URSODEOXYCHOLIC ACID

Brand name:

• Ursofalk®

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:

Change to PBS listing (Category 4)

Comment:

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Submission sponsor:

Dr Falk Pharma Australia Pty Ltd

Other PBAC consideration:

--

Submission received for:

March 2023 PBAC meeting

Opportunity for consumer comment:

Open 23/11/2022 and close 25/01/2023 (see PBS Website)

PBAC meeting:

Held on 08/03/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

28/07/2023

Lodgement of required documentation:

10/08/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 16/08/2023

Status:

Finalised

Government processes:

Commenced on 16/08/2023

Medicine listed on the PBS:

01/11/2023 (see PBS schedule)

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