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Patent details

2021C518 Product name: Une combinaison de formotérol (y compris tous ses sels, esters, solvates ou énantiomères pharmaceutiquement acceptables), glycopyrrolate (y compris tous ses sels, esters, solvates ou énantiomères pharmaceutiquement acceptables) et budésonide (y compris tous ses sels, esters, solvates ou énantiomères pharmaceutiquement acceptables)

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Basic information

Application number:
2021C/518
Type:
Certificate
SPC type:
Medical
Basic patent number:
107275513
Status:
Open & Published
Publication number:
2021C518
1rst applicant's nationality:
Procedural language:
French

Marketing authorization

Marketing authorization number:
EU/1/20/1498
Marketing authorization type:
National/EU
Designates country:
No
Marketing authorization date:
10/12/2020
Marketing authorization status:
Accepted
Marketing authorization country:
Belgium (BE)

Dates

Filing date:
25/05/2021
First marketing authorization date:
10/12/2020
Grant date:
Activation date:
BE Publication date:
26/05/2021
Lapsed date:
Expiration date (if granted and all annual fees paid):
Basic SPC Expiration (if granted and all annual fees paid):
28/05/2035
SPC/SPC Extension Expiration (if granted and all annual fees paid):
28/05/2035
Rejection date:
Withdrawal date:

Applicant

Name:
Pearl Therapeutics, Inc
Legal Form:
Inc
From:
26/05/2021
Address:
200 Saginaw Drive, 94063, Redwood City, United States (US)
To:

Agent

Name:
KIRKPATRICK
Legal Form:
S.A.
From:
26/05/2021
Address:
Avenue Wolfers 32, 1310, LA HULPE, Brabant wallon, Belgium (BE)
To:

Publication

Bulletin

Bulletin heading:
SPC
Journal edition number:
2021/10
Publication date:
28/06/2021
Description:
Contains data concerning applications for- or granted Supplementary Protection Certificates

Annual fee

Annual fee(s) Due Date:
31/05/2030
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
26/05/2021 Publication I1 1 PDF /3/1/6/7/2/0722127613/docs/2021c518_0_i1document_20210526_160204287.pdf
25/05/2021 Abstract Product Characteristics Abstract of the characteristics of the product 46 PDF /3/1/6/7/2/0722127613/docs/2021c518_1_abstractproductcharacteristics_20210526_084934084.pdf
13/03/2023 Request For Change Letter and/or Form requesting a change in the Register 1 PDF /3/1/6/7/2/0722127613/docs/2021c518_2_rfc_20230406_120158427.pdf
26/05/2021 Front Page 1 PDF /3/1/6/7/2/0722127613/docs/2021c518_3_i1frontpage_20210526_160203743.pdf
25/05/2021 Marketing Authorization 1st Marketing Authorization (EU) 3 PDF /3/1/6/7/2/0722127613/docs/2021c518_4_marketingauthorization_20210526_084946335.pdf
25/05/2021 General Document Other 3 PDF /3/1/6/7/2/0722127613/docs/2021c518_5_generaldocument_20210526_084932634.pdf
25/05/2021 General Document Other 5 PDF /3/1/6/7/2/0722127613/docs/2021c518_6_generaldocument_20210526_084933125.pdf
25/05/2021 Application Form 4 PDF /3/1/6/7/2/0722127613/docs/2021c518_7_applicationform_20210526_084947990.pdf
25/05/2021 MA Official Publication Official Publication of 1st Marketing Authorization 2 PDF /3/1/6/7/2/0722127613/docs/2021c518_8_maofficialpublication_20210526_084944995.pdf
26/05/2021 Outgoing Correspondence 2 PDF /3/1/6/7/2/0722127613/docs/2021c518_9_outgoingcorrespondence_20210602_042117735.pdf