Is Olanzapine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 29 valid registrations of Olanzapine, including LAPRIX 10MG COATED TABLET (10 mg, Film-coated tablet, SAR 218.50); LAPRIX 5MG COATED TABLET (5 mg, Film-coated tablet, SAR 133.25); OLANA 10 mg orodispersible tablet (10 mg, Tablet, SAR 196.65); OLANA 5 mg orodispersible tablet (5 mg, Tablet, SAR 119.90); OLAZINE 10MG FILM COATED TABLETS (10 mg, Film-coated tablet, SAR 242.80).

Is Olanzapine approved by the US FDA?

Drugs@FDA lists 50 application product lines for Olanzapine, including ZYPREXA (Prescription); ZYPREXA ZYDIS (Prescription); ZYPREXA (Prescription); ZYPREXA RELPREVV (Prescription); OLANZAPINE (Prescription).

Is Olanzapine authorised in the European Union?

EMA lists 10 centrally authorised medicines containing Olanzapine: Zyprexa, Zyprexa Velotab, Zalasta, Olanzapine Teva, Olanzapine Viatris (previously Olanzapine Mylan), Zypadhera, Olanzapine Glenmark, Olanzapine Glenmark Europe.

Is Olanzapine 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; Schizophrenia or other primary psychotic disorders.

Are there safety signals or safety updates for Olanzapine?

EMA PRAC: 15 entries; US FDA: 6 entries (latest 2026-05-07).

Active substance

Olanzapine

SFDA 39
US FDA 50
EMA 13
Health Canada 104
US price lines 13
NHS prices 17
WHO EML 1
Safety 21

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LAPRIX 10MG COATED TABLET	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 218.50	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
LAPRIX 5MG COATED TABLET	5 mg	Film-coated tablet · Oral use	28 Blister	SAR 133.25	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
OLANA 10 mg orodispersible tablet	10 mg	Tablet · Oral use	28 Blister	SAR 196.65	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
OLANA 5 mg orodispersible tablet	5 mg	Tablet · Oral use	28 Blister	SAR 119.90	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Valid
OLAZINE 10MG FILM COATED TABLETS	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 242.80	Generic · Prescription	RIYADH PHARMA	Valid
OLAZINE 15MG FILM COATED TABLETS	15 mg	Film-coated tablet · Oral use	28 Blister	SAR 364.20	Generic · Prescription	RIYADH PHARMA	Valid
OLAZINE 2.5MG FILM COATED TABLETS	2.5 mg	Film-coated tablet · Oral use	28 Blister	SAR 74.00	Generic · Prescription	RIYADH PHARMA	Valid
OLAZINE 20MG FILM COATED TABLETS	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 398.20	Generic · Prescription	RIYADH PHARMA	Valid
OLAZINE 5MG FILM COATED TABLETS	5 mg	Film-coated tablet · Oral use	28 Blister	SAR 148.05	Generic · Prescription	RIYADH PHARMA	Valid
OLENZA 10 mg orally disintegrating tablet	10 mg	Tablet, orally disintegrating · Oral use	30 Blister	SAR 210.50	Generic · Prescription	SPIMACO ADDWAEIH	Valid
OLENZA 15 mg orally disintegrating tablet	15 mg	Tablet, orally disintegrating · Oral use	30 Blister	SAR 315.80	Generic · Prescription	SPIMACO ADDWAEIH	Valid
OLENZA 5 mg orally disintegrating tablet	5 mg	Tablet, orally disintegrating · Oral use	30 Blister	SAR 128.40	Generic · Prescription	SPIMACO ADDWAEIH	Valid
OZAPIN	15 mg	Orodispersible tablet · Oral use	30 Blister	SAR 265.50	NCE · Prescription	DAMMAM PHARMA	Valid
OZAPIN	20 mg	Orodispersible tablet · Oral use	30 Blister	SAR 290.30	NCE · Prescription	DAMMAM PHARMA	Valid
OZAPIN 10 mg orally disintegrating tablet	10 mg	Orodispersible tablet · Oral use	30 Blister	SAR 177.00	Generic · Prescription	DAMMAM PHARMA	Valid
OZAPIN 5 mg orally disintegrating tablet	5 mg	Orodispersible tablet · Oral use	30 Blister	SAR 107.90	Generic · Prescription	DAMMAM PHARMA	Valid
PRANZA 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 177.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
PRANZA 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 107.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
PRANZA ODT 10 mg	10 mg	Orodispersible tablet · Oral use	30 Blister	SAR 177.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
PRANZA ODT 5 mg	5 mg	Orodispersible tablet · Oral use	30 Blister	SAR 107.90	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
PREXAL 10MG FILM COATED TABLETS	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 159.55	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
PREXAL 5MG FILM COATED TABLETS	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 97.30	Generic · Prescription	Jordan Sweden Medical and Sterilization Co.	Valid
Pinolanz	10 mg	Powder for injection · Intramuscular use	1 Vial	SAR 126.50	Generic · Prescription	Saudi Amarox	Valid
ZOLAN 10 MG FILM-COATED TABLET	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 217.60	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
ZOLAN 5 MG FILM-COATED TABLET	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 132.55	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid

