OBETICHOLIC ACID

Brand name:

• Ocaliva®

Form and strength:

Please search for and view the medicine's Public Summary Document (PSD) for more information

Condition/indication:
(therapeutic use)

• Primary biliary cholangitis

Listing requested:

Please see PSD for more information

Funding program:

Please see PSD for more information

Request authority level:

Please see PSD for more information

PBAC submission type:

New listing (Major submission)

Comment:

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Submission sponsor:

Chiesi Australia Pty Ltd

Other PBAC consideration:

• OBETICHOLIC ACID

Submission received for:

November 2020 PBAC meeting

Opportunity for consumer comment:

Open 26/08/2020 and close 07/10/2020 (see PBS Website)

PBAC meeting:

Held on 04/11/2020

PBAC outcome published:

Deferred (see PBAC Outcomes)

Lodgement of required documentation:

Not applicable

Agreement to listing arrangements:

Not applicable

Government processes:

Not applicable

Medicine listed on the PBS:

Not applicable

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