Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE
PCO Manufacturing
500 Milligram
Capsule
1987-08-12
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_ Přečtěte si celý dokument