AMINO ACID FORMULA WITH FAT, CARBOHYDRATE WITHOUT PHENYLALANINE

Brand name:

• PKU Easy®

Pharmaceutical company:

Orpharma Pty Ltd

Condition/indication:
(therapeutic use)

• Phenylketonuria (PKU)

PBAC Submission type:

New listing (Minor)

Comment:

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Public Summary Document:

PBAC Public Summary Documents - November 2019

Related medicines:

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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:

13/12/2019

Lodgement of required documentation:

20/12/2019

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 03/01/2020

Status:

Finalised

Government processes:

Commenced on 18/02/2020

Medicine listed on the PBS:

01/06/2020 (see PBS schedule)

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