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Patent details
2023C545 Product name: DOULUTEGRAVIR SODIQUE
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Basic information
- Application number:
- 2023C/545
- Type:
- Certificate
- SPC type:
- Medical
- Basic patent number:
- 067588434
- Status:
- Open & Published
- Publication number:
- 2023C545
- 1rst applicant's nationality:
- Procedural language:
- French
Paediatric extension
- SPC Extension filing date:
- 07/12/2023
- SPC Extension agent/owner name:
- AWA Benelux SA
- SPC Extension status:
- Open & Published
- SPC Extension grant date:
- SPC Extension Rejection Date:
Marketing authorization
- Marketing authorization number:
- EU/1/13/892
- Marketing authorization type:
- National/EU
- Designates country:
- No
- Marketing authorization date:
- 21/01/2014
- Marketing authorization status:
- Claimed
- Marketing authorization country:
- Belgium (BE)
Dates
- Filing date:
- 07/12/2023
- First marketing authorization date:
- 21/01/2014
- Grant date:
- Activation date:
- BE Publication date:
- 11/12/2023
- Lapsed date:
- Expiration date (if granted and all annual fees paid):
- Basic SPC Expiration (if granted and all annual fees paid):
- 21/01/2029
- SPC/SPC Extension Expiration (if granted and all annual fees paid):
- 21/07/2029
- Rejection date:
- Withdrawal date:
Applicant
1
- Name:
- VIIV Healthcare Company
- Legal Form:
- Healthcare Company
- From:
- 23/09/2024
- Address:
- 251 Little Falls Drive, Wilmington DE 19808, United States (US)
- To:
2
- Name:
- Shionogi
- Legal Form:
- Co., Ltd.
- From:
- 23/09/2024
- Address:
- 1-8 Doshomachi 3-chome, 541-0045, Chuo-ku Osaka, Japan (JP)
- To:
Agent
1
- Name:
- DE CLERCQ & PARTNERS C.V.B.A.
- Legal Form:
- From:
- 23/09/2024
- Address:
- Ed. Gevaertdreef 10a, 9830, ST MARTENS LATEM, Belgium (BE)
- To:
2
- Name:
- AWA Benelux SA
- Legal Form:
- From:
- 08/12/2023
- Address:
- Tour & Taxis - Royal Depot box: 216 Avenue du Port 86c, 1000, BRUXELLES, Belgium (BE)
- To:
- 23/09/2024
Publication
Bulletin
1
- Bulletin heading:
- SPC
- Journal edition number:
- 2023/23
- Publication date:
- 10/01/2024
- Description:
- Contains data concerning applications for- or granted Supplementary Protection Certificates
2
- Bulletin heading:
- SPC
- Journal edition number:
- 2023/23
- Publication date:
- 10/01/2024
- Description:
- Contains data concerning applications for- or granted Supplementary Protection Certificates
| Filing date | Document type | Publication Type | Document Description | Number of pages | File Type | ||
|---|---|---|---|---|---|---|---|
| 11/12/2023 | Publication | I1 | 1 | /4/1/6/8/7/0722378614/docs/2023c545_0_i1document_20231211_094408770.pdf | |||
| 11/12/2023 | Publication | I1E | 1 | /4/1/6/8/7/0722378614/docs/2023c545_1_i1edocument_20231211_094442242.pdf | |||
| 11/12/2023 | Outgoing Correspondence | 2 | /4/1/6/8/7/0722378614/docs/2023c545_2_outgoingcorrespondence_20231220_095317321.pdf | ||||
| 07/12/2023 | Marketing Authorization | 1st Marketing Authorization (EU) | 3 | /4/1/6/8/7/0722378614/docs/2023c545_3_marketingauthorization_20231208_084536401.pdf | |||
