SEREVENT INHALER 25 Microgram Pressurised Inhalation Suspension
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
07-06-2024
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:
SALMETEROL XINAFOATE
थमां उपलब्ध:
GlaxoSmithKline (Ireland) Limited
INN (इंटरनेशनल नाम):
SALMETEROL XINAFOATE
डोज़:
25 Microgram
फार्मास्यूटिकल फॉर्म:
Pressurised Inhalation Suspension
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2007-10-12
उत्पाद विशेषताएं
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA1077/047/001
Case No: 2032319
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GLAXOSMITHKLINE (IRELAND) LTD
STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SEREVENT 25 MCG/ACUTUATION PRESSURISED INHALATION SUSPENSION
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 19/01/2007 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 20/01/2007_
_CRN 2032319_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serevent Inhaler, 25 Micrograms, pressurised inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pressurised metered-dose inhaler delivering 25 micrograms of salmeterol as salmeterol xinafoate with each actuation.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension
Supplied in an aluminium can with metering value and actuator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults_
Salmeterol provides long-lasting (12 hour) bronchodilation in reversible airways obstruction due to asthma, chronic
bronchitis, emphysema and COPD. It is suitable for long-term regular, twice-d
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