Is Aripiprazole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 39 valid registrations of Aripiprazole, including ABILIFY MAINTENA 400 mg Powder And Solvent For Prolonged-Release (400 mg, Powder and solvent for prolonged-release suspension for injection, SAR 1188.65); ABILIRAZOLE (10 mg, Tablet, SAR 200.00); ABILIRAZOLE (15 mg, Tablet, SAR 248.50); ABILIRAZOLE (5 mg, Tablet, SAR 110.00); APIEXEL (5 mg, Tablet, SAR 98.00).

Is Aripiprazole approved by the US FDA?

Drugs@FDA lists 46 application product lines for Aripiprazole, including ABILIFY (Prescription); ABILIFY MAINTENA KIT (Prescription); ARIPIPRAZOLE (Prescription); ARIPIPRAZOLE (Prescription); ARIPIPRAZOLE (Prescription).

Is Aripiprazole authorised in the European Union?

EMA lists 6 centrally authorised medicines containing Aripiprazole: Abilify, Abilify Maintena, Aripiprazole Zentiva, Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen), Aripiprazole Sandoz, Aripiprazole Accord.

Is Aripiprazole on the WHO Model List of Essential Medicines?

Yes — 24.1. Medicines for psychotic disorders (core list): Therapeutic equivalent to risperidone for Schizophrenia or other primary psychotic disorders; Therapeutic equivalent to paliperidone for Schizophrenia or other primary psychotic disorders.

Are there safety signals or safety updates for Aripiprazole?

EMA PRAC: 8 entries; US FDA: 7 entries; MHRA: 1 entry (latest 2025-01-22).

Active substance

Aripiprazole

SFDA 49
US FDA 46
EMA 10
Health Canada 84
US price lines 21
NHS prices 13
WHO EML 1
Safety 16

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ABILIFY MAINTENA 400 mg Powder And Solvent For Prolonged-Release	400 mg	Powder and solvent for prolonged-release suspension for injection · Intramuscular use	1 Vial	SAR 1188.65	NCE · Prescription	H. LUNDBECK	Valid
ABILIRAZOLE	10 mg	Tablet · Oral use	30 Blister	SAR 200.00	Generic · Prescription	Saudi Amarox	Valid
ABILIRAZOLE	15 mg	Tablet · Oral use	30 Blister	SAR 248.50	Generic · Prescription	Saudi Amarox	Valid
ABILIRAZOLE	5 mg	Tablet · Oral use	30 Blister	SAR 110.00	Generic · Prescription	Saudi Amarox	Valid
APIEXEL	5 mg	Tablet · Oral use	28 Blister	SAR 98.00	Generic · Prescription	Medical Valley Invest AB	Valid
APIEXEL	10 mg	Tablet · Oral use	28 Blister	SAR 178.90	Generic · Prescription	Medical Valley Invest AB	Valid
APIEXEL	15 mg	Tablet · Oral use	28 Blister	SAR 222.00	Generic · Prescription	Medical Valley Invest AB	Valid
ARIPEX 10 mg tablet	10 mg	Tablet · Oral use	30 Blister	SAR 222.25	Generic · Prescription	DAMMAM PHARMA	Valid
ARIPEX 15 mg tablet	15 mg	Tablet · Oral use	30 Blister	SAR 276.10	Generic · Prescription	DAMMAM PHARMA	Valid
ARIPEX 2MG TABLET	2 mg	Tablet · Oral use	30 Blister	SAR 44.45	NCE · Prescription	DAMMAM PHARMA	Valid
ARIPEX 5 mg tablet	5 mg	Tablet · Oral use	30 Blister	SAR 111.10	Generic · Prescription	DAMMAM PHARMA	Valid
ARPENIA 1 mg/ml Oral Solution	1 mg/ml	Oral solution · Oral use	1 Bottle	SAR 219.25	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ARPENIA 10 mg ORODISPERSIBLE TABLET	10 mg	Orodispersible tablet · Oral use	30 Blister	SAR 200.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ARPENIA 10 mg tablet	10 mg	Tablet · Oral use	30 Bottle	SAR 200.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ARPENIA 15 mg ORODISPERSIBLE TABLET	15 mg	Orodispersible tablet · Oral use	30 Blister	SAR 248.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
ARPENIA 15 mg tablet	15 mg	Tablet · Oral use	30 Bottle	SAR 248.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Abilify Asimtufii	960 mg	Prolonged-release suspension for injection · Intramuscular use	1 Pre-filled syringe	SAR 2377.25	NCE · Prescription	H. LUNDBECK	Valid
Apilipx	10 mg	Tablet · Oral use	30 Blister	SAR 200.00	Generic · Prescription	Apex Pharma	Valid
Apilipx	5 mg	Tablet · Oral use	30 Blister	SAR 110.00	Generic · Prescription	Apex Pharma	Valid
Apilipx	15 mg	Tablet · Oral use	30 Blister	SAR 248.50	Generic · Prescription	Apex Pharma	Valid
Apilipx	30 mg	Tablet · Oral use	30 Blister	SAR 497.00	Generic · Prescription	Apex Pharma	Valid
Arify	10 mg	Tablet · Oral use	30 Blister	SAR 200.00	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
Arify	15 mg	Tablet · Oral use	30 Blister	SAR 248.50	Generic · Prescription	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
Aripro	10 mg	Tablet · Oral use	28 Blister	SAR 186.65	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Aripro	15 mg	Tablet · Oral use	28 Blister	SAR 231.95	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid

