300725 Product Name: Nintedanib, de tautomeren daarvan en de zouten daarvan, in het bijzonder nintedanib en fysiologisch aanvaardbare zouten daarvan, met name nintedanibesilaat.
Filing date | Document type | Document Description | Number of pages | File Type | ||
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01/11/2023 | Certificate | Certificate | 1 | /5/2/7/0/0/0400300725/docs/300725_16_spcxcertificate20231101120407695.pdf | ||
01/11/2023 | Outgoing Correspondence | Decision extension duration | 1 | /5/2/7/0/0/0400300725/docs/300725_17_574080l504c.pdf | ||
28/09/2023 | Outgoing Correspondence | Confirmation receipt request for extension | 2 | /5/2/7/0/0/0400300725/docs/300725_18_568428l505.pdf | ||
27/09/2023 | SPC Documents | Summary of the characteristics of the product | 35 | /5/2/7/0/0/0400300725/docs/300725_19_supplprotectioncertificate20230927044459323.pdf | ||
27/09/2023 | SPC Documents | Annex SPC | 2 | /5/2/7/0/0/0400300725/docs/300725_20_supplprotectioncertificate20230927044621076.pdf | ||
27/09/2023 | SPC Documents | Annex SPC | 9 | /5/2/7/0/0/0400300725/docs/300725_21_supplprotectioncertificate20230927043549863.pdf | ||
27/09/2023 | SPC Documents | Annex SPC | 6 | /5/2/7/0/0/0400300725/docs/300725_22_supplprotectioncertificate20230927044310678.pdf | ||
27/09/2023 | SPC Documents | Annex SPC | 8 | /5/2/7/0/0/0400300725/docs/300725_23_supplprotectioncertificate20230927043301201.pdf | ||
27/09/2023 | SPC Documents | Marketing Authorization SPC | 4 | /5/2/7/0/0/0400300725/docs/300725_24_supplprotectioncertificate20230927044123092.pdf | ||
27/09/2023 | SPC Documents | Marketing Authorization SPC | 4 | /5/2/7/0/0/0400300725/docs/300725_25_supplprotectioncertificate20230927043722274.pdf | ||
27/09/2023 | SPC Documents | Annex SPC | 10 | /5/2/7/0/0/0400300725/docs/300725_26_supplprotectioncertificate20230927043823375.pdf | ||
27/09/2023 | SPC Documents | SPC Documents | 4 | /5/2/7/0/0/0400300725/docs/300725_27_supplprotectioncertificate20230927044722223.pdf | ||
27/09/2023 | SPC Documents | Annex SPC | 5 | /5/2/7/0/0/0400300725/docs/300725_28_supplprotectioncertificate20230927043452177.pdf | ||
27/09/2023 | SPC Documents | Annex SPC | 1 | /5/2/7/0/0/0400300725/docs/300725_29_supplprotectioncertificate20230927043344416.pdf | ||
27/09/2023 | Application Form | First filed application form | 4 | /5/2/7/0/0/0400300725/docs/300725_30_applicationform20230927043145394.pdf | ||
27/09/2023 | SPC Documents | Annex SPC | 8 | /5/2/7/0/0/0400300725/docs/300725_31_supplprotectioncertificate20230927043943067.pdf | ||
17/08/2017 | Outgoing Correspondence | Letter to applicant | 1 | /5/2/7/0/0/0400300725/docs/300725_3_outgoingcorrespondence20170818115515914.pdf | ||
17/08/2017 | SPC Documents | Certificate SPC | 1 | /5/2/7/0/0/0400300725/docs/300725_9_supplprotectioncertificate20170818115515982.pdf | ||
19/07/2017 | SPC Documents | Accompanying letter SPC | 1 | /5/2/7/0/0/0400300725/docs/300725_13_supplprotectioncertificate20201027051045286.pdf | ||
13/07/2017 | SPC Documents | Certificate SPC | 1 | /5/2/7/0/0/0400300725/docs/300725_2_supplprotectioncertificate20170714123402333.pdf | ||
13/07/2017 | Outgoing Correspondence | Decision grant | 1 | /5/2/7/0/0/0400300725/docs/300725_8_outgoingcorrespondence20170714123402235.pdf | ||
31/08/2016 | SPC Documents | Annex SPC | 1 | /5/2/7/0/0/0400300725/docs/300725_10_supplprotectioncertificate20201027050626600.pdf | ||
31/08/2016 | SPC Documents | Accompanying letter SPC | 1 | /5/2/7/0/0/0400300725/docs/300725_12_supplprotectioncertificate20201027050808466.pdf | ||
30/06/2015 | SPC Documents | Accompanying letter SPC | 3 | /5/2/7/0/0/0400300725/docs/300725_11_supplprotectioncertificate20201027050420231.pdf | ||
23/04/2015 | SPC Documents | Accompanying letter SPC | 2 | /5/2/7/0/0/0400300725/docs/300725_14_supplprotectioncertificate20201027050205502.pdf | ||
26/03/2015 | Outgoing Correspondence | Outgoing Letter | 2 | /5/2/7/0/0/0400300725/docs/300725_6_outgoingcorrespondence20150326.pdf | ||
19/03/2015 | Outgoing Correspondence | Outgoing Letter | 1 | /5/2/7/0/0/0400300725/docs/300725_4_outgoingcorrespondence20150318.pdf | ||
18/03/2015 | SPC Documents | Accompanying letter SPC | 1 | /5/2/7/0/0/0400300725/docs/300725_7_supplprotectioncertificate20201027031709358.pdf | ||
16/03/2015 | SPC Documents | Annex SPC | 3 | /5/2/7/0/0/0400300725/docs/300725_0_supplprotectioncertificate20201027030453855.pdf | ||
16/03/2015 | Application Form | First filed application form | 3 | /5/2/7/0/0/0400300725/docs/300725_1_applicationform20150316.pdf | ||
16/03/2015 | SPC Documents | Marketing Authorization SPC | 3 | /5/2/7/0/0/0400300725/docs/300725_5_supplprotectioncertificate20201027030621819.pdf | ||
16/03/2015 | SPC Documents | Summary of the characteristics of the product | 36 | /5/2/7/0/0/0400300725/docs/300725_15_supplprotectioncertificate20201027031207608.pdf |