LIPANTIL SUPRA 145MG FILM-COATED TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
FENOFIBRATE
Available from:
Abbott Healthcare Products Ltd
Dosage:
145 Milligram
Pharmaceutical form:
Coated Tablets
Authorization date:
2007-01-05
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0108/030/005
Case No: 2077632
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ABBOTT HEALTHCARE PRODUCTS LTD
MANSBRIDGE ROAD, WEST END, SOUTHAMPTON SO18 3JD, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LIPANTIL SUPRA 145MG 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 21/06/2010 until 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/07/2010_
_CRN 2077632_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipantil Supra 145mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 145.0 mg fenofibrate (nanoparticles).
_For excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Film coated tablet.
White, oblong, film-coated tablets engraved “145” on one side and “Fournier logo” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypercholesterolaemia and hypertriglyceridaemia alone or combined (types IIa, IIb, IV dyslipidaemias, as well as
types III and V dyslipidaemias ) in patients unresponsive to dietary and other non-drug therapeutic measures (e.
Read the complete document
