Dianette 2 mg/35 microgram coated tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Cyproterone acetate; Ethinylestradiol

Pieejams no:

PCO Manufacturing Ltd.

ATĶ kods:

G03HB; G03HB01

SNN (starptautisko nepatentēto nosaukumu):

Cyproterone acetate; Ethinylestradiol

Deva:

2 mg/35 microgram(s)

Zāļu forma:

Coated tablet

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

Antiandrogens and estrogens; cyproterone and estrogen

Autorizācija statuss:

Authorised

Autorizācija datums:

1998-10-16

Produkta apraksts

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