Is Pramipexole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Pramipexole, including Dopaxol PR (0.375 mg, Prolonged-release tablet, SAR 107.40); Dopaxol PR (0.75 mg, Prolonged-release tablet, SAR 161.60); Dopaxol PR (1.5 mg, Prolonged-release tablet, SAR 264.25); Dopaxol PR (3 mg, Prolonged-release tablet, SAR 528.55); Pexoran (0.18 mg, Tablet, SAR 40.35).

Is Pramipexole approved by the US FDA?

Drugs@FDA lists 33 application product lines for Pramipexole, including MIRAPEX ER (Prescription); PRAMIPEXOLE DIHYDROCHLORIDE (Prescription); PRAMIPEXOLE DIHYDROCHLORIDE (Prescription); PRAMIPEXOLE DIHYDROCHLORIDE (Prescription); PRAMIPEXOLE DIHYDROCHLORIDE (Prescription).

Is Pramipexole authorised in the European Union?

EMA lists 4 centrally authorised medicines containing Pramipexole: Sifrol, Mirapexin, Oprymea, Pramipexole Teva.

Are there safety signals or safety updates for Pramipexole?

EMA PRAC: 3 entries; US FDA: 2 entries (latest 2024-06-07).

Active substance

Pramipexole

SFDA 9
US FDA 33
EMA 6
Health Canada 29
US price lines 13
NHS prices 11
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
Dopaxol PR	0.375 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 107.40	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Dopaxol PR	0.75 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 161.60	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Dopaxol PR	1.5 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 264.25	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Dopaxol PR	3 mg	Prolonged-release tablet · Oral use	30 Blister	SAR 528.55	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Pexoran	0.18 mg	Tablet · Oral use	30 Blister	SAR 40.35	Generic · Prescription	Spectro Pharma	Valid
Pexoran	0.7 mg	Tablet · Oral use	30 Blister	SAR 132.10	Generic · Prescription	Spectro Pharma	Valid
SIFROL 0.18 MG (EQU.0.25MG) TAB	180 mg	Tablet · Oral use	30 Blister	SAR 57.70	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
SIFROL 0.7MG (EQU. 1.00MG) TAB	700 mg	Tablet · Oral use	30 Blister	SAR 188.75	NCE · Prescription	BOEHRINGER INGELHEIM	Valid
SIFROL 0.088 MG (EQU.0.125MG) TAB	88 mg	Tablet · Oral use	30 Blister	SAR 38.35	NCE · Prescription	BOEHRINGER INGELHEIM	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ACUTE BIPOLAR I DEPRESSION; BIPOLAR II DISORDER; PARKINSONISM