24 more — full table

Indications — CHI Daman Drug Formulary

ACUTE BIPOLAR I DEPRESSION; ACUTE MANIA; ALZHEIMER / DEMENTIA; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); BIPOLAR I DISORDER MAINTENANCE; DEPRESSION; SCHIZOPHRENIA

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

Product	Strength	Form · route	Applicant	Status	First approved
ABILIFY	10MG; 15MG; 20MG; 30MG; 5MG; 2MG	tablet · oral	OTSUKA	Prescription	15 Nov 2002
ABILIFY MAINTENA KIT	300MG/VIAL; 400MG/VIAL; 300MG; 400MG	for suspension, extended release · intramuscular	OTSUKA PHARM CO LTD	Prescription	28 Feb 2013
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	TORRENT	Prescription	28 Apr 2015
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	ALEMBIC	Prescription	28 Apr 2015
ARIPIPRAZOLE	10MG; 15MG	tablet, orally disintegrating · oral	ALEMBIC	Prescription	28 Apr 2015
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	HETERO LABS LTD V	Prescription	28 Apr 2015
ARIPIPRAZOLE	1MG/ML	solution · oral	AMNEAL PHARMS	Prescription	14 Aug 2015
ARIPIPRAZOLE	1MG/ML	solution · oral	LANNETT CO INC	Prescription	14 Aug 2015
ARIPIPRAZOLE	1MG/ML	solution · oral	APOTEX	Prescription	30 Sep 2015
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	AUROBINDO PHARMA	Prescription	8 Oct 2015
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	AMNEAL PHARMS	Prescription	17 Jun 2016
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	AJANTA PHARMA LTD	Prescription	12 Sep 2016
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	SCIEGEN PHARMS	Prescription	29 Sep 2016
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	MACLEODS PHARMS	Prescription	7 Oct 2016
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	ACCORD HLTHCARE	Prescription	7 Dec 2016
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	ORBION PHARMS	Prescription	23 May 2017
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	PRINSTON INC	Prescription	4 Dec 2017
ARIPIPRAZOLE	10MG; 15MG	tablet, orally disintegrating · oral	ORBION PHARMS	Prescription	11 Dec 2017
ARIPIPRAZOLE	10MG; 15MG	tablet, orally disintegrating · oral	SCIEGEN PHARMS	Prescription	18 Apr 2018
ARIPIPRAZOLE	10MG; 15MG; 20MG; 30MG	tablet, orally disintegrating · oral	SQUARE PHARMS	Prescription	28 Aug 2018
ARIPIPRAZOLE	1MG/ML	solution · oral	AUROBINDO PHARMA LTD	Prescription	29 Jan 2019
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	ALKEM LABS LTD	Prescription	21 Feb 2019
ARIPIPRAZOLE	1MG/ML	solution · oral	VISTAPHARM LLC	Prescription	26 Dec 2019
ARIPIPRAZOLE	2MG; 5MG; 10MG; 15MG; 20MG; 30MG	tablet · oral	UNICHEM	Prescription	1 Dec 2021
ARIPIPRAZOLE	1MG/ML	solution · oral	CHARTWELL RX	Prescription	25 Oct 2022

