ETHINYLESTRADIOL/DROSPIRENONE LEON FARMA & PLACEBO
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
DROSPIRENONE ETHINYLESTRADIOL
Available from:
Laboratorios Leon Farma, S.A.
Dosage:
0.03 / 3 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-10-09
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1474/007/002
Case No: 2046884
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 & PLACEBO 0.03 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 24/10/2009_
_CRN 2046884_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03 mg/3 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
YELLOW TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone
Excipients:
Lactose monohydrate 62 mg
WHITE TABLETS (PLACEBO TABLETS)
The tablet does not contain active substances
Excipient:
Lactose, anhydrous 89.5 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Yellow, round film-coated tablets.
Placebo tablets:
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