300779 Product Name: Combinatie van a) olodaterol, het individuele optische R-isomeer daarvan, mengsels van individuele enantiomeren of racematen, zuuradditiezouten daarvan met farmacologisch aanvaardbare zuren, desgewenst in de vorm van solvaten en/of hydraten, en b) een tiotropiumzout; in het bijzonder combinatie van a) olodaterol en zuuradditiezouten daarvan met farmacologisch aanvaardbare zuren, en b) tiotropiumbromide, desgewenst in de vorm van een solvaat en/of hydraat; meer in het bijzonder combinatie van a) olodaterolhydrochloride en b) tiotropiumbromide, desgewenst in de vorm van het monohydraat
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 02/11/2017 | Outgoing Correspondence | Decision grant | 1 | /8/8/3/9/1/0800019388/docs/300779_6_outgoingcorrespondence20171103112212398.pdf | ||
| 02/11/2017 | SPC Documents | Certificate SPC | 1 | /8/8/3/9/1/0800019388/docs/300779_10_supplprotectioncertificate20171103112212472.pdf | ||
| 13/10/2017 | Incoming Correspondence Paper | Accompanying letter incoming document | 2 | /8/8/3/9/1/0800019388/docs/300779_18_incomingcorrespondencepaper20210319121035442.pdf | ||
| 13/07/2017 | Outgoing Correspondence | Outgoing Letter | 8 | /8/8/3/9/1/0800019388/docs/300779_4_outgoingcorrespondence20170714123825593.pdf | ||
| 13/07/2017 | Outgoing Correspondence | Letter to applicant | 2 | /8/8/3/9/1/0800019388/docs/300779_8_149044l173.pdf | ||
| 29/01/2016 | SPC Documents | Annex SPC | 5 | /8/8/3/9/1/0800019388/docs/300779_19_supplprotectioncertificate20201215014028383.pdf | ||
| 29/01/2016 | SPC Documents | Annex SPC | 4 | /8/8/3/9/1/0800019388/docs/300779_27_supplprotectioncertificate20201215014521710.pdf | ||
| 29/01/2016 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /8/8/3/9/1/0800019388/docs/300779_31_incomingcorrespondencepaper20210319120837358.pdf | ||
| 18/12/2015 | SPC Documents | Marketing Authorization SPC | 2 | /8/8/3/9/1/0800019388/docs/300779_0_supplprotectioncertificate20151222015908363.pdf | ||
| 18/12/2015 | SPC Documents | Annex SPC | 21 | /8/8/3/9/1/0800019388/docs/300779_1_supplprotectioncertificate20201215125212945.pdf | ||
| 18/12/2015 | SPC Documents | Annex SPC | 4 | /8/8/3/9/1/0800019388/docs/300779_3_supplprotectioncertificate20201215124555057.pdf | ||
| 18/12/2015 | SPC Documents | Annex SPC | 4 | /8/8/3/9/1/0800019388/docs/300779_11_supplprotectioncertificate20201215124432112.pdf | ||
| 18/12/2015 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /8/8/3/9/1/0800019388/docs/300779_28_incomingcorrespondencepaper20210319120612519.pdf | ||
| 18/12/2015 | SPC Documents | Annex SPC | 21 | /8/8/3/9/1/0800019388/docs/300779_29_supplprotectioncertificate20201215125521893.pdf | ||
| 18/12/2015 | SPC Documents | Marketing Authorization SPC | 2 | /8/8/3/9/1/0800019388/docs/300779_34_supplprotectioncertificate20151222015908680.pdf | ||
| 14/12/2015 | Outgoing Correspondence | Outgoing Letter | 1 | /8/8/3/9/1/0800019388/docs/300779_33_21782l174.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 3 | /8/8/3/9/1/0800019388/docs/300779_2_supplprotectioncertificate20201215092832412.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 1 | /8/8/3/9/1/0800019388/docs/300779_5_supplprotectioncertificate20201215083712325.pdf | ||
| 01/12/2015 | Application Form | First filed application form | 3 | /8/8/3/9/1/0800019388/docs/300779_7_applicationform20151210032435877.pdf | ||
| 01/12/2015 | SPC Documents | Marketing Authorization SPC | 1 | /8/8/3/9/1/0800019388/docs/300779_9_supplprotectioncertificate20151210032437107.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 32 | /8/8/3/9/1/0800019388/docs/300779_12_supplprotectioncertificate20201215092832508.pdf | ||
| 01/12/2015 | SPC Documents | Summary of the characteristics of the product | 41 | /8/8/3/9/1/0800019388/docs/300779_13_supplprotectioncertificate20201215091225802.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 2 | /8/8/3/9/1/0800019388/docs/300779_14_supplprotectioncertificate20201215085248177.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 6 | /8/8/3/9/1/0800019388/docs/300779_15_supplprotectioncertificate20201215091225660.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 1 | /8/8/3/9/1/0800019388/docs/300779_16_supplprotectioncertificate20201215093920214.pdf | ||
| 01/12/2015 | SPC Documents | Summary of the characteristics of the product | 21 | /8/8/3/9/1/0800019388/docs/300779_17_supplprotectioncertificate20201215091816738.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 3 | /8/8/3/9/1/0800019388/docs/300779_20_supplprotectioncertificate20201215103047627.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 1 | /8/8/3/9/1/0800019388/docs/300779_21_supplprotectioncertificate20201215084126189.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 1 | /8/8/3/9/1/0800019388/docs/300779_22_supplprotectioncertificate20201215085248078.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 33 | /8/8/3/9/1/0800019388/docs/300779_23_supplprotectioncertificate20201215103047696.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 4 | /8/8/3/9/1/0800019388/docs/300779_24_supplprotectioncertificate20201215085728415.pdf | ||
| 01/12/2015 | SPC Documents | Accompanying letter SPC | 4 | /8/8/3/9/1/0800019388/docs/300779_25_supplprotectioncertificate20201215092204441.pdf | ||
| 01/12/2015 | SPC Documents | Marketing Authorization SPC | 1 | /8/8/3/9/1/0800019388/docs/300779_26_supplprotectioncertificate20201215091816658.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 2 | /8/8/3/9/1/0800019388/docs/300779_30_supplprotectioncertificate20201215120447277.pdf | ||
| 01/12/2015 | SPC Documents | Annex SPC | 1 | /8/8/3/9/1/0800019388/docs/300779_32_supplprotectioncertificate20201215114841760.pdf |