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 info@hpra.ie


Dretinelle 0.02 mg/3 mg Film-coated Tablets

0.02 mg / 3 milligram(s) Film-coated tablet

Theramex Ireland LimitedPA22668/006/001

Main Information

Trade NameDretinelle 0.02 mg/3 mg Film-coated Tablets
Active SubstancesEthinylestradiol
Drospirenone
Strength0.02 mg / 3 milligram(s)
Dosage FormFilm-coated tablet
Licence HolderTheramex Ireland Limited
Licence NumberPA22668/006/001

Group Information

ATC CodeG03FA Progestogens and estrogens, fixed combinations
G03FA17 drospirenone and estrogen

Status

Authorised/WithdrawnAuthorised
Licence Issued09/10/2009
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 StatusNot marketed

Documents

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