300387 Product Name: ROACTEMRA, TOCILIZUMAB, gehumaniseerd lgG1 monoklonaal antilich aam tegen de menselijke interleukine-6 (IL-6) receptor geprodu ceerd in Chinese hamster-ovarium (CHO)cellen door recombinant DNA-technologie.
Filing date | Document type | Document Description | Number of pages | File Type | ||
---|---|---|---|---|---|---|
07/09/2010 | Outgoing Correspondence | Outgoing Letter | 10 | /7/8/3/0/0/0400300387/docs/300387_8_outgoingcorrespondence20100907.pdf | ||
26/07/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /7/8/3/0/0/0400300387/docs/300387_19_outgoingcorrespondence20100726.pdf | ||
16/07/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /7/8/3/0/0/0400300387/docs/300387_18_outgoingcorrespondence20100716.pdf | ||
15/07/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /7/8/3/0/0/0400300387/docs/300387_23_outgoingcorrespondence20100715.pdf | ||
29/06/2010 | Internal | Internal other | 8 | /7/8/3/0/0/0400300387/docs/300387_17_internal20100629.pdf | ||
29/06/2010 | Appeal | Appeal | 2 | /7/8/3/0/0/0400300387/docs/300387_28_appeal20100629.pdf | ||
04/05/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /7/8/3/0/0/0400300387/docs/300387_12_outgoingcorrespondence20100504.pdf | ||
03/05/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /7/8/3/0/0/0400300387/docs/300387_22_outgoingcorrespondence20100503.pdf | ||
31/03/2010 | Appeal | Request appeal | 13 | /7/8/3/0/0/0400300387/docs/300387_2_appeal20100331.pdf | ||
31/03/2010 | Incoming Correspondence Paper | Other | 15 | /7/8/3/0/0/0400300387/docs/300387_10_incomingcorrespondencepaper20100331.pdf | ||
31/03/2010 | Appeal | Accompanying letter appeal procedure | 1 | /7/8/3/0/0/0400300387/docs/300387_15_appeal20100331.pdf | ||
30/03/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /7/8/3/0/0/0400300387/docs/300387_7_outgoingcorrespondence20100330.pdf | ||
30/03/2010 | Outgoing Correspondence | Outgoing Letter | 1 | /7/8/3/0/0/0400300387/docs/300387_24_outgoingcorrespondence20100330.pdf | ||
29/03/2010 | Appeal | Request appeal | 13 | /7/8/3/0/0/0400300387/docs/300387_4_appeal20100329.pdf | ||
29/03/2010 | Appeal | Accompanying letter appeal procedure | 1 | /7/8/3/0/0/0400300387/docs/300387_6_appeal20100329.pdf | ||
16/02/2010 | Outgoing Correspondence | Outgoing Letter | 7 | /7/8/3/0/0/0400300387/docs/300387_1_outgoingcorrespondence20100216.pdf | ||
15/12/2009 | Incoming Correspondence Paper | Other | 1 | /7/8/3/0/0/0400300387/docs/300387_27_incomingcorrespondencepaper20091215.pdf | ||
14/12/2009 | Incoming Correspondence Paper | Other | 1 | /7/8/3/0/0/0400300387/docs/300387_5_incomingcorrespondencepaper20091214.pdf | ||
01/12/2009 | Incoming Correspondence Paper | Other | 2 | /7/8/3/0/0/0400300387/docs/300387_0_incomingcorrespondencepaper20091201.pdf | ||
30/11/2009 | Incoming Correspondence Paper | Other | 2 | /7/8/3/0/0/0400300387/docs/300387_29_incomingcorrespondencepaper20091130.pdf | ||
02/09/2009 | Incoming Correspondence Paper | Other | 24 | /7/8/3/0/0/0400300387/docs/300387_11_incomingcorrespondencepaper20090902.pdf | ||
02/09/2009 | Outgoing Correspondence | Outgoing Letter | 3 | /7/8/3/0/0/0400300387/docs/300387_20_outgoingcorrespondence20090902.pdf | ||
10/06/2009 | General | 1 | /7/8/3/0/0/0400300387/docs/300387_16_spc-documents20090610.pdf | |||
10/06/2009 | Incoming Correspondence Paper | Other | 1 | /7/8/3/0/0/0400300387/docs/300387_30_incomingcorrespondencepaper20090610.pdf | ||
29/04/2009 | Outgoing Correspondence | Outgoing Letter | 1 | /7/8/3/0/0/0400300387/docs/300387_26_outgoingcorrespondence20090429.pdf | ||
28/04/2009 | General | 5 | /7/8/3/0/0/0400300387/docs/300387_9_spc-documents20090428.pdf | |||
28/04/2009 | Application Form | First filed application form | 2 | /7/8/3/0/0/0400300387/docs/300387_13_applicationform20090428.pdf | ||
28/04/2009 | General | 2 | /7/8/3/0/0/0400300387/docs/300387_14_spc-documents20090428.pdf | |||
28/04/2009 | General | 15 | /7/8/3/0/0/0400300387/docs/300387_25_spc-documents20090428.pdf | |||
27/04/2009 | General | 2 | /7/8/3/0/0/0400300387/docs/300387_3_spc-documents20090427.pdf | |||
27/04/2009 | Application Form | First filed application form | 2 | /7/8/3/0/0/0400300387/docs/300387_21_applicationform20090427.pdf |