CRESTOR Film Coated Tablet 10 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
ROSUVASTATIN
Available from:
IPS Healthcare Limited
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-10-08
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA1659/003/001
Case No: 2085239
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
IPS HEALTHCARE LIMITED
STERLING HOUSE, 501 MIDDLETON ROAD, CHADDERTON, OLDHAM, LANCASHIRE OL9 9LY, UNITED KINGDOM
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 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 08/10/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/10/2010_
_CRN 2085239_
_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 10 mg rosuvastatin (as rosuvastatin calcium). Each tablets contains 91.3 mg lactose monohydrate.
For a full list of excipients, _see Section 6.1._
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from United Kingdom:_
Round, pink coloured tablets, intag1iated with _'ZD4S22' _and '10' on one side and plain on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia (type IIa i
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