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Notice Type
Departmental
Notice Title

Corrigendum—Provisional Consent to the Distribution of New Medicines

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: Lyrica
Active Ingredient: Pregabalin 25mg
Dosage Form: Capsule
New Zealand Sponsor: Upjohn New Zealand ULC
Manufacturers: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico

Note: This consent is given subject to the following conditions:

  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other pregabalin capsule with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or if the medicine is required to maintain assurance of supply for PHARMAC contract obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lyrica
Active Ingredient: Pregabalin 75mg
Dosage Form: Capsule
New Zealand Sponsor: Upjohn New Zealand ULC
Manufacturers: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico

Note: This consent is given subject to the following conditions:

  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other pregabalin capsule with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or if the medicine is required to maintain assurance of supply for PHARMAC contract obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lyrica
Active Ingredient: Pregabalin 150mg
Dosage Form: Capsule
New Zealand Sponsor: Upjohn New Zealand ULC
Manufacturers: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico

Note: This consent is given subject to the following conditions:

  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other pregabalin capsule with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or if the medicine is required to maintain assurance of supply for PHARMAC contract obligations.
Note: This consent is valid for two years from the date of publication of this notice.
   
Product: Lyrica
Active Ingredient: Pregabalin 300mg
Dosage Form: Capsule
New Zealand Sponsor: Upjohn New Zealand ULC
Manufacturers: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany
Pfizer Pharmaceuticals LLC, Vega Baja, Puerto Rico

Note: This consent is given subject to the following conditions:

  • Provisional consent is to be granted for two years to address an urgent shortage in the market.
  • The medicine may only be marketed or distributed when no other pregabalin capsule with consent under section 20 of the Medicines Act 1981 is available in the New Zealand market, or if the medicine is required to maintain assurance of supply for PHARMAC contract obligations.
Note: This consent is valid for two years from the date of publication of this notice.


Dated this 10th day of November 2020.

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

Note: This notice replaces the notice published in the New Zealand Gazette, 10 November 2020, Notice No. 2020-go5202.