We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
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 Ingredient | Brand name Sponsor | PI updates (sections updated and summary of key information) | Date of approval |
|---|---|---|---|
| ambrisentan | GlaxoSmithKline Australia Pty Ltd | 4.4 - Special warnings and precautions for use
| 2025-07-24 |
| atropine sulfate monohydrate | Aspen Pharmacare Australia Pty Ltd | 4.7 - Effects on ability to drive and use machines
| 2025-07-29 |
| avanafil | A Menarini Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-10 |
| busulfan | Aspen Pharmacare Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-01 |
| calcifediol monohydrate | Aspen Pharmacare Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects) Added:
| 2025-08-04 |
| clozapine | Pfizer Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.6 - Fertility, pregnancy and lactation Added:
4.8 - Adverse effects (undesirable effects)
| 2025-07-08 |
| dactinomycin | Recordati Rare Diseases Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.6 - Fertility, pregnancy and lactation
| 2025-07-07 |
| dalteparin sodium | Pfizer Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.5 - Interactions with other medicines and other forms of interactions
| 2025-07-02 |
| denosumab | Amgen Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-17 |
| dexamethasone sodium phosphate | DBL Dexamethasone Sodium Phosphate Injection Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-08-03 |
| dolutegravir sodium | ViiV Healthcare Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-09 |
| dolutegravir, rilpivirine hydrochloride | ViiV Healthcare Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-06-30 |
| estriol | Aspen Pharmacare Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects) Added:
| 2025-07-30 |
| fentanyl citrate | A Menarini Australia Pty Ltd | 4.5 - Interactions with other medicines and other forms of interactions
| 2025-07-14 |
| fentanyl citrate | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-13 |
| gadobutrol | Bayer Australia Ltd | 4.4 Special warnings and precautions for use
| 2025-07-24 |
| glibenclamide/metformin hydrochloride | Alphapharm Pty Ltd | 4.4 - Special warnings and precautions for use Added:
| 2025-07-15 |
| guanfacine hydrochloride | Takeda Pharmaceuticals Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
4.9 - Overdose
| 2025-06-30 |
| heparin sodium | Pfizer Australia Pty Ltd | 4.5 - Interactions with other medicines and other forms of interactions
| 2025-07-13 |
| hydrocortisone sodium succinate | Solu-Cortef / Solu-Cortef Act-O-Vial Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-16 |
| mesalazine | Mesalazine 1.2 Takeda / Mezavant Takeda Pharmaceuticals Australia Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 2025-07-08 |
| methylprednisolone acetate | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-16 |
| modafinil | Teva Pharma Australia Pty Ltd | 4.3 - Contraindications
4.4 - Special warnings and precautions for use
4.6 - Fertility, pregnancy and lactation
| 2025-07-06 |
| morphine sulfate pentahydrate | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-27 |
| obeticholic acid | Chiesi Australia Pty Ltd | Boxed warning
| 2025-07-09 |
| paclitaxel | Pfizer Australia Pty Ltd | 4.6 - Fertility, pregnancy and lactation Added:
| 2025-08-03 |
| pethidine hydrochloride | Pfizer Australia Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-07-13 |
| ripretinib | Specialised Therapeutics PM Pty Ltd | 4.5 - Interactions with other medicines and other forms of interactions
| 2025-07-24 |
| risperidone | Boucher & Muir Pty Ltd | 4.2 Dose and Method of Administration
| 2025-07-17 |
| sodium zirconium cyclosilicate hydrate | AstraZeneca Pty Ltd | 4.4 - Special warnings and precautions for use
4.8 - Adverse effects (undesirable effects)
| 2025-07-09 |
| sotatercept | Merck Sharp & Dohme (Australia) Pty Ltd | 4.8 - Adverse effects (undesirable effects)
| 2025-06-26 |
| tamoxifen citrate | AstraZeneca Pty Ltd | 4.4 - Special warnings and precautions for use
| 2025-07-17 |
| trabectedin | Specialised Therapeutics Pharma Pty Ltd | 4.4 - Special warnings and precautions for use
4.6 - Fertility, pregnancy and lactation
| 2025-08-04 |
| vedolizumab | Takeda Pharmaceuticals Australia Pty Ltd | 4.8 Adverse effects (undesirable effects)
| 2025-07-23 |