Is Lanreotide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Lanreotide, including SOMATULINE AUTOGEL 120 MG SOLUTION FOR INJECTION IN PRE-FILLE (120 mg, Solution for injection in pre-filled syringe, SAR 4377.55); SOMATULINE AUTOGEL 60 MG SOLUTION FOR INJECTION IN PRE-FILLE (60 mg, Solution for injection in pre-filled syringe, SAR 3433.60); SOMATULINE AUTOGEL 90 MG SOLUTION FOR INJECTION IN PRE-FILLE (90 mg, Solution for injection in pre-filled syringe, SAR 4190.70).

Is Lanreotide approved by the US FDA?

Drugs@FDA lists 4 application product lines for Lanreotide, including SOMATULINE DEPOT (Prescription); LANREOTIDE ACETATE (Prescription); LANREOTIDE ACETATE (Prescription); LANREOTIDE ACETATE (Prescription).

Are there safety signals or safety updates for Lanreotide?

US FDA: 2 entries (latest 2024-09-16).

Active substance

Lanreotide

SFDA 3
US FDA 4
Health Canada 6
NHS prices 3
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
SOMATULINE AUTOGEL 120 MG SOLUTION FOR INJECTION IN PRE-FILLE	120 mg	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 4377.55	NCE · Prescription	IPSEN PHARMA	Valid
SOMATULINE AUTOGEL 60 MG SOLUTION FOR INJECTION IN PRE-FILLE	60 mg	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 3433.60	NCE · Prescription	IPSEN PHARMA	Valid
SOMATULINE AUTOGEL 90 MG SOLUTION FOR INJECTION IN PRE-FILLE	90 mg	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 4190.70	NCE · Prescription	IPSEN PHARMA	Valid

Indications — CHI Daman Drug Formulary

ACROMEGALY; NEUROENDOCRINE TUMORS

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

Product	Strength	Form · route	Applicant	Status	First approved
SOMATULINE DEPOT	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML); EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML); EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	solution · subcutaneous	IPSEN PHARMA	Prescription	30 Aug 2007
LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML); EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML); EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	solution · subcutaneous	INVAGEN PHARMS	Prescription	17 Dec 2021
LANREOTIDE ACETATE	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML); EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML); EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	solution · subcutaneous	INVAGEN PHARMS	Prescription	21 May 2024
LANREOTIDE ACETATE	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)	solution · subcutaneous	AMNEAL	Prescription	18 Sep 2026

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MYTOLAC	02555867	60 MG / SYR	SOLUTION (EXTENDED-RELEASE) · SUBCUTANEOUS	ADVANZ PHARMA CANADA INC.
MYTOLAC	02555875	90 MG / SYR	SOLUTION (EXTENDED-RELEASE) · SUBCUTANEOUS	ADVANZ PHARMA CANADA INC.
MYTOLAC	02555883	120 MG / SYR	SOLUTION (EXTENDED-RELEASE) · SUBCUTANEOUS	ADVANZ PHARMA CANADA INC.
SOMATULINE AUTOGEL	02283395	60 MG / SYR	SOLUTION (EXTENDED-RELEASE) · SUBCUTANEOUS	IPSEN BIOPHARMACEUTICALS CANADA INC
SOMATULINE AUTOGEL	02283409	90 MG / SYR	SOLUTION (EXTENDED-RELEASE) · SUBCUTANEOUS	IPSEN BIOPHARMACEUTICALS CANADA INC
SOMATULINE AUTOGEL	02283417	120 MG / SYR	SOLUTION (EXTENDED-RELEASE) · SUBCUTANEOUS	IPSEN BIOPHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Lanreotide 120mg/0.5ml solution for injection pre-filled syringes	£937.00	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Lanreotide 60mg/0.5ml solution for injection pre-filled syringes	£551.00	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Lanreotide 90mg/0.5ml solution for injection pre-filled syringes	£736.00	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.

Safety signals and safety-related labeling changes

US FDA 16 Sep 2024 LANREOTIDE ACETATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2024 SOMATULINE DEPOT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for lanreotide →

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.