300435 Product Name: Prucalopride, desgewenst in de vorm van een farmaceutisch aanvaardbaar zuuradditie zout, in het bijzonder het succinaat.
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 05/03/2020 | Outgoing Correspondence | Decision extension duration | 2 | /5/3/4/0/0/0400300435/docs/300435_0_327860l504c.pdf | ||
| 05/03/2020 | SPC Documents | Certificate SPC | 1 | /5/3/4/0/0/0400300435/docs/300435_23_supplprotectioncertificate20200306113028719.pdf | ||
| 05/03/2020 | SPC Documents | Annex SPC | 1 | /5/3/4/0/0/0400300435/docs/300435_27_supplprotectioncertificate20200306113028796.pdf | ||
| 17/09/2019 | Incoming Correspondence Paper | Accompanying letter incoming document | 5 | /5/3/4/0/0/0400300435/docs/300435_2_incomingcorrespondencepaper20190920014656158.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 28 | /5/3/4/0/0/0400300435/docs/300435_10_supplprotectioncertificate20210218034008259.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 2 | /5/3/4/0/0/0400300435/docs/300435_15_supplprotectioncertificate20190920014555093.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 19 | /5/3/4/0/0/0400300435/docs/300435_20_supplprotectioncertificate20210218033630484.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 2 | /5/3/4/0/0/0400300435/docs/300435_38_supplprotectioncertificate20190920013725237.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 13 | /5/3/4/0/0/0400300435/docs/300435_42_supplprotectioncertificate20190920013725321.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 2 | /5/3/4/0/0/0400300435/docs/300435_46_supplprotectioncertificate20210218033326264.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 5 | /5/3/4/0/0/0400300435/docs/300435_47_supplprotectioncertificate20210218033508683.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 28 | /5/3/4/0/0/0400300435/docs/300435_48_supplprotectioncertificate20210218033812459.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 13 | /5/3/4/0/0/0400300435/docs/300435_49_supplprotectioncertificate20190920014555180.pdf | ||
| 17/09/2019 | SPC Documents | Summary of the characteristics of the product | 19 | /5/3/4/0/0/0400300435/docs/300435_53_supplprotectioncertificate20190920014555004.pdf | ||
| 17/09/2019 | SPC Documents | Summary of the characteristics of the product | 1 | /5/3/4/0/0/0400300435/docs/300435_56_supplprotectioncertificate20190923051333158.pdf | ||
| 17/09/2019 | SPC Documents | Annex SPC | 3 | /5/3/4/0/0/0400300435/docs/300435_62_supplprotectioncertificate20210218033226581.pdf | ||
| 20/06/2019 | Outgoing Correspondence | Outgoing Letter | 2 | /5/3/4/0/0/0400300435/docs/300435_25_outgoingcorrespondence20190621101947502.pdf | ||
| 03/06/2019 | Outgoing Correspondence | Confirmation receipt request for extension | 1 | /5/3/4/0/0/0400300435/docs/300435_30_277258l505.pdf | ||
| 29/05/2019 | Restoration | Decision final restoration procedure | 4 | /5/3/4/0/0/0400300435/docs/300435_55_restoration20190529113545612.pdf | ||
| 23/04/2019 | Outgoing Correspondence | Letter restoration procedure | 2 | /5/3/4/0/0/0400300435/docs/300435_51_268312l124.pdf | ||
| 05/04/2019 | Restoration | Annex | 2 | /5/3/4/0/0/0400300435/docs/300435_5_restoration20190408021743182.pdf | ||
| 05/04/2019 | Restoration | Annex | 2 | /5/3/4/0/0/0400300435/docs/300435_11_restoration20190408021743275.pdf | ||
| 05/04/2019 | Restoration | Annex | 13 | /5/3/4/0/0/0400300435/docs/300435_13_restoration20190408021743836.pdf | ||
| 05/04/2019 | Restoration | Annex | 4 | /5/3/4/0/0/0400300435/docs/300435_16_restoration20190408021743547.pdf | ||
| 05/04/2019 | Restoration | Annex | 2 | /5/3/4/0/0/0400300435/docs/300435_28_restoration20190408021743456.pdf | ||
| 05/04/2019 | Restoration | Annex | 2 | /5/3/4/0/0/0400300435/docs/300435_31_restoration20190408021743367.pdf | ||
| 05/04/2019 | Restoration | Annex | 2 | /5/3/4/0/0/0400300435/docs/300435_32_restoration20190408021743737.pdf | ||
| 05/04/2019 | Restoration | Subsequently filed documents restoration procedure | 9 | /5/3/4/0/0/0400300435/docs/300435_41_restoration20190408021743086.pdf | ||
| 05/04/2019 | Restoration | Annex | 2 | /5/3/4/0/0/0400300435/docs/300435_52_restoration20190408021743648.pdf | ||
| 05/04/2019 | Restoration | Subsequently filed documents restoration procedure | 8 | /5/3/4/0/0/0400300435/docs/300435_54_restoration20190408021742994.pdf | ||
| 08/03/2019 | Outgoing Correspondence | Letter restoration procedure | 1 | /5/3/4/0/0/0400300435/docs/300435_14_258274l124.pdf | ||
| 07/03/2019 | Restoration | Subsequently filed documents restoration procedure | 1 | /5/3/4/0/0/0400300435/docs/300435_40_restoration20190308101514380.pdf | ||
