QLAIRA

This brand name is authorized in Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain.

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 more 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 more about Dienogest

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
QLAIRA Film-coated tablet	MPI, EU: SmPC	Medicines & Healthcare Products Regulatory Agency (GB)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		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)
BR	Câmara de Regulação do Mercado de Medicamentos	538901401111319, 538901402116314
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	29277-06-10
EE	Ravimiamet	1322660, 1322671, 1322682
ES	Centro de información online de medicamentos de la AEMPS	70367
FI	Lääkealan turvallisuus- ja kehittämiskeskus	158508, 158520, 158531
FR	Base de données publique des médicaments	67361246
HK	Department of Health Drug Office	59784
HR	Agencija za lijekove i medicinske proizvode	HR-H-182628999
IE	Health Products Regulatory Authority	56907
LT	Valstybinė vaistų kontrolės tarnyba	1027211, 1037217, 1037218
MT	Medicines Authority	MA639/02701
MX	Comisión Federal para la Protección contra Riesgos Sanitarios	049M2011
NL	Z-Index G-Standaard, PRK	89745
NZ	Medicines and Medical Devices Safety Authority	14099
PL	Rejestru Produktów Leczniczych	100217216
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W63889001, W63889002, W63889003
SG	Health Sciences Authority	13847P
ZA	Health Products Regulatory Authority	43/18.8/0591