Patent details
300788 Product Name: Pembrolizumab
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Basic Information
- Publication number:
- 300788
- Type:
- Certificate
- SPC Type:
- Medical
- Basic Patent Number:
- EP2170959
- Status:
- SPC granted but not yet in force
- Application number:
- 300788
- Procedural language:
- Dutch
- First Applicant Residence Country:
- Netherlands (NL)
Paediatric Extension
- SPC Extension Filing Date:
- 18/11/2021
- SPC Extension Agent/Owner Name:
- Merck Sharp & Dohme B.V. , ir. M.F.J.M. Ketelaars c.s.
- SPC Extension Status:
- Extension Granted
- SPC Extension Grant Date:
- 06/03/2024
- SPC Extension Request Refusal Date:
- SPC Extension Revocation Date:
Marketing Authorization
- Marketing Authorization Number:
- EU/1/15/1024/001
- Marketing Authorization Type:
- EEA
- Marketing Authorization Date:
- 21/07/2015
- Marketing Authorization Country:
- European Union (EU)
Dates
- Filing date:
- 28/12/2015
- First Marketing Authorization date:
- 21/07/2015
- Grant date:
- 06/03/2024
- Activation date:
- Lapsed By Non Payment Annual Fee Date:
- Renunciation Date:
- NullificationDate:
- Registration date:
- 10/05/2016
- SPC/SPC Extension Expiration Date:
- 20/01/2031
- Lapsed By Expiration Date:
- Withdrawal date:
- Revocation Date:
- Invalidity Date:
- Withdrawal Market Authorization Date:
- Refusal Date:
Applicant/holder
- From:
- 28/12/2015
- Name:
- Merck Sharp & Dohme B.V.
- Address:
- Waarderweg 39, 2031 BN, HAARLEM, Netherlands (NL)
Agent
- Name:
- ir. M.F.J.M. Ketelaars c.s.
- From:
- 29/12/2015
- Address:
- NLO Postbus 29720, 2502 LS, Den Haag, Netherlands (NL)
- To:
Publication
Bulletin
1
- Bulletin Heading:
- SPC
- Journal edition number:
- 11/24
- Publication date:
- 13/03/2024
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
2
- Bulletin Heading:
- SPC
- Journal edition number:
- 11/24
- Publication date:
- 13/03/2024
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
3
- Bulletin Heading:
- SPC
- Journal edition number:
- 48/21
- Publication date:
- 01/12/2021
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
4
- Bulletin Heading:
- SPC
- Journal edition number:
- 19/16
- Publication date:
- 11/05/2016
- Description:
- Applications and granted Supplementary Protection Certificates (or the extensions of the Supplementary Protection Certificates)
Annual Fee
- Annual Fee(s) Due Date:
- 30/06/2028
- Annual Fee Number:
- 21
- Annual Fee Amount:
- 1600 Euro
- Last Annual Payment Date:
- Last Annual Fee Paid Number:
- Payer:
| Filing date | Document type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|
| 06/03/2024 | Outgoing Correspondence | Decision grant | 1 | /7/4/6/1/2/0800021647/docs/300788_21_595379l504a.pdf | ||
| 06/03/2024 | Outgoing Correspondence | Decision extension duration | 1 | /7/4/6/1/2/0800021647/docs/300788_22_595394l504c.pdf | ||
| 06/03/2024 | Certificate | Certificate | 1 | /7/4/6/1/2/0800021647/docs/300788_23_spcmedcertificate20240306103221285.pdf | ||
| 06/03/2024 | Certificate | Certificate | 1 | /7/4/6/1/2/0800021647/docs/300788_24_spcxcertificate20240306105537364.pdf | ||
