TOPAMAX Film Coated Tablet 25 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
TOPIRAMATE
Available from:
Profind Wholesale Ltd.
Dosage:
25 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2010-02-26
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PPA1500/050/001
Case No: 2083758
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
PROFIND WHOLESALE LTD.
UNIT 625, KILSHANE AVENUE, NORTHWEST BUSINESS PARK, DUBLIN 15, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
TOPAMAX 25MG FILM-COATED TABLETS
the particulars of which are set out in 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 28/07/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2010_
_CRN 2083758_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topamax 25mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg topiramate.
Excipients: contains lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from _Greece:
White, embossed, round, film-coated tablets imprinted with “TOP” on one side and “25” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPILEPSY
Topamax is indicated as monotherapy or adjunctive therapy for adults and children over 4 years of age for partial onset
seizures with or without secondarily generalised seizures and primary gener
Read the complete document
