SIMATOR Tablets 10 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-05-2024
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Active ingredient:
SIMVASTATIN
Available from:
Arrow Generics Limited
Dosage:
10 Milligram
Pharmaceutical form:
Tablets
Authorization date:
2004-01-26
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA1130/001/001
Case No: 2084274
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ARROW GENERICS LIMITED
UNIT 2, EASTMAN WAY, STEVENAGE, HERTFORDSHIRE, SG1 4SZ, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SIMATOR 10 MG 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 28/06/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/06/2010_
_CRN 2084274_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Simator 10 mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10mg simvastatin.
Excipient: 73.43mg lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
Shield-shaped, pink tablets with “SV 10” on one side and “
≫” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Treatment of primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and
other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate.
Treatment of homozygous
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