300626 Product Name: Combinatie van: (a) dextromethorfan, desgewenst in de vorm van een farmaceutisch aanvaardbaar zout, in het bijzonder dextromethorfanhydrobromide, meer in het bijzonder dextromethorfanhydrobromide monohydraat; en (b) kinidine, desgewenst in de vorm van een farmaceutisch aanvaardbaar zout, in het bijzonder kinidinesulfaat, meer in het bijzonder kinidinesulfaatdihydraat.
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 09/03/2016 | Restoration | Restoration | 2 | /6/2/6/0/0/0400300626/docs/300626_7_beschikking c300626.pdf | ||
| 09/03/2016 | Restoration | Restoration | 1 | /6/2/6/0/0/0400300626/docs/300626_14_certificaat c300626.pdf | ||
| 22/10/2015 | Appeal | Request appeal | 2 | /6/2/6/0/0/0400300626/docs/300626_15_appeal20201019031109698.pdf | ||
| 22/10/2015 | Appeal | Subsequently filed documents appeal procedure | 1 | /6/2/6/0/0/0400300626/docs/300626_17_appeal20201019031147343.pdf | ||
| 15/10/2015 | Appeal | Request appeal | 3 | /6/2/6/0/0/0400300626/docs/300626_0_appeal20151019035416774.pdf | ||
| 03/09/2015 | SPC Documents | Certificate SPC | 1 | /6/2/6/0/0/0400300626/docs/300626_11_supplprotectioncertificate20201016025930472.pdf | ||
| 03/09/2015 | Outgoing Correspondence | Outgoing Letter | 2 | /6/2/6/0/0/0400300626/docs/300626_24_outgoingcorrespondence20150903.pdf | ||
| 31/08/2015 | Incoming Correspondence Paper | Accompanying letter incoming document | 2 | /6/2/6/0/0/0400300626/docs/300626_6_incomingcorrespondencepaper20210315012145494.pdf | ||
| 15/10/2014 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /6/2/6/0/0/0400300626/docs/300626_16_incomingcorrespondencepaper20210315012036435.pdf | ||
| 29/07/2014 | Incoming Correspondence Paper | Accompanying letter incoming document | 4 | /6/2/6/0/0/0400300626/docs/300626_4_incomingcorrespondencepaper20210315011826051.pdf | ||
| 03/06/2014 | Outgoing Correspondence | Outgoing Letter | 1 | /6/2/6/0/0/0400300626/docs/300626_2_outgoingcorrespondence20140603.pdf | ||
| 26/05/2014 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /6/2/6/0/0/0400300626/docs/300626_22_incomingcorrespondencepaper20210315011707569.pdf | ||
| 27/02/2014 | Outgoing Correspondence | Outgoing Letter | 2 | /6/2/6/0/0/0400300626/docs/300626_1_outgoingcorrespondence20140227.pdf | ||
| 27/02/2014 | Outgoing Correspondence | Outgoing Letter | 6 | /6/2/6/0/0/0400300626/docs/300626_8_outgoingcorrespondence20140227.pdf | ||
| 27/02/2014 | Outgoing Correspondence | Outgoing Letter | 2 | /6/2/6/0/0/0400300626/docs/300626_10_outgoingcorrespondence20140227.pdf | ||
| 25/11/2013 | Application Form | First filed application form | 3 | /6/2/6/0/0/0400300626/docs/300626_3_applicationform20131125.pdf | ||
| 25/11/2013 | SPC Documents | Annex SPC | 21 | /6/2/6/0/0/0400300626/docs/300626_5_supplprotectioncertificate20201016014447193.pdf | ||
| 25/11/2013 | Incoming Correspondence Paper | Incoming Correspondence Paper | 3 | /6/2/6/0/0/0400300626/docs/300626_9_incomingcorrespondencepaper20131125.pdf | ||
| 25/11/2013 | SPC Documents | Marketing Authorization SPC | 3 | /6/2/6/0/0/0400300626/docs/300626_12_supplprotectioncertificate20201016014624489.pdf | ||
| 25/11/2013 | SPC Documents | Annex SPC | 1 | /6/2/6/0/0/0400300626/docs/300626_13_supplprotectioncertificate20201016014252681.pdf | ||
| 25/11/2013 | SPC Documents | Summary of the characteristics of the product | 33 | /6/2/6/0/0/0400300626/docs/300626_18_supplprotectioncertificate20201016015158940.pdf | ||
| 25/11/2013 | SPC Documents | Annex SPC | 3 | /6/2/6/0/0/0400300626/docs/300626_19_supplprotectioncertificate20201016015158996.pdf | ||
| 25/11/2013 | SPC Documents | Annex SPC | 21 | /6/2/6/0/0/0400300626/docs/300626_20_supplprotectioncertificate20201016015159060.pdf | ||
| 25/11/2013 | SPC Documents | Annex SPC | 1 | /6/2/6/0/0/0400300626/docs/300626_21_supplprotectioncertificate20201016015343968.pdf | ||
| 22/11/2013 | Outgoing Correspondence | Outgoing Letter | 1 | /6/2/6/0/0/0400300626/docs/300626_23_outgoingcorrespondence20131122.pdf |