GYNO-PEVARYL 150 MG VAGINAL PESSARIES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
ECONAZOLE NITRATE
Available from:
Janssen-Cilag Ltd
Dosage:
150mg Milligram
Pharmaceutical form:
Pessary
Authorization date:
1993-01-12
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)
PA0748/017/003
Case No: 2066954
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
JANSSEN-CILAG LTD
50-100 HOLMERS FARM WAY, HIGH WYCOMBE, BUCKINGHAMSHIRE, HP12 4EG, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GYNO-PEVARYL 150 MG VAGINAL PESSARIES
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 09/03/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/03/2010_
_CRN 2066954_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gyno-Pevaryl 150 mg Vaginal Pessaries
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains 150 mg Econazole Nitrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pessary
The pessaries are white to off white and torpedo shaped.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of fungal or yeast infections of the vagina and vulva.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For vaginal use.
One pessary to be inserted deep into the vagina daily for three consecutive days.
4.3 CONTRAINDICATIONS
Hypersensitivity to any imidazole preparation or
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