300529 Product Name: Rilpivirine, desgewenst in de vorm van een farmaceutisch aanvaardbaar additiezout, in het bijzonder het hydrochloridezout.
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 05/12/2024 | Certificate | Certificate | 1 | /9/2/5/0/0/0400300529/docs/300529_17_spcxcertificate20241205110543697.pdf | ||
| 05/12/2024 | Outgoing Correspondence | Decision extension duration | 1 | /9/2/5/0/0/0400300529/docs/300529_18_634371l504c.pdf | ||
| 29/10/2024 | SPC Documents | Annex SPC | 1 | /9/2/5/0/0/0400300529/docs/300529_10_supplprotectioncertificate20241029034435300.pdf | ||
| 29/10/2024 | SPC Documents | Marketing Authorization SPC | 3 | /9/2/5/0/0/0400300529/docs/300529_11_supplprotectioncertificate20241029034900417.pdf | ||
| 29/10/2024 | SPC Documents | Summary of the characteristics of the product | 49 | /9/2/5/0/0/0400300529/docs/300529_12_supplprotectioncertificate20241029034810276.pdf | ||
| 29/10/2024 | SPC Documents | Annex SPC | 1 | /9/2/5/0/0/0400300529/docs/300529_13_supplprotectioncertificate20241029035010104.pdf | ||
| 29/10/2024 | Application Form | First filed application form | 4 | /9/2/5/0/0/0400300529/docs/300529_14_applicationform20241029034239786.pdf | ||
| 29/10/2024 | SPC Documents | Accompanying letter SPC | 1 | /9/2/5/0/0/0400300529/docs/300529_15_supplprotectioncertificate20241029034353726.pdf | ||
| 29/10/2024 | Outgoing Correspondence | Confirmation receipt request for extension | 2 | /9/2/5/0/0/0400300529/docs/300529_16_629417l505.pdf | ||
| 14/10/2014 | SPC Documents | Certificate SPC | 1 | /9/2/5/0/0/0400300529/docs/300529_2_supplprotectioncertificate20200918041916481.pdf | ||
| 14/10/2014 | Outgoing Correspondence | Outgoing Letter | 1 | /9/2/5/0/0/0400300529/docs/300529_9_outgoingcorrespondence20141014.pdf | ||
| 24/07/2014 | Incoming Correspondence Paper | Accompanying letter incoming document | 2 | /9/2/5/0/0/0400300529/docs/300529_3_incomingcorrespondencepaper20210310032514814.pdf | ||
| 23/07/2014 | Incoming Correspondence Paper | Accompanying letter incoming document | 2 | /9/2/5/0/0/0400300529/docs/300529_1_incomingcorrespondencepaper20210310032357761.pdf | ||
| 24/04/2014 | Incoming Correspondence Paper | Accompanying letter incoming document | 2 | /9/2/5/0/0/0400300529/docs/300529_6_incomingcorrespondencepaper20210310032257618.pdf | ||
| 07/05/2012 | Outgoing Correspondence | Outgoing Letter | 1 | /9/2/5/0/0/0400300529/docs/300529_0_outgoingcorrespondence20120507.pdf | ||
| 07/05/2012 | SPC Documents | Summary of the characteristics of the product | 20 | /9/2/5/0/0/0400300529/docs/300529_4_supplprotectioncertificate20200918040616556.pdf | ||
| 07/05/2012 | SPC Documents | Marketing Authorization SPC | 3 | /9/2/5/0/0/0400300529/docs/300529_5_supplprotectioncertificate20200918040759596.pdf | ||
| 07/05/2012 | SPC Documents | Annex SPC | 2 | /9/2/5/0/0/0400300529/docs/300529_7_supplprotectioncertificate20200918040936103.pdf | ||
| 07/05/2012 | Application Form | First filed application form | 3 | /9/2/5/0/0/0400300529/docs/300529_8_applicationform20120507.pdf |