Is Atropine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 11 valid registrations of Atropine, including ATROPINE SULF. E.S 50MCG-ML (50 µ/ml, Solution for injection, SAR 30.65); ATROPINE SULF.E.S 100MCG-ML (100 µ/ml, Solution for injection, SAR 30.65); ATROPINE SULPHATE 0.5MG\ML AMPOULE (0.5 mg/ml, Solution, SAR 3.70); ATROPINE SULPHATE 0.6MG\ML AMPOULE (0.6 mg/ml, Solution, SAR 1.55); ATROPINE SULPHATE 600 mcg/ml injection (0.6 mg/ml, Solution, SAR 28.20).

Is Atropine approved by the US FDA?

Drugs@FDA lists 27 application product lines for Atropine, including ATROPINE SULFATE (Prescription); ATROPINE SULFATE (Prescription); ISOPTO ATROPINE (Prescription); ATROPINE SULFATE (Prescription); ATROPINE SULFATE (Prescription).

Is Atropine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Atropine: Ryjunea.

Is Atropine on the WHO Model List of Essential Medicines?

Yes — 14.1. Diagnostic agents > Ophthalmic medicines (core list): Therapeutic equivalent to tropicamide for Cycloplegic drug.

Are there safety signals or safety updates for Atropine?

EMA PRAC: 1 entry; US FDA: 9 entries (latest 2026-02-04).

Active substance

Atropine

SFDA 18
US FDA 27
EMA 2
Health Canada 9
US price lines 8
NHS prices 3
WHO EML 4
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ATROPINE SULF. E.S 50MCG-ML	50 µ/ml	Solution for injection · Parenteral use	1 Pre-filled syringe	SAR 30.65	Generic · Prescription	HOSPIRA INC	Valid
ATROPINE SULF.E.S 100MCG-ML	100 µ/ml	Solution for injection · Parenteral use	1 Pre-filled syringe	SAR 30.65	Generic · Prescription	HOSPIRA INC	Valid
ATROPINE SULF.E.S 100MCG-ML	100 µ/ml	Solution for injection · Parenteral use	1 Pre-filled syringe	SAR 30.65	Generic · Prescription	HOSPIRA INC	Valid
ATROPINE SULPHATE 0.5MG\ML AMPOULE	0.5 mg/ml	Solution · Intravenous use	1 Ampoule	SAR 3.70	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
ATROPINE SULPHATE 0.5MG\ML AMPOULE	0.5 mg/ml	Solution · Intravenous use	1 Ampoule	SAR 0.95	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
ATROPINE SULPHATE 0.6MG\ML AMPOULE	0.6 mg/ml	Solution · Intravenous use	1 Ampoule	SAR 1.55	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
ATROPINE SULPHATE 0.6MG\ML AMPOULE	0.6 mg/ml	Solution · Intravenous use	1 Ampoule	SAR 1.05	Generic · Prescription	Pharmaceutical Solution Industries (PSI)	Valid
ATROPINE SULPHATE 600 mcg/ml injection	0.6 mg/ml	Solution · Intramuscular and intravenous use	10 Ampoule	SAR 28.20	Generic · Prescription	MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS	Valid
Atropine Sulfate Aguettant	0.1 mg/ml	Solution for injection in pre-filled syringe · Intramuscular and intravenous use	10 Pre-filled syringe	SAR 306.60	Generic · Prescription	AGUETTANT LABORATORIES	Valid
RIATROPINE 0.5%	0.5 %	Eye drops · Ophthalmic use	1 Dropper Container	SAR 12.55	Generic · Prescription	RIYADH PHARMA	Valid
RIATROPINE 1%	1 %	Eye drops · Ophthalmic use	1 Dropper Container	SAR 12.55	Generic · Prescription	RIYADH PHARMA	Valid
ATROPINE	600 µ/ml	Solution for injection · Parenteral use	10 Ampoule	SAR 11.70	Generic · Prescription	ANTIGEN	Withdrawn by MAH · Not Marketed
ATROPINE SULPHATE INJ 1MG-1 ML	1 mg/ml	Solution · Parenteral use	100 Ampoule	SAR 33.65	NCE · Prescription	AGUETTANT LABORATORIES	Withdrawn by regulatory authority · Not Marketed
COLIRCUSI ATROPINE 0.5% drops	0.5 %	Eye drops, solution · Ocular use	1 Dropper Container	SAR 3.65	Generic · Prescription	ALCON CUSI	Withdrawn by MAH · Not Marketed
COLIRCUSI ATROPINE 1%	1 %	Eye drops, solution · Ocular use	1 Dropper Container	SAR 3.65	NCE · Prescription	ALCON CUSI	Withdrawn by MAH · Not Marketed
MINIMS ATROPINE SULPHATE 1%	1 %	Eye drops, solution · Ophthalmic use	20 Single Dose Container	SAR 25.10	NCE · Prescription	CHAUVIN BAUSCH & LOMB	Withdrawn by regulatory authority · Not Marketed
OFTALMOLOSA CUSI ATROPINE 1%	1 %	Eye ointment · Topical	1 Tube	SAR 8.10	Generic · Prescription	ALCON CUSI	Withdrawn by MAH · Not Marketed
RIATROPINE 1%	1 %	Eye ointment · Ophthalmic use	1 Bottle	SAR 12.55	Generic · Prescription	RIYADH PHARMA	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ CARDIAC ARREST, CARDIOVASCULAR EMERGENCIES AND/OR DYSRHYTHMIAS; BRADYCARDIA; BURN MANAGEMENT; COLORECTAL CANCER-CHOLINERGIC SIDE EFFECTS; ESOPHAGEAL CANCER-CHOLINERGIC SIDE EFFECTS; GASTRIC CANCER-CHOLINERGIC SIDE EFFECTS

