MINADEX TONIC HALF STRENGTH ORAL EMULSION %v/v Oral Emulsion

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

RETINOL PALMITATE COLECALCIFEROL FERRIC AMMONIUM CITRATE POTASSIUM GLYCEROPHOSPHATE CALCIUM GLYCEROPHOSPHATE MANGANESE SULFATE COPPER SULFATE

Tilgjengelig fra:

Seven Seas Ltd

INN (International Name):

RETINOL PALMITATE COLECALCIFEROL FERRIC AMMONIUM CITRATE POTASSIUM GLYCEROPHOSPHATE CALCIUM GLYCEROPHOSPHATE MANGANESE SULF

Dosering :

%v/v

Legemiddelform:

Oral Emulsion

Resept typen:

Product not subject to medical prescription

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2010-07-12

Preparatomtale

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0417/007/001
Case No: 2068893
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
MINADEX TONIC HALF STRENGTH ORAL EMULSION
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 10/09/2009 until 12/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/09/2009_
_CRN 2068893_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Minadex Tonic Half Strength Oral Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral emulsion
Yellowish to green translucent oral emulsion with an odour and taste of orange.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a treatment for vitamin and mineral deficiency and as an appetite stimulant during and after illness.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of Administration:
Oral.
Dosage:
Children 6 months to 3 years: 2 teaspoonfuls (10ml) twice daily.
Children 3 years to 12 years: 2 teaspoonfuls (10ml) three times da