Is Glycopyrronium registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Glycopyrronium, including GLYCOPYRRONIUM BROMIDE 200 mcg/ml solution for injection (200 µ/ml, Solution for injection, SAR 29.95); Glycopyrrolate Amarox (0.2 mg/ml, Oral solution, SAR 2000.00).

Is Glycopyrronium approved by the US FDA?

Drugs@FDA lists 73 application product lines for Glycopyrronium, including ROBINUL (Prescription); ROBINUL FORTE (Prescription); ROBINUL (Prescription); GLYCOPYRROLATE (Prescription); GLYCOPYRROLATE (Prescription).

Is Glycopyrronium authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Glycopyrronium: Seebri Breezhaler, Tovanor Breezhaler, Sialanar.

Is Glycopyrronium on the WHO Model List of Essential Medicines?

Yes — 25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease (core list): Therapeutic equivalent to tiotropium bromide for Chronic obstructive pulmonary disease.

Are there safety signals or safety updates for Glycopyrronium?

EMA PRAC: 1 entry; US FDA: 8 entries (latest 2026-04-27).

Active substance

Glycopyrronium

SFDA 3
US FDA 73
EMA 4
Health Canada 10
US price lines 5
NHS prices 8
WHO EML 1
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
GLYCOPYRRONIUM BROMIDE 200 mcg/ml solution for injection	200 µ/ml	Solution for injection · Intramuscular and intravenous use	10 Ampoule	SAR 29.95	Generic · Prescription	MACARTHYS LABORATORIES Ltd T/A MARTINDALE PHARMACEUTICALS	Valid
Glycopyrrolate Amarox	0.2 mg/ml	Oral solution · Oral use	1 Bottle	SAR 2000.00	Generic · Prescription	Saudi Amarox	Valid
SEEBRI BREEZHALER	50 µg	Capsule, hard · Inhalation use	30 Blister	SAR 150.00	NCE · Prescription	NOVARTIS PHARMA AG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ANESTHESIA-SUPPORTIVE AGENTS/ INHIBITION OF SALIVARY GLAND AND RESPIRATORY TRACT SECRETIONS; SPINAL MUSCULAR ATROPHY - TREATMENT OF HYPERSALIVATION

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

Product	Strength	Form · route	Applicant	Status	First approved
ROBINUL	1MG	tablet · oral	CASPER PHARMA LLC	Prescription	11 Aug 1961
ROBINUL FORTE	2MG	tablet · oral	CASPER PHARMA LLC	Prescription	11 Aug 1961
ROBINUL	0.2MG/ML	injectable · injection	HIKMA PHARMS	Prescription	6 Feb 1975
GLYCOPYRROLATE	0.2MG/ML	injectable · injection	AM REGENT	Prescription	23 Jul 1986
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	PH HEALTH	Prescription	31 Aug 2006
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	CHARTWELL RX	Prescription	21 Mar 2008
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	RISING	Prescription	29 Dec 2008
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	SUN PHARM INDS LTD	Prescription	18 Aug 2009
CUVPOSA	1MG/5ML	solution · oral	MERZ PHARMS	Prescription	28 Jul 2010
GLYCOPYRROLATE	0.2MG/ML	injectable · injection	HIKMA FARMACEUTICA	Prescription	21 Sep 2011
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	OXFORD PHARMS	Prescription	19 Oct 2011
GLYCOPYRROLATE	1.5MG	tablet · oral	LGM PHARMA	Prescription	12 Mar 2012
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	VELZEN PHARMA PVT	Prescription	21 Sep 2012
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	AUROBINDO PHARMA	Prescription	15 Apr 2013
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	REGCON HOLDINGS	Prescription	3 Feb 2014
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	NATCO	Prescription	20 Jun 2016
GLYCOPYRROLATE	1MG; 2MG	tablet · oral	APPCO	Prescription	3 Jan 2017
GLYCOPYRROLATE	0.2MG/ML	injectable · injection	AMNEAL	Prescription	15 Jun 2017
GLYCOPYRROLATE	0.2MG/ML	injectable · injection	SOMERSET THERAPS LLC	Prescription	23 Jun 2017
GLYCOPYRROLATE	0.2MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	27 Oct 2017
QBREXZA	EQ 2.4% BASE	cloth · topical	JOURNEY	Prescription	28 Jun 2018
GLYRX-PF	0.4MG/2ML (0.2MG/ML); 1MG/5ML (0.2MG/ML)	solution · intramuscular, intravenous	EXELA PHARMA	Prescription	11 Jul 2018
GLYCOPYRROLATE	0.2MG/ML	injectable · injection	PIRAMAL CRITICAL	Prescription	25 Oct 2018
GLYCOPYRROLATE	0.2MG/ML	injectable · injection	FRESENIUS KABI USA	Prescription	31 Oct 2018
GLYCOPYRROLATE	0.2MG/ML	injectable · injection	PRINSTON INC	Prescription	31 Oct 2018

