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:
Product: | Lenalidomide-Teva |
Active Ingredient: | Lenalidomide hydrochloride monohydrate 3.025mg equivalent to lenalidomide 2.5mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
Note: This consent is given subject to the following conditions:
Note: This consent is valid for two years from the date of publication of this notice.
Product: | Lenalidomide-Teva |
Active Ingredient: | Lenalidomide hydrochloride monohydrate 6.05mg equivalent to lenalidomide 5mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
Note: This consent is given subject to the following conditions:
Note: This consent is valid for two years from the date of publication of this notice.
Product: | Lenalidomide-Teva |
Active Ingredient: | Lenalidomide hydrochloride monohydrate 9.075mg equivalent to lenalidomide 7.5mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
Note: This consent is given subject to the following conditions:
Note: This consent is valid for two years from the date of publication of this notice.
Product: | Lenalidomide-Teva |
Active Ingredient: | Lenalidomide hydrochloride monohydrate 12.1mg equivalent to lenalidomide 10mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
Note: This consent is given subject to the following conditions:
Note: This consent is valid for two years from the date of publication of this notice.
Product: | Lenalidomide-Teva |
Active Ingredient: | Lenalidomide hydrochloride monohydrate 18.15mg equivalent to lenalidomide 15mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
Note: This consent is given subject to the following conditions:
Note: This consent is valid for two years from the date of publication of this notice.
Product: | Lenalidomide-Teva |
Active Ingredient: | Lenalidomide hydrochloride monohydrate 24.2mg equivalent to lenalidomide 20mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
Note: This consent is given subject to the following conditions:
Note: This consent is valid for two years from the date of publication of this notice.
Product: | Lenalidomide-Teva |
Active Ingredient: | Lenalidomide hydrochloride monohydrate 30.25mg equivalent to lenalidomide 25mg |
Dosage Form: | Capsule |
New Zealand Sponsor: | Teva Pharma (New Zealand) Limited |
Manufacturer: | PLIVA Croatia Limited, Zagreb, Croatia |
Note: This consent is given subject to the following conditions:
Note: This consent is valid for two years from the date of publication of this notice.
Dated this 9th day of September 2022.
CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).