Tirzepatide on the eMC: reading the SmPC for Mounjaro

What is the eMC, and why does the tirzepatide SmPC matter?

The Electronic Medicines Compendium is a publicly searchable database of SmPCs and Patient Information Leaflets for medicines authorised in the UK. Every licensed medicine must have one, and the SmPC is what the MHRA approves at the point of authorisation. For tirzepatide, marketed as Mounjaro by Eli Lilly, the SmPC is the legal backbone of the product: it defines the precise wording of the licence, the approved indications, the dosing schedule, the contraindications, and every safety obligation that prescribers take on when they issue a prescription.

If you have seen a reference to "tirzepatide emc" or searched for the Mounjaro SmPC, you are looking for this document, and you can read the Mounjaro eMC entry directly on our dedicated page. It differs from the Patient Information Leaflet in one key way: the SmPC is written for healthcare professionals, and the leaflet is written for patients. Both are hosted on the eMC and are freely accessible to anyone. Our clinical team at nume works from the SmPC as a primary reference alongside the BNF and NICE guidance when assessing suitability and reviewing dose changes.

A question our prescribers hear most weeks is whether the SmPC overrides the advice given at consultation. It does not override a clinical decision, but it does set the boundaries within which prescribers must operate. Anything outside the licensed indications or safety parameters in the SmPC requires a documented clinical justification. That is a safeguard, not a bureaucratic hurdle.

What does the SmPC say about who tirzepatide is licensed for?

The SmPC defines two licensed indications for tirzepatide in the UK. The first is weight management in adults with a BMI of 30 or above, or a BMI of 27 or above where at least one weight-related condition is present, such as high blood pressure, high cholesterol, obstructive sleep apnoea, cardiovascular disease or type 2 diabetes. The second indication is type 2 diabetes management. These are the only legally approved uses; prescribing for any other purpose falls outside the licence.

The SmPC also lists the populations excluded from the licence: people under 18, those who are pregnant or breastfeeding, and those with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. A history of pancreatitis requires careful prescriber assessment. Lower BMI thresholds may apply for certain ethnic backgrounds under UK guidance, the NICE appraisal of tirzepatide (TA1026) recommends a 2.5 kg/m² reduction for South Asian, Chinese, Middle Eastern, Black African or African-Caribbean backgrounds, and prescribers factor this into eligibility decisions.

BMI alone is never the whole picture. The SmPC makes clear that tirzepatide should be used alongside a reduced-calorie diet and increased physical activity, it is a clinical tool within a broader programme, not a standalone treatment. You can read more about what private treatment involves on our tirzepatide overview page.

What does the SmPC say about doses and storage?

The SmPC specifies six dose strengths for Mounjaro: 2.5, 5, 7.5, 10, 12.5 and 15 mg, each delivered as a once-weekly subcutaneous injection via the pre-filled KwikPen. Treatment begins at 2.5 mg, which the SmPC describes as a tolerability dose, its purpose is to let the body adjust before the dose is stepped up, and if you are curious about how the titration schedule works in practice, our page covering tirzepatide across a 30-day supply period explains what to expect month by month. The prescriber manages that titration, typically at four-week intervals, with the maintenance dose agreed based on the individual's response and tolerability.

Storage requirements and missed-dose guidance are set out in full in the SmPC and in the Patient Information Leaflet that comes inside the box. The KB approach here is consistent with the SmPC's own intent: rather than stating a specific room-temperature window in content like this, we direct readers to those documents directly, because the exact figures are the prescriber's and manufacturer's responsibility to communicate, not a website's. The tirzepatide leaflet page expands on what the Patient Information Leaflet covers in plain English.

Injection sites listed in the SmPC are the abdomen, thigh and upper arm; rotation is advised. Mounjaro's Black Triangle (▼) status means the MHRA continues to monitor it actively post-authorisation. Suspected side effects should be reported via the Yellow Card scheme, which patients can use directly.

How does the SmPC relate to what a private prescriber decides?

The SmPC defines the outer limits; the prescriber exercises clinical judgement within them. For context, the BNF entry for tirzepatide draws directly from the SmPC and translates it into the concise reference format that GPs and pharmacists use day to day. NICE TA1026, which recommended tirzepatide for NHS use, also interpreted the SmPC's licence when setting eligibility criteria, though NICE's NHS-access thresholds are more restrictive than the licence itself.

For private treatment, a prescriber can work within the full licence, so someone who meets the SmPC's BMI and eligibility criteria but falls outside the NICE NHS criteria may be clinically suitable for private treatment. The consultation is where that is established. If you are considering tirzepatide and want to understand how the licensed criteria apply to your situation, the comparison of Mounjaro and tirzepatide branding explains the relationship between the two names, and our free consultation is the place to check your own eligibility with a GPhC-registered prescriber.

For broader context on what private weight-loss treatment costs and what that price covers, the Mounjaro pricing page sets out what to expect without printing per-pen figures in editorial copy. And if you want to explore treatment options more generally before starting a consultation, the weight-loss treatment overview is a useful starting point.