DIACARDYNE SR
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-03-2023
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Active ingredient:
DILTIAZEM HYDROCHLORIDE
Available from:
Ethypharm
Dosage:
120 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Authorization date:
1991-01-18
Summary of Product characteristics
License
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. No.142 of 1998)
PA0549/001/002
Case No: 2015522
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Ethypharm SA
17-21 rue St. Mattieu, 78550 Houdan, France
an authorisation, subject to the provisions of the said Regulations, in respect of the product
Diacardyne SR 120mg prolonged-release capsules, hard
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 18/01/2006.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
Irish Medicines Board
______________________________________________________________________________________________________________________
Date Printed 25/04/2007
CRN 2015522
page number: 1
Part II
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Diacardyne SR 120mg prolonged-release capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains diltiazem h
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