Is tirzepatide centrally authorised in the EU? Give the product names, marketing authorisation holder, authorisation date, approved indications and any EMA safety updates, citing the EPAR.

Yes. Tirzepatide is centrally authorised in the EU as one product, Mounjaro (EMEA/H/C/005620). Its status is "Authorised", the marketing authorisation holder is Eli Lilly Nederland B.V., and the marketing authorisation date is 15/09/2022 ^[1]. PRAC has reviewed three safety signals that cover tirzepatide. Only one led to a product-information update: aspiration and aspiration pneumonia, a signal reviewed for the whole GLP-1 receptor agonist class, in July 2024.

Approach: I searched EMA's register of centrally authorised medicines, which carries the EPAR summary fields and the EPAR page link. I also searched the PRAC safety-signal list, PSUSA outcomes, referrals, shortages and paediatric investigation plans. The full EPAR documents (the SmPC text and assessment reports) are not in the datasets I can search, so the details below come from the EPAR record, not the PDFs.

Authorisation details (EPAR record for Mounjaro)

Field	Value
Product names	Mounjaro (no other tirzepatide product found)
MA holder	Eli Lilly Nederland B.V.
CHMP opinion adopted	21/07/2022
Marketing authorisation date	15/09/2022
Latest European Commission decision	25/06/2026
Latest procedure affecting product information	VR/0000310637 (revision 21; EPAR page last updated 28/08/2026)
ATC code	A10BX16
Special status flags	Not conditional, not orphan, no additional monitoring, no accelerated assessment, not PRIME
EPAR page	https://www.ema.europa.eu/en/medicines/human/EPAR/mounjaro

All rows above: ^[1][2]

Approved indications

• Type 2 diabetes mellitus: for adults, adolescents and children aged 10 years and above whose type 2 diabetes is not adequately controlled, as an adjunct to diet and exercise. It can be used alone (monotherapy) when metformin is unsuitable because of intolerance or contraindications, or in addition to other diabetes medicines ^[1].

• Weight management (including weight loss and weight maintenance): for adults, as an adjunct to a reduced-calorie diet and increased physical activity, with either:

  • a starting BMI of 30 kg/m² or more (obesity), or
  • a starting BMI of 27 to under 30 kg/m² (overweight) plus at least one weight-related condition, such as hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes or type 2 diabetes.

  The EPAR record points to SmPC section 5.1 for trial results in obstructive sleep apnoea and in heart failure with preserved ejection fraction (HFpEF) ^[1].

EMA safety updates

PRAC meeting	Signal	Product information update requested?
25-28 September 2023	Aspiration and aspiration pneumonia (GLP-1 receptor agonist class review, including tirzepatide)	No [3]
4-7 March 2024	Aspiration and aspiration pneumonia (class review)	No [4]
8-11 July 2024	Aspiration and aspiration pneumonia (class review)	Yes [5]
29 Sep-2 Oct 2025	Interaction with warfarin and other coumarin anticoagulants leading to a decreased INR	No [6]
7-10 April 2026	Warfarin/coumarin interaction, decreased INR (follow-up)	No [7]

The signal list shows that an update was requested in July 2024 but does not give the wording of the SmPC change. I found no PSUSA single-assessment outcome, no referral and no EMA shortage notice for tirzepatide or Mounjaro. The EPAR record also does not carry the "Patient safety" flag ^[1].

Related: paediatric investigation plans

Two tirzepatide paediatric investigation plans have modification decisions:

• Type 2 diabetes: EMA/PE/0000237950, decision dated 16/04/2025 ^[8].
• Obesity (Mounjaro): P/0478/2023, decision dated 01/12/2023 ^[9].