País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
DOXAZOSIN MESILATE
Jacobsen Pharma A/S
4mg Base Milligrams
Tablet Prolonged Release
2007-11-23
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 tablet contains doxazosin 4mg (as mesilate) For a full list of excipients, see 6.1 3 PHARMACEUTICAL FORM Prolonged release tablets White round, biconvex tablets with ‘DL’ embossed on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Duraglan XL is indicated for the treatment of hypertension and can be used as a sole agent to control blood pressure in hypertensive patients. In patients inadequately controlled on single antihypertensive therapy, Duraglan XL tablets may be used in combination with a thiazi Leia o documento completo