Zonisamide was trial authorised in Japan on 31 March 1989 and in Europe on 10 March 2005. It is approved in 42 countries worldwide including the United States (US) and EU member states. The monotherapy indication is approved in Japan. A similar application to extend the indications was approved in the EU in June 2012 and is under evaluation in Switzerland (see Table 1). No such submission has been made in the USA, Canada or NZ. 1. International regulatory status for Zonegran extension of indication to include monotherapy. Country Marketing Proposed Indication Marketing Approved Status approval date Indication* EU Approved 27 June 2012 Monotherapy in the Monotherapy in the (centralised treatment of partial treatment of partial procedure) seizures, with or without seizures, with or secondary generalisation, without secondary in adults with newly generalisation, in diagnosed epilepsy. adults with newly diagnosed epilepsy. Switzerland Submitted Monotherapy in the Pending Pending treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. USA Authorised for adjunctive use only *EU, Switzerland and the US have an existing adjunctive use indication. Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be as Attachment 1. II. Quality findings There was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings Introduction A summary of the clinical findings is presented in this section. Further details of these clinical findings can be found at Attachment 2 of this AusPAR.
Zonisamide was authorised in Japan on 31 March 1989 and in Europe on 10 March 2005. It is approved in 42 countries worldwide including the United States (US) and EU member states. The monotherapy indication is approved in Japan. A similar application to extend the indications was approved in the EU in June 2012 and is under evaluation in Switzerland (see Table 1). No such submission has been made in the USA, Canada or NZ. 1. International regulatory status for Zonegran extension of indication to include monotherapy. Country Marketing Status Proposed Indication Marketing approval date Approved Indication* EU (centralised procedure) Approved Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. 27 June 2012 Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. Switzerland Submitted Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy. Pending Pending USA Authorised for adjunctive use only *EU, Switzerland and the US have an existing adjunctive use indication. Product Information The approved Product Information (PI) current at the time this AusPAR was prepared can be as Attachment 1. II. Quality findings There was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings Introduction A summary of the clinical findings is presented in this section. Further details of these clinical findings can be found at Attachment 2 of this AusPAR. trial
auspar-zonisamide-130722.docx