VIOFORM HYDROCORTISONE 3/1 %w/w %w/w Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CLIOQUINOL HYDROCORTISONE

Available from:

Novartis Consumer Health UK Limited

INN (International Name):

CLIOQUINOL HYDROCORTISONE

Dosage:

3/1 %w/w %w/w

Pharmaceutical form:

Ointment

Prescription type:

Product subject to prescription which may be renewed (B)

Authorization status:

Withdrawn

Authorization date:

2009-05-29

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)
PA0030/015/002
Case No: 2045318
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVARTIS CONSUMER HEALTH UK LTD
WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VIOFORM HYDROCORTISONE 3/1 % W/W OINTMENT
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 12/05/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/01/2009_
_CRN 2045318_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vioform Hydrocortisone 3/1 % w/w Ointment.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
A white to cream coloured ointment which gives a homogenous smear apart from trapped air bubbles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Exudative and secondarily infected eczema and dermatitis, including atopic eczema, primary irritant dermatitis, allergic
and seborrhoeic dermatitis. Infected insect bite reactions. Genital or peri-anal intertrigo.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF APPLICATION:
The preparation