GERAMOX Powder for Oral Suspension 250 MG/5ml
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
AMOXICILLIN TRIHYDRATE
Available from:
Generics (UK) Limited
Dosage:
250 MG/5ml
Pharmaceutical form:
Powder for Oral Suspension
Authorization date:
1989-11-20
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)
PA0405/005/004
Case No: 2043367
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GENERICS (UK) LIMITED
12 STATION CLOSE, POTTERS BAR, HERTFORDSHIRE EN6 1TL, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GERAMOX 250MG/5 ML 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 30/04/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/05/2010_
_CRN 2043367_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Geramox 250mg/5ml Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate equivalent to 250 mg of Amoxicillin.
Excipients: Each 5ml contains 15mg aspartame and 1149mg sorbitol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral suspension.
White to off white free flowing powder with an odour of raspberry. When reconstituted it readily produces a white to
cream coloured completely homogenous suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of i
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