301088 Product Name: Sacubitril/valsartan, als sacubitril valsartan natriumzoutcomplex, dat wil zeggen [((S)-N-valeryl-N-{[2'-(1H-tetrazol-5-yl)-bifenyl-4-yl]-methyl}-valine) ((2R,4S)-5-bifenyl-4-yl-4-(3-carboxypropionylamino)-2-methyl-pentaanzuurethylester)]Na3·x H2O, waarbij x 0 tot en met 3 is.
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 06/10/2025 | Outgoing Correspondence | Letter confirmation withdrawal | 1 | /1/0/4/4/4/0800644401/docs/301088_12_301088676943l193.pdf | ||
| 15/05/2025 | SPC Documents | SPC Documents | 1 | /1/0/4/4/4/0800644401/docs/301088_11_supplprotectioncertificate20250516083500024.pdf | ||
| 14/01/2021 | Outgoing Correspondence | Confirmation receipt request | 1 | /1/0/4/4/4/0800644401/docs/301088_10_389328l174.pdf | ||
| 13/01/2021 | SPC Documents | Marketing Authorization SPC | 3 | /1/0/4/4/4/0800644401/docs/301088_0_supplprotectioncertificate20210114083020235.pdf | ||
| 13/01/2021 | SPC Documents | Annex SPC | 2 | /1/0/4/4/4/0800644401/docs/301088_1_supplprotectioncertificate20210114084207221.pdf | ||
| 13/01/2021 | SPC Documents | Accompanying letter SPC | 8 | /1/0/4/4/4/0800644401/docs/301088_2_supplprotectioncertificate20210114082904199.pdf | ||
| 13/01/2021 | SPC Documents | Annex SPC | 115 | /1/0/4/4/4/0800644401/docs/301088_3_supplprotectioncertificate20210114084019791.pdf | ||
| 13/01/2021 | SPC Documents | Annex SPC | 2 | /1/0/4/4/4/0800644401/docs/301088_4_supplprotectioncertificate20210114083428647.pdf | ||
| 13/01/2021 | SPC Documents | Annex SPC | 1 | /1/0/4/4/4/0800644401/docs/301088_5_supplprotectioncertificate20210114084134421.pdf | ||
| 13/01/2021 | SPC Documents | Annex SPC | 28 | /1/0/4/4/4/0800644401/docs/301088_6_supplprotectioncertificate20210114083635360.pdf | ||
| 13/01/2021 | SPC Documents | Annex SPC | 2 | /1/0/4/4/4/0800644401/docs/301088_7_supplprotectioncertificate20210114083827252.pdf | ||
| 13/01/2021 | SPC Documents | Summary of the characteristics of the product | 20 | /1/0/4/4/4/0800644401/docs/301088_8_supplprotectioncertificate20210114083245780.pdf | ||
| 13/01/2021 | Application Form | First filed application form | 3 | /1/0/4/4/4/0800644401/docs/301088_9_applicationform20210114082608127.pdf |