300585 Product Name: Dapagliflozine, desgewenst in de vorm van een farmaceutisch aanvaardbaar zout.
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 17/11/2022 | Outgoing Correspondence | Decision extension duration | 1 | /5/8/5/0/0/0400300585/docs/300585_21_515393l504c.pdf | ||
| 17/11/2022 | Certificate | Certificate | 1 | /5/8/5/0/0/0400300585/docs/300585_22_spcxcertificate20221117105425106.pdf | ||
| 09/11/2022 | Outgoing Correspondence | Confirmation receipt request for extension | 1 | /5/8/5/0/0/0400300585/docs/300585_10_513819l505.pdf | ||
| 08/11/2022 | SPC Documents | Annex SPC | 1 | /5/8/5/0/0/0400300585/docs/300585_9_supplprotectioncertificate20221109104346279.pdf | ||
| 08/11/2022 | Application Form | First filed application form | 3 | /5/8/5/0/0/0400300585/docs/300585_12_applicationform20221109095836693.pdf | ||
| 08/11/2022 | SPC Documents | Annex SPC | 77 | /5/8/5/0/0/0400300585/docs/300585_13_supplprotectioncertificate20221109100412083.pdf | ||
| 08/11/2022 | SPC Documents | Annex SPC | 2 | /5/8/5/0/0/0400300585/docs/300585_14_supplprotectioncertificate20221109100412117.pdf | ||
| 08/11/2022 | SPC Documents | Annex SPC | 2 | /5/8/5/0/0/0400300585/docs/300585_15_supplprotectioncertificate20221109100951274.pdf | ||
| 08/11/2022 | SPC Documents | Summary of the characteristics of the product | 38 | /5/8/5/0/0/0400300585/docs/300585_16_supplprotectioncertificate20221109100951249.pdf | ||
| 08/11/2022 | SPC Documents | Annex SPC | 12 | /5/8/5/0/0/0400300585/docs/300585_17_supplprotectioncertificate20221109100508921.pdf | ||
| 08/11/2022 | SPC Documents | Annex SPC | 20 | /5/8/5/0/0/0400300585/docs/300585_18_supplprotectioncertificate20221109100951295.pdf | ||
| 08/11/2022 | SPC Documents | Annex SPC | 2 | /5/8/5/0/0/0400300585/docs/300585_19_supplprotectioncertificate20221109100951329.pdf | ||
| 08/11/2022 | SPC Documents | Marketing Authorization SPC | 3 | /5/8/5/0/0/0400300585/docs/300585_20_supplprotectioncertificate20221109101037365.pdf | ||
| 31/01/2017 | Outgoing Correspondence | Decision grant | 1 | /5/8/5/0/0/0400300585/docs/300585_2_outgoingcorrespondence20170201113529068.pdf | ||
| 31/01/2017 | SPC Documents | Certificate SPC | 1 | /5/8/5/0/0/0400300585/docs/300585_11_supplprotectioncertificate20170201113452931.pdf | ||
| 04/01/2017 | Incoming Correspondence Paper | Accompanying letter incoming document | 2 | /5/8/5/0/0/0400300585/docs/300585_1_incomingcorrespondencepaper20170105115016144.pdf | ||
| 04/01/2017 | SPC Documents | Annex SPC | 6 | /5/8/5/0/0/0400300585/docs/300585_7_supplprotectioncertificate20201005030957155.pdf | ||
| 23/05/2013 | SPC Documents | Certificate SPC | 1 | /5/8/5/0/0/0400300585/docs/300585_5_supplprotectioncertificate20201005030729043.pdf | ||
| 23/05/2013 | Outgoing Correspondence | Outgoing Letter | 1 | /5/8/5/0/0/0400300585/docs/300585_8_outgoingcorrespondence20130523.pdf | ||
| 27/03/2013 | Application Form | First filed application form | 2 | /5/8/5/0/0/0400300585/docs/300585_0_applicationform20130327.pdf | ||
| 27/03/2013 | SPC Documents | Marketing Authorization SPC | 4 | /5/8/5/0/0/0400300585/docs/300585_3_supplprotectioncertificate20201002013647586.pdf | ||
| 27/03/2013 | Outgoing Correspondence | Outgoing Letter | 1 | /5/8/5/0/0/0400300585/docs/300585_4_outgoingcorrespondence20130328.pdf | ||
| 27/03/2013 | SPC Documents | Summary of the characteristics of the product | 37 | /5/8/5/0/0/0400300585/docs/300585_6_supplprotectioncertificate20201002014127205.pdf |