| 07/12/2023 | Application Form | 4 | /4/1/6/8/7/0722378614/docs/2023c545_4_applicationform_20231208_084536675.pdf | ||||
| 07/12/2023 | MA Official Publication | Official Publication of 1st Marketing Authorization | 16 | /4/1/6/8/7/0722378614/docs/2023c545_5_maofficialpublication_20231208_084535847.pdf | |||
| 07/12/2023 | Abstract Product Characteristics | Abstract of the characteristics of the product | 3 | /4/1/6/8/7/0722378614/docs/2023c545_6_abstractproductcharacteristics_20231208_084535548.pdf | |||
| 07/12/2023 | Paediatric Investigation Plan | Paediatric Investigation Plan (PIP) | 3 | /4/1/6/8/7/0722378614/docs/2023c545_7_paediatricinvestigationplan_20231208_084535235.pdf | |||
| 23/07/2024 | Outgoing Correspondence | 1 | /4/1/6/8/7/0722378614/docs/2023c545_8_outgoingcorrespondence_20240724_120313265.pdf | ||||
| 26/12/2024 | Request For Change | Free translation of the deed or extract | 1 | /4/1/6/8/7/0722378614/docs/2023c545_9_rfc_20241227_084548090.pdf | |||
| 26/12/2024 | Request For Change | Deed or extract allowing the change | 2 | /4/1/6/8/7/0722378614/docs/2023c545_10_rfc_20241227_084548183.pdf | |||
| 26/12/2024 | Request For Change | Letter of regularisation of a change | 1 | /4/1/6/8/7/0722378614/docs/2023c545_11_rfc_20241227_084548491.pdf | |||
| 20/01/2025 | Outgoing Correspondence | Outgoing Correspondence | 2 | /4/1/6/8/7/0722378614/docs/2023c545_12_209184_pie.rfc.per.notif.pdf | |||
| 20/01/2025 | Outgoing Correspondence | Outgoing Correspondence | 1 | /4/1/6/8/7/0722378614/docs/2023c545_13_209187_pie.rfc.man.not.anc.notif.pdf | |||
| 20/01/2025 | Outgoing Correspondence | Outgoing Correspondence | 1 | /4/1/6/8/7/0722378614/docs/2023c545_14_209188_pie.rfc.man.not.anc.notif.pdf | |||
| 20/01/2025 | Outgoing Correspondence | Outgoing Correspondence | 1 | /4/1/6/8/7/0722378614/docs/2023c545_15_209189_pie.rfc.man.not.anc.notif.pdf | |||
| 23/09/2024 | Incoming Correspondence (Email) | Cover letter | 1 | /4/1/6/8/7/0722378614/docs/2023c545_16_incomingcorrespondenceelectronic_20240924_084527565.pdf | |||
| 26/12/2024 | Incoming Correspondence (Email) | Cover letter | 1 | /4/1/6/8/7/0722378614/docs/2023c545_17_incomingcorrespondenceelectronic_20241227_084548580.pdf | |||
| 23/09/2024 | Outgoing Correspondence | 1 | /4/1/6/8/7/0722378614/docs/2023c545_18_outgoingcorrespondence_20240924_084526738.pdf | ||||
| 26/12/2024 | Outgoing Correspondence | 1 | /4/1/6/8/7/0722378614/docs/2023c545_19_outgoingcorrespondence_20241227_084548020.pdf | ||||
| 23/09/2024 | Request For Change | Power of attorney deed | 1 | /4/1/6/8/7/0722378614/docs/2023c545_20_rfc_20240924_084526887.pdf | |||
| 23/09/2024 | Request For Change | Power of attorney deed | 1 | /4/1/6/8/7/0722378614/docs/2023c545_21_rfc_20240924_084527103.pdf | |||
| 23/09/2024 | Request For Change | Letter and/or Form requesting a change in the Register | 3 | /4/1/6/8/7/0722378614/docs/2023c545_22_rfc_20240924_084527369.pdf | |||
| 23/09/2024 | Request For Change | Document with several annexes | 1 | /4/1/6/8/7/0722378614/docs/2023c545_23_rfc_20240924_084527457.pdf |