Year:
2019
Region / City:
Australia
Topic:
Hormone Replacement Therapy (HRT)
Document Type:
Regulatory Submission
Organization / Institution:
Besins Healthcare Australia Pty Ltd
Author:
Not specified
Target Audience:
Health professionals and regulatory authorities
Period of Effectiveness:
Not specified
Approval Date:
8 May 2019
Modification Date:
Not specified
Registration Status:
TGA Registered
Indications:
Estrogen deficiency, prevention of osteoporosis, menstrual irregularities, hormone replacement therapy
Purpose:
Request for listing of medications in General Schedule
Product Names:
Estrogel®, Prometrium®, Estrogel Pro
Safety Data:
Includes safety outcomes such as breast pain, tenderness, breakthrough bleeding, and breast cancer risk
Comparator Products:
Sandrena®, MPA (medroxyprogesterone acetate)
Clinical Claims:
Efficacy and safety comparison of Estrogel and MP to Sandrena and MPA
Source:
Tables 1.2, pp23-24
Price: 8 / 10 USD
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