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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.
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.
| Active ingredients | Brand name Sponsor | PI updates (sections updated and summary of key information) | Date of approval |
|---|---|---|---|
Albey venoms | Albey Bee Venom, Albey Yellow Jacket, Albey Paper Wasp Venom Stallergenes Australia Pty Ltd | 4.3 −Contraindications
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)
4.9 −Overdose
| 19 June 2024 |
amoxicillin sodium amoxicillin trihydrate | Amoxil syrup, paediatric drops and capsule Aspen Pharmacare Australia Pty Ltd | 4.8 − Adverse Effects (Undesirable effects)
| 20 May 2024 |
amoxicillin sodium/ potassium clavulanate | Sandoz Pty Ltd | 4.4 − Special warnings and precautions for use
4.8 − Adverse effects (undesirable effects)
| 12 June 2024
|
anifrolumab | AstraZeneca Pty Ltd | 4.8 − Adverse effects (undesirable effects)
| 26 June 2024 |
avelumab | Merck Healthcare Pty Ltd | 4.4 – Special warnings and precautions for use
4.8 – Adverse effects (undesirable effects)
| 6 June 2024 |
brolucizumab | Novartis Pharmaceuticals Australia Pty Ltd | 4.8 − Adverse effects (Undesirable effects)
| 19 June 2024 |
bupropion hydrochloride | Zyban | 4.3 − Contraindications
| 31 May 2024 |
busulfan | Aspen Pharmacare Australia Pty Ltd | 4.5 − Interactions with other medicines and other forms of interactions
| 20 June 2024 |
cefuroxime axetil | Zinnat tablet Zinnat suspension Aspen Pharmacare Australia Pty Ltd | 4.8 − Adverse effects (Undesirable effects)
| 18 June 2024 |
clarithromycin | Viatris Pty Ltd | 4.4 − Special warnings and precautions for use
4.5 − Interactions with other medicines and other forms of interactions
| 7 June 2024 |
elasomeran | Moderna Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 24 June 2024 |
elasomeran/ davesomeran | Spikevax Bivalent Original/Omicron Ba.4-5 Moderna Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 24 June 2024 |
esketamine hydrochloride | Janssen-Cilag Pty Ltd | 4.8 − Adverse effects (undesirable effects)
| 12 June 2024 |
etoposide phosphate
|
| 4.8 − Adverse effects (undesirable effects)
| 12 June 2024 |
flucloxacillin (as sodium) | Aspen Pharmacare Australia Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
4.8 – Adverse effects (undesirable effects)
| 6 June 2024 |
imiglucerase | Sanofi-Aventis Australia Pty Ltd | 4.4 − Special warnings and precautions for use 4.8 − Adverse effects (undesirable effects)
| 12 June 2024 |
indometacin | Alphapharm Pty Ltd | 4.5 − Interactions with other medicines and other forms of interactions
| 12 June 2024 |
liraglutide | Novo Nordisk Pharmaceuticals Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 17 June 2024 |
octreotide | Novartis Pharmaceuticals Australia Pty Limited | 4.4 – Special warnings and precautions for use
| 11 June 2024 |
palbociclib | Pfizer Australia Pty Ltd | 4.5 – Interactions with other medicines and other forms of interactions
| 12 June 2024 |
paracetamol/ ibuprofen
| Maxigesic IV | 4.4 − Special warnings and precautions for use 4.8 − Adverse effects (undesirable effects) 4.9 − Overdose
| 21 June 2024 |
raxtozinameran | Pfizer Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 24 June 2024 |
timolol maleate/ dorzolamide hydrochloride | Viatris Pty Ltd | 4.3 − Contraindications
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
| 20 June 2024 |
tozinameran | Pfizer Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 24 June 2024 |
tozinameran/ famtozinameran | COMIRNATY ORIGINAL/ OMICRON BA.4-5 Pfizer Australia Pty Ltd | 4.8 – Adverse effects (undesirable effects)
| 24 June 2024 |
triptorelin embonate | Ipsen Pty Ltd | 4.4 − Special warnings and precautions for use 4.8 − Adverse effects (undesirable effects)
| 12 June 2024 |