Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
CHLORHEXIDINE GLUCONATE
Pierre Fabre Medicament
0.1 %w/v
Mouth Wash
1999-06-25
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0329/001/001 Case No: 2053168 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PIERRE FABRE MEDICAMENT 45 PLACE ABEL GANCE, 92100 BOULOGNE, CEDEX, FRANCE an authorisation, subject to the provisions of the said Regulations, in respect of the product ELUDRIL MOUTHWASH 1 MG/ML 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 21/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/07/2010_ _CRN 2053168_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eludril Mouthwash 1 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains chlorhexidine digluconate solution 0.005 ml (corresponding to 1 mg chlorhexidine digluconate). The content of chlorhexidine digluconate per ml when diluted as recommended is 0.22mg/ml - 0.33mg/ml Excipients: contains Cochineal Red A (E124) 0.003g/100 ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Mouthwash Clear, pink liquid with an odour of menthol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an adjunct in the topical prophylaxis and management of inflammation and minor infections of the mouth and oral pharynx, including use after Đọc toàn bộ tài liệu