301239 Product Name: etranacogene dezaparvovec (an adeno-associated viral vector containing a codon-optimized Padua derivative of human coagulation factor IX gene for the treatment of hemophilia B)
Filing date | Document type | Document Description | Number of pages | File Type | ||
---|---|---|---|---|---|---|
12/03/2025 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /5/1/9/2/0/0800902915/docs/301239_11_incomingcorrespondencepaper20250312035936201.pdf | ||
12/03/2025 | SPC Documents | Marketing Authorization SPC | 4 | /5/1/9/2/0/0800902915/docs/301239_12_supplprotectioncertificate20250312035936231.pdf | ||
28/07/2023 | Outgoing Correspondence | Confirmation receipt request | 2 | /5/1/9/2/0/0800902915/docs/301239_2_558545l174.pdf | ||
26/07/2023 | SPC Documents | Annex SPC | 2 | /5/1/9/2/0/0800902915/docs/301239_0_supplprotectioncertificate20230728023606693.pdf | ||
26/07/2023 | SPC Documents | Annex SPC | 8 | /5/1/9/2/0/0800902915/docs/301239_1_supplprotectioncertificate20230728023606735.pdf | ||
26/07/2023 | SPC Documents | Annex SPC | 2 | /5/1/9/2/0/0800902915/docs/301239_3_supplprotectioncertificate20230727033209218.pdf | ||
26/07/2023 | Application Form | First filed application form | 3 | /5/1/9/2/0/0800902915/docs/301239_4_applicationform20230727032825581.pdf | ||
26/07/2023 | SPC Documents | Summary of the characteristics of the product | 22 | /5/1/9/2/0/0800902915/docs/301239_5_supplprotectioncertificate20230727033352472.pdf | ||
26/07/2023 | SPC Documents | Accompanying letter SPC | 4 | /5/1/9/2/0/0800902915/docs/301239_6_supplprotectioncertificate20230727033318035.pdf | ||
26/07/2023 | SPC Documents | Marketing Authorization SPC | 4 | /5/1/9/2/0/0800902915/docs/301239_7_supplprotectioncertificate20230727033424815.pdf | ||
26/07/2023 | SPC Documents | Annex SPC | 5 | /5/1/9/2/0/0800902915/docs/301239_8_supplprotectioncertificate20230727033501423.pdf | ||
26/07/2023 | SPC Documents | Annex SPC | 18 | /5/1/9/2/0/0800902915/docs/301239_9_supplprotectioncertificate20230727033103803.pdf | ||
26/07/2023 | SPC Documents | Annex SPC | 17 | /5/1/9/2/0/0800902915/docs/301239_10_supplprotectioncertificate20230727032952843.pdf |