XATRAL 10 Milligram Tablet Prolonged Release

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

ALFUZOSIN HYDROCHLORIDE

Tilgjengelig fra:

Profind Wholesale Ltd

INN (International Name):

ALFUZOSIN HYDROCHLORIDE

Dosering :

10 Milligram

Legemiddelform:

Tablet Prolonged Release

Resept typen:

Product subject to prescription which may be renewed (B)

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2013-01-29

Preparatomtale

IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA1500/024/001
Case No: 2083742
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PROFIND WHOLESALE LTD.
UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
XATRAL 10MG PROLONGED RELEASE 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 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2010_
_CRN 2083742_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xatral 10mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg alfuzosin hydrochloride.
Fora full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
_Product imported from the UK:_
Round biconvex three layer tablet: one white layer between two yellow layers.
_Product imported from the Italy:_
Round biconvex three layer tablet: one white layer between two yellow layers.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of the functional symptoms of benign prostatic hypertrophy.
Adjunctive therapy with urethral catheterization for Acute Urinary R