Thirteen medicines gain pregnancy safety ratings in TGA database update

Nov 2026
TGA pregnancy database: Pregnant woman holding her bump beside prescription medicine, illustrating the TGA pregnancy database update
The TGA pregnancy database now includes 13 new medicines, and insulin degludec has been reclassified to Category A.

The TGA pregnancy database has 13 new entries. On 21 October 2026, the Therapeutic Goods Administration (TGA) added 13 medicines to its Prescribing Medicines in Pregnancy database, giving each a pregnancy category from B1 to D. One existing entry, insulin degludec, has been moved to Category A.

New entries across five categories

The 13 additions fall into five of the seven pregnancy categories. Birch bark dry extract, plozasiran and donidalorsen have been placed in B1. Tofersen, the dengue tetravalent vaccine and efanesoctocog alfa are in B2. Tolebrutinib and elinzanetant are in B3, and orelabrutinib is in Category C. Axatilimab, remibrutinib, eplontersen and loncastuximab tesirine have all been placed in Category D.

Insulin degludec moves to Category A

Insulin degludec has been reclassified from B3 to A, making it the only Category A entry in this round of changes. This is welcome news for clinicians managing diabetes in pregnancy.

Who should check the TGA pregnancy database

Prescribers and pharmacists should note that the 13 new entries and the insulin degludec change have been in the database since 21 October 2026. The TGA designs the database for health professionals rather than the public, so anyone who is pregnant and has questions about their medicines should speak to their doctor or pharmacist.

You might also like: WA workers to get two extra public holidays from 2028


General information only, not legal advice. Check the official source before acting.

Source: Therapeutic Goods Administration.

Scroll to Top