14 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; HUNTINGTON'S DISEASE-CHOREA; NAUSEA AND VOMITING IN CANCER; SCHIZOPHRENIA

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

Product	Strength	Form · route	Applicant	Status	First approved
ZYPREXA	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	CHEPLAPHARM	Prescription	30 Sep 1996
ZYPREXA ZYDIS	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	CHEPLAPHARM	Prescription	6 Apr 2000
ZYPREXA	10MG/VIAL	powder · intramuscular	CHEPLAPHARM	Prescription	29 Mar 2004
ZYPREXA RELPREVV	EQ 210MG BASE/VIAL; EQ 300MG BASE/VIAL; EQ 405MG BASE/VIAL	suspension, extended release · intramuscular	CHEPLAPHARM	Prescription	11 Dec 2009
OLANZAPINE	15MG; 20MG	tablet · oral	DR REDDYS LABS LTD	Prescription	24 Oct 2011
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	DR REDDYS LABS LTD	Prescription	24 Oct 2011
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	STRIDES PHARMA INTL	Prescription	24 Oct 2011
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	APOTEX INC	Prescription	24 Oct 2011
OLANZAPINE	10MG/VIAL	powder · intramuscular	SANDOZ INC	Prescription	24 Oct 2011
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	TORRENT	Prescription	25 Oct 2011
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	BARR LABS INC	Prescription	30 Jan 2012
OLANZAPINE	10MG/VIAL	powder · intramuscular	AM REGENT	Prescription	20 Mar 2012
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG	tablet · oral	DR REDDYS LABS LTD	Prescription	23 Apr 2012
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	APOTEX INC	Prescription	23 Apr 2012
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	TORRENT PHARMS LTD	Prescription	23 Apr 2012
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	23 Apr 2012
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	ORBION PHARMS	Prescription	23 Apr 2012
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	JUBILANT GENERICS	Prescription	12 Sep 2012
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	AUROBINDO PHARMA LTD	Prescription	15 May 2014
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	MACLEODS PHARMS LTD	Prescription	15 Aug 2014
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	MACLEODS PHARMS	Prescription	20 Feb 2015
OLANZAPINE	5MG; 10MG; 15MG; 20MG	tablet, orally disintegrating · oral	ORBION PHARMS	Prescription	2 Mar 2015
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	ALKEM LABS LTD	Prescription	20 Oct 2015
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	QILU	Prescription	27 Jan 2016
OLANZAPINE	2.5MG; 5MG; 7.5MG; 10MG; 15MG; 20MG	tablet · oral	CHARTWELL MOLECULAR	Prescription	15 Mar 2016

25 more — full table

EMA European Union — centrally authorised medicines

Zyprexa CHEPLAPHARM Registration GmbH · Authorised · authorised 27 Sep 1996 · ATC N05AH03

Therapeutic indication (EMA)

Coated tablets Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder. Injection Adults Zyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.

