ETRIVEX Cutaneous Emulsion 500 Micrograms/g
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
16-04-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
CLOBETASOL PROPIONATE
थमां उपलब्ध:
Galderma (UK) Ltd
डोज़:
500 Micrograms/g
फार्मास्यूटिकल फॉर्म:
Cutaneous Emulsion
प्राधिकरण की तारीख:
2005-11-11
उत्पाद विशेषताएं
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0590/022/001
Case No: 2033593
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GALDERMA (UK) LTD
MERIDIEN HOUSE, 69-71 CLARENDON ROAD, WATFORD, HERTS WD17 1DS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ETRIVEX 500 MICROGRAMS/G CUTANEOUS EMULSION
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 02/08/2007 until .
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 03/08/2007_
_CRN 2033593_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etrivex 500 micrograms/g cutaneous emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of cutaneous emulsion contains 500 micrograms of clobetasol propionate.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous emulsion
White, fluid emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Topical treatment of moderate to severe plaque-type psoriasis in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use.
Etrivex 500 micrograms/g cutaneous emulsion should be applied in thin layer without occlusion to the psoriasis
affected areas not more than twice per day. It should b
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