48 more — full table

EMA European Union — centrally authorised medicines

Seebri Breezhaler Novartis Europharm Limited · Authorised · authorised 28 Sep 2012 · ATC R03BB06

Therapeutic indication (EMA)

Seebri Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Tovanor Breezhaler Novartis Europharm Limited · Authorised · authorised 28 Sep 2012 · ATC R03BB06

Therapeutic indication (EMA)

Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Sialanar Proveca Pharma Limited · Authorised · authorised 15 Sep 2016 · ATC A03AB02

Therapeutic indication (EMA)

Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.

Enurev Breezhaler Novartis Europharm Ltd · Withdrawn · authorised 28 Sep 2012 · ATC R03BB06

Therapeutic indication (EMA)

Enurev Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CUVPOSA	02469332	1 MG / 5 ML	SOLUTION · ORAL	MEDEXUS PHARMACEUTICALS INC.
GLYCOPYRROLATE INJECTION	02382857	0.2 MG / ML	LIQUID · INTRAMUSCULAR; INTRAVENOUS	OMEGA LABORATORIES LIMITED
GLYCOPYRROLATE INJECTION MULTIDOSE	02382849	0.2 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	OMEGA LABORATORIES LIMITED
GLYCOPYRROLATE INJECTION USP	02039508	0.2 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	SANDOZ CANADA INCORPORATED
GLYCOPYRROLATE INJECTION USP	02473879	0.2 MG / 1 ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	STERIMAX INC
GLYCOPYRROLATE INJECTION USP	02473887	4 MG / 20 ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	STERIMAX INC
GLYCOPYRROLATE INJECTION USP	02473895	0.4 MG / 2 ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	STERIMAX INC
GLYCOPYRROLATE INJECTION USP	02513749	0.2 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	JAMP PHARMA CORPORATION
GLYCOPYRROLATE INJECTION USP	02532379	0.2 MG / ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	JAMP PHARMA CORPORATION
SEEBRI BREEZHALER	02394936	50 MCG	CAPSULE · INHALATION	NOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CUVPOSA 1 MG/5 ML SOLUTION	$1.00673	per ML	23 Sep 2026
US NADAC	GLYCOPYRROLATE 0.2 MG/ML VIAL	$1.51425	per ML	23 Sep 2026
US NADAC	GLYCOPYRROLATE 1 MG TABLET	$0.09972	per EA	23 Sep 2026
US NADAC	GLYCOPYRROLATE 1 MG/5 ML ORAL SOLUTION	$0.2019	per ML	23 Sep 2026
US NADAC	GLYCOPYRROLATE 2 MG TABLET	$0.14813	per EA	23 Sep 2026
NHS Drug Tariff	Glycopyrronium bromide 1mg tablets	£74.14	30 tablet	1 Oct 2026
NHS Drug Tariff	Glycopyrronium bromide 1mg/5ml oral solution sugar free	£42.64	150 ml	1 Oct 2026
NHS Drug Tariff	Glycopyrronium bromide 200micrograms/1ml solution for injection ampoules	£6.73	10 ampoule	1 Oct 2026
NHS Drug Tariff	Glycopyrronium bromide 2mg tablets	£198.00	30 tablet	1 Oct 2026
NHS Drug Tariff	Glycopyrronium bromide 400micrograms/ml oral solution sugar free	£76.80	60 ml	1 Oct 2026
NHS Drug Tariff	Glycopyrronium bromide 400micrograms/ml oral solution sugar free	£320.00	250 ml	1 Oct 2026
NHS Drug Tariff	Glycopyrronium bromide 55microgram inhalation powder capsules with device	£27.50	30 capsule	1 Oct 2026
NHS Drug Tariff	Glycopyrronium bromide 600micrograms/3ml solution for injection ampoules	£22.70	10 ampoule	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)

25.1. Antiasthmatic and medicines for chronic obstructive pulmonary disease · core
Therapeutic equivalent to tiotropium bromide for Chronic obstructive pulmonary disease

Safety signals and safety-related labeling changes

US FDA 27 Apr 2026 BREZTRI AEROSPHERE — 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
US FDA 24 Feb 2026 ROBINUL — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 28 Oct 2022 QBREXZA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Sep 2022 ROBINUL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Sep 2022 ROBINUL FORTE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Jul 2021 UTIBRON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Jul 2021 SEEBRI — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
US FDA 5 Nov 2020 BEVESPI AEROSPHERE — 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 7 Nov 2013 PRAC signal: Angioedema
Action for MAH: update of the product information: No

All safety entries for glycopyrronium →

Combinations containing Glycopyrronium

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.