Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsvaerd, Denmark
Vagifem 10 micrograms vaginal tablets.
| Pharmaceutical Form |
|---|
|
Vaginal tablet. White, film-coated, biconvex tablet, engraved with NOVO 278 on one side. Diameter 6 mm. |
Each vaginal tablet contains: estradiol hemihydrate equivalent to estradiol 10 micrograms.
For the full list of excipients, see section 6.
| Active Ingredient | Description | |
|---|---|---|
| Estradiol |
Estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in menopausal women, and alleviates menopausal symptoms. Oestrogens prevent bone loss following menopause or ovariectomy. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose Film-coating: Hypromellose |
Each tablet is contained in a disposable single-use polyethylene/polypropylene applicator.
The applicators are packed separately in PVC/aluminium foil blisters.
18 vaginal tablets with applicators.
24 vaginal tablets with applicators.
Not all pack sizes may be marketed.
Novo Nordisk A/S, Novo Allé, DK-2880, Bagsvaerd, Denmark
PA0218/030/002
Date of first authorisation: 19th March 2010
Date of last renewal: 6th January 2015
| Drug | Countries | |
|---|---|---|
| VAGIFEM | Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States, South Africa |
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