300796 Product Name: Ledipasvir, desgewenst in de vorm van een farmaceutisch aanvaardbaar zout
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 21/01/2021 | Certificate | Certificate | 1 | /2/0/8/1/3/0800031802/docs/300796_4_spcxcertificate20210121094550977.pdf | ||
| 21/01/2021 | Outgoing Correspondence | Decision extension duration | 1 | /2/0/8/1/3/0800031802/docs/300796_21_390679l504c.pdf | ||
| 04/01/2021 | Outgoing Correspondence | Confirmation receipt request for extension | 1 | /2/0/8/1/3/0800031802/docs/300796_10_387362l505.pdf | ||
| 30/12/2020 | SPC Documents | Annex SPC | 3 | /2/0/8/1/3/0800031802/docs/300796_1_supplprotectioncertificate20210104100414869.pdf | ||
| 30/12/2020 | SPC Documents | Marketing Authorization SPC | 3 | /2/0/8/1/3/0800031802/docs/300796_2_supplprotectioncertificate20210104095610290.pdf | ||
| 30/12/2020 | Application Form | First filed application form | 3 | /2/0/8/1/3/0800031802/docs/300796_7_applicationform20210104094711147.pdf | ||
| 30/12/2020 | SPC Documents | Annex SPC | 29 | /2/0/8/1/3/0800031802/docs/300796_8_supplprotectioncertificate20210104100626554.pdf | ||
| 30/12/2020 | SPC Documents | Annex SPC | 60 | /2/0/8/1/3/0800031802/docs/300796_15_supplprotectioncertificate20210104095208079.pdf | ||
| 30/12/2020 | SPC Documents | Annex SPC | 1 | /2/0/8/1/3/0800031802/docs/300796_16_supplprotectioncertificate20210104095450221.pdf | ||
| 30/12/2020 | SPC Documents | Annex SPC | 4 | /2/0/8/1/3/0800031802/docs/300796_18_supplprotectioncertificate20210104095348877.pdf | ||
| 30/12/2020 | SPC Documents | Summary of the characteristics of the product | 85 | /2/0/8/1/3/0800031802/docs/300796_19_supplprotectioncertificate20210104100126677.pdf | ||
| 30/12/2020 | SPC Documents | Annex SPC | 2 | /2/0/8/1/3/0800031802/docs/300796_20_supplprotectioncertificate20210104100719229.pdf | ||
| 30/06/2016 | Outgoing Correspondence | Outgoing Letter | 1 | /2/0/8/1/3/0800031802/docs/300796_9_outgoingcorrespondence20160701045951029.pdf | ||
| 30/06/2016 | SPC Documents | Certificate SPC | 1 | /2/0/8/1/3/0800031802/docs/300796_14_supplprotectioncertificate20201214052937005.pdf | ||
| 13/06/2016 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /2/0/8/1/3/0800031802/docs/300796_3_incomingcorrespondencepaper20160614121928444.pdf | ||
| 15/03/2016 | Outgoing Correspondence | Outgoing Letter | 1 | /2/0/8/1/3/0800031802/docs/300796_5_outgoingcorrespondence20160318112503238.pdf | ||
| 24/02/2016 | Outgoing Correspondence | Outgoing Letter | 1 | /2/0/8/1/3/0800031802/docs/300796_12_outgoingcorrespondence20201214052536625.pdf | ||
| 19/02/2016 | Application Form | Confirmed application form | 3 | /2/0/8/1/3/0800031802/docs/300796_0_applicationform20160223015953715.pdf | ||
| 19/02/2016 | SPC Documents | Annex SPC | 12 | /2/0/8/1/3/0800031802/docs/300796_6_supplprotectioncertificate20201214052104929.pdf | ||
| 19/02/2016 | SPC Documents | Summary of the characteristics of the product | 33 | /2/0/8/1/3/0800031802/docs/300796_11_supplprotectioncertificate20201214052104775.pdf | ||
| 19/02/2016 | SPC Documents | Annex SPC | 11 | /2/0/8/1/3/0800031802/docs/300796_13_supplprotectioncertificate20201214052432021.pdf | ||
| 19/02/2016 | SPC Documents | Annex SPC | 2 | /2/0/8/1/3/0800031802/docs/300796_17_supplprotectioncertificate20201214052104866.pdf | ||
| 19/02/2016 | SPC Documents | Marketing Authorization SPC | 3 | /2/0/8/1/3/0800031802/docs/300796_22_supplprotectioncertificate20201214052104678.pdf |