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January 2020

Rinvoq

24 January 2020

Australian prescription medicine decision summary
Beovu

24 January 2020

Australian prescription medicine decision summary
Idhifa

24 January 2020

Australian prescription medicine decision summary
Five Australian innovators of therapeutic goods

24 January 2020

This Australia Day, we celebrate some Australian innovators in therapeutic goods.
AusPAR: Fremanezumab

24 January 2020

Australian Public Assessment Report for Fremanezumab
Submissions received and TGA response: Increased online access to ingredient information

23 January 2020

Submissions received in response to public consultation on increasing online access to ingredient information
Measles vaccines available in Australia continue to meet quality standards

22 January 2020

Measles vaccine testing shows the vaccine meets required standards
Database of section 19A approvals to import and supply medicines to address medicine shortages

22 January 2020

Section 19A database has been updated to include new approvals
AusPAR: Inactivated quadrivalent influenza vaccine (split virion)

22 January 2020

Australian Public Assessment Report for Inactivated quadrivalent influenza vaccine (split virion)
AusPAR: Isavuconazole (as sulphate)

22 January 2020

Australian Public Assessment Report for Isavuconazole (as sulphate)
Consultation: Fees and charges proposal 2020-21

20 January 2020

The TGA is seeking comments on the proposed changes in fees and charges for 2020-2021. Closing date: 28 February 2020
New science strategy prepares regulatory scientists for the future

20 January 2020

The Health Products Regulation Group has published a new regulatory science strategy
Breast implant associated cancer (BIA-ALCL): Information for consumers

16 January 2020

Health professionals answer questions about BIA-ALCL
TGA presentations: The 2nd Industry Forum on Good Manufacturing Practice (GMP), 21 November 2019

16 January 2020

2019 GMP Forum presentations now available
Influenza reagents

16 January 2020

Updated IFU for Lot 2019/131B is now available
Health Products Regulation Group: Regulatory Science Strategy, 2020-2025

16 January 2020

Our plan for how HPRG will maintain and build its regulatory science capability over the next 5 years
Consultation: Draft standards for faecal microbiota transplant (FMT) products

15 January 2020

The closing date on the proposed standards for faecal microbiota transplant (FMT) products in Australia. has been extended to: 31 January 2020
Notice of recommendations to prepare a document in substitution for the current Poisons Standard - New Chemical Entities (NCEs)

14 January 2020

Recommendations for the scheduling of New Chemical Entities for inclusion in the Poisons Standard
Notice of final decision to amend (or not amend) the current Poisons Standard: Risankizumab

14 January 2020

Final decision in relation to risankizumab
Uniform recall procedure for therapeutic goods (URPTG)

14 January 2020

Information about the new online form for the notification of recall and non-recall actions
No shortage of salbutamol asthma inhalers

10 January 2020

Adequate stock available despite bushfires
Prescription medicines: registration of new chemical entities in Australia

10 January 2020

1 medicine registration added
Prescription medicines: new or extended uses, or new combinations of registered medicines

10 January 2020

5 medicine registrations added
Prescription medicines: registration of new generic medicines and biosimilar medicines

10 January 2020

5 medicine registrations added
Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019

10 January 2020

This is the first package of regulatory changes for the broader medical device reforms
Medicines: Suspensions from the ARTG

8 January 2020

Remaining ranitidine medicines suspended from the ARTG
Variations to prescription medicines - excluding variations requiring evaluation of clinical or bioequivalence data, Appendix 1: Variation types - chemical entities

8 January 2020

Updated with minor corrections
TGA Laboratories testing report: Measles vaccines monitoring

7 January 2020

The TGA Laboratories has published a detailed report related to the testing of measles vaccines available in Australia
Temporary permission granted to advertise puffers and other inhalers with salbutamol

7 January 2020

Pharmacies and others can advertise availability of OTC salbutamol products during the bushfire season
TGA operations from 6 January 2020

6 January 2020

The TGA's telephone lines currently have limited operations
Faecal Microbiota Transplant (FMT) product regulation

6 January 2020

All FMT products are regulated as biologicals
Consultation: Proposed amendments to the Poisons Standard - Joint ACCS/ACMS meetings, March 2020

6 January 2020

The Secretary invites public submissions on scheduling proposals referred to the March 2020 meeting of the Joint ACMS-ACCS. Closing date: 10 February 2020
Outcomes of the Lower Risk Registered Over-the-Counter (OTC) Products Review Pilot Project

3 January 2020

The TGA has finalised the outcomes of the Lower Risk Registered OTC Products Review Pilot Project
AusPAR: Alirocumab (rch)

2 January 2020

Australian Public Assessment Report for Alirocumab (rch)
AusPAR: Siponimod

2 January 2020

Australian Public Assessment Report for Siponimod
AusPAR: Polatuzumab vedotin

2 January 2020

Australian Public Assessment Report for Polatuzumab vedotin
Midodrine SCP, Midodrine ANS, Vasodrine

2 January 2020

Australian prescription medicine decision summary

Last month's news & updates

URL:https://www.tga.gov.au/node/3394

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