COMBIVENT METERED AERSOL 20/100 Mcg/Acutuation Unknown
Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Карактеристике производа
(SPC)
25-05-2024
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Активни састојак:
IPRATROPIUM BROMIDE/SALBUTAMOL
Доступно од:
Imbat Limited
INN (Међународно име):
IPRATROPIUM BROMIDE/SALBUTAMOL
Дозирање:
20/100 Mcg/Acutuation
Фармацеутски облик:
Unknown
Статус ауторизације:
Withdrawn
Датум одобрења:
2012-02-24
Карактеристике производа
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA1151/032/001
Case No: 2069197
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
IMBAT LIMITED
UNIT L2, NORTH RING BUSINESS PARK, SANTRY, DUBLIN 9
an authorisation, subject to the provisions of the said Regulations, in respect of the product
COMBIVENT METERED AERSOL, 20/100 MCG/ACUTUATION
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 26/08/2009 until 21/06/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 04/09/2009_
_CRN 2069197_
_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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
_Product imported from Greece._
Pressurised metered dose inhaler with a metal canister covered with a transparent plastic cover and a grey mouthpiece
and cap containing a creamy-white suspension.
Boehringer logo is embossed
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