21 more — full table

EMA European Union — centrally authorised medicines

Abilify Otsuka Pharmaceutical Netherlands B.V. · Authorised · authorised 4 Jun 2004 · ATC N05AX12

Therapeutic indication (EMA)

Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

Abilify Maintena Otsuka Pharmaceutical Netherlands B.V. · Authorised · authorised 14 Nov 2013 · ATC N05AX12

Therapeutic indication (EMA)

Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

Aripiprazole Zentiva Zentiva k.s. · Authorised · authorised 25 Jun 2015 · ATC N05AX12

Therapeutic indication (EMA)

Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Zentiva is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Zentiva is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Mylan Pharmaceuticals Limited · Authorised · authorised 30 Jun 2015 · ATC N05AX12

Therapeutic indication (EMA)

Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Mylan Pharma is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Mylan Pharma is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

Aripiprazole Sandoz Sandoz GmbH · Authorised · authorised 20 Aug 2015 · ATC N05AX12

Therapeutic indication (EMA)

Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Sandoz is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

Aripiprazole Accord Accord Healthcare S.L.U. · Authorised · authorised 15 Nov 2015 · ATC N05AX12

Therapeutic indication (EMA)

Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole Accord is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.

Aripiprazole Mylan Generics (UK) Limited · Application withdrawn · ATC N05AX12

Therapeutic indication (EMA)

Treatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder

Aripiprazole Mylan Mylan S.A.S. · Application withdrawn · ATC N05AX12

Therapeutic indication (EMA)

Treatment of schizophrenia, treatment and prevention of bipolar disorder (manic episodes).

Abilify MyCite Otsuka Pharmaceutical Netherlands B.V. · Application withdrawn · ATC N05AX12

Therapeutic indication (EMA)

Treatment of schizophrenia, or of moderate to severe manic episodes in bipolar I disorder with sensor to measure medication adherence

Asimtufii Otsuka Pharmaceutical Netherlands B.V. · Application withdrawn · ATC N05AX12

Therapeutic indication (EMA)

Maintenance treatment of schizophrenia.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ABILIFY	02322374	2 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY	02322382	5 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY	02322390	10 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY	02322404	15 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY	02322412	20 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY	02322455	30 MG	TABLET · ORAL	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY ASIMTUFII	02554569	720 MG / 2.4 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY ASIMTUFII	02554577	960 MG / 3.2 ML	SUSPENSION (EXTENDED-RELEASE) · INTRAMUSCULAR	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY MAINTENA	02420864	300 MG / VIAL	KIT; POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULAR	OTSUKA PHARMACEUTICAL CO LTD
ABILIFY MAINTENA	02420872	400 MG / VIAL	POWDER FOR SUSPENSION (SUSTAINED-RELEASE; KIT · INTRAMUSCULAR	OTSUKA PHARMACEUTICAL CO LTD
AG-ARIPIPRAZOLE	02448173	2 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-ARIPIPRAZOLE	02448181	5 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-ARIPIPRAZOLE	02448203	10 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-ARIPIPRAZOLE	02448211	15 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-ARIPIPRAZOLE	02448238	20 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-ARIPIPRAZOLE	02448246	30 MG	TABLET · ORAL	ANGITA PHARMA INC.
APO-ARIPIPRAZOLE	02471086	2 MG	TABLET · ORAL	APOTEX INC
APO-ARIPIPRAZOLE	02471094	5 MG	TABLET · ORAL	APOTEX INC
APO-ARIPIPRAZOLE	02471108	10 MG	TABLET · ORAL	APOTEX INC
APO-ARIPIPRAZOLE	02471116	15 MG	TABLET · ORAL	APOTEX INC
APO-ARIPIPRAZOLE	02471124	20 MG	TABLET · ORAL	APOTEX INC
APO-ARIPIPRAZOLE	02471132	30 MG	TABLET · ORAL	APOTEX INC
ARIPIPRAZOLE	02488000	2 MG	TABLET · ORAL	PRO DOC LIMITEE
ARIPIPRAZOLE	02488019	5 MG	TABLET · ORAL	PRO DOC LIMITEE
ARIPIPRAZOLE	02488027	10 MG	TABLET · ORAL	PRO DOC LIMITEE

