301257 Product Name: cedazuridine of een farmaceutisch aanvaardbaar zout daarvan en decitabine
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 06/11/2025 | Outgoing Correspondence | Decision grant | 1 | /1/3/9/7/5/0800957931/docs/301257_16_301257681534l504a.pdf | ||
| 06/11/2025 | Certificate | Certificate | 1 | /1/3/9/7/5/0800957931/docs/301257_17_spcmedcertificate20251106090504416.pdf | ||
| 05/11/2025 | Incoming Correspondence Electronic | Accompanying letter incoming document | 1 | /1/3/9/7/5/0800957931/docs/301257_15_incomingcorrespondenceelectronic20251105034140130.pdf | ||
| 14/08/2025 | Outgoing Correspondence | Letter to applicant | 2 | /1/3/9/7/5/0800957931/docs/301257_14_301257669571l173.pdf | ||
| 29/12/2023 | Outgoing Correspondence | Confirmation receipt request | 2 | /1/3/9/7/5/0800957931/docs/301257_13_583278l174.pdf | ||
| 27/12/2023 | Application Form | First filed application form | 3 | /1/3/9/7/5/0800957931/docs/301257_0_applicationform20231228013929818.pdf | ||
| 27/12/2023 | SPC Documents | Accompanying letter SPC | 5 | /1/3/9/7/5/0800957931/docs/301257_1_supplprotectioncertificate20231228013929851.pdf | ||
| 27/12/2023 | SPC Documents | Marketing Authorization SPC | 3 | /1/3/9/7/5/0800957931/docs/301257_2_supplprotectioncertificate20231228013929877.pdf | ||
| 27/12/2023 | SPC Documents | Marketing Authorization SPC | 4 | /1/3/9/7/5/0800957931/docs/301257_3_supplprotectioncertificate20231228013929885.pdf | ||
| 27/12/2023 | SPC Documents | Annex SPC | 2 | /1/3/9/7/5/0800957931/docs/301257_4_supplprotectioncertificate20231228013929912.pdf | ||
| 27/12/2023 | SPC Documents | Summary of the characteristics of the product | 19 | /1/3/9/7/5/0800957931/docs/301257_5_supplprotectioncertificate20231228013929903.pdf | ||
| 27/12/2023 | SPC Documents | Annex SPC | 14 | /1/3/9/7/5/0800957931/docs/301257_6_supplprotectioncertificate20231228013929921.pdf | ||
| 27/12/2023 | SPC Documents | Annex SPC | 9 | /1/3/9/7/5/0800957931/docs/301257_7_supplprotectioncertificate20231228013929895.pdf | ||
| 27/12/2023 | SPC Documents | Annex SPC | 2 | /1/3/9/7/5/0800957931/docs/301257_8_supplprotectioncertificate20231228014652016.pdf | ||
| 27/12/2023 | SPC Documents | Annex SPC | 13 | /1/3/9/7/5/0800957931/docs/301257_9_supplprotectioncertificate20231228014652025.pdf | ||
| 27/12/2023 | SPC Documents | Summary of the characteristics of the product | 18 | /1/3/9/7/5/0800957931/docs/301257_10_supplprotectioncertificate20231228014651999.pdf | ||
| 27/12/2023 | SPC Documents | Annex SPC | 5 | /1/3/9/7/5/0800957931/docs/301257_11_supplprotectioncertificate20231228014652033.pdf | ||
| 27/12/2023 | SPC Documents | Annex SPC | 58 | /1/3/9/7/5/0800957931/docs/301257_12_supplprotectioncertificate20231228014652042.pdf |