Is Tirzepatide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 12 valid registrations of Tirzepatide, including Mounjaro (5 mg, Solution for injection in pre-filled pen, SAR 1261.40); Mounjaro (7.5 mg, Solution for injection in pre-filled pen, SAR 1261.40); Mounjaro (10 mg, Solution for injection in pre-filled pen, SAR 1261.40); Mounjaro (12.5 mg, Solution for injection in pre-filled pen, SAR 1261.40); Mounjaro (15 mg, Solution for injection in pre-filled pen, SAR 1261.40).

Is Tirzepatide approved by the US FDA?

Drugs@FDA lists 6 application product lines for Tirzepatide, including MOUNJARO (AUTOINJECTOR) (Prescription); MOUNJARO (Prescription); MOUNJARO KWIKPEN (Prescription); ZEPBOUND (AUTOINJECTOR) (Prescription); ZEPBOUND (Prescription).

Is Tirzepatide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tirzepatide: Mounjaro.

Is Tirzepatide on the WHO Model List of Essential Medicines?

Yes — 18.5.2. Hypoglycaemic agents (core list): Therapeutic equivalent to semaglutide for Type 2 diabetes mellitus.

Are there safety signals or safety updates for Tirzepatide?

EMA PRAC: 5 entries; US FDA: 2 entries (latest 2026-08-27).

Active substance

Tirzepatide

SFDA 12
US FDA 6
EMA 1
Health Canada 18
US price lines 18
NHS prices 6
WHO EML 1
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Mounjaro	5 mg	Solution for injection in pre-filled pen · Subcutaneous use	4 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly and Company	Valid
Mounjaro	7.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	4 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly and Company	Valid
Mounjaro	10 mg	Solution for injection in pre-filled pen · Subcutaneous use	4 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly and Company	Valid
Mounjaro	12.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	4 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly and Company	Valid
Mounjaro	15 mg	Solution for injection in pre-filled pen · Subcutaneous use	4 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly and Company	Valid
Mounjaro	2.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	4 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly and Company	Valid
Mounjaro KwikPen	10 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly Nederland B.V	Valid
Mounjaro KwikPen	2.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly Nederland B.V	Valid
Mounjaro KwikPen	12.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly Nederland B.V	Valid
Mounjaro KwikPen	7.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly Nederland B.V	Valid
Mounjaro KwikPen	5 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly Nederland B.V	Valid
Mounjaro KwikPen	15 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1261.40	NCE · Prescription	Eli Lilly Nederland B.V	Valid

Indications — CHI Daman Drug Formulary

DIABETES MELLITUS TYPE 2

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
MOUNJARO (AUTOINJECTOR)	2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.5ML (5MG/0.5ML); 7.5MG/0.5ML (7.5MG/0.5ML); 10MG/0.5ML (10MG/0.5ML); 12.5MG/0.5ML (12.5MG/0.5ML); 15MG/0.5ML (15MG/0.5ML)	solution · subcutaneous	ELI LILLY AND CO	Prescription	13 May 2022
MOUNJARO	2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.5ML (5MG/0.5ML); 7.5MG/0.5ML (7.5MG/0.5ML); 10MG/0.5ML (10MG/0.5ML); 12.5MG/0.5ML (12.5MG/0.5ML); 15MG/0.5ML (15MG/0.5ML); 10MG/2.4ML (4.17MG/ML); 20MG/2.4ML (8.33MG/ML); 30MG/2.4ML (12.5MG/ML); 40MG/2.4ML (16.7MG/ML); 50MG/2.4ML (20.8MG/ML); 60MG/2.4ML (25MG/ML)	solution · subcutaneous	ELI LILLY AND CO	Prescription	13 May 2022
MOUNJARO KWIKPEN	10MG/2.4ML (4.17MG/ML); 20MG/2.4ML (8.33MG/ML); 30MG/2.4ML (12.5MG/ML); 40MG/2.4ML (16.7MG/ML); 50MG/2.4ML (20.8MG/ML); 60MG/2.4ML (25MG/ML)	solution · subcutaneous	ELI LILLY AND CO	Prescription	13 May 2022
ZEPBOUND (AUTOINJECTOR)	2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.5ML (5MG/0.5ML); 7.5MG/0.5ML (7.5MG/0.5ML); 10MG/0.5ML (10MG/0.5ML); 12.5MG/0.5ML (12.5MG/0.5ML); 15MG/0.5ML (15MG/0.5ML)	solution · subcutaneous	ELI LILLY AND CO	Prescription	8 Nov 2023
ZEPBOUND	2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.5ML (5MG/0.5ML); 7.5MG/0.5ML (7.5MG/0.5ML); 10MG/0.5ML (10MG/0.5ML); 12.5MG/0.5ML (12.5MG/0.5ML); 15MG/0.5ML (15MG/0.5ML); 10MG/2.4ML (4.17MG/ML); 20MG/2.4ML (8.33MG/ML); 30MG/2.4ML (12.5MG/ML); 40MG/2.4ML (16.7MG/ML); 50MG/2.4ML (20.8MG/ML); 60MG/2.4ML (25MG/ML)	solution · subcutaneous	ELI LILLY AND CO	Prescription	8 Nov 2023
ZEPBOUND KWIKPEN	10MG/2.4ML (4.17MG/ML); 20MG/2.4ML (8.33MG/ML); 30MG/2.4ML (12.5MG/ML); 40MG/2.4ML (16.7MG/ML); 50MG/2.4ML (20.8MG/ML); 60MG/2.4ML (25MG/ML)	solution · subcutaneous	ELI LILLY AND CO	Prescription	8 Nov 2023

