Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
HYOSCINE HYDROBROMIDE
Bayer PLC
HYOSCINE HYDROBROMIDE
150 Microgram
Tablets
Withdrawn
2008-08-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0021/070/001 Case No: 2048521 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAYER PLC BAYER HOUSE, STRAWBERRY HILL, NEWBURY, BERKSHIRE RG14 1JA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product JUNIOR KWELLS 150 MICROGRAM TABLETS 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 03/04/2008 until 19/04/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 05/04/2008_ _CRN 2048521_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Junior Kwells 150 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hyoscine Hydrobromide 150 micrograms. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet Small, circular, white, flat tablet with bevelled edges and a single scoreline on the surface. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention of motion sickness. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tablets to be sucked, chewed or swallowed. Tablets to be taken up to 30 minutes before the start of the journey to prevent travel sickness, or at the onset of nausea. Adults: Not applicable. Elderly p Прочетете целия документ