SUSCARD BUCCAL
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
GLYCERYL TRINITRATE
Available from:
Forest Laboratories UK Ltd
Dosage:
2.0 mg Milligram
Pharmaceutical form:
Tablet Prolonged Release
Authorization date:
1983-08-28
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)
PA0100/033/003
Case No: 2071722
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
FOREST LABORATORIES UK LTD
RIVERBRIDGE HOUSE, CROSSWAYS BUSINESS P, KENT, DA2 6SL, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
SUSCARD BUCCAL TABLET 2MG
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 25/09/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/09/2009_
_CRN 2071722_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Suscard Buccal Tablet 2 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of glyceryl trinitrate as Diluted Nitroglycerin.
Also contains 19.89mg of Lactose Monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release Buccal Tablet.
White, biconvex, round tablets having the number ‘2’ imprinted on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the management and treatment of angina pectoris. This product may also be of benefit in the in-patient
management of unstable angina.
For the treatment of acute and congestive cardi
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