by PhVWP November 2011

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Rosuvastatin (Crestor) and March 2012 Page 1 of 1 risk of gynaecomastia

Rosuvastatin (Crestor) and risk of gynaecomastia

Final SmPC and PL wording agreed by PhVWP November 2011

Doc.Ref.: CMDh/PhVWP/041/2012 March 2012, Rev1

SUMMARY OF PRODUCT CHARACTERISTICS Section 4.8 Undesirable effect

Reproductive system and breast disorders

… gynaecomastia Frequency

- Very rare

PACKAGE LEAFLET

Section 4 ‘Possible side effects’

Gynecomastia (breast enlargement in men) - Very rare

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