SAPROPTERIN

Brand name:

• Kuvan®

Form and strength:

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

Submission sponsor:

BioMarin Pharmaceutical Australia Pty Ltd

Condition/indication:
(therapeutic use)

• Phenylketonuria

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 1)

Comment:

--

Other PBAC consideration:

--

Submission received for:

July 2022 PBAC meeting

Opportunity for consumer comment:

Open 30/03/2022 and close 25/05/2022 (see PBS Website)

PBAC meeting:

Held on 06/07/2022

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

25/10/2022

Lodgement of required documentation:

02/11/2022

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 23/11/2022

Status:

Finalised

Government processes:

Commenced on 03/02/2023

Medicine listed on the PBS:

01/04/2023 (see PBS schedule)