Is Semaglutide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 17 valid registrations of Semaglutide, including Glucentra (1.34 mg/ml, Solution for injection in pre-filled pen, SAR 322.15); Lugyda (1.34 mg/ml, Solution for injection in pre-filled pen, SAR 357.95); Ozempic (1 mg, Solution for injection in pre-filled pen, SAR 418.65); Ozempic (0.5 mg, Solution for injection in pre-filled pen, SAR 418.65); Ozempic (0.25 mg, Solution for injection in pre-filled pen, SAR 418.65).

Is Semaglutide approved by the US FDA?

Drugs@FDA lists 9 application product lines for Semaglutide, including OZEMPIC (Prescription); RYBELSUS (Prescription); OZEMPIC (Prescription); RYBELSUS (Prescription); WEGOVY (Prescription).

Is Semaglutide authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Semaglutide: Ozempic, Rybelsus, Wegovy, Kayshild.

Is Semaglutide on the WHO Model List of Essential Medicines?

Yes — 18.5.2. Hypoglycaemic agents (core list): Type 2 diabetes mellitus.

Are there safety signals or safety updates for Semaglutide?

EMA PRAC: 17 entries; US FDA: 4 entries; MHRA: 1 entry (latest 2026-06-01).

Active substance

Semaglutide

SFDA 20
US FDA 9
EMA 4
Health Canada 18
US price lines 19
NHS prices 12
WHO EML 1
Safety 22

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Glucentra	1.34 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 322.15	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Glucentra	1.34 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 322.15	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Lugyda	1.34 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 357.95	Biological · Prescription	Siraj Omar Abid Pharma Co.,	Valid
Lugyda	1.34 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 357.95	Biological · Prescription	Siraj Omar Abid Pharma Co.,	Valid
Ozempic	1 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 418.65	Biological · Prescription	NOVO NORDISK	Valid
Ozempic	0.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 418.65	Biological · Prescription	NOVO NORDISK	Valid
Ozempic	0.25 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 418.65	Biological · Prescription	NOVO NORDISK	Valid
Rybelsus	14 mg	Tablet · Oral use	30 Blister	SAR 456.70	Biological · Prescription	NOVO NORDISK	Valid
Rybelsus	7 mg	Tablet · Oral use	30 Blister	SAR 456.70	Biological · Prescription	NOVO NORDISK	Valid
Rybelsus	3 mg	Tablet · Oral use	30 Blister	SAR 456.70	Biological · Prescription	NOVO NORDISK	Valid
Tasylev	1.34 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 397.70	Generic · Prescription	Boston Oncology Arabia	Valid
Tasylev	1.34 mg/ml	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 397.70	Generic · Prescription	Boston Oncology Arabia	Valid
Wegovy	2.4 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 1155.45	Biological · Prescription	NOVO NORDISK	Valid
Wegovy	1.7 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 818.45	Biological · Prescription	NOVO NORDISK	Valid
Wegovy	1 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 481.45	Biological · Prescription	NOVO NORDISK	Valid
Wegovy	0.5 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 481.45	Biological · Prescription	NOVO NORDISK	Valid
Wegovy	0.25 mg	Solution for injection in pre-filled pen · Subcutaneous use	1 Pre-filled pen	SAR 481.45	Biological · Prescription	NOVO NORDISK	Valid
Rybelsus	3 mg	Tablet · Oral use	90 Blister	SAR 1370.15	Biological · Prescription	NOVO NORDISK	Withdrawn by MAH · Not Marketed
Rybelsus	7 mg	Tablet · Oral use	90 Blister	SAR 1370.15	Biological · Prescription	NOVO NORDISK	Withdrawn by MAH · Not Marketed
Rybelsus	14 mg	Tablet · Oral use	90 Blister	SAR 1370.15	Biological · Prescription	NOVO NORDISK	Withdrawn by MAH · Not Marketed

