TOLVAPTAN

Brand name:

• Jinarc®

Form and strength:

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

Submission sponsor:

Otsuka Australia Pharmaceutical Pty Ltd

Condition/indication:
(therapeutic use)

• Autosomal dominant polycystic kidney disease (ADPKD)

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:

--

Other PBAC consideration:

--

Submission received for:

November 2019 PBAC meeting

Opportunity for consumer comment:

Open 28/08/2019 and close 09/10/2019 (see PBS Website)

PBAC meeting:

Held on 06/11/2019

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

09/11/2020

Lodgement of required documentation:

01/12/2020

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 02/03/2021

Status:

Finalised

Government processes:

Commenced on 09/03/2021

Medicine listed on the PBS:

01/06/2021 (see PBS schedule)