ACTIVELLE

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

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 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
ACTIVELLE Film-coated tablet	MPI, EU: SmPC	Health Products Regulatory Authority (IE)

Medicine classification

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

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