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

Product	Strength	Form · route	Applicant	Status	First approved
ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML); 0.25MG/5ML (0.05MG/ML); 1MG/10ML (0.1MG/ML)	solution · intravenous	HOSPIRA	Prescription	9 Jul 2001
ATROPINE SULFATE	1%	solution/drops · ophthalmic	RISING	Prescription	18 Jul 2014
ISOPTO ATROPINE	1%	solution/drops · ophthalmic	ALCON LABS INC	Prescription	1 Dec 2016
ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	solution · intravenous, intramuscular, subcutaneous, intraosseous, endotracheal	FRESENIUS KABI USA	Prescription	26 Jan 2018
ATROPINE SULFATE	0.4MG/ML (0.4MG/ML); 1MG/ML (1MG/ML)	solution · intravenous	ACCORD HLTHCARE	Prescription	29 Sep 2020
ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	solution · intravenous	INTL MEDICATION SYS	Prescription	5 Oct 2020
ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	solution · intravenous, intramuscular, subcutaneous, intraosseous, endotracheal	ACCORD HLTHCARE	Prescription	19 Mar 2021
ATROPINE SULFATE	0.25MG/5ML (0.05MG/ML); 0.5MG/5ML (0.1MG/ML); 1MG/10ML (0.1MG/ML)	solution · intravenous	ACCORD HLTHCARE	Prescription	26 Jul 2021
ATROPINE SULFATE	1%	solution/drops · ophthalmic	APOTEX	Prescription	26 Nov 2021
ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	solution · intravenous, intramuscular, subcutaneous, intraosseous, endotracheal	HIKMA PHARMS	Prescription	1 Dec 2021
ATROPINE SULFATE	0.5MG/5ML (0.1MG/ML); 1MG/10ML (0.1MG/ML)	solution · intravenous	AMNEAL	Prescription	26 Jan 2022
ATROPINE SULFATE	1%	solution/drops · ophthalmic	BAUSCH AND LOMB INC	Prescription	15 Mar 2022
ATROPINE SULFATE	0.4MG/ML (0.4MG/ML); 1MG/ML (1MG/ML)	solution · intravenous	AM REGENT	Prescription	26 May 2022
ATROPINE SULFATE	1%	solution/drops · ophthalmic	AMNEAL	Prescription	14 Jul 2022
ATROPINE SULFATE	1MG/10ML (0.1MG/ML)	solution · intravenous	MEDEFIL INC	Prescription	4 Nov 2022
ATROPINE SULFATE	1%	solution/drops · ophthalmic	MANKIND PHARMA	Prescription	8 Jan 2024
ATROPINE SULFATE	1%	solution/drops · ophthalmic	SOMERSET	Prescription	29 Apr 2024
ATROPINE SULFATE	1%	solution/drops · ophthalmic	SOMERSET THERAPS LLC	Prescription	1 Jul 2024
ATROPINE SULFATE	0.4MG/ML (0.4MG/ML); 1MG/ML (1MG/ML)	solution · intravenous	SOMERSET THERAPS LLC	Prescription	3 Jul 2024
ATROPINE SULFATE	8MG/20ML (0.4MG/ML)	solution · intravenous, intramuscular, subcutaneous, intraosseous, endotracheal	SOMERSET THERAPS LLC	Prescription	29 Nov 2024
ATROPINE SULFATE	0.4MG/ML (0.4MG/ML); 1MG/ML (1MG/ML)	solution · intravenous	HIKMA	Prescription	24 Oct 2025
ATROPINE SULFATE	1%	solution/drops · ophthalmic	EDENBRIDGE PHARMS	Prescription	15 Apr 2026
ATROPINE SULFATE	1%	solution/drops · ophthalmic	GLAND	Prescription	31 Jul 2026
ATROPEN	EQ 2MG SULFATE/0.7ML; EQ 1MG SULFATE/0.7ML; EQ 0.5MG SULFATE/0.7ML; EQ 0.25MG SULFATE/0.3ML	solution · intramuscular	MMT	Discontinued	15 May 1973
ATROPINE	EQ 2MG SULFATE/0.7ML	solution · intramuscular	ABBVIE	Discontinued	30 Jan 1987

2 more — full table

EMA European Union — centrally authorised medicines

Ryjunea Santen Oy · Authorised · authorised 2 Jun 2025 · ATC S01FA01

Therapeutic indication (EMA)

Ryjunea is indicated for slowing the progression of myopia in paediatric patients. Treatment may be initiated in children aged 3-14 years with a progression rate of 0.5 D or more per year and a severity of -0.5 D to -6.0 D.

