Reviewed: May 2012
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|Data sheets contain detailed prescribing information on a specific medicine. Pharmaceutical companies are
required to prepare data sheets for all prescription medicines and restricted (pharmacist only) medicines in
accordance with the Medicines Regulations 1984
and Part 10:
Requirements for information for prescribers and consumers of the
regulatory guidelines (Microsoft Word document 1870KB) published by Medsafe. Medsafe
approves each data sheet on the basis of the company declaring that the data sheet conforms with the specified
requirements and accurately reflects the product approved for distribution in New Zealand. Data sheets are
updated as required to include newly approved dose forms, strengths or indications, or to update warnings, adverse
effects, contra-indications etc. as new safety information becomes available.
Data sheets electronically submitted to Medsafe are available on this web site. For copies of data sheets not currently on this site, contact the pharmaceutical company directly. Any queries relating to information contained in a data sheet should be directed to the pharmaceutical company named as the sponsor in the data sheet.
Data sheets are published on the Medsafe website in Portable Document Format (PDF). To read a PDF you need Adobe Acrobat Reader installed on your computer. You can download the latest free version of Adobe Acrobat Reader from the Adobe website.
Commercial Use (i.e. the on-selling) of the data sheets available on the Medsafe web site requires permission to be sought and obtained from the sponsors (pharmaceutical companies) of the medicines concerned.