Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ISOSORBIDE MONONITRATE
UCB (Pharma) Ireland Limited
50 Milligram
Prolonged Release Capsules
2009-06-12
License IRISH MEDICINES BOARD ACT 1995, as amended Medicinal Products (Control of Placing on the Market) Regulations, 2007, as amended PA0891/011/002 Case No: 2086513 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to UCB (Pharma) Ireland Limited United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland an authorisation, subject to the provisions of the said Regulations, in respect of the product Elantan LA 50 mg Prolonged Release Capsules, hard the particulars of which are set out in 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 28/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. Irish Medicines Board ______________________________________________________________________________________________________________________ Date Printed 28/07/2010 CRN 2086513 page number: 1 Part II Summary of Product Characteristics 1 NAME OF THE MEDICINAL PRODUCT Elantan LA 50 mg Prolonged Release Capsules, hard. 2 Read the complete document