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Roche Products Pty Limited

Regulatory activities for this sponsor.

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Type

Designation or determination (21)
Australian public assessment report (AusPar) (11)
Prescription medicine decision summary (5)
Prescription medicine registration (2)

Date

2023 (3)
2022 (2)
2021 (7)
2020 (9)
2019 (6)
2018 (6)
2017 (4)
2016 (1)
2014 (1)

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39 result(s) found, displaying 31 to 39

Notice for emicizumab (Roche Products Pty Limited)

22 March 2018

Designation or determination

Priority review
HEMLIBRA (Roche Products Pty Limited)

22 February 2018

Prescription medicine registration

Active ingredients: emicizumab (rch).
ALECENSA (Roche Products Pty Limited)

30 January 2018

Prescription medicine registration

Active ingredients: alectinib hydrochloride.
AusPAR: Alectinib hydrochloride

5 December 2017

Australian public assessment report (AusPar)

Alectinib hydrochloride
Notice for emicizumab (Roche Products Pty Limited)

29 August 2017

Designation or determination

Priority review
Notice for emicizumab (Roche Products Pty Limited)

25 August 2017

Designation or determination

Orphan drug
Notice for alectinib (Roche Products Pty Limited)

21 August 2017

Designation or determination

Priority review
AusPAR: Pertuzumab

23 August 2016

Australian public assessment report (AusPar)

Australian Public Assessment Report for Pertuzumab
AusPAR: Rituximab

13 October 2014

Australian public assessment report (AusPar)

Australian Public Assessment Report for Rituximab

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