AMOXICILLIN SANDOZ 250 Milligram Capsules Hard
Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Charakterystyka produktu
(SPC)
14-06-2024
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Składnik aktywny:
AMOXICILLIN TRIHYDRATE
Dostępny od:
Sandoz GmbH
INN (International Nazwa):
AMOXICILLIN TRIHYDRATE
Dawkowanie:
250 Milligram
Forma farmaceutyczna:
Capsules Hard
Typ recepty:
Product subject to prescription which may not be renewed (A)
Status autoryzacji:
Withdrawn
Data autoryzacji:
2010-01-25
Charakterystyka produktu
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0111/004/001
Case No: 2064165
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SANDOZ GMBH
BIOCHEMIESTRASSE 10, A-6250 KUNDL, AUSTRIA
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AMOXICILLIN SANDOZ 250 MG CAPSULES
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 22/07/2009 until 13/09/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 22/07/2009_
_CRN 2064165_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin Sandoz 250 mg capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg amoxicillin (as trihydrate)
For a full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Capsule, hard
Yellow, opaque capsules with black imprints alternately “AMX” and "250" axially
(if appropriate)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxicillin Sandoz is indicated for the oral treatment of the following bacterial infections caused by amoxicillin-
sensitive gram-positive and gram-negative pathogens (see section 5.1.):
o
Infections of the upper respiratory tract, including infections of the ears, nose
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