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.
