300525 Product Name: Azilsartan medoxomil, desgewenst in de vorm van een farmaceutische aanvaardbaar zout, in het bijzonder het kaliumzout.
Filing date | Document type | Document Description | Number of pages | File Type | ||
---|---|---|---|---|---|---|
26/08/2013 | Outgoing Correspondence | Outgoing Letter | 6 | /5/2/5/0/0/0400300525/docs/300525_4_outgoingcorrespondence20130826.pdf | ||
13/08/2013 | Appeal | Subsequently filed documents appeal procedure | 7 | /5/2/5/0/0/0400300525/docs/300525_5_appeal20130813.pdf | ||
13/08/2013 | Appeal | Subsequently filed documents appeal procedure | 6 | /5/2/5/0/0/0400300525/docs/300525_7_appeal20130813.pdf | ||
13/08/2013 | Appeal | Subsequently filed documents appeal procedure | 2 | /5/2/5/0/0/0400300525/docs/300525_13_appeal20130813.pdf | ||
09/07/2012 | Appeal | Subsequently filed documents appeal procedure | 1 | /5/2/5/0/0/0400300525/docs/300525_8_appeal20120709.pdf | ||
28/06/2012 | Appeal | Appeal | 4 | /5/2/5/0/0/0400300525/docs/300525_24_appeal20120628.pdf | ||
08/06/2012 | Outgoing Correspondence | Outgoing Letter | 1 | /5/2/5/0/0/0400300525/docs/300525_1_outgoingcorrespondence20120608.pdf | ||
05/06/2012 | Outgoing Correspondence | Outgoing Letter | 1 | /5/2/5/0/0/0400300525/docs/300525_12_outgoingcorrespondence20120605.pdf | ||
31/05/2012 | Appeal | Request appeal | 3 | /5/2/5/0/0/0400300525/docs/300525_0_appeal20120531.pdf | ||
31/05/2012 | Appeal | Subsequently filed documents appeal procedure | 10 | /5/2/5/0/0/0400300525/docs/300525_9_appeal20120531.pdf | ||
31/05/2012 | Appeal | Subsequently filed documents appeal procedure | 3 | /5/2/5/0/0/0400300525/docs/300525_10_appeal20120531.pdf | ||
31/05/2012 | Appeal | Subsequently filed documents appeal procedure | 6 | /5/2/5/0/0/0400300525/docs/300525_14_appeal20120531.pdf | ||
24/05/2012 | SPC Documents | Certificate SPC | 1 | /5/2/5/0/0/0400300525/docs/300525_18_supplprotectioncertificate20200916050848534.pdf | ||
24/05/2012 | Outgoing Correspondence | Outgoing Letter | 2 | /5/2/5/0/0/0400300525/docs/300525_23_outgoingcorrespondence20120524.pdf | ||
19/04/2012 | Outgoing Correspondence | Outgoing Letter | 1 | /5/2/5/0/0/0400300525/docs/300525_2_outgoingcorrespondence20120419.pdf | ||
18/04/2012 | Application Form | First filed application form | 2 | /5/2/5/0/0/0400300525/docs/300525_3_applicationform20120418.pdf | ||
18/04/2012 | SPC Documents | Annex SPC | 2 | /5/2/5/0/0/0400300525/docs/300525_6_supplprotectioncertificate20200916045452228.pdf | ||
18/04/2012 | SPC Documents | Annex SPC | 2 | /5/2/5/0/0/0400300525/docs/300525_11_supplprotectioncertificate20200916050151268.pdf | ||
18/04/2012 | SPC Documents | Annex SPC | 18 | /5/2/5/0/0/0400300525/docs/300525_15_supplprotectioncertificate20200916045452276.pdf | ||
18/04/2012 | SPC Documents | Accompanying letter SPC | 1 | /5/2/5/0/0/0400300525/docs/300525_16_supplprotectioncertificate20200916050557393.pdf | ||
18/04/2012 | SPC Documents | Summary of the characteristics of the product | 34 | /5/2/5/0/0/0400300525/docs/300525_17_supplprotectioncertificate20200916050151201.pdf | ||
18/04/2012 | SPC Documents | Summary of the characteristics of the product | 34 | /5/2/5/0/0/0400300525/docs/300525_19_supplprotectioncertificate20200916045452148.pdf | ||
18/04/2012 | SPC Documents | Annex SPC | 18 | /5/2/5/0/0/0400300525/docs/300525_20_supplprotectioncertificate20200916050151328.pdf | ||
18/04/2012 | SPC Documents | Marketing Authorization SPC | 5 | /5/2/5/0/0/0400300525/docs/300525_21_supplprotectioncertificate20200916044150625.pdf | ||
18/04/2012 | SPC Documents | Annex SPC | 5 | /5/2/5/0/0/0400300525/docs/300525_22_supplprotectioncertificate20200916044720399.pdf |