Data Sheets
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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 regulatory guidelines 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.
Note for Prescribers: The authority to prescribe medicines is controlled by the Medicines Act 1981. However, such prescribing needs to be in conformance with the Code of Health and Disability Services Consumers' Rights 1996. The patient has the right to treatment meeting appropriate ethical and professional standards, and the patient needs to be fully informed with frank discussion of risk/benefit issues relating to medicine efficacy and safety when used in the treatment regimen proposed. Information about the unapproved ('off-label') use of medicines is given in a Prescriber Update article.
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.
