This brand name is authorized in Brazil
The drug TOTELLE contains a combination of these active pharmaceutical ingredients (APIs):
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1
Estradiol
UNII 4TI98Z838E - ESTRADIOL
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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. |
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2
Trimegestone
UNII 4658K0H08W - TRIMEGESTONE
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Trimegestone is a 19-norpregnane progestagen, with an in vitro affinity for the progesterone receptor approximately 6 times that of progesterone. As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestagen reduces, but does not eliminate the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| TOTELLE Coated tablet | Health Products Regulatory Authority (IE) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| G03FA16 | Trimegestone and estrogen | G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03F Progestogens and estrogens in combination → G03FA Progestogens and estrogens, fixed combinations |
| G03FB11 | Trimegestone and estrogen | G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03F Progestogens and estrogens in combination → G03FB Progestogens and estrogens, sequential preparations |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: BR | Câmara de Regulação do Mercado de Medicamentos | Identifier(s): 522709903114311, 522709904110318 |
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