- EMA updated Wegovy (semaglutide) SmPC to allow final delivery at up to 30°C for up to 48 hours during last‑mile distribution.
- Wegovy injection approved as once‑weekly semaglutide 1.7 mg, 2.4 mg and 7.2 mg; Wegovy pill (semaglutide 25 mg) is pending EMA decision in 2026.
- After first use patients may store Wegovy injection for up to 28 days below 30°C or refrigerated.
- The change reduces cold‑chain needs, lowering packaging and transport weight and enabling direct‑to‑patient online and home delivery channels.
Regulatory update
The EMA approved an SmPC change allowing Wegovy injection (semaglutide) to be delivered in the final stage at controlled temperatures up to 30°C for up to 48 hours.
Distribution impact
The change relaxes last‑mile cold‑chain requirements, reducing packaging volume and weight and simplifying home and direct‑to‑patient delivery by pharmacies and online dispensers.
Storage and patient information
The patient leaflet is unchanged: after first use patients may store Wegovy injection for up to 28 days at under 30°C or refrigerated; the EMA update applies only to the injection, not the oral tablet.
Product status and indications
Wegovy injection is approved as once‑weekly semaglutide (1.7 mg, 2.4 mg and 7.2 mg) and is indicated for weight reduction in adults and patients aged 12 and older; the once‑daily 25 mg semaglutide pill is FDA‑approved in the US and pending EMA decision in 2026.
