301122 Product Name: evinacumab
Filing date | Document type | Document Description | Number of pages | File Type | ||
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22/07/2025 | Outgoing Correspondence | Decision extension duration | 1 | /0/2/9/0/2/0800720920/docs/301122_16_301122665948l504c.pdf | ||
22/07/2025 | Certificate | Certificate | 1 | /0/2/9/0/2/0800720920/docs/301122_17_spcxcertificate20250722075642962.pdf | ||
11/06/2025 | Application Form | First filed application form | 2 | /0/2/9/0/2/0800720920/docs/301122_10_applicationform20250611035827681.pdf | ||
11/06/2025 | SPC Documents | Summary of the characteristics of the product | 14 | /0/2/9/0/2/0800720920/docs/301122_11_supplprotectioncertificate20250611040133868.pdf | ||
11/06/2025 | SPC Documents | Marketing Authorization SPC | 3 | /0/2/9/0/2/0800720920/docs/301122_12_supplprotectioncertificate20250611040046559.pdf | ||
11/06/2025 | SPC Documents | Annex SPC | 1 | /0/2/9/0/2/0800720920/docs/301122_13_supplprotectioncertificate20250611040014878.pdf | ||
11/06/2025 | SPC Documents | Annex SPC | 1 | /0/2/9/0/2/0800720920/docs/301122_14_supplprotectioncertificate20250611040202272.pdf | ||
11/06/2025 | Outgoing Correspondence | Confirmation receipt request for extension | 2 | /0/2/9/0/2/0800720920/docs/301122_15_660102l505.pdf | ||
30/12/2021 | Certificate | Certificate | 1 | /0/2/9/0/2/0800720920/docs/301122_0_spcmedcertificate20211230121158466.pdf | ||
30/12/2021 | Outgoing Correspondence | Decision grant | 1 | /0/2/9/0/2/0800720920/docs/301122_7_453602l504a.pdf | ||
01/09/2021 | SPC Documents | Annex SPC | 2 | /0/2/9/0/2/0800720920/docs/301122_1_supplprotectioncertificate20210901090730144.pdf | ||
01/09/2021 | SPC Documents | Marketing Authorization SPC | 3 | /0/2/9/0/2/0800720920/docs/301122_2_supplprotectioncertificate20210901090648179.pdf | ||
01/09/2021 | SPC Documents | Annex SPC | 3 | /0/2/9/0/2/0800720920/docs/301122_3_supplprotectioncertificate20210901091136488.pdf | ||
01/09/2021 | SPC Documents | Annex SPC | 2 | /0/2/9/0/2/0800720920/docs/301122_4_supplprotectioncertificate20210901091136660.pdf | ||
01/09/2021 | Application Form | First filed application form | 2 | /0/2/9/0/2/0800720920/docs/301122_5_applicationform20210901090321177.pdf | ||
01/09/2021 | Outgoing Correspondence | Confirmation receipt request | 1 | /0/2/9/0/2/0800720920/docs/301122_6_432415l174.pdf | ||
01/09/2021 | SPC Documents | Summary of the characteristics of the product | 12 | /0/2/9/0/2/0800720920/docs/301122_8_supplprotectioncertificate20210901091136397.pdf | ||
01/09/2021 | SPC Documents | Annex SPC | 11 | /0/2/9/0/2/0800720920/docs/301122_9_supplprotectioncertificate20210901091136564.pdf |