| 07/03/2019 | Restoration | Subsequently filed documents restoration procedure | 3 | /5/3/4/0/0/0400300435/docs/300435_43_restoration20190308101514579.pdf | ||
| 07/02/2019 | Outgoing Correspondence | Letter restoration procedure | 1 | /5/3/4/0/0/0400300435/docs/300435_37_253321l124.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 15 | /5/3/4/0/0/0400300435/docs/300435_1_supplprotectioncertificate20190529043907083.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 2 | /5/3/4/0/0/0400300435/docs/300435_3_supplprotectioncertificate20190529043611592.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 5 | /5/3/4/0/0/0400300435/docs/300435_4_supplprotectioncertificate20190529043708584.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 5 | /5/3/4/0/0/0400300435/docs/300435_9_supplprotectioncertificate20210218025746857.pdf | ||
| 04/02/2019 | SPC Documents | Marketing Authorization SPC | 3 | /5/3/4/0/0/0400300435/docs/300435_17_supplprotectioncertificate20190529044017243.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 9 | /5/3/4/0/0/0400300435/docs/300435_21_supplprotectioncertificate20210218033000580.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 10 | /5/3/4/0/0/0400300435/docs/300435_22_supplprotectioncertificate20210218034406555.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 2 | /5/3/4/0/0/0400300435/docs/300435_24_supplprotectioncertificate20190529043952429.pdf | ||
| 04/02/2019 | SPC Documents | Summary of the characteristics of the product | 19 | /5/3/4/0/0/0400300435/docs/300435_34_supplprotectioncertificate20210218025644065.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 9 | /5/3/4/0/0/0400300435/docs/300435_35_supplprotectioncertificate20210218032658401.pdf | ||
| 04/02/2019 | Restoration | Subsequently filed documents restoration procedure | 2 | /5/3/4/0/0/0400300435/docs/300435_36_restoration20190205035107924.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 19 | /5/3/4/0/0/0400300435/docs/300435_39_supplprotectioncertificate20190529043512501.pdf | ||
| 04/02/2019 | Restoration | Subsequently filed documents restoration procedure | 3 | /5/3/4/0/0/0400300435/docs/300435_44_restoration20190205035108203.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 10 | /5/3/4/0/0/0400300435/docs/300435_45_supplprotectioncertificate20210218031601157.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 2 | /5/3/4/0/0/0400300435/docs/300435_57_supplprotectioncertificate20210218025852095.pdf | ||
| 04/02/2019 | SPC Documents | Annex SPC | 15 | /5/3/4/0/0/0400300435/docs/300435_59_supplprotectioncertificate20210218030046726.pdf | ||
| 04/02/2019 | Application Form | First filed application form | 3 | /5/3/4/0/0/0400300435/docs/300435_60_applicationform20190529043433826.pdf | ||
| 04/02/2019 | SPC Documents | Marketing Authorization SPC | 3 | /5/3/4/0/0/0400300435/docs/300435_61_supplprotectioncertificate20210218032419006.pdf | ||
| 24/02/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /5/3/4/0/0/0400300435/docs/300435_26_outgoingcorrespondence20100224.pdf | ||
| 24/02/2010 | SPC Documents | Certificate SPC | 1 | /5/3/4/0/0/0400300435/docs/300435_33_supplprotectioncertificate20210218025415345.pdf | ||
| 16/02/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /5/3/4/0/0/0400300435/docs/300435_50_outgoingcorrespondence20100216.pdf | ||
| 09/02/2010 | SPC Documents | Summary of the characteristics of the product | 17 | /5/3/4/0/0/0400300435/docs/300435_6_supplprotectioncertificate20210218024404543.pdf | ||
| 09/02/2010 | SPC Documents | Marketing Authorization SPC | 3 | /5/3/4/0/0/0400300435/docs/300435_7_supplprotectioncertificate20210218024540259.pdf | ||
| 09/02/2010 | SPC Documents | Annex SPC | 2 | /5/3/4/0/0/0400300435/docs/300435_8_supplprotectioncertificate20210218025158741.pdf | ||
| 09/02/2010 | Application Form | First filed application form | 2 | /5/3/4/0/0/0400300435/docs/300435_12_applicationform20100209.pdf | ||
| 09/02/2010 | SPC Documents | Annex SPC | 1 | /5/3/4/0/0/0400300435/docs/300435_18_supplprotectioncertificate20210218024008684.pdf | ||
| 09/02/2010 | SPC Documents | Annex SPC | 11 | /5/3/4/0/0/0400300435/docs/300435_19_supplprotectioncertificate20210218024646196.pdf | ||
| 09/02/2010 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /5/3/4/0/0/0400300435/docs/300435_29_incomingcorrespondencepaper20100209.pdf | ||
| 09/02/2010 | SPC Documents | Annex SPC | 1 | /5/3/4/0/0/0400300435/docs/300435_58_supplprotectioncertificate20210218025257102.pdf |