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: 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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