| 29/02/2024 | Incoming Correspondence Electronic | Accompanying letter incoming document | 1 | /7/4/6/1/2/0800021647/docs/300788_20_incomingcorrespondenceelectronic20240301021632361.pdf | ||
| 30/11/2021 | Outgoing Correspondence | Confirmation receipt request for extension | 1 | /7/4/6/1/2/0800021647/docs/300788_8_448530l505.pdf | ||
| 18/11/2021 | SPC Documents | Summary of the characteristics of the product | 53 | /7/4/6/1/2/0800021647/docs/300788_2_supplprotectioncertificate20211122103725376.pdf | ||
| 18/11/2021 | SPC Documents | Annex SPC | 1 | /7/4/6/1/2/0800021647/docs/300788_11_supplprotectioncertificate20211122104129176.pdf | ||
| 18/11/2021 | SPC Documents | Marketing Authorization SPC | 3 | /7/4/6/1/2/0800021647/docs/300788_12_supplprotectioncertificate20211122103611106.pdf | ||
| 18/11/2021 | Application Form | First filed application form | 2 | /7/4/6/1/2/0800021647/docs/300788_19_applicationform20211122103456787.pdf | ||
| 08/05/2017 | Incoming Correspondence Paper | Accompanying letter incoming document | 9 | /7/4/6/1/2/0800021647/docs/300788_4_incomingcorrespondencepaper20170509014835949.pdf | ||
| 07/02/2017 | Outgoing Correspondence | Outgoing correspondence | 1 | /7/4/6/1/2/0800021647/docs/300788_16_outgoingcorrespondence20170207104339712.pdf | ||
| 06/02/2017 | Incoming Correspondence Paper | 1 | /7/4/6/1/2/0800021647/docs/300788_10_incomingcorrespondencepaper20200410101540497.pdf | |||
| 07/12/2016 | Outgoing Correspondence | Letter to applicant | 1 | /7/4/6/1/2/0800021647/docs/300788_0_outgoingcorrespondence20161208030556809.pdf | ||
| 05/12/2016 | Incoming Correspondence Paper | Accompanying letter incoming document | 2 | /7/4/6/1/2/0800021647/docs/300788_5_incomingcorrespondencepaper20161206023835889.pdf | ||
| 19/10/2016 | Outgoing Correspondence | Outgoing Letter | 1 | /7/4/6/1/2/0800021647/docs/300788_15_outgoingcorrespondence20161019010906443.pdf | ||
| 04/10/2016 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /7/4/6/1/2/0800021647/docs/300788_18_incomingcorrespondencepaper20161006114151370.pdf | ||
| 21/07/2016 | Incoming Correspondence Paper | Accompanying letter incoming document | 1 | /7/4/6/1/2/0800021647/docs/300788_7_incomingcorrespondencepaper20160722012803547.pdf | ||
| 21/07/2016 | SPC Documents | Annex SPC | 1 | /7/4/6/1/2/0800021647/docs/300788_13_supplprotectioncertificate20200410100745188.pdf | ||
| 05/07/2016 | Outgoing Correspondence | Letter to applicant | 2 | /7/4/6/1/2/0800021647/docs/300788_1_outgoingcorrespondence20160705104650674.pdf | ||
| 10/05/2016 | Outgoing Correspondence | Outgoing Letter | 1 | /7/4/6/1/2/0800021647/docs/300788_6_54748l174.pdf | ||
| 28/12/2015 | SPC Documents | Summary of the characteristics of the product | 23 | /7/4/6/1/2/0800021647/docs/300788_3_supplprotectioncertificate20200410100341347.pdf | ||
| 28/12/2015 | SPC Documents | Annex SPC | 10 | /7/4/6/1/2/0800021647/docs/300788_9_supplprotectioncertificate20200410095758400.pdf | ||
| 28/12/2015 | Application Form | First filed application form | 2 | /7/4/6/1/2/0800021647/docs/300788_14_applicationform20151229025045442.pdf | ||
| 28/12/2015 | SPC Documents | Marketing Authorization SPC | 3 | /7/4/6/1/2/0800021647/docs/300788_17_supplprotectioncertificate20151229025045649.pdf |