GABTURE Capsule 300 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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:
GABAPENTIN
Available from:
Milpharm Limited
Dosage:
300 Milligram
Pharmaceutical form:
Capsule
Authorization date:
2003-11-18
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)
PA1050/001/002
Case No: 2062962
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
MILPHARM LIMITED
ARES, ODYSSEY BUSINESS PARK, WEST END ROAD, SOUTH RUISLIP HA4 6QD, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GABTURE 300 MG CAPSULES
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 12/03/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/03/2009_
_CRN 2062962_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabture 300 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gabapentin 300mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule hard
Size '1' yellow/yellow hard gelatin capsule marked 'MG 300'.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Monotherapy in adults and children over 12 years of age_
Gabapentin is used as an antiepileptic indicated for monotherapy or add-on treatment for adults and children over 12
years of age with partial seizures or partial seizures with secondary generalisation, including patients with newly
diagnosed seizures.
Monotherapy in childr
Read the complete document
