Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
DILTIAZEM HYDROCHLORIDE
Ethypharm
120 Milligram
Prolonged Release Capsules
1991-01-18
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 hydrochloride 120 mg. Excipients: Sucrose 24.35mg For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release capsule, hard. Hard gelatin capsules with an opaque white body and opaque brown cap, marked with ‘120 mg’ in black ink on the body and containing off-white spherical micro granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of angina pectoris. Treatment of mild to moderate hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use only ADULTS : Hypertension: The Đọc toàn bộ tài liệu