β¨ 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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β¨ LLM interpretation of page content
π₯
Consent to the Distribution of New Medicines
(continued from previous page)
π₯ Health & Social Welfare6 March 2017
New Medicines, Distribution, Ilevro, Praluent, Nepafenac, Alirocumab
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of New Medicines
π₯ Health & Social Welfare6 March 2017
New Medicines, Distribution, Silvasta, Sildenafil citrate
- CHRIS JAMES, Group Manager, Medsafe, Ministry of Health
π° Approval of Qualified Persons for the Purposes of Section 36(1)(d)(ii) of the Financial Reporting Act 2013
π° Finance & RevenueFinancial Reporting, Qualified Persons, Approval
NZ Gazette 2017, No 25