NOVOFEM

This brand name is authorized in Croatia, Estonia, Finland, Germany, Hong Kong SAR China, Ireland, Israel, Lithuania, Poland, South Africa, UK.

Active ingredients

The drug NOVOFEM contains a combination of these active pharmaceutical ingredients (APIs):

1	Estradiol UNII CXY7B3Q98Z - ESTRADIOL HEMIHYDRATE
	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	Norethisterone UNII 9S44LIC7OJ - NORETHINDRONE ACETATE
	Norethisterone has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak oestrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle.
	Read more about Norethisterone

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
NOVOFEM 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
G03FB05	Norethisterone 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
Discover more medicines within G03FB05

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
DE	Bundesinstitut für Arzneimittel und Medizinprodukte	01288138, 01288150, 12723755
EE	Ravimiamet	1116560, 1178962
FI	Lääkealan turvallisuus- ja kehittämiskeskus	007439
GB	Medicines & Healthcare Products Regulatory Agency	44992
HK	Department of Health Drug Office	51323
HR	Agencija za lijekove i medicinske proizvode	HR-H-818589847
IE	Health Products Regulatory Authority	15628
IL	מִשְׂרַד הַבְּרִיאוּת	4622
LT	Valstybinė vaistų kontrolės tarnyba	1004205, 1019419, 1085573
PL	Rejestru Produktów Leczniczych	100147480, 100384010
ZA	Health Products Regulatory Authority	37/21.8.2/0297