Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Cyproterone acetate; Ethinylestradiol
PCO Manufacturing Ltd.
G03HB; G03HB01
Cyproterone acetate; Ethinylestradiol
2 mg/35 microgram(s)
Coated tablet
Product subject to prescription which may be renewed (B)
Antiandrogens and estrogens; cyproterone and estrogen
Authorised
1998-10-16
Health Products Regulatory Authority 09 January 2024 CRN00F17L Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dianette 2 mg/35 microgram coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.0 mg cyproterone acetate and 0.035 mg ethinylestradiol. Excipients with known effect: contains lactose and sucrose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet (tablet). _ _ _Product imported from Romania_ Round, beige, sugar-coated tablets. 4 CLINICAL PARTICULARS As per PA1410/003/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/003/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Product imported from UK: Lactose Maize starch Povidone Talc Magnesium stearate (E572) Sucrose Macrogol 6000 Calcium carbonate (E170) Titanium dioxide (E171) Glycerol (E422) Montan glycol wax Yellow ferric oxide pigment (E172) Product imported from Romania: Lactose monohydrate Maize starch Povidone 25000 Magnesium stearate Sucrose Povidone 700000 Macrogol 6000 Calcium carbonate Talc Glycerol 85% Health Products Regulatory Authority 09 January 2024 CRN00F17L Page 2 of 2 Titanium dioxide (E171) Yellow ferric oxide pigment (E172) Montan glycol wax 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 °C. 6.5 NATURE AND CONTENTS OF CONTAINER Dianette tablets come in calendar blister packs of 21 and 63 (3x21) tablets. Not all pack sizes may be marketed. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/050/001 9 DATE OF FIRST AUTHORISATIO Прочитајте комплетан документ