HISTACLAR SYRUP 1 Mg/Ml Syrup
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
10-06-2024
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Virkt innihaldsefni:
LORATADINE
Fáanlegur frá:
McDermott Laboratories Ltd t/a Gerard Laboratories
INN (Alþjóðlegt nafn):
LORATADINE
Skammtar:
1 Mg/Ml
Lyfjaform:
Syrup
Leyfisstaða:
Withdrawn
Leyfisdagur:
0000-00-00
Vara einkenni
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0577/046/003
Case No: 2031637
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MCDERMOTT LABORATORIES LTD T/A GERARD LABORATORIES
35/36 BALDOYLE INDUSTRIAL ESTATE, GRANGE ROAD, DUBLIN 13, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
HISTACLAR 1 MG/ML SYRUP
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 07/02/2007 until 17/03/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/02/2007_
_CRN 2031637_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Histaclar 1 mg/ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of syrup contains 1 mg of loratadine.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
Clear, slightly viscous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Loratadine Syrup is indicated for the symptomatic treatment of allergic rhinitis (AR) and chronic idiopathic
urticaria (CIU).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years:
10mg once daily (10 ml (10 mg) of the syrup once daily). The syrup may be taken without regard to mealtime.
Children 2 to 12 years of ag
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