CALCIL 0.05 mg/g Ointment
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:
CALCIPOTRIOL ANHYDROUS
थमां उपलब्ध:
Rowex Ltd
INN (इंटरनेशनल नाम):
CALCIPOTRIOL ANHYDROUS
डोज़:
0.05 mg/g
फार्मास्यूटिकल फॉर्म:
Ointment
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2009-01-23
उत्पाद विशेषताएं
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0711/093/001
Case No: 2042715
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
CALCIL 50 MICROGRAMS/G 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 21/08/2008 until 12/07/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 29/09/2008_
_CRN 2042715_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcil 50 micrograms/g Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One gram of ointment contains 0.05 mg (is equal to 50 micrograms) of calcipotriol.
Excipient: Propylene glycol 10 mg/g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
White to off-white ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calcil is indicated for the topical treatment of mild to moderately severe psoriasis (psoriasis vulgaris).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults:_
As monotherapy
Calcil should be applied to the affected skin once or twice daily. At the beginning of treatment, twice daily application
is
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