AMOXIL Capsule 500 Milligram
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
30-04-2024
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Virkt innihaldsefni:
AMOXICILLIN TRIHYDRATE
Fáanlegur frá:
PCO Manufacturing
Skammtar:
500 Milligram
Lyfjaform:
Capsule
Leyfisdagur:
1987-08-12
Vara einkenni
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PPA0465/008/002B
Case No: 2043232
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PCO MANUFACTURING LIMITED
UNIT 222, WESTERN INDUSTRIAL ESTATE, NAAS ROAD, DUBLIN 12, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AMOXIL 500 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 22/11/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/11/2007_
_CRN 2043232_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
4 CLINICAL PARTICULARS
5 PHARMACOLOGICAL PROPERTIES
6 PHARMACEUTICAL PARTICULARS
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/11/2007_
_CRN 2043232_
_page number: 2_
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