BENPROTAN Tablet Prolonged Release 5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-03-2023
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Active ingredient:
ALFUZOSIN HYDROCHLORIDE
Available from:
Clonmel Healthcare Ltd
Dosage:
5 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
2006-12-15
Summary of Product characteristics
License
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. No.142 of 1998)
PA0126/160/001
Case No: 2014768
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Clonmel Healthcare Limited
Waterford Road, Clonmel, Co. Tipperary, Ireland
an authorisation, subject to the provisions of the said Regulations, in respect of the product
Benprotan 5 mg Prolonged Release Tablets
The particulars of which are set out in Part I and Part II of 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 15/12/2006 until 14/12/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 19/12/2006
CRN 2014768
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Benprotan 5 mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
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