Is Octreotide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Octreotide, including OCRAN (500 µ/ml, Solution for injection, SAR 665.00); OCRAN (100 µ/ml, Solution for injection, SAR 133.00); Octreotide BOS (100 µg/ml, concentrate for solution for injection, SAR 252.70); SANDOSTATIN 0.1MG-ML AMP (0.1 mg/ml, Solution for injection/infusion, SAR 153.85); SANDOSTATIN LAR 20MG VIAL (20 mg, Powder and solvent for suspension for injection, SAR 4316.75).

Is Octreotide approved by the US FDA?

Drugs@FDA lists 28 application product lines for Octreotide, including SANDOSTATIN (Prescription); SANDOSTATIN LAR (Prescription); OCTREOTIDE ACETATE (PRESERVATIVE FREE) (Prescription); OCTREOTIDE ACETATE (Prescription); OCTREOTIDE ACETATE (Prescription).

Is Octreotide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Octreotide: Oczyesa.

Is Octreotide on the WHO Model List of Essential Medicines?

Yes — 18.8. Medicines for disorders of the pituitary hormone system (complementary list): Acromegaly or pituitary gigantism.

Are there safety signals or safety updates for Octreotide?

EMA PRAC: 2 entries; US FDA: 3 entries (latest 2024-07-11).

Active substance

Octreotide

SFDA 13
US FDA 28
EMA 2
Health Canada 14
US price lines 4
NHS prices 11
WHO EML 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
OCRAN	500 µ/ml	Solution for injection · Intravenous, Subcutaneous	5 Ampoule	SAR 665.00	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
OCRAN	100 µ/ml	Solution for injection · Intravenous, Subcutaneous	5 Ampoule	SAR 133.00	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Octreotide BOS	100 µg/ml	concentrate for solution for injection · Intravenous, Subcutaneous	10 Vial	SAR 252.70	Generic · Prescription	Boston Oncology Arabia	Valid
SANDOSTATIN 0.1MG-ML AMP	0.1 mg/ml	Solution for injection/infusion · Subcutaneous use	5 Ampoule	SAR 153.85	Biological · Prescription	NOVARTIS	Valid
SANDOSTATIN LAR 20MG VIAL	20 mg	Powder and solvent for suspension for injection · Intramuscular use	1 Vial	SAR 4316.75	Biological · Prescription	NOVARTIS PHARMA AG	Valid
SANDOSTATIN LAR 30MG VIAL	30 mg	Powder and solvent for suspension for injection · Intramuscular use	1 Vial	SAR 5227.65	Biological · Prescription	NOVARTIS	Valid
Syngro	10 mg	Powder and solvent for prolonged-release suspension for injection · Intramuscular use	1 Vial	SAR 1510.30	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Syngro	20 mg	Powder and solvent for prolonged-release suspension for injection · Intramuscular use	1 Vial	SAR 3020.45	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Syngro	30 mg	Powder and solvent for prolonged-release suspension for injection · Intramuscular use	1 Vial	SAR 4530.65	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
SANDOSTATIN 0.05MG-ML AMP	0.05 mg/ml	Solution for injection/infusion · Subcutaneous use	5 Ampoule	SAR 107.95	Biological · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
SANDOSTATIN 0.2MG-ML 5ML AMP	0.2 mg/ml	Solution for injection/infusion · Subcutaneous use	1 Ampoule	SAR 348.35	Biological · Prescription	NOVARTIS PHARMA AG	Withdrawn by MAH · Not Marketed
SANDOSTATIN 0.2MG-ML 5ML AMP	0.2 mg/ml	Solution for injection/infusion · Subcutaneous use	1 Ampoule	SAR 348.35	Biological · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
SANDOSTATIN LAR 20MG VIAL	20 mg	Powder and solvent for suspension for injection · Intramuscular use	1 Vial	SAR 5326.70	Biological · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACROMEGALY; DIARRHEA; HYPOGLYCEMIA; HYPOTENSION; LIVER CIRRHOSIS; NEUROENDOCRINE TUMORS

