BELLRAMIL Capsules Hard 1.25 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
RAMIPRIL
Available from:
Ranbaxy (UK) Limited
Dosage:
1.25 Milligram
Pharmaceutical form:
Capsules Hard
Authorization date:
2007-07-27
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)
PA0967/006/001
Case No: 2064661
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
BELLRAMIL, 1.25 MILLIGRAM
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 19/05/2009 until 26/07/2012.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 19/05/2009_
_CRN 2064661_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bellramil 1.25 mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains ramipril 1.25 mg.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsule, hard, Size 4 with yellow cap/white body imprinted with ‘R’ on cap and ‘1.25’ on body. Contains white to off-
white granular powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For reducing the risk of myocardial infarction, stroke, cardiovascular death or need for revascularisation procedures in
patients of 55 years or more who have clinical evidence of cardiovascular disease (previous MI, unstable
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