CRESTOR Film Coated Tablet 10 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
ROSUVASTATIN
Available from:
Pharma First Limited
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2009-10-16
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)
PPA1592/002/001
Case No: 2069114
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PHARMA FIRST LIMITED
UNIT 1A - MONREAD BUSINESS PARK, MONREAD ROAD, NAAS, CO. KILDARE, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CRESTOR 10MG FILM-COATED TABLETS
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 16/10/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 24/10/2009_
_CRN 2069114_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Crestor 10mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of rosuvastatin (as rosuvastatin calcium)
Excipient(s): Lactose Monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from _Italy
Pink coloured, round film-coated tablet with ‘ZD4522’ and 10 engraved on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed
dyslipidaemia (type IIb) as an adjunct to die
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