ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
25-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
DROSPIRENONE ETHINYLESTRADIOL
थमां उपलब्ध:
Laboratorios Leon Farma, S.A.
डोज़:
0.02 / 3 Milligram
फार्मास्यूटिकल फॉर्म:
Film Coated Tablet
प्राधिकरण की तारीख:
2009-10-09
उत्पाद विशेषताएं
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1474/002/001
Case No: 2046797
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
LABORATORIOS LEON FARMA, S.A.
C/ ROA DE LA VEGA, 15, 1 - 24008 LEON, SPAIN
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA 0.02 MG/3 MG FILM-COATED TABLETS
The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as
may be specified in the said Regulations as listed on the reverse of this document.
This authorisation, unless previously revoked, shall continue in force from 09/10/2009 until 08/10/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/10/2009_
_CRN 2046797_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethinylestradiol / Drospirenone Leon Farma 0.02 mg/3 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone
Excipients:
Lactose monohydrate 44 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round film-coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use.
HOW TO TAKE ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA 0.0
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