ACTIVELLE

This brand name is authorized in Austria, Canada, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Singapore, Turkey, South Africa

Active ingredients

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

1 Estradiol UNII 4TI98Z838E - ESTRADIOL

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
ACTIVELLE Film-coated tablet	Health Products Regulatory Authority (IE)	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
G03FA01	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 → G03FA Progestogens and estrogens, fixed combinations
Discover more medicines within G03FA01

Authorization and marketing

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

Country	Identification scheme	Identifier(s)
Country: CA	Health Products and Food Branch	Identifier(s): 02249405, 02309009
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 00017868, 00017874, 00080513, 00080536, 06946126, 06946132, 07391469
Country: EE	Ravimiamet	Identifier(s): 1175464, 1175475, 1730887, 1730898, 1731013, 1771826, 1771837, 1880344, 1880355, 1887992, 1888005
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 62465
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 540229
Country: FR	Base de données publique des médicaments	Identifier(s): 62210849
Country: HK	Department of Health Drug Office	Identifier(s): 44368
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-673855616
Country: IE	Health Products Regulatory Authority	Identifier(s): 10454, 10631
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 3811
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1003449, 1020221, 1068159, 1086440, 1086445, 1091556
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 50954
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100090402
Country: SG	Health Sciences Authority	Identifier(s): 10960P
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699676090617
Country: ZA	Health Products Regulatory Authority	Identifier(s): 33/21.8.2/0532