EMA approves updated storage guidance for Wegovy injection, allowing delivery at up to 30°C for 48 hours, reducing cold-chain complexity and supporting home delivery options in Europe.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
The European Medicines Agency (EMA) has approved an update to the product information for Wegovy injection that allows the medicine to remain at controlled temperatures of up to 30°C for up to 48 hours during delivery. The change reduces distribution complexity and introduces additional flexibility for pharmacies and online partners.
With this update, Wegovy becomes the only GLP-1 therapy for weight management in Europe with this delivery flexibility.
Previously, Wegovy distribution required full cold-chain handling, meaning the medicine had to be kept refrigerated from manufacturing through patient use. Following the EMA decision, the final delivery stage from pharmacies to patients can now occur within a 48-hour window at temperatures up to 30°C. This added flexibility is expected to simplify logistics and support broader delivery options.
The updated guidance may also help expand eHealth and direct-to-patient delivery models across Europe. Reduced reliance on cold-chain transport could lower packaging requirements and decrease shipment weight, potentially improving operational efficiency for distribution partners.
Mike Doustdar, CEO and president of Novo Nordisk, highlighted that home delivery of medicines is increasing due to convenience and patient preference. He noted that people using prescription medicines for obesity may experience stigma and said the added distribution flexibility could enable more discreet home delivery while reducing logistical complexity.
The approval reflects evolving industry practices, including increased use of direct-to-patient distribution models such as online pharmacies and other non-traditional dispensing channels. The update has been incorporated into the Summary of Product Characteristics (SmPC) for healthcare professionals, including physicians and pharmacists.
There is no change to patient instructions. After first use, patients may continue storing Wegovy for up to 28 days at temperatures below 30°C or under refrigeration.
The update applies only to Wegovy injection and not to the oral formulation. The oral version does not require refrigeration, is approved in the United States, and is currently pending a European regulatory decision expected later in 2026.
In the European Union, Wegovy is approved by the European Medicines Agency as a once-weekly subcutaneous semaglutide injection for chronic weight management across multiple dose strengths, including 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and the standard maintenance dose of 2.4 mg for dose escalation and long-term treatment. In addition, the EU has also approved a higher-dose 7.2 mg formulation for patients requiring additional weight-loss efficacy beyond the 2.4 mg regimen. All approved EU presentations are pre-filled injectable pens, while an oral formulation of Wegovy is approved in the United States and remains under regulatory review in Europe, with a decision anticipated later in 2026.
Reference
Novo Nordisk A/S: Wegovy® injection becomes first GLP-1 weight-loss treatment approved for 48-hour controlled-temperature delivery in the EU, 09 April 2026, News Details
About the Writer
Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.