This consent is given subject to the following conditions:

The New Zealand Sponsor must fulfil the following obligations within the timelines specified, the date of which may be altered by mutual agreement with Medsafe:

1. Provide all reports regarding confirmatory Phase III randomized controlled study GO41944 when these become available.
2. Provide Periodic Safety Update Reports (PSURs) when these become available.
3. Re-evaluate the drug substance and drug product release and stability specifications five years post-approval.

This consent is given subject to the following conditions:

The New Zealand Sponsor must fulfil the following obligations within the timelines specified, the date of which may be altered by mutual agreement with Medsafe:

1. Provide all reports regarding confirmatory Phase III randomized controlled study GO41944 when these become available.
2. Provide Periodic Safety Update Reports (PSURs) when these become available.
3. Re-evaluate the drug substance and drug product release and stability specifications five years post-approval.

This consent is given subject to the following condition:

• The medicine may only be marketed or distributed when no other scopolamine (hyoscine) transdermal patch medicine with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or to meet PHARMAC supply obligations.