Zyprexa Velotab CHEPLAPHARM Registration GmbH · Authorised · authorised 3 Feb 2000 · ATC N05AH03

Therapeutic indication (EMA)

Adults Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Zalasta Krka · Authorised · authorised 27 Sep 2007 · ATC N05AH03

Therapeutic indication (EMA)

Olanzapine is indicated for the treatment of schizophrenia. Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Olanzapine is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Olanzapine Teva Teva B.V. · Authorised · authorised 12 Dec 2007 · ATC N05AH03

Therapeutic indication (EMA)

Olanzapine Viatris (previously Olanzapine Mylan) Viatris Limited · Authorised · authorised 6 Oct 2008 · ATC N05AH03

Therapeutic indication (EMA)

Zypadhera CHEPLAPHARM Registration GmbH · Authorised · authorised 19 Nov 2008 · ATC N05AH03

Therapeutic indication (EMA)

Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.

Olanzapine Glenmark Glenmark Arzneimittel GmbH · Authorised · authorised 3 Dec 2009 · ATC N05AH03

Therapeutic indication (EMA)

Olanzapine Glenmark Europe Glenmark Arzneimittel GmbH · Authorised · authorised 3 Dec 2009 · ATC N05AH03

Therapeutic indication (EMA)

Olazax Disperzi Glenmark Pharmaceuticals s.r.o. · Authorised · authorised 10 Dec 2009 · ATC N05AH03

Therapeutic indication (EMA)

Olazax Glenmark Pharmaceuticals s.r.o. · Authorised · authorised 11 Dec 2009 · ATC N05AH03

Therapeutic indication (EMA)

Olansek Eli Lilly Co. Ltd. · Withdrawn · authorised 7 Oct 1996 · ATC N05AH03

Therapeutic indication (EMA)

Olanzapine is indicated for the treatment of schizophrenia.Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.Olanzapine is indicated for the treatment of moderate to severe manic episode. Olanzapine has not been demonstrated to prevent recurrence of manic or depressive episodes (see Section 5.1).

Olanzapine Cipla (previously Olanzapine Neopharma) Cipla (EU) Limited · Withdrawn · authorised 14 Nov 2007 · ATC N05AH03

Therapeutic indication (EMA)

Olanzapine Apotex Apotex Europe BV · Withdrawn · authorised 10 Jun 2010 · ATC N05AH03

Therapeutic indication (EMA)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-OLANZAPINE	02281791	2.5 MG	TABLET · ORAL	APOTEX INC
APO-OLANZAPINE	02281805	5 MG	TABLET · ORAL	APOTEX INC
APO-OLANZAPINE	02281813	7.5 MG	TABLET · ORAL	APOTEX INC
APO-OLANZAPINE	02281821	10 MG	TABLET · ORAL	APOTEX INC
APO-OLANZAPINE	02281848	15 MG	TABLET · ORAL	APOTEX INC
APO-OLANZAPINE	02333015	20 MG	TABLET · ORAL	APOTEX INC
APO-OLANZAPINE ODT	02360616	5 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	APOTEX INC
APO-OLANZAPINE ODT	02360624	10 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	APOTEX INC
APO-OLANZAPINE ODT	02360632	15 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	APOTEX INC
APO-OLANZAPINE ODT	02360640	20 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	APOTEX INC
AURO-OLANZAPINE ODT	02448726	5 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	AURO PHARMA INC
AURO-OLANZAPINE ODT	02448734	10 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	AURO PHARMA INC
AURO-OLANZAPINE ODT	02448742	15 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	AURO PHARMA INC
AURO-OLANZAPINE ODT	02448750	20 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	AURO PHARMA INC
JAMP OLANZAPINE FC	02417243	2.5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE FC	02417251	5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE FC	02417278	7.5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE FC	02417286	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE FC	02417294	15 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE FC	02417308	20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE ODT	02406624	5 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE ODT	02406632	10 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE ODT	02406640	15 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	JAMP PHARMA CORPORATION
JAMP OLANZAPINE ODT	02406659	20 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	JAMP PHARMA CORPORATION
MINT-OLANZAPINE	02410141	2.5 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC

