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Scheduling delegate's final decisions, March 2017

23 March 2017

Book pagination

1. Summary of delegate's final decisions

Part B - Final decisions on matters not referred to an expert advisory committee

New Chemical Entities – medicines for human therapeutic use

Summary of delegate's final decisions

The implementation date of the below final decisions is 1 June 2017 unless separately specified.

Substance Final Decision
Albutrepenonacog alfa Albutrepenonacog alfa is exempt from scheduling as it falls under the Appendix A entry for human blood products.
Sebelipase alfa

Schedule 4 - New Entry

SEBELIPASE ALFA.

Meningococcal Group B Vaccine

Schedule 4 - New Entry

MENINGOCOCCAL GROUP B VACCINE.

Index - New Entry

MENINGOCOCCAL GROUP B VACCINE
cross reference: Neisseria Meningitidis Serogroup B Recombinant LP2086 (MnB rLP2086) Subfamily A Protein and Subfamily B Protein

Schedule 4

Sodium Phenylbutyrate

Schedule 4 - New Entry

SODIUM PHENYLBUTYRATE.

Silodosin

Schedule 4 - New Entry

SILODOSIN.

Dengue Vaccine

Also known as: Live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4)

Schedule 4 - New Entry

DENGUE VACCINE.

Index - New Entry

DENGUE VACCINE
crosses reference: LIVE ATTENUATED CHIMERIC DENGUE VIRUS (SEROTYPES 1, 2, 3 & 4)

Schedule 4

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