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

Product	Strength	Form · route	Applicant	Status	First approved
SANDOSTATIN	EQ 0.05MG BASE/ML; EQ 0.1MG BASE/ML; EQ 0.5MG BASE/ML	injectable · injection	NOVARTIS	Prescription	21 Oct 1988
SANDOSTATIN LAR	EQ 10MG BASE/VIAL; EQ 20MG BASE/VIAL; EQ 30MG BASE/VIAL	injectable · injection	NOVARTIS	Prescription	25 Nov 1998
OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML; EQ 0.5MG BASE/ML; EQ 0.1MG BASE/ML	injectable · injection	WEST-WARD PHARMS INT	Prescription	28 Mar 2005
OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	WEST-WARD PHARMS INT	Prescription	8 Apr 2005
OCTREOTIDE ACETATE	EQ 0.05MG BASE/ML; EQ 0.1MG BASE/ML; EQ 0.5MG BASE/ML	injectable · injection	MEITHEAL	Prescription	3 Oct 2005
OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	MEITHEAL	Prescription	21 Nov 2005
OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	10 Feb 2006
OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML; EQ 0.1MG BASE/ML; EQ 0.5MG BASE/ML	injectable · injection	FRESENIUS KABI USA	Prescription	10 Feb 2006
OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML; EQ 0.1MG BASE/ML; EQ 0.5MG BASE/ML	injectable · injection	MYLAN INSTITUTIONAL	Prescription	10 Feb 2011
OCTREOTIDE ACETATE (PRESERVATIVE FREE)	EQ 0.05MG BASE/ML; EQ 0.1MG BASE/ML; EQ 0.5MG BASE/ML	injectable · injection	SAGENT PHARMS INC	Prescription	12 Nov 2013
OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	SAGENT PHARMS INC	Prescription	12 Nov 2013
OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	HERITAGE	Prescription	7 Sep 2018
OCTREOTIDE ACETATE	EQ 0.05MG BASE/ML; EQ 0.1MG BASE/ML; EQ 0.5MG BASE/ML	injectable · injection	HERITAGE	Prescription	27 Dec 2018
MYCAPSSA	EQ 20MG BASE	capsule, delayed release · oral	CHIESI	Prescription	26 Jun 2020
OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	GLAND	Prescription	13 Jun 2023
OCTREOTIDE ACETATE	EQ 0.5MG BASE/ML; EQ 0.1MG BASE/ML	injectable · injection	GLAND	Prescription	22 Jun 2023
OCTREOTIDE ACETATE	EQ 10MG BASE/VIAL; EQ 20MG BASE/VIAL; EQ 30MG BASE/VIAL	injectable · injection	TEVA PHARMS USA INC	Prescription	5 Dec 2023
BYNFEZIA PEN	EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)	solution · subcutaneous	SUN PHARM	Prescription	27 Sep 2024
OCTREOTIDE ACETATE	EQ 10MG BASE/VIAL; EQ 20MG BASE/VIAL; EQ 30MG BASE/VIAL	injectable · injection	MYLAN LABS LTD	Prescription	12 Dec 2025
SANDOSTATIN	EQ 0.2MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	NOVARTIS	Discontinued	21 Oct 1988
OCTREOTIDE ACETATE	EQ 0.05MG BASE/ML; EQ 0.1MG BASE/ML; EQ 0.5MG BASE/ML	injectable · injection	SUN PHARM INDS	Discontinued	14 Aug 2007
OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML; EQ 1MG BASE/ML	injectable · injection	SUN PHARM INDS	Discontinued	14 Aug 2007
OCTREOTIDE ACETATE	EQ 0.05MG BASE/ML; EQ 0.1MG BASE/ML; EQ 0.5MG BASE/ML	injectable · injection	SUN PHARM INDS	Discontinued	4 Mar 2008
OCTREOTIDE ACETATE	EQ 0.2MG BASE/ML	injectable · injection	SUN PHARM INDS	Discontinued	4 Mar 2008
OCTREOTIDE ACETATE	EQ 1MG BASE/ML	injectable · injection	SUN PHARM INDS	Discontinued	4 Mar 2008

3 more — full table

EMA European Union — centrally authorised medicines

Oczyesa Camurus AB · Authorised · authorised 30 Jun 2025 · ATC H01CB02

Therapeutic indication (EMA)

Oczyesa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Mycapssa Amryt Pharmaceuticals DAC · Withdrawn · authorised 2 Dec 2022 · ATC H01CB02

Therapeutic indication (EMA)