79 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	OLANZAPINE 10 MG TABLET	$0.10905	per EA	23 Sep 2026
US NADAC	OLANZAPINE 10 MG VIAL	$20.923	per EA	23 Sep 2026
US NADAC	OLANZAPINE 15 MG TABLET	$0.13454	per EA	23 Sep 2026
US NADAC	OLANZAPINE 2.5 MG TABLET	$0.08111	per EA	23 Sep 2026
US NADAC	OLANZAPINE 20 MG TABLET	$0.14674	per EA	23 Sep 2026
US NADAC	OLANZAPINE 5 MG TABLET	$0.08709	per EA	23 Sep 2026
US NADAC	OLANZAPINE 7.5 MG TABLET	$0.09436	per EA	23 Sep 2026
US NADAC	OLANZAPINE ODT 10 MG TABLET	$0.36633	per EA	23 Sep 2026
US NADAC	OLANZAPINE ODT 15 MG TABLET	$0.63877	per EA	23 Sep 2026
US NADAC	OLANZAPINE ODT 20 MG TABLET	$0.72217	per EA	23 Sep 2026
US NADAC	OLANZAPINE ODT 5 MG TABLET	$0.30355	per EA	23 Sep 2026
US NADAC	ZYPREXA 20 MG TABLET	$49.88179	per EA	23 Sep 2026
NHS Drug Tariff	Olanzapine 10mg oral lyophilisates sugar free	£87.40	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 10mg orodispersible tablets	£6.42	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 10mg orodispersible tablets sugar free	£5.37	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 10mg tablets	£1.07	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 15mg oral lyophilisates sugar free	£131.10	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 15mg orodispersible tablets sugar free	£6.50	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 15mg tablets	£1.46	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 2.5mg tablets	£0.94	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 20mg oral lyophilisates sugar free	£174.79	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 20mg orodispersible tablets	£7.70	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 20mg orodispersible tablets sugar free	£8.15	28 tablet	1 Oct 2026
NHS Drug Tariff	Olanzapine 20mg tablets	£1.34	28 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.

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; Schizophrenia or other primary psychotic disorders
Parenteral > General injections > IM: 10 mg in vial powder for injection

Safety signals and safety-related labeling changes

US FDA 7 May 2026 ZYPREXA RELPREVV — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 30 Jan 2026 LYBALVI — 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 30 Jan 2026 ZYPREXA — 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 30 Jan 2026 ZYPREXA — 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 30 Jan 2026 ZYPREXA ZYDIS — 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 22 Jan 2025 SYMBYAX — 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
EMA PRAC 10 Jun 2021 PRAC signal: Cardiomyopathy
Action for MAH: update of the product information: No
EMA PRAC 11 Feb 2021 PRAC signal: Cardiomyopathy
Action for MAH: update of the product information: No
EMA PRAC 14 Feb 2019 PRAC signal: Gestational diabetes
Action for MAH: update of the product information: No
EMA PRAC 14 Feb 2019 PRAC signal: Salivary hypersecretion
Action for MAH: update of the product information: No
EMA PRAC 4 Oct 2018 PRAC signal: Gestational diabetes
Action for MAH: update of the product information: No
EMA PRAC 6 Sep 2018 PRAC signal: Somnambulism
Action for MAH: update of the product information: No
EMA PRAC 12 Apr 2018 PRAC signal: Somnambulism
Action for MAH: update of the product information: No
EMA PRAC 27 Oct 2016 PRAC signal: Restless legs syndrome (RLS)
Action for MAH: update of the product information: Yes
EMA PRAC 9 Jun 2016 PRAC signal: Restless legs syndrome (RLS)
Action for MAH: update of the product information: No

All safety entries for olanzapine →

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.