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Regarding Janssen-Cilag’s application to get Concerta approved for adults in Europe

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December 10, 2010

Janssen-Cilag (Johnson & Johnson) is now applying for adult indication (ADHD) for Concerta in Europe (attached). The MHRA is handling the application.

The application should be disapproved, mainly for the following reasons:

The company has not adhered to and fulfilled the conditions for continued marketing authorisation of Concerta, as advised by the EMA and decided by the European Commission 27 May 2009. [1]

The MHRA must be aware of the fact that Janssen-Cilag and the other manufacturers of methylphenidate products have done nothing effective to handle the safety issues decided by the European Commission. It can be supposed that the MHRA, EMA and the Commission were sincere when stating that the actions listed in the decision were conditions to be adhered to and fulfilled; meaning that if the listed actions were not done the marketing authorisation for Concerta would be withdrawn.

We are now at the point where Concerta and other methylphenidate products should be withdrawn from the market in Europe – and very far away from a situation where Concerta could be approved also for adults.


Continue reading: RegardingJanssen.Application-Concerta-Adults.pdf - Concerta-application-adults.pdf

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