Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Moxifloxacin hydrochloride
PCO Manufacturing Ltd.
J01MA; J01MA14
Moxifloxacin hydrochloride
400 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Fluoroquinolones; moxifloxacin
Authorised
2009-07-24
Health Products Regulatory Authority 09 April 2021 CRN00C8J3 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Avelox 400 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride). Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. _Product imported from Portugal and Greece:_ Dull red film-coated tablet with an oblong, convex shape with facet, and marked with "M400" on one side and "BAYER" on the other side. 4 CLINICAL PARTICULARS As per PA1410/027/001 5 PHARMACOLOGICAL PROPERTIES As per PA1410/027/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Film coat: Hypromellose Macrogol 4000 Iron oxide (E172) Titanium dioxide (E171) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the blister and outer package of the product on the market in the country of origin. Health Products Regulatory Authority 09 April 2021 CRN00C8J3 Page 2 of 2 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 o C. Store in the original package in order to protect from moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Cartons containing colourless or white opaque polypropylene/aluminium blisters: The film-coated tablets are available in packs of 5 tablets. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/230/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24th July 2009 10 DATE OF REVISION OF THE TEXT April 2021 read_full_document