RYNACROM Nasal Spray Solution 2 %w/v %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
CROMOGLICATE SODIUM
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
2 %w/v %w/v
Pharmaceutical form:
Nasal Spray Solution
Authorization date:
2004-12-03
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0540/123/002
Case No: 2029151
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANOFI-AVENTIS IRELAND LIMITED
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
RYNACROM 2% W/V NASAL SPRAY, SOLUTION
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 26/10/2006 until 14/02/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 01/11/2006_
_CRN 2029151_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rynacrom 2 % w/v Nasal Spray, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 2.6 mg sodium cromoglicate.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, solution.
A clear, colourless or pale yellow aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rynacrom is indicated for the preventative treatment of allergic rhinitis (seasonal and perennial)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For nasal use.
Adults and children:
One spray to each nostril four to six times daily at three to four hourly intervals (i.e. on average daily dosage between
10.4 mg a
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