Novartis transfers the marketing authorisation of Clozaril to Mylan

 In Mental Health, Simplifying Product Supply

Clozaril (clozapine) is indicated in treatment-resistant or difficult-to-treat schizophrenia, and for psychosis with Parkinson’s disease. Results from studies, such as the International Suicide Prevention Trial in the U.S., show that it can reduce suicide rates in these patients. The original manufacturer of Clozaril®, Novartis, has transferred the marketing authorisation to a different company – Mylan Products Ltd. There will be minor changes to the packaging of Clozaril® to show the change in manufacturer’s name and address, but nothing else should change.

Some patients may notice the different packaging and require to be reassured, but there will be no difference in the appearance or content of the Clozaril® tablets so this can be confirmed to them. The revised Summary of Product Characteristics for Clozaril® is available at http://www.medicines.org.uk/emc/medicine/32564


 

Other related news…

Quetiapine oral suspension – New licensed version

Quetiapine is a drug indicated for use in the treatment of schizophrenia and bipolar disorder. It is available in tablet form and prolonged release tablets. Until recently, quetiapine in liquid form had to be specially manufactured, and this product was therefore unlicensed.

A licensed oral suspension 100mg/5ml formulation has now been produced by Rosemont and it can be ordered as a stock drug from the Ashtons online ordering system. The price for a 150ml bottle will be cheaper than the unlicensed version (to be confirmed).

It requires to be stored in a fridge and must be used within 28 days of opening.

The full Summary of Product Characteristics for Quetiapine 100mg/5ml oral suspension (Rosemont) is available – https://www.medicines.org.uk/emc/medicine/33199

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