INDACATEROL with GLYCOPYRRONIUM and MOMETASONE

Brand name:

• Enerzair Breezhaler®

Form and strength:

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

Submission sponsor:

Novartis Pharmaceuticals Australia Pty Ltd

Condition/indication:
(therapeutic use)

• Asthma

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 (Major)

Comment:

--

Other PBAC consideration:

• INDACATEROL with GLYCOPYRRONIUM and MOMETASONE

Submission received for::

November 2020 PBAC meeting

Opportunity for consumer comment:

Open 29/04/2020 and close 10/06/2020 (see PBS Website)

PBAC meeting:

Held on 04/11/2020

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

26/11/2020

Lodgement of required documentation:

10/12/2020

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 16/12/2020

Status:

Finalised

Government processes:

Commenced on 27/01/2021

Medicine listed on the PBS:

01/04/2021 (see PBS schedule)