Atropine sulfate FGK FGK Representative Service GmbH · Refused · ATC S01FA01

Therapeutic indication (EMA)

Atropine sulfate FGK 0.1 mg/ml is indicated to slow myopia progression in children aged 6 to 10 years with spherical equivalent refraction (SER) in the range of -0.50 to ‑6.00 diopter (D).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALCON ATROPINE	00035017	1 % / W/V	SOLUTION · OPHTHALMIC	ALCON CANADA INC
ATROPINE	02023695	1 %	SOLUTION · OPHTHALMIC	PHARMA STULLN INC.
ATROPINE INJECTION BP	02432188	0.4 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS	HIKMA CANADA LIMITED
ATROPINE INJECTION BP	02432196	0.6 MG / ML	SOLUTION · INTRAMUSCULAR; SUBCUTANEOUS; INTRAVENOUS	HIKMA CANADA LIMITED
ATROPINE SULFATE INJECTION	02426269	0.5 MG / 5 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS; INTRAMUSCULAR	LABORATOIRE AGUETTANT
ATROPINE SULFATE INJECTION	02426277	1 MG / 5 ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR; SUBCUTANEOUS	LABORATOIRE AGUETTANT
ATROPINE SULFATE INJECTION USP	00392693	.6 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS	SANDOZ CANADA INCORPORATED
ATROPINE SULFATE INJECTION USP	00392782	0.4 MG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
MINIMS ATROPINE SULPHATE	02148358	1 % / W/V	DROPS · OPHTHALMIC	BAUSCH & LOMB INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ATROPINE 1% EYE DROP	$11.51489	per ML	23 Sep 2026
US NADAC	ATROPINE 1% EYE DROP	$5.13389	per ML	23 Sep 2026
US NADAC	ATROPINE 1% EYE DROP	$4.16186	per ML	23 Sep 2026
US NADAC	ATROPINE 1% EYE DROPS	$10.34502	per ML	23 Sep 2026
US NADAC	ATROPINE 1% EYE DROPS	$19.98626	per ML	23 Sep 2026
US NADAC	ATROPINE 1% EYE DROPS	$11.51489	per ML	23 Sep 2026
US NADAC	ATROPINE 1% EYE DROPS	$5.13389	per ML	23 Sep 2026
US NADAC	ATROPINE 1% EYE DROPS	$4.16186	per ML	23 Sep 2026
NHS Drug Tariff	Atropine 1% eye drops	£6.94	10 ml	1 Oct 2026
NHS Drug Tariff	Atropine 1% eye drops 0.5ml unit dose preservative free	£18.27	20 unit dose	1 Oct 2026
NHS Drug Tariff	Atropine 3mg/10ml solution for injection pre-filled syringes	£13.00	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)

14.1. Diagnostic agents > Ophthalmic medicines · core
Therapeutic equivalent to tropicamide for Cycloplegic drug
21.5. Ophthalmological preparations > Mydriatics · core
Anterior uveitis
Local > Ophthalmological > Solution (eye drops): 0.1% (sulfate); 0.5% (sulfate); 1% (sulfate)
4.2. Antidotes and other substances used in poisonings > Specific · core
Exposure to or harmful effects of undetermined intent of pesticides
Parenteral > General injections > unspecified: 1 mg in 1 mL ampoule or vial (sulfate)
1.3. Preoperative medication and sedation for short-term procedures · core
Parasympatholytics [anticholinergics and antimuscarinics] and spasmolytics
Parenteral > General injections > unspecified: 1 mg in 1 mL ampoule or vial (sulfate); 400 µg per mL in 1 mL ampoule or vial (sulfate) (EMLc)

Safety signals and safety-related labeling changes

US FDA 4 Feb 2026 ATROPINE SULFATE — safety-related labeling change
Labeling sections changed: Use in Specific Populations
EMA PRAC 15 Jan 2026 PRAC signal: Strabismus
Action for MAH: update of the product information: No
US FDA 18 Sep 2025 ATROPINE SULFATE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Jul 2025 ATROPINE SULFATE — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 20 Nov 2020 ATROPEN — 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 24 Jun 2020 ATROPINE SULFATE ANSYR PLASTIC SYRINGE — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 22 May 2020 ATNAA — 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 9 Jul 2019 ATROPINE (AUTOINJECTOR) — 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 6 Oct 2017 DUODOTE — 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 5 Oct 2017 LOMOTIL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions

All safety entries for atropine →

Combinations containing Atropine

Atropine + diphenoxylate

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.