301316 Product Name: fidanacogene elaparvovec
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 16/09/2025 | Outgoing Correspondence | Letter confirmation withdrawal | 1 | /0/4/2/1/8/0801081240/docs/301316_13_301316674305l193.pdf | ||
| 15/09/2025 | Incoming Correspondence Electronic | Withdrawal application | 1 | /0/4/2/1/8/0801081240/docs/301316_12_incomingcorrespondenceelectronic20250915044406963.pdf | ||
| 03/09/2025 | Incoming Correspondence Electronic | Incoming Correspondence Paper | 3 | /0/4/2/1/8/0801081240/docs/301316_11_incomingcorrespondenceelectronic20250903122817223.pdf | ||
| 23/01/2025 | Outgoing Correspondence | Confirmation receipt request | 2 | /0/4/2/1/8/0801081240/docs/301316_10_640628l174.pdf | ||
| 22/01/2025 | SPC Documents | Summary of the characteristics of the product | 25 | /0/4/2/1/8/0801081240/docs/301316_0_supplprotectioncertificate20250122042544169.pdf | ||
| 22/01/2025 | SPC Documents | Marketing Authorization SPC | 4 | /0/4/2/1/8/0801081240/docs/301316_1_supplprotectioncertificate20250122042544159.pdf | ||
| 22/01/2025 | SPC Documents | Annex SPC | 2 | /0/4/2/1/8/0801081240/docs/301316_2_supplprotectioncertificate20250122042544204.pdf | ||
| 22/01/2025 | SPC Documents | Annex SPC | 24 | /0/4/2/1/8/0801081240/docs/301316_3_supplprotectioncertificate20250122042544189.pdf | ||
| 22/01/2025 | SPC Documents | Summary of the characteristics of the product | 25 | /0/4/2/1/8/0801081240/docs/301316_4_supplprotectioncertificate20250122042544214.pdf | ||
| 22/01/2025 | SPC Documents | Annex SPC | 6 | /0/4/2/1/8/0801081240/docs/301316_5_supplprotectioncertificate20250122042544179.pdf | ||
| 22/01/2025 | Application Form | First filed application form | 3 | /0/4/2/1/8/0801081240/docs/301316_6_applicationform20250122042544126.pdf | ||
| 22/01/2025 | SPC Documents | Accompanying letter SPC | 3 | /0/4/2/1/8/0801081240/docs/301316_7_supplprotectioncertificate20250122042544150.pdf | ||
| 22/01/2025 | SPC Documents | Annex SPC | 29 | /0/4/2/1/8/0801081240/docs/301316_8_supplprotectioncertificate20250122043012469.pdf | ||
| 22/01/2025 | SPC Documents | Annex SPC | 1 | /0/4/2/1/8/0801081240/docs/301316_9_supplprotectioncertificate20250122043012498.pdf |