NOVOFEM

This brand name is authorized in Germany, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Poland, United Kingdom, South Africa

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 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 about Norethisterone

Medication package inserts

Below package inserts are available for further reading:

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