ADVANTAN CREAM 0.1% W/W
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
METHYLPREDNISOLONE ACEPONATE
Available from:
Intendis GmbH
Dosage:
0.1%w/w %w/w
Pharmaceutical form:
Cream
Authorization date:
2007-07-27
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)
PA1407/001/001
Case No: 2042218
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
INTENDIS GMBH
MAX-DOHRN-STR. 10, D-10589 BERLIN, GERMANY
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ADVANTAN CREAM 0.1% W/W
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 03/04/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/07/2008_
_CRN 2042218_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Advantan 0.1% w/w cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g cream contains 1 mg (0.1%) methylprednisolone aceponate.
Excipients: Also contains Cetostearyl Alcohol and Butylhydroxytoluene (E321)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White opaque cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of corticosteroid sensitive dermatoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
In general, the Advantan formulation appropriate to the skin condition is applied thinly once per day to the diseased
areas of skin.
In general, the duration of use should not exceed 12 weeks in adults an
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