Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DIPYRIDAMOLE ACETYLSALICYLIC ACID
B & S Healthcare
200/25 Milligram
Capsules Modified Release
2007-02-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/069/001 Case No: 2066357 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ASASANTIN RETARD 200 MG /25 MG MODIFIED-RELEASE HARD 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 12/06/2009 until 22/02/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/06/2009_ _CRN 2066357_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ASASANTIN Retard 200 mg / 25 mg Modified-release Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each modified release hard capsule contains dipyridamole 200 mg and acetysalicylic acid 25 mg. Excipients : Lactose and sucrose. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Modified-release hard capsule _Product imported from France:_ Capsules consisting of a red cap and an ivory body _Product imported from the United Kingdom:_ Capsules consisting of a red cap and an ivory body imprinted with the company logo and the figures ‘01 Read the complete document