HALIBORANGE VITAMIN C 500 Milligram Tablets Effervescent
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-05-2024
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Active ingredient:
ASCORBIC ACID
Available from:
Seven Seas Ltd
INN (International Name):
ASCORBIC ACID
Dosage:
500 Milligram
Pharmaceutical form:
Tablets Effervescent
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization date:
0000-00-00
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0417/016/004
Case No: 2061607
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SEVEN SEAS LTD
HEDON ROAD, MARFLEET, KINGSTON-UPON-HULL HU9 5NJ, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
HALIBORANGE VITAMIN C 500MG EFFERVESCENT TABLETS (LEMON FLAVOUR)
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 06/08/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/08/2010_
_CRN 2061607_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Haliborange Vitamin C 500 mg Effervescent Tablets (Lemon Flavour)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ascorbic Acid 500 mg.
Also contains: sucrose 1.030g, glucose 2.0mg, Sodium 264.64mg.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet
Round, unvaulted, speckled, yellowish effervescent tablets with a lemon flavour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis and treatment of ascorbic acid deficiency.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years: One tablet to be taken daily. Do not exceed stated dose.
The tablet should be di
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