CEFALEXIN Capsules Hard 500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
CEFALEXIN
Available from:
Actavis Group PTC ehf
Dosage:
500 Milligram
Pharmaceutical form:
Capsules Hard
Authorization date:
2009-04-03
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA1380/041/002
Case No: 2084272
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
CEFALEXIN 500MG HARD CAPSULES
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 19/08/2010 until 02/04/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/08/2010_
_CRN 2084272_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefalexin 500mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains, as active ingredient, cefalexin monohydrate equivalent to 500 mg of cefalexin base.
Excipients: Brilliant blue (E133) and sunset yellow (E110).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Green coloured opaque cap and light green coloured opaque body size “0” hard gelatin capsules imprinted with black
“CEF” on cap and “500” on body, filled with white to off white granular powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cefalexin is a semi-synthetic cephalosporin antibiotic for oral
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