301353 Product Name: Acalabrutinib of een farmaceutisch aanvaardbaar zout daarvan in combinatie met venetoclax, optioneel met obinutuzumab
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 02/12/2025 | Outgoing Correspondence | Confirmation receipt request | 2 | /7/8/4/6/8/0801186487/docs/301353_17_301353685076l174.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 1 | /7/8/4/6/8/0801186487/docs/301353_0_supplprotectioncertificate20251202120409535.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 217 | /7/8/4/6/8/0801186487/docs/301353_1_supplprotectioncertificate20251202120702480.pdf | ||
| 01/12/2025 | SPC Documents | Marketing Authorization SPC | 3 | /7/8/4/6/8/0801186487/docs/301353_2_supplprotectioncertificate20251202120812280.pdf | ||
| 01/12/2025 | SPC Documents | Summary of the characteristics of the product | 77 | /7/8/4/6/8/0801186487/docs/301353_3_supplprotectioncertificate20251202122130089.pdf | ||
| 01/12/2025 | SPC Documents | Summary of the characteristics of the product | 26 | /7/8/4/6/8/0801186487/docs/301353_4_supplprotectioncertificate20251202121524489.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 2 | /7/8/4/6/8/0801186487/docs/301353_5_supplprotectioncertificate20251202121524516.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 13 | /7/8/4/6/8/0801186487/docs/301353_6_supplprotectioncertificate20251202121524529.pdf | ||
| 01/12/2025 | SPC Documents | SPC Documents | 2 | /7/8/4/6/8/0801186487/docs/301353_7_supplprotectioncertificate20251202115755728.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 24 | /7/8/4/6/8/0801186487/docs/301353_8_supplprotectioncertificate20251202122130125.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 2 | /7/8/4/6/8/0801186487/docs/301353_9_supplprotectioncertificate20251202122130113.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 25 | /7/8/4/6/8/0801186487/docs/301353_10_supplprotectioncertificate20251202120234617.pdf | ||
| 01/12/2025 | SPC Documents | SPC Documents | 77 | /7/8/4/6/8/0801186487/docs/301353_11_supplprotectioncertificate20251202120234580.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 1 | /7/8/4/6/8/0801186487/docs/301353_12_supplprotectioncertificate20251202115839095.pdf | ||
| 01/12/2025 | Application Form | First filed application form | 2 | /7/8/4/6/8/0801186487/docs/301353_13_applicationform20251202115702812.pdf | ||
| 01/12/2025 | SPC Documents | Annex SPC | 2 | /7/8/4/6/8/0801186487/docs/301353_14_supplprotectioncertificate20251202120234607.pdf | ||
| 01/12/2025 | SPC Documents | Marketing Authorization SPC | 3 | /7/8/4/6/8/0801186487/docs/301353_15_supplprotectioncertificate20251202120510842.pdf | ||
| 01/12/2025 | SPC Documents | SPC Documents | 3 | /7/8/4/6/8/0801186487/docs/301353_16_supplprotectioncertificate20251202120323318.pdf |