EU approves six additional Mounjaro strengths for the multi-dose pen

On April 19, 2024, the European Commission approved a line extension for Mounjaro (tirzepatide) that added six new strengths to a multidose prefilled pen known as the KwikPen ^[1]. The change, filed under application number X/0015, let the manufacturer offer the drug in 2.5 mg/dose (4.17 mg/ml), 5 mg/dose (8.33 mg/ml), 7.5 mg/dose (12.5 mg/ml), 10 mg/dose (16.67 mg/ml), 12.5 mg/dose (20.83 mg/ml), and 15 mg/dose (25 mg/ml) presentations ^[1].

The EU's scientific committee gave a positive opinion on the extension on February 22, 2024, and the European Commission issued its formal decision on April 19, 2024 ^[1]. The approval updated Mounjaro's Summary of Product Characteristics, Annex II, labeling, and package leaflet across the European Union ^[1]. Unlike a single-dose pen, a multidose pen can deliver more than one weekly injection before it is discarded, spanning the range of doses used from the start of treatment through higher maintenance levels ^[1].

This pen-format expansion followed an earlier, larger regulatory step for Mounjaro in the EU. On November 9, 2023, regulators recommended extending the drug's approved use to include chronic weight management in adults with obesity, or in adults who are overweight with at least one weight-related health condition, based on the SURMOUNT-1 trial and five supportive SURPASS studies in people with type 2 diabetes ^[1]. The European Commission finalized that decision on December 11, 2023 ^[1]. The multidose pen extension approved four months later did not change what the drug is used for; it changed how the drug is packaged and delivered ^[1].

The source record does not include a specific US approval date for the equivalent multidose pen device, so a direct day-by-day comparison between the EU and US timelines cannot be confirmed from this document ^[1]. What is documented is that the EU authorized the six-strength multidose pen configuration in April 2024, and that this device format later became available in the US market as well, though the exact American date is not detailed here ^[1].

Why it matters for patients

A multidose pen means a single device can supply the dose a patient needs during dose escalation, rather than requiring a new pen for each strength change. For people starting tirzepatide, treatment typically begins at lower doses and increases over time, so having several strengths built into one pen type can simplify pharmacy pickups and reduce the number of devices a patient handles. This is a packaging and delivery change, not a change to the medicine itself or its underlying safety profile, which is governed separately through the drug's approved indications and safety monitoring ^[1].

Patients using Mounjaro in the EU during this period gained access to this pen configuration before some other markets did, based on the timeline in the regulatory record ^[1]. The record does not describe whether cost, insurance coverage, or supply availability changed for patients as a direct result of the pen format itself.

What happens next

Regulatory filings for Mounjaro continued after this approval. The EU later authorized use of the drug for people with obstructive sleep apnea and obesity based on two additional trials, with regulators recommending that expansion on December 12, 2024, and the European Commission approving it on February 14, 2025 ^[1]. A further application tied to a heart failure trial in people with preserved ejection fraction and obesity was still under review as of a January 29, 2026 opinion date listed in the record ^[1]. These later filings involve new medical uses rather than pen design and are separate from the multidose pen extension described here.