LAMOTRIGINE RANBAXY 200 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-05-2024
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Active ingredient:
LAMOTRIGINE
Available from:
Ranbaxy (UK) Limited
INN (International Name):
LAMOTRIGINE
Dosage:
200 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2009-02-17
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)
PA0967/012/004
Case No: 2037874
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
RANBAXY (UK) LIMITED
20 BALDERTON STREET, LONDON W1K 6TL, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
LAMOTRIGINE RANBAXY 200 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 14/12/2007 until 11/10/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 04/01/2008_
_CRN 2037874_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamotrigine Ranbaxy 200 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg lamotrigine
Excipients: 23.75 mg of lactose, 1.68 mg of sodium
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
Yellow coloured, capsule shaped, biconvex tablets debossed with ‘L’ and ‘200’ on either side of the score line on one
side and a deep breakline on the other side. The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_EPILEPSY_
_Adults and adolescents_
Monotherapy of:
- Partial epilepsy with or without generali
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