SODIUM PHENYLBUTYRATE

Brand name:

• Pheburane®

Form and strength:

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

Condition/indication:
(therapeutic use)

• Urea cycle disorder (UCD)

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 (Minor)

Comment:

--

Submission sponsor:

Orpharma Pty Ltd

Other PBAC consideration:

--

Submission received for:

July 2019 PBAC meeting

Opportunity for consumer comment:

Open 01/05/2019 and close 12/06/2019 (see PBS Website)

PBAC meeting:

Held on 10/07/2019

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

09/08/2019

Lodgement of required documentation:

19/08/2019

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 22/08/2019

Status:

Finalised

Government processes:

Commenced on 03/09/2019

Medicine listed on the PBS:

01/12/2019 (see PBS schedule)

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