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Patent details

2019C005 Product name: Doravirine,desgewenst in de vorm van een farmaceutisch aanvaardbaar zout in combinatie met lamivudine, desgewenst in de vorm van een farmaceutisch aanvaardbaarzout, in combinatie met tenofovir of een ester daarvan, in het bijzonder een disoproxil ester, desgewenst in de vorm van een farmaceutisch aanvaardbaar zout, in het bijzonder een fumaraat zout

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Basic information

Application number:
2019C/005
Type:
Certificate
SPC type:
Medical
Basic patent number:
151573482
Status:
Open & Published
Publication number:
2019C005
1rst applicant's nationality:
Procedural language:
Dutch

Marketing authorization

Marketing authorization number:
EU/1/18/1333/001-002
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
26/11/2018
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
17/04/2019
First marketing authorization date:
26/11/2018
Grant date:
Activation date:
BE Publication date:
07/05/2019
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
26/11/2033
SPC/SPC Extension Expiration (if granted and all annual fees paid):
26/11/2033
Rejection date:
Withdrawal date:

Applicant

Name:
Merck Canada Inc.
Legal Form:
From:
07/05/2019
Address:
16711 Trans-Canada Highway, Kirkland QC H9H 3L1, Canada (CA)
To:

Agent

1

Name:
NLO
Legal Form:
From:
28/01/2026
Address:
New Babylon City Offices Anna van Buerenplein 21A, 2595 DA DEN HAAG, Netherlands (NL)
To:

2

Name:
MANNAERTS Jaap
Legal Form:
From:
07/05/2019
Address:
Technologiepark 122, 9052, ZWIJNAARDE - GENT, Belgium (BE)
To:
16/12/2024

3

Name:
MANNAERTS Jaap
Legal Form:
From:
16/12/2024
Address:
New Babylon City Offices Anna van Buerenplein 21A, 2595 DA DEN HAAG, Netherlands (NL)
To:
28/01/2026

Publication

Bulletin

Bulletin heading:
SPC
Journal edition number:
2019/14
Publication date:
12/06/2019
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Annual fee

Annual fee(s) Due Date:
31/03/2031
Annual fee number:
21
Annual fee amount:
650 Euro
Expected payer:
Last annual fee payment date:
Last annual fee paid number:
Payer:
Filing date Document type Publication Type Document Description Number of pages File Type
17/04/2019 Application Form 3 PDF /8/9/0/6/4/0721846098/docs/2019c005_0_applicationform_20190423_012949507.pdf
17/04/2019 Abstract Product Characteristics Abstract of the characteristics of the product 43 PDF /8/9/0/6/4/0721846098/docs/2019c005_1_abstractproductcharacteristics_20190423_012949685.pdf
17/04/2019 General Document Other 55 PDF /8/9/0/6/4/0721846098/docs/2019c005_2_generaldocument_20190423_012949866.pdf
17/04/2019 Marketing Authorization 1st Marketing Authorization (EU) 3 PDF /8/9/0/6/4/0721846098/docs/2019c005_3_marketingauthorization_20190423_012949756.pdf
17/04/2019 MA Official Publication Official Publication of 1st Marketing Authorization 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_4_maofficialpublication_20190423_012949598.pdf
18/12/2024 Outgoing Correspondence Outgoing Correspondence 2 PDF /8/9/0/6/4/0721846098/docs/2019c005_5_207803_pie.rfc.per.notif.pdf
16/12/2024 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_6_rfc_20241217_095655680.pdf
07/05/2019 Front Page 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_7_i1frontpage_20190507_193458682.pdf
07/05/2019 Publication I1 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_8_i1document_20190507_193459653.pdf
17/04/2019 Incoming Correspondence (Post) 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_9_incomingcorrespondencepaper_20190423_012949814.pdf
28/01/2026 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_10_rfc_20260129_084546630.pdf
09/03/2026 Outgoing Correspondence Outgoing Correspondence 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_11_230009_pie.rfc.man.notif.pdf
28/01/2026 Incoming Correspondence (Email) Cover letter 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_12_incomingcorrespondenceelectronic_20260129_084546749.pdf
28/01/2026 Outgoing Correspondence 1 PDF /8/9/0/6/4/0721846098/docs/2019c005_13_outgoingcorrespondence_20260129_084546556.pdf