BEROTEC 100 INHALER CFC-FREE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
FENOTEROL HYDROBROMIDE
Available from:
Boehringer Ingelheim Limited
Dosage:
100 Microgram
Pharmaceutical form:
Solution for Inhalation
Authorization date:
2004-12-17
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)
PA0007/033/005
Case No: 2065924
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
BEROTEC INHALER CFC-FREE 100 MICROGRAMS/METERED DOSE, PRESSURISED INHALATION, 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 11/06/2009 until 31/10/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 03/07/2009_
_CRN 2065924_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BEROTEC Inhaler CFC-Free 100 micrograms/metered dose, pressurised inhalation, solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 metered dose (puff) contains 100 micrograms fenoterol hydrobromide.
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pressurised inhalation, solution.
Each container is filled with 10 ml of a clear, colourless or almost colourless liquid, free from suspended particles and
is supplied with a white plastic oral adaptor (mouthpiece).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the t
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