QLAIRA

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

Active ingredients

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. Read about Estradiol

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. Read about Dienogest

Medication package inserts

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

Medicine classification

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
Discover more medicines within G03AB08

Authorization and marketing

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: 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