VENLAFAXINE 50 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-06-2024
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Active ingredient:
VENLAFAXINE
Available from:
Pliva Pharma Limited
INN (International Name):
VENLAFAXINE
Dosage:
50 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2009-04-03
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0585/028/002
Case No: 2036003
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PLIVA PHARMA LIMITED
VISION HOUSE, BEDFORD ROAD, PETERSFIELD, HAMPSHIRE GU32 3QB, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VENLAFAXINE 50 MG TABLETS
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 01/08/2008 until 31/07/2013.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/08/2008_
_CRN 2036003_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Venlafaxine 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains venlafaxine hydrochloride, equivalent to 50mg of venlafaxine.
Excipients:
Venlafaxine 50mg Tablets contain 90.25mg of lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Light yellow, round, biconvex tablets, with marking VN 50 on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MODERATE TO SEVERE MAJOR DEPRESSIVE DISORDER
Venlafaxine Tablets are indicated for the treatment of moderate to severe major depressive disorder including
depression accompanied by anxiet
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