STERIPASTE MEDICATED PASTE BANDAGE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
ZINC OXIDE
Available from:
Medlock Medical Ltd
Dosage:
15 %w/w
Pharmaceutical form:
Impregnated Dressing
Authorization date:
2006-11-10
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)
PA1175/012/001
Case No: 2062971
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MEDLOCK MEDICAL LTD
TUBITON HOUSE, MEDLOCK STREET, OLDHAM, OL1 3HS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
STERIPASTE 15%W/W MEDICATED PASTE BANDAGE
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 26/07/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/09/2009_
_CRN 2062971_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Steripaste 15% w/w Medicated Paste Bandage
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc Oxide 15% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Impregnated dressing
Bandage with serrated edges evenly impregnated with white opaque, homogeneous paste, packed in heat-sealed
sachets of laminated foil in cartons.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of venous ulcers where sensitisation has been a problem.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS, CHILDREN AND THE ELDERLY
Frequency of dressing changes is at the discretion of the responsible
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