The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail

Activelle 1 mg/0.5 mg film-coated tablets

Novo Nordisk A/SPA0218/052/001

Main Information

Trade NameActivelle 1 mg/0.5 mg film-coated tablets
Active SubstancesEstradiol
Norethisterone acetate
Dosage FormFilm-coated tablet
Licence HolderNovo Nordisk A/S
Licence NumberPA0218/052/001

Group Information

ATC CodeG03FA Progestogens and estrogens, fixed combinations
G03FA01 norethisterone and estrogen


License statusAuthorised
Licence Issued28/08/1998
Legal statusProduct subject to prescription which may be renewed (B)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing StatusMarketed


Summary of Product CharacteristicsPDF Version
Package LeafletPDF Version
Public Assessment ReportNo document available
« Back