VITILE MR 30 Milligram Modified-release Tablets
Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Ürün özellikleri
(SPC)
14-06-2024
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Aktif bileşen:
GLICLAZIDE
Mevcut itibaren:
Actavis Group PTC ehf
INN (International Adı):
GLICLAZIDE
Doz:
30 Milligram
Farmasötik formu:
Modified-release Tablets
Reçete türü:
Product subject to prescription which may be renewed (B)
Yetkilendirme durumu:
Withdrawn
Yetkilendirme tarihi:
2014-04-07
Ürün özellikleri
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA1380/068/001
Case No: 2083126
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ACTAVIS GROUP PTC EHF
REYKJAVIKURVEGI 76-78, 220 HAFNARFJORDUR, ICELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VITILE MR 30 MG MODIFIED-RELEASE TABLETS
the particulars of which are set out in 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 31/08/2010 until 26/08/2015.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 31/08/2010_
_CRN 2083126_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitile MR 30 mg Modified-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains gliclazide 30 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release tablet.
White, oval, biconvex 4.5 x 10.1 mm tablets marked “G” on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are
not sufficient to control blood glucose.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral use.
For adult use only.
The daily dose may vary from 1 to 4 tablets
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