Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** Vagifem® is administered intravaginally as a local oestrogen therapy by use of an applicator. Initial dose: One vaginal tablet daily for two weeks. Maintenance dose: One vaginal tablet twice a week. Treatment may be started on any convenient day. If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) should be used. For oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains **within** the normal postmenopausal range, such as Vagifem®, it is not recommended to add a progestagen (but see section 4.4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Vagifem® may be used in women with or without an intact uterus. Vaginal infections should be treated before start of the Vagifem® therapy. Administration: 1. Open the blister pack at the plunger end. 2. Insert the applicator in the vagina until resistance is met (8–10 cm). 3. Release the tablet by pressing the plunger. 4. Withdraw the applicator and discard.
VAGINAL
Medical Information
**4.1 Therapeutic indications** Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The experience of treating women older than 65 years is limited.
**4.3 Contraindications** - Known, past or suspected breast cancer - Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer) - Undiagnosed genital bleeding - Untreated endometrial hyperplasia - Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) - Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency, see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) - Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal - Known hypersensitivity to the active substances or to any of the excipients - Porphyria.
G03CA03
estradiol
Manufacturer Information
NOVO NORDISK PHARMA (SINGAPORE) PTE LTD
Novo Nordisk A/S
Active Ingredients
Documents
Package Inserts
Vagifem TABLET 10MCG PI.pdf
Approved: June 23, 2021