Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
PARACETAMOL
Reckitt Benckiser Ireland Ltd
120 Milligram
Tablets Effervescent
1996-11-19
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0979/008/002 Case No: 2033335 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RECKITT BENCKISER IRELAND LTD 7 RIVERWALK, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product DISPROL SOLUBLE PARACETAMOL EFFERVESCENT TABLETS 120MG 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 19/09/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/09/2007_ _CRN 2033335_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Disprol Soluble Paracetamol Effervescent Tablets 120mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Paracetamol 120mg. Excipients: Also includes 5.3 mmol sodium (121.6mg) per typical dose, and sulphur dioxide (E220), trace amounts. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet Circular, beveled edge, white, effervescent tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Analgesic/antipyretic. In the management of symptoms of headache, toothache, common cold, influenza and musculo-skeletal pain. 4.2 POSOLOGY AND METHOD OF ADMI Citiți documentul complet