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
OZEMPIC	4MG/3ML (1.34MG/ML); 8MG/3ML (2.68MG/ML); 2MG/3ML (0.68MG/ML); 0.25MG/0.5ML (0.25MG/0.5ML); 0.5MG/0.5ML (0.5MG/0.5ML); 1MG/0.5ML (1MG/0.5ML)	solution · subcutaneous	NOVO	Prescription	5 Dec 2017
RYBELSUS	3MG; 7MG; 14MG	tablet · oral	NOVO	Prescription	20 Sep 2019
OZEMPIC	1.5MG; 4MG; 9MG	tablet · oral	NOVO	Prescription	20 Sep 2019
RYBELSUS	3MG; 7MG	tablet · oral	NOVO NORDISK INC	Prescription	16 Jan 2020
WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML); 0.5MG/0.5ML (0.5MG/0.5ML); 1MG/0.5ML (1MG/0.5ML); 1.7MG/0.75ML (1.7MG/0.75ML); 2.4MG/0.75ML (2.4MG/0.75ML)	solution · subcutaneous	NOVO	Prescription	4 Jun 2021
WEGOVY HD	7.2MG/0.75ML (7.2MG/0.75ML)	solution · subcutaneous	NOVO	Prescription	4 Jun 2021
WEGOVY FLEXTOUCH	9.6MG/3ML (3.2MG/ML)	solution · subcutaneous	NOVO	Prescription	4 Jun 2021
WEGOVY	1.5MG; 4MG; 9MG; 25MG	tablet · oral	NOVO	Prescription	22 Dec 2025
OZEMPIC	2MG/1.5ML (1.34MG/ML)	solution · subcutaneous	NOVO	Discontinued	5 Dec 2017

EMA European Union — centrally authorised medicines

Ozempic Novo Nordisk A/S · Authorised · authorised 8 Feb 2018 · ATC A10BJ06

Therapeutic indication (EMA)

Treatment of adults 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 cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Rybelsus Novo Nordisk A/S · Authorised · authorised 3 Apr 2020 · ATC A10BJ06

Therapeutic indication (EMA)

Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in combination with other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Wegovy Novo Nordisk A/S · Authorised · authorised 6 Jan 2022 · ATC A10BJ06

Therapeutic indication (EMA)

Adults Wegovy 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 comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease. For trial results with respect to cardiovascular risk reduction and populations studied, see section 5.1. Adolescents (≥12 years) Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents ages 12 years and above with obesity* and body weight above 60 kg. Treatment with Wegovy should be discontinued and re-evaluated if adolescent patients have not reduced their BMI by at least 5% after 12 weeks on the 2.4 mg or maximum tolerated dose. *Obesity (BMI ≥95th percentile) as defined on sex- and age-specific BMI growth charts (CDC.gov) (see Table 1 in 4.1 of SmPC). Table 1 BMI cut-off points for obesity (≥95th percentile) by sex and age for paediatric patients aged 12 and older (CDC criteria)

Kayshild Novo Nordisk A/S · Authorised · authorised 26 Mar 2026 · ATC A10BJ06

Therapeutic indication (EMA)

