Država: Malta
Jezik: angleščina
Source: Medicines Authority
fluvastatin 80 mg
Novartis Pharmaceuticals UK Limited
C10AA04
fluvastatin
prolonged-release tablet
Authorised
2005-08-03
Approval Box and Ready for Print Box only to be used
in case AWF is not used.
Hurix
House,
New No. 34, Old No. 10,
Taylors
Road,
Kilpauk, Chennai-600 010.
HURIX SYSTEMS PRIVATE LIMITED
Tel: + 91-44-4228 4888
Fax: + 91-44-4228 4899
Checking against manuscript according to
SOP-0022667. To be signed by AwOps.
TYPESETTING ORDER/CTM-OWNER: 587040/Riera M.
MATERIAL NO.:
1124946-ST 12 A/B-MT
T NUMBER:
n.a.
REPLACED NO.:
32313-ST 12A/B-MT
NO OF COLOUR:
1
PRODUCT:
LFT LESCOL 20/40 MG CAP /
LESCOL XL 80 MG FCT MT
COLOUR:
314 Blue
PRESENTATION TYPE: MT
Technical approval. To be signed by Manufacturing Site.
CODE-NO.: 1281
CODE TYPE: Laetuscode
EDGE MARKS:
1/2/3/6/8
DIMENSION:
420 x 148 mm
COLOUR/TECHNICAL:
Cutting
DRAWING NO.:
n.a.
PERFORATION:
n.a.
PROOF DATE:
26.11.2012
RECEIVING PLANT:
Barbera
USED FONTS:
News Gothic TL Cond, News Gothic TL Cond Italic, News Gothic TL
Bold Cond
SMALLEST FONT SIZE:
9 pt
Text (News Gothic TL-Cond)
SMALLEST FONT SIZE:
7 pt
Code (News Gothic TL-Cond)
SMALLEST VECTORIZED TEXT: n.a.
This information was compiled with utmost care and on completion was
subjected to strict Internal checks. However, the handling of data
always involves a certain degree of risk and the impossibility of
error
cannot be guaranteed. Therefore we would ask you to check the proof
thoroughly. Hurix assumes no liability for errors identified only
after print approval has been given.
2. Proof
Sridhar
Page 1/2
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Preberite celoten dokument
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT Lescol 20 mg capsules, hard Lescol 40 mg capsules, hard Lescol XL 80 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: fluvastatin (as fluvastatin sodium) Lescol 20 mg capsules: One capsule contains 21.06 mg fluvastatin sodium equivalent to 20 mg fluvastatin free acid. Lescol 40 mg capsules: One capsule contains 42.12 mg fluvastatin sodium equivalent to 40 mg fluvastatin free acid. Lescol XL 80 mg prolonged-release tablets: One prolonged-release tablet of Lescol XL contains 84.24 mg fluvastatin sodium equivalent to 80 mg fluvastatin free acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Capsule, hard Prolonged-release tablet Lescol 20 mg capsules: Cap: Strong reddish brown opaque . Body: Pale yellow opaque; imprint: XU 20 mg (red ink) . Lescol 40 mg capsules: Cap: Strong reddish brown opaque . Body: Orange yellow opaque; imprint: XU 40 mg (red ink) . Lescol XL 80 mg prolonged-release tablets: Yellow, round, slightly biconvex film-coated tablets with beveled edges, approx. 10 mm in diame- ter, debossed with “LE” on one side and “NVR” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dyslipidaemia Page 2 of 15 Treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduc- tion) is inadequate. Secondary prevention in coronary heart disease Secondary prevention of major adverse cardiac events in adults with coronary heart disease after percutaneous coronary interventions (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults _ Dyslipidaemia Prior to initiating treatment with Lescol/Lescol XL, p Preberite celoten dokument