AVODART Capsules, Soft 0.5 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
DUTASTERIDE
Available from:
McDowell Pharmaceuticals
Dosage:
0.5 Milligram
Pharmaceutical form:
Capsules, Soft
Authorization date:
2010-07-16
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA1473/046/001
Case No: 2078035
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MCDOWELL PHARMACEUTICALS
4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AVODART 0.5MG SOFT CAPSULES
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 16/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/07/2010_
_CRN 2078035_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Avodart 0.5mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5mg dutasteride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
_Product imported from _the UK:
The capsules are opaque, yellow, oblong soft gelatin capsules imprinted with GX CE2 on one side in red ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of
BPH.
For information on effects of treatment and patient populations studied i
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