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Notice Type
Departmental
Notice Title

Provisional Consent to the Distribution of New Medicines

Publication Date
4 Apr 2024

Tags

Medicines Act Provisional consent to the distribution of new medicines Health

Notice Number

2024-go1465
Title
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PDF (37 KB)

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of the new medicines set out in the Schedule hereto:

Schedule

Product: Columvi (2.5mg/2.5mL)
Active Ingredient: Glofitamab 1mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Genentech Inc, California, United States of America

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 valid for two years from the date of publication of this notice.
Product: Columvi (10mg/10mL)
Active Ingredient: Glofitamab 1mg/mL
Dosage Form: Concentrate for infusion
New Zealand Sponsor: Roche Products (NZ) Limited
Manufacturer: Genentech Inc, California, United States of America

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 valid for two years from the date of publication of this notice.
   
Product: Scopolamine Transdermal System
Active Ingredient: Hyoscine 1.45mg
Dosage Form: Transdermal patch
New Zealand Sponsor: Viatris Limited
Manufacturer: Mylan Technologies, Vermont, United States of America

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.
This consent is valid for two years from the date of publication of this notice.


Dated this 2nd day of April 2024.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).