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

Product	Strength	Form · route	Applicant	Status	First approved
MIRAPEX ER	0.375MG; 0.75MG; 1.5MG; 3MG; 4.5MG	tablet, extended release · oral	BOEHRINGER INGELHEIM	Prescription	19 Mar 2010
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 1MG; 1.5MG; 0.75MG	tablet · oral	ZYDUS PHARMS USA INC	Prescription	6 Jul 2010
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 1MG; 1.5MG; 0.75MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	8 Oct 2010
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 0.75MG; 1MG; 1.5MG	tablet · oral	TORRENT PHARMS	Prescription	8 Oct 2010
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 1MG; 1.5MG; 0.75MG	tablet · oral	PHARMOBEDIENT	Prescription	30 Apr 2012
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 0.75MG; 1MG; 1.5MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	26 Oct 2012
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 0.75MG; 1MG; 1.5MG	tablet · oral	STRIDES PHARMA	Prescription	3 Jun 2014
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 0.75MG; 1MG; 1.5MG	tablet · oral	SCIEGEN PHARMS	Prescription	28 Oct 2014
PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG; 0.75MG; 1.5MG; 3MG; 4.5MG	tablet, extended release · oral	CHARTWELL RX	Prescription	4 Dec 2014
PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG; 0.75MG; 1.5MG; 3MG; 4.5MG	tablet, extended release · oral	DR REDDYS	Prescription	7 Aug 2015
PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG; 0.75MG; 1.5MG; 3MG; 4.5MG	tablet, extended release · oral	ACTAVIS ELIZABETH	Prescription	21 Apr 2016
PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG; 0.75MG; 1.5MG; 2.25MG; 3MG; 4.5MG; 3.75MG	tablet, extended release · oral	MACLEODS PHARMS	Prescription	24 Jun 2016
PRAMIPEXOLE DIHYDROCHLORIDE	2.25MG; 3.75MG	tablet, extended release · oral	ACTAVIS ELIZABETH	Prescription	14 Oct 2016
PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG; 0.75MG; 1.5MG; 2.25MG; 3MG; 3.75MG; 4.5MG	tablet, extended release · oral	ZYDUS PHARMS	Prescription	12 Dec 2017
PRAMIPEXOLE DIHYDROCHLORIDE	0.25MG; 0.5MG; 0.75MG; 1MG; 1.5MG	tablet · oral	RISING	Prescription	3 Oct 2018
PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG; 0.75MG; 1.5MG; 2.25MG; 3MG; 3.75MG; 4.5MG	tablet, extended release · oral	ALEMBIC	Prescription	2 Jan 2019
PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG; 0.75MG	tablet, extended release · oral	XIAMEN LP PHARM CO	Prescription	11 Jun 2021
PRAMIPEXOLE DIHYDROCHLORIDE	0.375MG; 0.75MG; 1.5MG; 2.25MG; 3MG; 3.75MG; 4.5MG	tablet, extended release · oral	NOVAST LABS	Prescription	3 Feb 2022
MIRAPEX	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 1.25MG; 1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 0.75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	BOEHRINGER INGELHEIM	Discontinued	1 Jul 1997
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 1MG; 1.5MG	tablet · oral	HERITAGE PHARMA AVET	Discontinued	19 Feb 2008
MIRAPEX ER	0.375MG; 0.75MG; 1.5MG; 3MG; 4.5MG; 2.25MG; 3.75MG	tablet, extended release · oral	BOEHRINGER INGELHEIM	Discontinued	19 Feb 2010
PRAMIPEXOLE DIHYDROCHLORIDE	0.75MG	tablet · oral	NATCO PHARMA	Discontinued	9 Apr 2010
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 1MG; 1.5MG; 0.75MG	tablet · oral	SANDOZ	Discontinued	6 Jul 2010
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 1MG; 1.5MG	tablet · oral	NATCO	Discontinued	8 Oct 2010
PRAMIPEXOLE DIHYDROCHLORIDE	0.125MG; 0.25MG; 0.5MG; 1MG; 1.5MG	tablet · oral	HERITAGE PHARMA AVET	Discontinued	8 Oct 2010

8 more — full table

EMA European Union — centrally authorised medicines

Sifrol Boehringer Ingelheim International GmbH · Authorised · authorised 13 Oct 1997 · ATC N04BC05

Therapeutic indication (EMA)

Sifrol is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, though to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Sifrol is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).

Mirapexin Boehringer Ingelheim International GmbH · Authorised · authorised 23 Feb 1998 · ATC N04BC05

Therapeutic indication (EMA)

Mirapexin is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).

Oprymea Krka, d.d., Novo mesto · Authorised · authorised 12 Sep 2008 · ATC N04BC05

Therapeutic indication (EMA)

Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations). Oprymea is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).

Pramipexole Teva Teva Pharma B.V. · Authorised · authorised 18 Dec 2008 · ATC N04BC05

Therapeutic indication (EMA)

Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).

Daquiran Dr. Karl Thomae GmbH · Withdrawn · authorised 27 Oct 1997 · ATC N04BC05

Therapeutic indication (EMA)

DAQUIRAN tablets are indicated for treatment of the signs and symptoms of advanced idiopathic Parkinson's disease in combination with levodopa, i.e. over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).

