AIROMIR INHALER 100 MICROGRAMS PER METERED DOSE PR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
SALBUTAMOL SULFATE
Available from:
Norton Waterford
Dosage:
100 Mcg/Acutuation
Pharmaceutical form:
Pressurised Inhalation Suspension
Authorization date:
2000-09-19
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0436/033/001
Case No: 2055550
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NORTON WATERFORD LIMITED
T/A IVAX PHARMACEUTICALS IRELAND, UNIT 301, IDA INDUSTRIAL PARK, WATERFORD, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AIROMIR INHALER 100 MICROGRAMS PER METERED DOSE PRESSURISED INHALATION 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 01/10/2008 until 18/09/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 01/10/2008_
_CRN 2055550_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Airomir Inhaler 100 micrograms per metered dose pressurised inhalation suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 100 micrograms Salbutamol (as sulphate).
For excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension
A homogenous, creamy – white to grey suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Airomir Inhaler is indicated for the treatment of acute attacks or exacerbations of bronchial asthma and for the
treatment of reversible airways obstr
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