Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
PARACETAMOL
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
1000 Milligram
Oral Powder
2006-06-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0678/104/001 Case No: 2054166 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GLAXOSMITHKLINE CONSUMER HEALTHCARE (IRELAND) LIMITED STONEMASONS WAY, RATHFARNHAM, DUBLIN 16, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BEECHAMS MAX STRENGTH COLD AND FLU 1000 MG POWDER FOR ORAL SOLUTION. 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 11/09/2008 until 01/06/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/10/2008_ _CRN 2054166_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Beechams Max strength Cold and Flu 1000mg Powder for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 1000mg of Paracetamol. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for Oral Solution Pale yellow soluble powder with an odour and taste of lemon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Short term symptomatic relief of influenza, feverishness, chills and colds including headache, sore throat pain, sinusitis, aches and pains. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administrat Đọc toàn bộ tài liệu