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Merck Healthcare Pty Ltd

Regulatory activities for this sponsor.

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Type

ARTG (36)
Designation or determination (9)
Cancellation by sponsor (6)
Prescription medicine registration (5)
Australian public assessment report (AusPar) (1)
Prescription medicine decision summary (1)

Date

2026 (6)
2025 (1)
2024 (1)
2023 (1)
2022 (5)
2021 (3)
2020 (7)
2018 (4)
2011 (3)
2010 (7)
2009 (3)
2008 (2)
2007 (2)
2003 (10)
2002 (2)
2000 (1)

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Sponsor content

58 result(s) found, displaying 21 to 30

Merck Healthcare Pty Ltd - Clinical data collection/management information application software Cancelled under Section 41GL(d) of the Act

22 October 2020

Cancellation by sponsor

Requested by Merck Healthcare Pty Ltd
Notice for tepotinib (as hydrochloride monohydrate) (Merck Healthcare Pty Ltd)

10 September 2020

Designation or determination

Orphan drug
BAVENCIO avelumab (rch) 200 mg/10 mL concentrated solution for intravenous infusion vial (282729)

3 January 2018

ARTG

Australian Register of Therapeutic Goods (ARTG) information for BAVENCIO avelumab (rch) 200 mg/10 mL concentrated solution for intravenous infusion vial.
Merck Healthcare Pty Ltd - Skin moisturizing/barrier dressing Cancelled under Section 41GL(d) of the Act

14 July 2020

Cancellation by sponsor

Requested by Merck Healthcare Pty Ltd
BAVENCIO (Merck Healthcare Pty Ltd)

4 May 2020

Prescription medicine registration

Active ingredients: avelumab.
Notice for avelumab (Merck Healthcare Pty Ltd)

24 April 2020

Designation or determination

Priority review
SEROPHENE clomifene citrate 50mg tablet blister pack Section 30(1)(c) of the Act

14 April 2020

Cancellation by sponsor

Requested by Merck Healthcare Pty Ltd
SAIZEN 3 somatropin (rmc) 3.0 mg powder for injection vial with diluent vial Cancelled under Section 30(1)(c) of the Act

4 March 2020

Cancellation by sponsor

Requested by Merck Healthcare Pty Ltd
SAIZEN somatropin (rmc) 12mg/1.5mL solution for injection multidose cartridge (166478)

22 August 2011

ARTG

Australian Register of Therapeutic Goods (ARTG) information for SAIZEN somatropin (rmc) 12mg/1.5mL solution for injection multidose cartridge.
SAIZEN somatropin (rmc) 6mg/1.03mL solution for injection multidose cartridge (166475)

22 August 2011

ARTG

Australian Register of Therapeutic Goods (ARTG) information for SAIZEN somatropin (rmc) 6mg/1.03mL solution for injection multidose cartridge.

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