301277 Product Name: dolutegravir of een farmaceutisch aanvaardbaar zout, waaronder dolutegravirnatrium, en lamivudine
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 24/09/2025 | Outgoing Correspondence | Letter to applicant | 1 | /6/8/4/6/0/0801006486/docs/301277_11_301277675486l173.pdf | ||
| 16/09/2025 | Incoming Correspondence Electronic | Accompanying letter incoming document | 1 | /6/8/4/6/0/0801006486/docs/301277_10_incomingcorrespondenceelectronic20250917085223560.pdf | ||
| 24/07/2025 | Outgoing Correspondence | Letter to applicant | 5 | /6/8/4/6/0/0801006486/docs/301277_9_301277666526l173.pdf | ||
| 04/06/2024 | Outgoing Correspondence | Confirmation receipt request | 2 | /6/8/4/6/0/0801006486/docs/301277_0_606424l174.pdf | ||
| 04/06/2024 | SPC Documents | Annex SPC | 20 | /6/8/4/6/0/0801006486/docs/301277_5_supplprotectioncertificate20240604121003103.pdf | ||
| 04/06/2024 | SPC Documents | Annex SPC | 2 | /6/8/4/6/0/0801006486/docs/301277_6_supplprotectioncertificate20240604121003084.pdf | ||
| 03/06/2024 | SPC Documents | Accompanying letter SPC | 3 | /6/8/4/6/0/0801006486/docs/301277_1_supplprotectioncertificate20240604120504972.pdf | ||
| 03/06/2024 | SPC Documents | Annex SPC | 16 | /6/8/4/6/0/0801006486/docs/301277_2_supplprotectioncertificate20240604120521784.pdf | ||
| 03/06/2024 | SPC Documents | Marketing Authorization SPC | 3 | /6/8/4/6/0/0801006486/docs/301277_3_supplprotectioncertificate20240604120545706.pdf | ||
| 03/06/2024 | SPC Documents | Summary of the characteristics of the product | 24 | /6/8/4/6/0/0801006486/docs/301277_4_supplprotectioncertificate20240604121003061.pdf | ||
| 03/06/2024 | SPC Documents | Annex SPC | 52 | /6/8/4/6/0/0801006486/docs/301277_7_supplprotectioncertificate20240604121039343.pdf | ||
| 03/06/2024 | Application Form | First filed application form | 2 | /6/8/4/6/0/0801006486/docs/301277_8_applicationform20240604121418436.pdf |