This brand name is authorized in Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa
The drug QLAIRA contains a combination of these active pharmaceutical ingredients (APIs):
1
Estradiol
UNII OKG364O896 - ESTRADIOL VALERATE
|
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. |
2
Dienogest
UNII 46M3EV8HHE - DIENOGEST
|
Dienogest is a nortestosterone derivative with no androgenic but rather an antiandrogenic activity of approximately one third of that of cyproterone acetate. Dienogest binds to the progesterone receptor of the human uterus with only 10% of the relative affinity of progesterone. |
Below package inserts are available for further reading:
Title | Information Source | Document Type | |
---|---|---|---|
QLAIRA Film-coated tablet | Medicines & Healthcare Products Regulatory Agency (GB) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
ATC code | Group title | Classification |
---|---|---|
G03AB08 | Dienogest and estradiol | G Genito urinary system and sex hormones → G03 Sex hormones and modulators of the genital system → G03A Hormonal contraceptives for systemic use → G03AB Progestogens and estrogens, fixed combinations |
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): 538901401111319, 538901402116314 |
Country: EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | Identifier(s): 29277-06-10 |
Country: EE | Ravimiamet | Identifier(s): 1322660, 1322671, 1322682 |
Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 70367 |
Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 158508, 158520, 158531 |
Country: FR | Base de données publique des médicaments | Identifier(s): 67361246 |
Country: HK | Department of Health Drug Office | Identifier(s): 59784 |
Country: HR | Agencija za lijekove i medicinske proizvode | Identifier(s): HR-H-182628999 |
Country: IE | Health Products Regulatory Authority | Identifier(s): 56907 |
Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1027211, 1037217, 1037218 |
Country: MT | Medicines Authority | Identifier(s): MA639/02701 |
Country: MX | Comisión Federal para la Protección contra Riesgos Sanitarios | Identifier(s): 049M2011 |
Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 89745 |
Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 14099 |
Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100217216 |
Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W63889001, W63889002, W63889003 |
Country: SG | Health Sciences Authority | Identifier(s): 13847P |
Country: ZA | Health Products Regulatory Authority | Identifier(s): 43/18.8/0591 |
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