OXYBUTYNIN STADA

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

01-06-2024

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।

सक्रिय संघटक:

OXYBUTYNIN HYDROCHLORIDE

थमां उपलब्ध:

Stada Arzneimittel AG

डोज़:

5 Milligram

फार्मास्यूटिकल फॉर्म:

Tablets

प्राधिकरण की तारीख:

2000-11-10

उत्पाद विशेषताएं

IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0593/022/001
Case No: 2022410
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
STADA ARZNEIMITTEL AG
STADASTRASSE 2-18, D-61118 BAD VILBEL, GERMANY
an authorisation, subject to the provisions of the said Regulations, in respect of the product
OXYBUTYNIN STADA 5 MG, TABLET
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 16/02/2007 until 03/09/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/02/2007_
_CRN 2022410_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxybutynin Stada 5 mg, tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxybutynin hydrochloride 5mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Tablets
White, round tablets, scored on both sides and marked 'OBC5' on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of detrusor overactivity (neurogenic or idiopathic detrusor overactivity) with the symptoms of
urgency, frequency, and urge incontinence.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage should be individualised to disease severity and the patient's clinical response. As a rule, the lowest
effective dose should be determined and used, tak

पूरा दस्तावेज़ पढ़ें

OXYBUTYNIN STADA

सक्रिय संघटक:

थमां उपलब्ध:

डोज़:

फार्मास्यूटिकल फॉर्म:

प्राधिकरण की तारीख:

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