Pramipexole Accord Accord Healthcare S.L.U. · Withdrawn · authorised 29 Sep 2011 · ATC N04BC05

Therapeutic indication (EMA)

Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACT PRAMIPEXOLE	02297302	0.25 MG	TABLET · ORAL	TEVA CANADA LIMITED
ACT PRAMIPEXOLE	02297310	0.5 MG	TABLET · ORAL	TEVA CANADA LIMITED
ACT PRAMIPEXOLE	02297329	1 MG	TABLET · ORAL	TEVA CANADA LIMITED
ACT PRAMIPEXOLE	02297337	1.5 MG	TABLET · ORAL	TEVA CANADA LIMITED
APO-PRAMIPEXOLE	02292378	0.25 MG	TABLET · ORAL	APOTEX INC
APO-PRAMIPEXOLE	02292386	0.5 MG	TABLET · ORAL	APOTEX INC
APO-PRAMIPEXOLE	02292394	1.0 MG	TABLET · ORAL	APOTEX INC
APO-PRAMIPEXOLE	02292408	1.5 MG	TABLET · ORAL	APOTEX INC
AURO-PRAMIPEXOLE	02424061	0.25 MG	TABLET · ORAL	AURO PHARMA INC
AURO-PRAMIPEXOLE	02424088	0.5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-PRAMIPEXOLE	02424096	1 MG	TABLET · ORAL	AURO PHARMA INC
AURO-PRAMIPEXOLE	02424118	1.5 MG	TABLET · ORAL	AURO PHARMA INC
MIRAPEX	02237145	0.25 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
MIRAPEX	02297256	0.125 MG	TABLET · ORAL	BOEHRINGER INGELHEIM (CANADA) LTD LTEE
PRAMIPEXOLE	02309122	0.25 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
PRAMIPEXOLE	02309130	0.5 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
PRAMIPEXOLE	02309149	1 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
PRAMIPEXOLE	02309157	1.5 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
PRAMIPEXOLE	02325802	0.25 MG	TABLET · ORAL	PRO DOC LIMITEE
PRAMIPEXOLE	02325810	0.5 MG	TABLET · ORAL	PRO DOC LIMITEE
PRAMIPEXOLE	02325829	1 MG	TABLET · ORAL	PRO DOC LIMITEE
PRAMIPEXOLE	02325837	1.5 MG	TABLET · ORAL	PRO DOC LIMITEE
PRAMIPEXOLE	02367602	0.25 MG	TABLET · ORAL	SANIS HEALTH INC
PRAMIPEXOLE	02367610	0.5 MG	TABLET · ORAL	SANIS HEALTH INC
PRAMIPEXOLE	02367629	1 MG	TABLET · ORAL	SANIS HEALTH INC

4 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PRAMIPEXOLE 0.125 MG TABLET	$0.03943	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE 0.25 MG TABLET	$0.04517	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE 0.5 MG TABLET	$0.05665	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE 0.75 MG TABLET	$0.07211	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE 1 MG TABLET	$0.06192	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE 1.5 MG TABLET	$0.06049	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE ER 0.375 MG TABLET	$0.94832	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE ER 0.75 MG TABLET	$0.71785	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE ER 1.5 MG TABLET	$1.68274	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE ER 2.25 MG TABLET	$1.46337	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE ER 3 MG TABLET	$1.47943	per EA	23 Sep 2026
US NADAC	PRAMIPEXOLE ER 3.75 MG TABLET	$2.38933	per EA	22 Oct 2025
NHS Drug Tariff	Pramipexole 1.05mg modified-release tablets	£8.22	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 1.57mg modified-release tablets	£191.11	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 180microgram tablets	£2.40	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 2.1mg modified-release tablets	£245.47	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 2.62mg modified-release tablets	£404.72	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 260microgram modified-release tablets	£5.08	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 3.15mg modified-release tablets	£467.84	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 350microgram tablets	£3.63	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 520microgram modified-release tablets	£6.90	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 700microgram tablets	£2.46	30 tablet	1 Oct 2026
NHS Drug Tariff	Pramipexole 88microgram tablets	£2.43	30 tablet	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 7 Jun 2024 MIRAPEX ER — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 14 Apr 2023 PRAC signal: Intestinal obstruction
Action for MAH: update of the product information: No
US FDA 12 Jul 2021 MIRAPEX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 1 Sep 2017 PRAC signal: Dystonia
Action for MAH: update of the product information: Yes
EMA PRAC 6 Apr 2017 PRAC signal: Dystonia
Action for MAH: update of the product information: No

All safety entries for pramipexole →

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.