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IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0899/017/002
Case No: 1025955
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GOLDSHIELD PHARMACEUTICALS LTD
NLA TOWER, 12-16 ADDISCOMBE ROAD,CROYDON, SURREY CRO 0XT, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
BECLO-RHINO ALLERGY 50 MICROGRAM AQUEOUS NASAL SPRAY 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 10/11/2006 until 09/11/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/11/2006_
_CRN 1025955_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beclo-Rhino Allergy 50 microgram Aqueous Nasal Spray Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Beclometasone Dipropionate 50 micrograms per spray.
For full list of Excipients see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Suspension.
A glass vial fitted with a metering pump and nasal tip containing an opaque white nasal spray suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and treatment of seasonal allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
1 Spray = 50µg beclometasone dipropionate
For administration by the int
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