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

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

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

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