Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
ALPROSTADIL
Pharmacia Limited
5 Microgram
Pdr+Solv for Soln for Inj
1997-04-04
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0016/046/002 Case No: 2082960 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PHARMACIA LIMITED RAMSGATE ROAD, SANDWICH, KENT, CT13 9NJ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product CAVERJECT 5 MICROGRAMS POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 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 17/06/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 17/06/2010_ _CRN 2082960_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caverject 5 micrograms Powder and Solvent for Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Alprostadil 5 micrograms When reconstituted, each 1 ml delivers a dose of 5 micrograms of alprostadil. Excipients: also includes benzyl alcohol 7.96mg per 1ml of reconstituted solution. _For a full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection. Powder: A white to off-white lyophilized powder. Solvent: A clear, colourless liquid. 4 CLINICAL PARTICULARS Caverject is indicated for the treatment of erectile dysfunction in adult males due to neurogen Прочитайте повний документ