COMBIVENT METERED AEROSOL 20 MICROGRAMS/100 MICROG
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-05-2024
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Active ingredient:
IPRATROPIUM BROMIDE SALBUTAMOL SULFATE
Available from:
Boehringer Ingelheim Limited
Dosage:
20/100mcg/ Mcg/Dose
Pharmaceutical form:
Pressurised Inhalation Suspension
Authorization date:
1994-04-14
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)
PA0007/052/001
Case No: 2062024
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
BOEHRINGER INGELHEIM LIMITED
ELLESFIELD AVENUE, BRACKNELL, BERKSHIRE RG12 8YS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
COMBIVENT METERED AEROSOL 20 MICROGRAMS/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 27/02/2009 until 12/11/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/04/2009_
_CRN 2062024_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
COMBIVENT Metered Aerosol 20 micrograms/100 micrograms per metered dose, Pressurised Inhalation Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose delivers 20 micrograms of ipratropium bromide (as monohydrate) and 100 micrograms of
salbutamol (as sulphate).
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
Pressurised aluminium container closed with a metering valve containing a creamy-white suspension inserted into a
grey plastic actuator (mouthpiece).
4 CLINICAL PART
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