CLAVAMEL 125MG/62.5MG PER 5ML JUNIOR POWDER FOR OR 125/62.5 Milligram Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM

Available from:

Clonmel Healthcare Ltd

INN (International Name):

AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM

Dosage:

125/62.5 Milligram

Pharmaceutical form:

Powder for Oral Suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Withdrawn

Authorization date:

2009-09-16

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)
PA0126/103/003
Case No: 2051983
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
CLONMEL HEALTHCARE LIMITED
WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CLAVAMEL 125MG/62.5MG PER 5ML JUNIOR POWDER FOR ORAL SUSPENSION
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 26/06/2008 until 16/09/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/06/2008_
_CRN 2051983_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clavamel 125 mg/62.5 mg per 5 ml Junior Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate equivalent to 125 mg of amoxicillin and
potassium clavulanate equivalent to 62.5mg of clavulaic acid.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension
Clear, glass bottles, containing a white to off-white powder for reconstitution with water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clavamel is indicated for short term treatment of bacterial infections at the fol
                                
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