DURAGLAN Tablet Prolonged Release 4mg Base Milligrams

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

DOXAZOSIN MESILATE

Available from:

Jacobsen Pharma A/S

Dosage:

4mg Base Milligrams

Pharmaceutical form:

Tablet Prolonged Release

Authorization date:

2007-11-23

Summary of Product characteristics

                                
License
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. No.540 of 2007)
PA1035/001/001
Case No: 1025972
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Jacobsen Pharma
Vemmingbund Strandvej 111, DK-6310, Broadger, Denmark
an authorisation, subject to the provisions of the said Regulations, in respect of the product
Duraglan 4 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 23/11/2007 until 22/11/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 30/11/2007
CRN 1025972
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Duraglan 4mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
                                
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