Is Rivastigmine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 16 valid registrations of Rivastigmine, including EXELON 1.5 mg capsule (1.5 mg, Capsule, SAR 147.40); EXELON 3 mg capsule (3 mg, Capsule, SAR 154.10); EXELON 4.6MG-24H TRANSDERMAL PATCHES (4.6 mg, Transdermal patch, SAR 271.25); EXELON 6 mg capsule (6 mg, Capsule, SAR 162.90); EXELON 9.5MG-24H TRANSDERMAL PATCHES (9.5 mg, Transdermal patch, SAR 271.25).

Is Rivastigmine approved by the US FDA?

Drugs@FDA lists 19 application product lines for Rivastigmine, including EXELON (Prescription); RIVASTIGMINE TARTRATE (Prescription); RIVASTIGMINE TARTRATE (Prescription); RIVASTIGMINE TARTRATE (Prescription); RIVASTIGMINE TARTRATE (Prescription).

Is Rivastigmine authorised in the European Union?

EMA lists 7 centrally authorised medicines containing Rivastigmine: Exelon, Prometax, Nimvastid, Rivastigmine Sandoz, Rivastigmine 1 A Pharma, Rivastigmine Hexal, Rivastigmine Actavis.

Are there safety signals or safety updates for Rivastigmine?

US FDA: 3 entries (latest 2024-05-08).

Active substance

Rivastigmine

SFDA 19
US FDA 19
EMA 9
Health Canada 28
US price lines 9
NHS prices 10
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
EXELON 1.5 mg capsule	1.5 mg	Capsule · Oral use	28 Blister	SAR 147.40	NCE · Prescription	NOVARTIS	Valid
EXELON 3 mg capsule	3 mg	Capsule · Oral use	28 Blister	SAR 154.10	NCE · Prescription	NOVARTIS	Valid
EXELON 4.6MG-24H TRANSDERMAL PATCHES	4.6 mg	Transdermal patch · Topical	30 Box	SAR 271.25	NCE · Prescription	NOVARTIS	Valid
EXELON 6 mg capsule	6 mg	Capsule · Oral use	28 Blister	SAR 162.90	NCE · Prescription	NOVARTIS	Valid
EXELON 9.5MG-24H TRANSDERMAL PATCHES	9.5 mg	Transdermal patch · Topical	30 Box	SAR 271.25	NCE · Prescription	NOVARTIS	Valid
RIVAXEL 13.3MG/24HRS TRANSDERMAL PATCHES	27 mg	Transdermal patch · Transdermal use	30 Patch	SAR 185.50	Generic · Prescription	SK CHEMICALS CO . LTD	Valid
RIVAXEL 4.6MG/24HRS TRANSDERMAL PATCHES	9 mg	Transdermal patch · Transdermal use	30 Patch	SAR 185.50	Generic · Prescription	SK CHEMICALS CO . LTD	Valid
RIVAXEL 9.5MG/24HRS TRANSDERMAL PATCHES	18 mg	Transdermal patch · Transdermal use	30 Patch	SAR 185.50	Generic · Prescription	SK CHEMICALS CO . LTD	Valid
RIVETAL 1.5 mg Capsule	1.5 mg	Capsule, hard · Oral use	28 Blister	SAR 101.45	Generic · Prescription	GENEPHARM S.A.	Valid
RIVETAL 3 mg Capsule	3 mg	Capsule, hard · Oral use	28 Blister	SAR 114.05	Generic · Prescription	GENEPHARM S.A.	Valid
RIVETAL 4.5 mg Capsule	4.5 mg	Capsule, hard · Oral use	28 Blister	SAR 133.05	Generic · Prescription	GENEPHARM S.A.	Valid
RIVETAL 6 mg Capsule	6 mg	Capsule, hard · Oral use	28 Blister	SAR 160.50	Generic · Prescription	GENEPHARM S.A.	Valid
TRIVACIN 4.6MG/24H TRANSDERMAL PATCHES	9 mg	Transdermal patch · Transdermal use	30 Pouch	SAR 166.95	Generic · Prescription	Acino AG	Valid
TRIVACIN 9.5MG/24H TRANSDERMAL PATCHES	18 mg	Transdermal patch · Transdermal use	30 Pouch	SAR 166.95	Generic · Prescription	Acino AG	Valid
Zeyzelf	25.92 mg	Transdermal patch · Transdermal use	8 Sachet	SAR 204.00	NCE · Prescription	Luye Pharma Limited	Valid
Zeyzelf	51.84 mg	Transdermal patch · Transdermal use	8 Sachet	SAR 204.00	NCE · Prescription	Luye Pharma Limited	Valid
EXELON 2MG-ML ORAL SOLUTION	2 mg/ml	Oral solution · Oral use	1 Bottle	SAR 245.65	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
EXELON 2MG-ML ORAL SOLUTION	2 mg/ml	Oral solution · Oral use	1 Bottle	SAR 516.95	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed
EXELON 4.5 mg capsule	4.5 mg	Capsule · Oral use	28 Blister	SAR 154.10	NCE · Prescription	NOVARTIS	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ALZHEIMER / DEMENTIA; HIP AND KNEE REPLACEMENT SURGERY

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

Product	Strength	Form · route	Applicant	Status	First approved
EXELON	4.6MG/24HR; 9.5MG/24HR; 13.3MG/24HR	film, extended release · transdermal	SANDOZ	Prescription	6 Jul 2007
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	DR REDDYS LABS INC	Prescription	31 Oct 2007
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	WATSON LABS	Prescription	8 Jan 2008
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	ALEMBIC PHARMS LTD	Prescription	12 Jun 2012
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	MACLEODS PHARMS LTD	Prescription	22 Aug 2014
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	ORBION PHARMS	Prescription	10 Jun 2015
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	AUROBINDO PHARMA	Prescription	25 Mar 2016
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	CADILA PHARMS LTD	Prescription	13 Feb 2017
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	CHARTWELL RX	Prescription	28 Sep 2017
RIVASTIGMINE	4.6MG/24HR; 9.5MG/24HR; 13.3MG/24HR	film, extended release · transdermal	MYLAN TECHNOLOGIES	Prescription	20 Jun 2018
RIVASTIGMINE	4.6MG/24HR; 9.5MG/24HR; 13.3MG/24HR	film, extended release · transdermal	AMNEAL PHARMS	Prescription	8 Jan 2019
RIVASTIGMINE	4.6MG/24HR; 9.5MG/24HR; 13.3MG/24HR	film, extended release · transdermal	ZYDUS PHARMS	Prescription	4 Mar 2019
RIVASTIGMINE	4.6MG/24HR; 9.5MG/24HR; 13.3MG/24HR	film, extended release · transdermal	BRECKENRIDGE	Prescription	26 Nov 2019
RIVASTIGMINE	4.6MG/24HR; 9.5MG/24HR; 13.3MG/24HR	film, extended release · transdermal	YICHANG HUMANWELL	Prescription	23 Sep 2025
EXELON	EQ 1.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 4.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; EQ 6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	capsule · oral	NOVARTIS	Discontinued	21 Apr 2000
EXELON	EQ 2MG BASE/ML	solution · oral	NOVARTIS	Discontinued	21 Apr 2000
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	SUN PHARM	Discontinued	22 Oct 2007
RIVASTIGMINE TARTRATE	EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE	capsule · oral	APOTEX INC	Discontinued	16 May 2013
RIVASTIGMINE	4.6MG/24HR; 9.5MG/24HR; 13.3MG/24HR	film, extended release · transdermal	ALVOGEN	Discontinued	31 Aug 2015