GEMCITABINE MARTINDALE PHARMA 1000 Milligram Pdr for Soln for Infusion
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
31-05-2024
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:
GEMCITABINE HYDROCHLORIDE
थमां उपलब्ध:
Martindale Pharmaceuticals Ltd
INN (इंटरनेशनल नाम):
GEMCITABINE HYDROCHLORIDE
डोज़:
1000 Milligram
फार्मास्यूटिकल फॉर्म:
Pdr for Soln for Infusion
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may not be renewed (A)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
0000-00-00
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)
PA0361/022/002
Case No: 2050873
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MARTINDALE PHARMACEUTICALS LTD
BAMPTON ROAD, HAROLD HILL, ROMFORD, RM3 8UG, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GEMCITABINE MARTINDALE PHARMA 1000MG POWDER FOR SOLUTION FOR INFUSION
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 09/10/2009 until 08/10/2014.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 09/10/2009_
_CRN 2050873_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gemcitabine Martindale Pharma 1000mg Powder for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains gemcitabine hydrochloride equivalent to 1000 mg gemcitabine.
One ml of the solution for injection contains 38mg gemcitabine (as gemcitabine hydrochloride) after reconstitution
with 25ml of sterile sodium chloride 9 mg/ml (0.9 %) solution.
Excipients
One 1000mg vial contains approximately 0.75mmol (17.5 mg) of sodium.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
White
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