✨ Medicines and Financial Approvals




NEW ZEALAND GAZETTE, No. 25 β€” 9 MARCH 2017

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Ilevro
Nepafenac 3mg/mL
Eye drops, suspension
Pharmaco (NZ) Limited
SA Alcon Couvreur NV, Puurs, Belgium

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Praluent
Alirocumab 75mg/mL
Solution for injection
Sanofi-Aventis New Zealand Limited
Sanofi Winthrop Industrie, Le Trait, France
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Praluent
Alirocumab 150mg/mL
Solution for injection
Sanofi-Aventis New Zealand Limited
Sanofi Winthrop Industrie, Le Trait, France
Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany

Dated this 6th day of March 2017.

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

2017-go1103

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Silvasta
Sildenafil citrate 35.12mg equivalent to 25mg sildenafil
Tablet
Douglas Pharmaceuticals Limited
Actavis ehf, Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Silvasta
Sildenafil citrate 70.24mg equivalent to 50mg sildenafil
Tablet
Douglas Pharmaceuticals Limited
Actavis ehf, Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturers:

Silvasta
Sildenafil citrate 140.48mg equivalent to 100mg sildenafil
Tablet
Douglas Pharmaceuticals Limited
Actavis ehf, Hafnarfjordur, Iceland
Actavis Limited, Zejtun, Malta

Dated this 6th day of March 2017.

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

2017-go1104

Approval of Qualified Persons for the Purposes of Section 36(1)(d)(ii) of the Financial Reporting Act 2013

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Online Sources for this page:

Gazette.govt.nz PDF NZ Gazette 2017, No 25





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of New Medicines (continued from previous page)

πŸ₯ Health & Social Welfare
6 March 2017
New Medicines, Distribution, Ilevro, Praluent, Nepafenac, Alirocumab
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
6 March 2017
New Medicines, Distribution, Silvasta, Sildenafil citrate
  • CHRIS JAMES, Group Manager, Medsafe, Ministry of Health

πŸ’° Approval of Qualified Persons for the Purposes of Section 36(1)(d)(ii) of the Financial Reporting Act 2013

πŸ’° Finance & Revenue
Financial Reporting, Qualified Persons, Approval