Posted Mon, 16 May 2022 10:47:34 GMT by Eva Prokopova
Please note that we would like to update IRIS for Vfend to show that we have withdrawn/deleted 7 presentations from its label however the witdhrawal notitication does not allow us to withdraw certain presentations (it would withdraw the whole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,


 
Posted Wed, 01 Jun 2022 07:11:59 GMT by Virginia Rojo Guerra
Presentations that have been removed from the Marketing Authorization via variation are cancelled in IRIS once the variation is approved. There is currently an issue with data integration between our systems that will be fixed soon, so there may be a delay in removing cancelled presentations from the IRIS view. No action is expected from your side if the presentation has been cancelled via the corresponding variation to the terms of the marketing authorization. The Withdrawal notification is only intended when the entire product is withdrawn.

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