BENPROTAN 10 Milligram Tablet Prolonged Release

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

ALFUZOSIN HYDROCHLORIDE

Inapatikana kutoka:

Clonmel Healthcare Ltd

INN (Jina la Kimataifa):

ALFUZOSIN HYDROCHLORIDE

Kipimo:

10 Milligram

Dawa fomu:

Tablet Prolonged Release

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2009-05-28

Tabia za bidhaa

IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0126/160/002
Case No: 2052342
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 10 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 26/08/2008 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 21/10/2008_
_CRN 2052342_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benprotan 10 mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg alfuzosin hydrochloride.
Excipients:
Each tablet conains 8 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White, round, bevelled-edge, uncoated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe functional symptoms of benign prostatic hyperplasia (BPH).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The prolonged-release tablet should be swallowed whole with a sufficient amount of fluid