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ANDROFEME, ANDROFORTE (Lawley Pharmaceuticals Pty Ltd)
Product name
ANDROFEME, ANDROFORTE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
192 working days (255)
Active ingredients
testosterone
Registration type
EOI
Indication
ANDROFORTE 5 (cream) is indicated for use as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
ANDROFEME 1 (cream) is indicated for the treatment of hypoactive sexual desire dysfunction (HSDD) in postmenopausal women.
Therapeutic intervention with ANDROFEME 1 should only be initiated in women following failure of appropriate education and correction of modifiable biopsychosocial factors (which may include neuroendocrine imbalance, physical ill health or disease, interpersonal difficulties, psychological distress or specific cultural or religious beliefs), according to the International Society for the Study of Women's Sexual Health (ISSWSH) process of care (see Figure 1).