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Product Information safety updates - June 2025
When new safety information for medicines is identified, the Therapeutic Goods Administration (TGA) works with the sponsors to update Product Information (PI) to ensure that health professionals and consumers have access to this information. New safety information can be identified through the TGA’s ongoing safety monitoring activities or uncovered and submitted by sponsors themselves. Please see below details of some medicines that have recently had safety related updates to their PI.
The TGA monitors the safety of medicines marketed in Australia using:
- reports of adverse events
- Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs)
- reviews of literature
- sharing of information with other regulatory agencies
- sharing of information with Australian state and territory health authorities.
Changes to the PI that result from TGA safety monitoring activities may:
- narrow indications
- add or modify specific sections, such as:
- contraindications
- warnings or precautions
- use in fertility, pregnancy and lactation
- use in special populations
- adverse effects.
It is important for prescribers and other health professionals to be aware of safety-related PI changes, as they may require you to take actions or do things differently, such as:
- counsel patients on identified risks
- undertake special monitoring or precautions
- in some instances select alternate medications.
Significant PI changes are often supported by distribution of a Dear Health Care Professional Letter on the issue, which are produced by the medicine’s sponsor and sent directly to health professionals.
We will publish a Medicines Safety Update (MSU) article detailing recent safety-related PI updates each month, although this may not include all safety-related updates. We will continue to publish MSU articles for critical safety issues or topics of special interest.
The below medicines are generally innovator brands (generic brands may be included in some circumstances). Generic brands containing the same active ingredients as the medicines below are required to align with the safety information in the innovator’s PI and will be updated accordingly.
Active ingredients | Brand name Sponsor | PI updates (sections updated and summary of key information) | Date of approval |
---|---|---|---|
atomoxetine | Atomoxetine Sandoz Sandoz Pty Ltd | 4.4 Special warnings and precautions for use
4.5 Interactions with other medicines and other forms of interactions
4.8 Adverse effects (undesirable effects)
4.9 Overdose
| 30 May 2025 |
avelumab | Merck Healthcare Pty Ltd | 4.8 Adverse effects (undesirable effects)
| 19 May 2025 |
burosumab |
Kyowa Kirin Australia Pty Ltd | 4.2 - Dose and method of administration
4.4 - Special warnings and precautions for use
4.5 - Interactions with other medicines and other forms of interactions
4.6 - Fertility, pregnancy and lactation
4.8 - Adverse effects (undesirable effects)
| 7 May 2025 |
cladribine |
Viatris Pty Ltd |
| 21 May 2025 |
codeine phosphate hemihydrate, doxylamine succinate, paracetamol |
Sanofi-Aventis Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.5 - Interactions with other medicines and other forms of interactions
4.8 - Adverse effects (undesirable effects)
| 7 May 2025 |
codeine phosphate hemihydrate, paracetamol |
Sanofi-Aventis Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.5 - Interactions with other medicines and other forms of interactions
4.8 - Adverse effects (undesirable effects)
| 6 May 2025 |
diltiazem | Sanofi-Aventis Australia Pty Ltd | 4.8 Adverse effects (undesirable effects)
| 7 May 2025 |
empagliflozin / linagliptin empagliflozin empagliflozin / metformin hydrochloride | Boehringer Ingelheim Pty Ltd |
| 28 April 2025 |
entecavir |
Sandoz Pty Ltd | 4.4 - Special warnings and precautions for use
| 2 May 2025 |
factor xiii, fibrinogen, aprotinin, calcium chloride dihydrate, human thrombin |
Baxter Healthcare Pty Ltd | 4.3 – Contraindications
| 6 May 2025 |
finerenone |
Bayer Australia Ltd | 4.8 - Adverse effects (undesirable effects)
| 12 May 2025 |
fluvoxamine | Viatris Pty Ltd | 4.9 Overdose
| 5 May 2025 |
fondaparinux sodium |
Aspen Pharmacare Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 21 May 2025 |
ibrutinib | Janssen-Cilag Pty Ltd | 4.8 Adverse effects (undesirable effects)
| 27 May 2025 |
influenza virus haemagglutinin | Sanofi-Aventis Australia Pty Ltd | 4.8 Adverse effects (undesirable effects)
| 8 May 2025 |
interferon beta-1b | Bayer Australia Ltd | 4.4 Special warnings and precautions for use
4.8 Adverse effects (undesirable effects)
| 15 May 2025 |
lamotrigine |
Aspen Pharmacare Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
4.9 - Overdose
| 25 February 2025 |
lenvatinib mesilate |
Eisai Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 22 May 2025 |
mesalazine |
Dr Falk Pharma Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 1 May 2025 |
metronidazole benzoate |
Sanofi-Aventis Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 16 May 2025 |
mitomycin |
Echo Therapeutics Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 28 April 2025 |
paracetamol | Aft Pharmaceuticals Pty Ltd | 4.4 Special warnings and precautions for use
4.5 Interactions with other medicines and other forms of interactions
4.8 Adverse effects (undesirable effects)
| 12 May 2025 |
paracetamol and codeine phosphate hemihydrate | Mydol 15 Pharmacor Pty Ltd | 4.4 Special warnings and precautions for use
4.5 Interactions with other medicines and other forms of interactions
4.8 Adverse effects (undesirable effects)
| 29 May 2025 |
paracetamol and ibuprofen | Aft Pharmaceuticals Pty Ltd | 4.4 Special warnings and precautions for use
4.5 Interactions with other medicines and other forms of interactions
4.8 Adverse effects (undesirable effects)
| 9 May 2025 |
paracetamol, codeine phosphate hemihydrate, doxylamine succinate
| Trust Analgesic Calmative Pharmacor Pty Ltd | 4.4 Special warnings and precautions for use
4.5 Interactions with other medicines and other forms of interactions
4.8 Adverse effects (undesirable effects)
| 29 May 2025 |
recombinant Varicella Zoster Virus glycoprotein E antigen |
GlaxoSmithKline Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 26 May 2025 |
sodium oxidronate |
Landauer Radiopharmaceuticals Pty Ltd | 4.4 - Special warnings and precautions for use
4.5 - Interactions with other medicines and other forms of interactions
| 14 May 2025 |
To view the full PI for each listing, click on the name of the product in the ‘Brand/trade name’ column. A ‘Summary table of changes’ appears at the end of the PI. If the TGA has published any further risk communication, such as a safety alert or stand-alone MSU article, it will be linked to in the ‘Safety issue’ column.
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