β¨ Medicinal Product Notices
NEW ZEALAND GAZETTE, No. 99 β 3 NOVEMBER 2016
Product:
Humira
Active Ingredient:
Adalimumab 50mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
AbbVie Limited
Manufacturers:
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
Product:
Humira Pen
Active Ingredient:
Adalimumab 50mg/mL
Dosage Form:
Solution for injection
New Zealand Sponsor:
AbbVie Limited
Manufacturers:
Aesica Queenborough Limited, Queenborough, United Kingdom
Vetter Pharma-Fertigung GmbH & Co KG, Ravensburg, Germany
Vetter Pharma-Fertigung GmbH & Co KG, Langenargen, Germany
Product:
Prevenar 13
Active Ingredients:
Pneumococcal polysaccharide serotype 6A 2.2mcg
Pneumococcal polysaccharide type 1 2.2mcg
Pneumococcal polysaccharide type 14 2.2mcg
Pneumococcal polysaccharide type 18C 2.2mcg
Pneumococcal polysaccharide type 19A 2.2mcg
Pneumococcal polysaccharide type 19F 2.2mcg
Pneumococcal polysaccharide type 23F 2.2mcg
Pneumococcal polysaccharide type 3 2.2mcg
Pneumococcal polysaccharide type 4 2.2mcg
Pneumococcal polysaccharide type 5 2.2mcg
Pneumococcal polysaccharide type 6B 4.4mcg
Pneumococcal polysaccharide type 7F 2.2mcg
Pneumococcal polysaccharide type 9V 2.2mcg
Dosage Form:
Suspension for injection
New Zealand Sponsor:
Pfizer New Zealand Limited
Manufacturers:
Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, New York, United States of America
Baxter BioPharma Solutions LLC, Bloomington, United States of America
Pfizer Ireland Pharmaceuticals, Dublin, Ireland
Product:
Winglore
Active Ingredient:
Ipilimumab 50mg/10mL
Dosage Form:
Concentrate for injection
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturers:
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product:
Winglore
Active Ingredient:
Ipilimumab 200mg/40mL
Dosage Form:
Concentrate for injection
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturers:
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product:
Yervoy
Active Ingredient:
Ipilimumab 50mg/10mL
Dosage Form:
Concentrate for injection
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturers:
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Product:
Yervoy
Active Ingredient:
Ipilimumab 200mg/40mL
Dosage Form:
Concentrate for injection
New Zealand Sponsor:
Bristol-Myers Squibb (NZ) Limited
Manufacturers:
Baxter Pharmaceutical Solutions LLC, Bloomington, United States of America
Bristol-Myers Squibb Holdings Pharma Limited, Manati, Puerto Rico
Dated this 27th day of October 2016.
CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister)
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β¨ LLM interpretation of page content
π₯
Consent to the Distribution of Humira (Adalimumab) 20mg/0.4mL
(continued from previous page)
π₯ Health & Social Welfare27 October 2016
Medicine, Humira, Adalimumab, AbbVie Limited, Vetter Pharma-Fertigung GmbH & Co KG
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of Humira (Adalimumab) 50mg/mL
π₯ Health & Social Welfare27 October 2016
Medicine, Humira, Adalimumab, AbbVie Limited, Vetter Pharma-Fertigung GmbH & Co KG
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of Humira Pen (Adalimumab) 50mg/mL
π₯ Health & Social Welfare27 October 2016
Medicine, Humira Pen, Adalimumab, AbbVie Limited, Aesica Queenborough Limited, Vetter Pharma-Fertigung GmbH & Co KG
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of Prevenar 13
π₯ Health & Social Welfare27 October 2016
Medicine, Prevenar 13, Pneumococcal polysaccharide, Pfizer New Zealand Limited, Wyeth Pharmaceutical Division, Baxter BioPharma Solutions LLC, Pfizer Ireland Pharmaceuticals
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of Winglore (Ipilimumab) 50mg/10mL
π₯ Health & Social Welfare27 October 2016
Medicine, Winglore, Ipilimumab, Bristol-Myers Squibb (NZ) Limited, Baxter Pharmaceutical Solutions LLC, Bristol-Myers Squibb Holdings Pharma Limited
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of Winglore (Ipilimumab) 200mg/40mL
π₯ Health & Social Welfare27 October 2016
Medicine, Winglore, Ipilimumab, Bristol-Myers Squibb (NZ) Limited, Baxter Pharmaceutical Solutions LLC, Bristol-Myers Squibb Holdings Pharma Limited
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of Yervoy (Ipilimumab) 50mg/10mL
π₯ Health & Social Welfare27 October 2016
Medicine, Yervoy, Ipilimumab, Bristol-Myers Squibb (NZ) Limited, Baxter Pharmaceutical Solutions LLC, Bristol-Myers Squibb Holdings Pharma Limited
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
π₯ Consent to the Distribution of Yervoy (Ipilimumab) 200mg/40mL
π₯ Health & Social Welfare27 October 2016
Medicine, Yervoy, Ipilimumab, Bristol-Myers Squibb (NZ) Limited, Baxter Pharmaceutical Solutions LLC, Bristol-Myers Squibb Holdings Pharma Limited
- CHRIS JAMES, Acting Group Manager, Medsafe, Ministry of Health
NZ Gazette 2016, No 99