300922 Product Name: dupilumab
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 31/05/2023 | Outgoing Correspondence | Decision extension duration | 1 | /1/0/8/2/3/0800232801/docs/300922_16_547635l504c.pdf | ||
| 31/05/2023 | Certificate | Certificate | 1 | /1/0/8/2/3/0800232801/docs/300922_17_spcxcertificate20230531115027146.pdf | ||
| 01/05/2023 | Outgoing Correspondence | Confirmation receipt request for extension | 1 | /1/0/8/2/3/0800232801/docs/300922_14_543473l505.pdf | ||
| 13/04/2023 | SPC Documents | SPC Documents | 123 | /1/0/8/2/3/0800232801/docs/300922_9_supplprotectioncertificate20230414050433989.pdf | ||
| 13/04/2023 | Application Form | First filed application form | 4 | /1/0/8/2/3/0800232801/docs/300922_10_applicationform20230414045809812.pdf | ||
| 13/04/2023 | SPC Documents | SPC Documents | 3 | /1/0/8/2/3/0800232801/docs/300922_11_supplprotectioncertificate20230414050511791.pdf | ||
| 13/04/2023 | SPC Documents | SPC Documents | 1 | /1/0/8/2/3/0800232801/docs/300922_12_supplprotectioncertificate20230414045852669.pdf | ||
| 13/04/2023 | SPC Documents | Annex SPC | 1 | /1/0/8/2/3/0800232801/docs/300922_13_supplprotectioncertificate20230414050547036.pdf | ||
| 13/04/2023 | SPC Documents | Annex SPC | 1 | /1/0/8/2/3/0800232801/docs/300922_15_supplprotectioncertificate20230414050629100.pdf | ||
| 15/01/2019 | Outgoing Correspondence | Outgoing Letter | 1 | /1/0/8/2/3/0800232801/docs/300922_4_outgoingcorrespondence20190116023111364.pdf | ||
| 15/01/2019 | SPC Documents | Certificate SPC | 1 | /1/0/8/2/3/0800232801/docs/300922_5_supplprotectioncertificate20190116023111436.pdf | ||
| 22/10/2018 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /1/0/8/2/3/0800232801/docs/300922_1_incomingcorrespondencepaper20181023020419576.pdf | ||
| 12/01/2018 | Application Form | First filed application form | 3 | /1/0/8/2/3/0800232801/docs/300922_0_applicationform20180112023502685.pdf | ||
| 12/01/2018 | SPC Documents | Marketing Authorization SPC | 3 | /1/0/8/2/3/0800232801/docs/300922_2_supplprotectioncertificate20180112023502862.pdf | ||
| 12/01/2018 | SPC Documents | Annex SPC | 2 | /1/0/8/2/3/0800232801/docs/300922_3_supplprotectioncertificate20210114025713461.pdf | ||
| 12/01/2018 | SPC Documents | Accompanying letter SPC | 3 | /1/0/8/2/3/0800232801/docs/300922_6_supplprotectioncertificate20210114024915763.pdf | ||
| 12/01/2018 | SPC Documents | Summary of the characteristics of the product | 21 | /1/0/8/2/3/0800232801/docs/300922_7_supplprotectioncertificate20180112023503038.pdf | ||
| 12/01/2018 | Outgoing Correspondence | Confirmation receipt request | 1 | /1/0/8/2/3/0800232801/docs/300922_8_186971l174.pdf |