EMA European Union — centrally authorised medicines

Mounjaro Eli Lilly Nederland B.V. · Authorised · authorised 15 Sep 2022 · ATC A10BX16

Therapeutic indication (EMA)

Type 2 diabetes mellitus Mounjaro is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and the populations studied, see sections 4.4, 4.5 and 5.1. Weight management Mounjaro is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of ≥ 30 kg/m2 (obesity) or ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, prediabetes, or type 2 diabetes mellitus). For trial results with respect to obstructive sleep apnoea (OSA) and heart failure with preserved ejection fraction (HFpEF), see section 5.1.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MOUNJARO	02541041	2.5 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO	02541068	5 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO	02541076	7.5 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO	02541084	10 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO	02541092	12.5 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO	02541106	15 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO KWIKPEN	02551950	2.5 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO KWIKPEN	02551969	5 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO KWIKPEN	02551977	7.5 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO KWIKPEN	02551985	10 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO KWIKPEN	02551993	12.5 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
MOUNJARO KWIKPEN	02552000	15 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
ZEPBOUND	02557509	2.5 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
ZEPBOUND	02557517	5 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
ZEPBOUND	02557525	7.5 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
ZEPBOUND	02557533	10 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
ZEPBOUND	02557541	12.5 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC
ZEPBOUND	02557568	15 MG / 0.6 ML	SOLUTION · SUBCUTANEOUS	ELI LILLY CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MOUNJARO 10 MG/0.5 ML PEN	$538.68356	per ML	23 Sep 2026
US NADAC	MOUNJARO 12.5 MG/0.5 ML PEN	$538.52518	per ML	23 Sep 2026
US NADAC	MOUNJARO 15 MG/0.5 ML PEN	$538.51759	per ML	23 Sep 2026
US NADAC	MOUNJARO 2.5 MG/0.5 ML PEN	$538.68839	per ML	23 Sep 2026
US NADAC	MOUNJARO 5 MG/0.5 ML PEN	$538.63384	per ML	23 Sep 2026
US NADAC	MOUNJARO 7.5 MG/0.5 ML PEN	$538.68042	per ML	23 Sep 2026
US NADAC	ZEPBOUND 10 MG/0.5 ML PEN	$526.04607	per ML	23 Sep 2026
US NADAC	ZEPBOUND 10 MG/DOSE (40 MG/2.4 ML) KWIKPEN	$281.62145	per ML	23 Sep 2026
US NADAC	ZEPBOUND 12.5 MG/0.5 ML PEN	$525.84865	per ML	23 Sep 2026
US NADAC	ZEPBOUND 12.5 MG/DOSE (50 MG/2.4 ML) KWIKPEN	$281.98531	per ML	23 Sep 2026
US NADAC	ZEPBOUND 15 MG/0.5 ML PEN	$525.92209	per ML	23 Sep 2026
US NADAC	ZEPBOUND 15 MG/DOSE (60 MG/2.4 ML) KWIKPEN	$281.42838	per ML	23 Sep 2026
NHS Drug Tariff	Tirzepatide 10mg/0.6ml solution for injection 2.4ml pre-filled disposable devices	£255.00	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Tirzepatide 12.5mg/0.6ml solution for injection 2.4ml pre-filled disposable devices	£330.00	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Tirzepatide 15mg/0.6ml solution for injection 2.4ml pre-filled disposable devices	£330.00	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Tirzepatide 2.5mg/0.6ml solution for injection 2.4ml pre-filled disposable devices	£133.00	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Tirzepatide 5mg/0.6ml solution for injection 2.4ml pre-filled disposable devices	£180.00	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Tirzepatide 7.5mg/0.6ml solution for injection 2.4ml pre-filled disposable devices	£255.00	1 pre-filled disposable injection	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

18.5.2. Hypoglycaemic agents · core
Therapeutic equivalent to semaglutide for Type 2 diabetes mellitus

Safety signals and safety-related labeling changes

US FDA 27 Aug 2026 MOUNJARO — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 10 Apr 2026 PRAC signal: Drug interaction with warfarin and other coumarin derivatives leading to international normalised ratio decreased
Action for MAH: update of the product information: No
US FDA 25 Feb 2026 ZEPBOUND — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 2 Oct 2025 PRAC signal: Drug interaction with warfarin and other coumarin derivatives leading to international normalised ratio decreased
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2024 PRAC signal: Aspiration and pneumonia aspiration
Action for MAH: update of the product information: Yes
EMA PRAC 7 Mar 2024 PRAC signal: Aspiration and pneumonia aspiration
Action for MAH: update of the product information: No
EMA PRAC 28 Sep 2023 PRAC signal: Aspiration and pneumonia aspiration
Action for MAH: update of the product information: No

All safety entries for tirzepatide →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.