SAIZEN Pdr+Solv for Soln for Inj 1.33 mg 4I International Unit
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
SOMATROPIN
Available from:
Serono Limited
Dosage:
1.33 mg 4I International Unit
Pharmaceutical form:
Pdr+Solv for Soln for Inj
Authorization date:
1989-04-14
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0285/005/001
Case No: 2075212
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
SERONO LIMITED
BEDFONT CROSS, STANWELL ROAD, FELTHAM, MIDDLESEX, TW14 8NX, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SAIZEN 1.33 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION.
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 18/05/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/05/2010_
_CRN 2075212_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Saizen 1.33 mg powder and solvent for solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Saizen 1.33 mg contains somatropin* (recombinant human growth hormone).
*produced by recombinant DNA technology in mammalian cells
After reconstitution with the enclosed solvent, each vial shall contain 1.33 mg of Saizen/ml.
Excipients: 20 mg mannitol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Appearance of the powder: white lyophilised powder.
Appearance of the solvent: clear colourless solut
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