59 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ABILIFY 10 MG TABLET	$18.61552	per EA	23 Sep 2026
US NADAC	ABILIFY 15 MG TABLET	$18.65186	per EA	23 Sep 2026
US NADAC	ABILIFY 2 MG TABLET	$18.65546	per EA	23 Sep 2026
US NADAC	ABILIFY 20 MG TABLET	$26.25042	per EA	23 Sep 2026
US NADAC	ABILIFY 30 MG TABLET	$26.23171	per EA	23 Sep 2026
US NADAC	ABILIFY 5 MG TABLET	$18.6836	per EA	23 Sep 2026
US NADAC	ABILIFY ASIMTUFII 720 MG/2.4 ML	$1785.22689	per ML	23 Sep 2026
US NADAC	ABILIFY ASIMTUFII 960 MG/3.2 ML	$1782.92743	per ML	23 Sep 2026
US NADAC	ABILIFY MAINTENA ER 300 MG SYR	$2139.08683	per EA	23 Sep 2026
US NADAC	ABILIFY MAINTENA ER 300 MG VL	$2141.14811	per EA	23 Sep 2026
US NADAC	ABILIFY MAINTENA ER 400 MG SYR	$2853.24574	per EA	23 Sep 2026
US NADAC	ABILIFY MAINTENA ER 400 MG VL	$2857.76593	per EA	23 Sep 2026
NHS Drug Tariff	Aripiprazole 10mg orodispersible tablets sugar free	£6.92	28 tablet	1 Oct 2026
NHS Drug Tariff	Aripiprazole 10mg tablets	£1.74	28 tablet	1 Oct 2026
NHS Drug Tariff	Aripiprazole 15mg orodispersible tablets sugar free	£8.68	28 tablet	1 Oct 2026
NHS Drug Tariff	Aripiprazole 15mg tablets	£1.11	28 tablet	1 Oct 2026
NHS Drug Tariff	Aripiprazole 1mg/ml oral solution	£7.40	150 ml	1 Oct 2026
NHS Drug Tariff	Aripiprazole 1mg/ml oral solution sugar free	£101.20	150 ml	1 Oct 2026
NHS Drug Tariff	Aripiprazole 2.5mg tablets	£29.50	28 tablet	1 Oct 2026
NHS Drug Tariff	Aripiprazole 30mg tablets	£1.73	28 tablet	1 Oct 2026
NHS Drug Tariff	Aripiprazole 400mg powder and solvent for prolonged-release suspension for injection pre-filled syringes	£220.41	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Aripiprazole 400mg powder and solvent for prolonged-release suspension for injection vials	£220.41	1 vial	1 Oct 2026
NHS Drug Tariff	Aripiprazole 5mg tablets	£1.13	28 tablet	1 Oct 2026
NHS Drug Tariff	Aripiprazole 9.75mg/1.3ml solution for injection vials	£3.43	1 vial	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)

24.1. Medicines for psychotic disorders · core
Therapeutic equivalent to risperidone for Schizophrenia or other primary psychotic disorders; Therapeutic equivalent to paliperidone for Schizophrenia or other primary psychotic disorders

Safety signals and safety-related labeling changes

US FDA 22 Jan 2025 ABILIFY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Jan 2025 ABILIFY MAINTENA KIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Jan 2025 ABILIFY ASIMTUFII — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Jan 2025 ABILIFY MYCITE KIT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 18 Dec 2023 Aripiprazole (Abilify and generic brands): risk of pathological gambling
Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to be alert to these risks.
US FDA 5 Feb 2020 ABILIFY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Feb 2020 ABILIFY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Feb 2020 ABILIFY — 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 8 Jul 2016 PRAC signal: Compulsive shopping
Action for MAH: update of the product information: No
EMA PRAC 12 Mar 2015 PRAC signal: Aggression and related events
Action for MAH: update of the product information: Yes
EMA PRAC 12 Feb 2015 PRAC signal: Hyperprolactinaemia
Action for MAH: update of the product information: Yes
EMA PRAC 6 Nov 2014 PRAC signal: Aggression and related events
Action for MAH: update of the product information: No
EMA PRAC 9 Oct 2014 PRAC signal: Hyperprolactinaemia
Action for MAH: update of the product information: No
EMA PRAC 10 Apr 2014 PRAC signal: Diplopia
Action for MAH: update of the product information: No
EMA PRAC 3 Oct 2012 PRAC signal: Hypothyroidism
Action for MAH: update of the product information: No

All safety entries for aripiprazole →

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.