CAVERJECT Pdr+Solv for Soln for Inj 5 Microgram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
ALPROSTADIL
Available from:
Pharmacia Limited
Dosage:
5 Microgram
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Authorization date:
1997-04-04
Summary of Product characteristics
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
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