CLOROM Oral Suspension 125/5
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
CLARITHROMYCIN
Available from:
Rowex Ltd
Dosage:
125/5
Pharmaceutical form:
Oral Suspension
Authorization date:
2006-04-13
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)
PA0711/061/003
Case No: 2070934
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CLOROM, 125/5 MICROMOL
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 07/09/2009 until 12/04/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 07/09/2009_
_CRN 2070934_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clorom 125 mg/5 ml granules for oral suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of the suspension contains clarithromycin 125 mg.
1 ml of the suspension contains clarithromycin 25 mg.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White to off-white granules forming a white to off-white suspension on reconstitution with water.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of the following infections in children when caused by clarithromycin-susceptible organisms:
- Lower respiratory tract infections such as community acquired pneumonia.
- Upper respiratory tract infec
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