Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Endoceutics S.A., Rue Belliard 40, 1040, Brussels, Belgium
Intrarosa 6.5 mg pessary.
| Pharmaceutical Form |
|---|
|
Pessary. White to off-white, bullet-shaped pessary approximately 28 mm long and 9 mm in diameter at its widest end. |
Each pessary contains 6.5 mg of prasterone.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Prasterone |
Prasterone, i.e. dehydroepiandrosterone (DHEA), biochemically and biologically identical to the endogenous human DHEA, is a precursor steroid which is inactive by itself and it is converted into oestrogens and androgens. Intrarosa is thus different from the oestrogens preparations since it delivers also androgen metabolites. |
| List of Excipients |
|---|
|
Hard fat (adeps solidus) |
Blister composed of an outer layer of PVC and an inner layer of LDPE.
Applicator made of LDPE and 1% colorant (Titanium dioxide).
28 pessaries are packed in a carton with 6 applicators.
Endoceutics S.A., Rue Belliard 40, 1040, Brussels, Belgium
EU/1/17/1255/001
Date of first authorisation: 08 january 2018
| Drug | Countries | |
|---|---|---|
| INTRAROSA | Austria, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Poland, United Kingdom, United States |
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