Kayshild is indicated in conjunction with diet and exercise for the treatment of adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-SEMAGLUTIDE INJECTION	02568012	1.34 MG / ML	SOLUTION · SUBCUTANEOUS	APOTEX INC
APO-SEMAGLUTIDE INJECTION	02568020	0.68 MG / ML	SOLUTION · SUBCUTANEOUS	APOTEX INC
OZEMPIC	02471469	1.34 MG / ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
OZEMPIC	02540258	0.68 MG / ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
RYBELSUS	02497581	3 MG	TABLET · ORAL	NOVO NORDISK CANADA INC
RYBELSUS	02497603	7 MG	TABLET · ORAL	NOVO NORDISK CANADA INC
RYBELSUS	02497611	14 MG	TABLET · ORAL	NOVO NORDISK CANADA INC
RYBELSUS	02551012	1.5 MG	TABLET · ORAL	NOVO NORDISK CANADA INC
RYBELSUS	02551020	4 MG	TABLET · ORAL	NOVO NORDISK CANADA INC
RYBELSUS	02551039	9 MG	TABLET · ORAL	NOVO NORDISK CANADA INC
SEMAGLUTIDE INJECTION	02567806	1.34 MG / ML	SOLUTION · SUBCUTANEOUS	DR REDDY'S LABORATORIES LTD
SEMAGLUTIDE INJECTION	02567814	1.34 MG / ML	SOLUTION · SUBCUTANEOUS	DR REDDY'S LABORATORIES LTD
WEGOVY	02528509	1 MG / 1.5 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
WEGOVY	02528517	2 MG / 1.5 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
WEGOVY	02528525	4 MG / 3 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
WEGOVY	02528533	6.8 MG / 3 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
WEGOVY	02528541	9.6 MG / 3 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC
WEGOVY	02552698	2 MG / 3 ML	SOLUTION · SUBCUTANEOUS	NOVO NORDISK CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	OZEMPIC 0.25-0.5 MG/DOSE (2 MG/3 ML) PEN	$331.99085	per ML	23 Sep 2026
US NADAC	OZEMPIC 1 MG/DOSE (4 MG/3 ML) PEN	$331.90037	per ML	23 Sep 2026
US NADAC	OZEMPIC 1.5 MG TABLET	$33.12635	per EA	23 Sep 2026
US NADAC	OZEMPIC 2 MG/DOSE (8 MG/3 ML) PEN	$331.97208	per ML	23 Sep 2026
US NADAC	OZEMPIC 4 MG TABLET	$33.17974	per EA	23 Sep 2026
US NADAC	OZEMPIC 9 MG TABLET	$33.17868	per EA	23 Sep 2026
US NADAC	RYBELSUS 14 MG TABLET	$33.18852	per EA	23 Sep 2026
US NADAC	RYBELSUS 3 MG TABLET	$33.19015	per EA	23 Sep 2026
US NADAC	RYBELSUS 7 MG TABLET	$33.19336	per EA	23 Sep 2026
US NADAC	WEGOVY 0.25 MG/0.5 ML PEN	$653.29422	per ML	23 Sep 2026
US NADAC	WEGOVY 0.5 MG/0.5 ML PEN	$653.27365	per ML	23 Sep 2026
US NADAC	WEGOVY 1 MG/0.5 ML PEN	$653.04458	per ML	23 Sep 2026
NHS Drug Tariff	Semaglutide 0.25mg/0.19ml solution for injection 1.5ml pre-filled disposable devices	£73.25	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 0.25mg/0.37ml solution for injection 1.5ml pre-filled disposable devices	£73.25	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 0.5mg/0.37ml solution for injection 1.5ml pre-filled disposable devices	£73.25	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 0.5mg/0.75ml solution for injection 3ml pre-filled disposable devices	£73.25	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 1.5mg tablets	£120.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Semaglutide 1.7mg/0.75ml solution for injection 3ml pre-filled disposable devices	£124.53	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 1mg/0.74ml solution for injection 3ml pre-filled disposable devices	£73.25	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 1mg/0.75ml solution for injection 3ml pre-filled disposable devices	£73.25	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 2.4mg/0.75ml solution for injection 3ml pre-filled disposable devices	£175.80	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 2mg/0.74ml solution for injection 3ml pre-filled disposable devices	£146.50	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Semaglutide 4mg tablets	£120.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Semaglutide 9mg tablets	£120.00	30 tablet	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
Type 2 diabetes mellitus
Parenteral > General injections > SC: 0.68 mg per mL; 1.34 mg per mL; 2.68 mg per mL

Safety signals and safety-related labeling changes

US FDA 1 Jun 2026 OZEMPIC — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 7 May 2026 PRAC signal: Peripheral neuropathies
Action for MAH: update of the product information: No
EMA PRAC 7 May 2026 PRAC signal: Peripheral neuropathies
Action for MAH: update of the product information: No
EMA PRAC 7 May 2026 PRAC signal: Gastrointestinal volvulus
Action for MAH: update of the product information: No
EMA PRAC 7 May 2026 PRAC signal: Gastrointestinal volvulus
Action for MAH: update of the product information: No
US FDA 19 Mar 2026 WEGOVY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Mar 2026 WEGOVY — safety-related labeling change
Labeling sections changed: Adverse Reactions
MHRA 5 Feb 2026 Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden deterioration in vision, usually in one eye at a time, has been very rarely reported in association with semaglutide in the treatment of type 2 diabetes, weight management and cardiovascular risk reduction. Patients reporting a sudden loss of vision (including partial loss) while on semaglutide treatment should be urgently referred for ophthalmological examination.
US FDA 30 Jan 2026 RYBELSUS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jul 2024 PRAC signal: Aspiration and pneumonia aspiration
Action for MAH: update of the product information: Yes
EMA PRAC 11 Jul 2024 PRAC signal: Appendicitis
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2024 PRAC signal: Tubulointerstitial nephritis
Action for MAH: update of the product information: No
EMA PRAC 11 Apr 2024 PRAC signal: Thyroid cancer
Action for MAH: update of the product information: No
EMA PRAC 7 Mar 2024 PRAC signal: Aspiration and pneumonia aspiration
Action for MAH: update of the product information: No
EMA PRAC 30 Nov 2023 PRAC signal: Suicidal ideation and self-injurious ideation
Action for MAH: update of the product information: No

All safety entries for semaglutide →

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.