Eva Prokopova

Dear all, I would like to ask you when we change a license in a particular country to temporary unavailable and provide a new date when it will appear on the market again after the stock shortage, does IRIS automatically change the status to marketed again on the date we have put in the system? Or do I have to manually go in and change the status back to marketed? Thank you for your help

Please note that we would like to update IRIS for Vfend to show that we have withdrawn/deleted 7 presentations from its label however the witdhrawal notitication does not allow us to withdraw certain presentations (it would withdraw the whole product which we do not want). Can you please provide guidance what we should select to report this through IRIS?

The presentations in question are for all EU member states:
EU/1/02/212/010 - 50 mg Tablet, Film Coated | 1 x 2 Units Bottle
EU/1/02/212/011 - 50 mg Tablet, Film Coated | 1 x 30 Units Bottle
EU/1/02/212/012 - 50 mg Tablet, Film Coated | 1 x 100 Units Bottle
EU/1/02/212/022 - 200 mg Tablet, Film Coated | 1 x 2 Units Bottle
EU/1/02/212/023 - 200 mg Tablet, Film Coated | 1 x 30 Units Bottle
EU/1/02/212/024 - 200 mg Tablet, Film Coated | 1 x 100 Units Bottle
EU/1/02/212/027 - 200 mg; Injection, Powder, Lyophilized, For Solution | 1 x 200 mg Type I - Clear glass Vial with Rubber stopper/Aluminum seal/Flip off plastic cap

thank you for your kind advice and help,