Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
GUAIFENESIN
Crookes Healthcare Ltd
100mg MG/5ml
Oral Solution
2007-04-27
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0043/042/001 Case No: 1999891 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CROOKES HEALTHCARE LTD 1 THANE ROAD WEST, NOTTINGHAM, NG2 3AA, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product STREPSILS CHESTY COUGH 100MG/5ML 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 27/04/2007 until 26/04/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/04/2007_ _CRN 1999891_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strepsils Chesty Cough 100mg/5ml Oral solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml oral solution contains Guaifenesin 100mg. For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Oral solution A clear, bright green viscous oral solution with a lemon/lime odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS An expectorant for the symptomatic relief of chesty coughs, and to soothe and coat the throat. For oral administration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12 years: 10ml to be taken every four hours up to four times a day. Children 6 to Διαβάστε το πλήρες έγγραφο