301320 Product Name: autologe anti-CD19-getransduceerde CD3+-cellen (brexucabtagene autoleucel)
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 27/02/2025 | Outgoing Correspondence | Confirmation receipt request | 2 | /1/8/2/1/9/0801091281/docs/301320_25_645835l174.pdf | ||
| 25/02/2025 | SPC Documents | Marketing Authorization SPC | 4 | /1/8/2/1/9/0801091281/docs/301320_0_supplprotectioncertificate20250226025740285.pdf | ||
| 25/02/2025 | SPC Documents | Accompanying letter SPC | 3 | /1/8/2/1/9/0801091281/docs/301320_1_supplprotectioncertificate20250226025740273.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 16 | /1/8/2/1/9/0801091281/docs/301320_2_supplprotectioncertificate20250226025740311.pdf | ||
| 25/02/2025 | SPC Documents | Summary of the characteristics of the product | 20 | /1/8/2/1/9/0801091281/docs/301320_3_supplprotectioncertificate20250226025740293.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 4 | /1/8/2/1/9/0801091281/docs/301320_4_supplprotectioncertificate20250226025740302.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 2 | /1/8/2/1/9/0801091281/docs/301320_5_supplprotectioncertificate20250226025740320.pdf | ||
| 25/02/2025 | Application Form | First filed application form | 3 | /1/8/2/1/9/0801091281/docs/301320_6_applicationform20250226025740240.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 6 | /1/8/2/1/9/0801091281/docs/301320_7_supplprotectioncertificate20250226030944319.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 703 | /1/8/2/1/9/0801091281/docs/301320_8_supplprotectioncertificate20250226031735788.pdf | ||
| 25/02/2025 | SPC Documents | Summary of the characteristics of the product | 24 | /1/8/2/1/9/0801091281/docs/301320_9_supplprotectioncertificate20250226033205935.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 4 | /1/8/2/1/9/0801091281/docs/301320_10_supplprotectioncertificate20250226033205960.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 16 | /1/8/2/1/9/0801091281/docs/301320_11_supplprotectioncertificate20250226033205980.pdf | ||
| 25/02/2025 | SPC Documents | Summary of the characteristics of the product | 18 | /1/8/2/1/9/0801091281/docs/301320_12_supplprotectioncertificate20250226033900692.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 4 | /1/8/2/1/9/0801091281/docs/301320_13_supplprotectioncertificate20250226033900718.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 15 | /1/8/2/1/9/0801091281/docs/301320_14_supplprotectioncertificate20250226033900727.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 14 | /1/8/2/1/9/0801091281/docs/301320_15_supplprotectioncertificate20250226034003396.pdf | ||
| 25/02/2025 | SPC Documents | Marketing Authorization SPC | 4 | /1/8/2/1/9/0801091281/docs/301320_16_supplprotectioncertificate20250226034053834.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 18 | /1/8/2/1/9/0801091281/docs/301320_17_supplprotectioncertificate20250226034507824.pdf | ||
| 25/02/2025 | SPC Documents | Summary of the characteristics of the product | 29 | /1/8/2/1/9/0801091281/docs/301320_18_supplprotectioncertificate20250226034507791.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 4 | /1/8/2/1/9/0801091281/docs/301320_19_supplprotectioncertificate20250226034507816.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 127 | /1/8/2/1/9/0801091281/docs/301320_20_supplprotectioncertificate20250226033239310.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 28 | /1/8/2/1/9/0801091281/docs/301320_21_supplprotectioncertificate20250226031009237.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 3 | /1/8/2/1/9/0801091281/docs/301320_22_supplprotectioncertificate20250226030916795.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 131 | /1/8/2/1/9/0801091281/docs/301320_23_supplprotectioncertificate20250226030852751.pdf | ||
| 25/02/2025 | SPC Documents | Annex SPC | 24 | /1/8/2/1/9/0801091281/docs/301320_24_supplprotectioncertificate20250226034543478.pdf |