Mycapssa is indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
OCTREOTIDE ACETATE OMEGA	02248639	50 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	OMEGA LABORATORIES LIMITED
OCTREOTIDE ACETATE OMEGA	02248640	100 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	OMEGA LABORATORIES LIMITED
OCTREOTIDE ACETATE OMEGA	02248641	500 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	OMEGA LABORATORIES LIMITED
OCTREOTIDE ACETATE OMEGA	02248642	200 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	OMEGA LABORATORIES LIMITED
OCTREOTIDE DEPOT	02567776	10 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULAR	STERIMAX INC
OCTREOTIDE DEPOT	02567784	20 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULAR	STERIMAX INC
OCTREOTIDE DEPOT	02567792	30 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULAR	STERIMAX INC
OCTREOTIDE INJECTION	02560240	100 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	STERIMAX INC
OCTREOTIDE INJECTION	02560283	200 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	STERIMAX INC
OCTREOTIDE INJECTION	02560291	500 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	STERIMAX INC
SANDOSTATIN	00839191	50 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	NOVARTIS PHARMACEUTICALS CANADA INC
SANDOSTATIN LAR	02239323	10 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULAR	NOVARTIS PHARMACEUTICALS CANADA INC
SANDOSTATIN LAR	02239324	20 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULAR	NOVARTIS PHARMACEUTICALS CANADA INC
SANDOSTATIN LAR	02239325	30 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULAR	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	OCTREOTIDE 1,000 MCG/5 ML VIAL	$5.3404	per ML	22 Apr 2026
US NADAC	OCTREOTIDE ACET 100 MCG/ML SYR	$5.24	per ML	23 Sep 2026
US NADAC	OCTREOTIDE ACET 100 MCG/ML VL	$2.53458	per ML	23 Sep 2026
US NADAC	OCTREOTIDE ACET 50 MCG/ML VIAL	$2.6422	per ML	22 Apr 2026
NHS Drug Tariff	Octreotide 100micrograms/1ml solution for injection ampoules	£27.97	5 ampoule	1 Oct 2026
NHS Drug Tariff	Octreotide 100micrograms/1ml solution for injection pre-filled syringes	£55.00	5 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Octreotide 100micrograms/1ml solution for injection vials	£32.65	5 vial	1 Oct 2026
NHS Drug Tariff	Octreotide 10mg powder and solvent for suspension for injection vials	£549.71	1 vial	1 Oct 2026
NHS Drug Tariff	Octreotide 20mg powder and solvent for suspension for injection vials	£799.33	1 vial	1 Oct 2026
NHS Drug Tariff	Octreotide 30mg powder and solvent for suspension for injection vials	£998.41	1 vial	1 Oct 2026
NHS Drug Tariff	Octreotide 500micrograms/1ml solution for injection ampoules	£135.47	5 ampoule	1 Oct 2026
NHS Drug Tariff	Octreotide 500micrograms/1ml solution for injection pre-filled syringes	£250.00	5 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Octreotide 500micrograms/1ml solution for injection vials	£158.25	5 vial	1 Oct 2026
NHS Drug Tariff	Octreotide 50micrograms/1ml solution for injection ampoules	£14.87	5 ampoule	1 Oct 2026
NHS Drug Tariff	Octreotide 50micrograms/1ml solution for injection pre-filled syringes	£35.00	5 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)

18.8. Medicines for disorders of the pituitary hormone system · complementary
Acromegaly or pituitary gigantism
Parenteral > General injections > IM: 20 mg in vial (modified-release, as acetate) plus diluent | Parenteral > General injections > SC: 0.05 mg per mL in 1 mL vial (immediate-release, as acetate); 0.1 mg per mL in 1 mL vial (immediate-release, as acetate); 0.5 mg per mL in 1 mL vial (immediate-release, as acetate)

Safety signals and safety-related labeling changes

US FDA 11 Jul 2024 MYCAPSSA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2024 SANDOSTATIN — 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
US FDA 11 Jul 2024 SANDOSTATIN LAR — 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
EMA PRAC 8 Jul 2021 PRAC signal: Pancreatic exocrine insufficiency
Action for MAH: update of the product information: Yes
EMA PRAC 11 Mar 2021 PRAC signal: Pancreatic exocrine insufficiency
Action for MAH: update of the product information: No

All safety entries for octreotide →

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.