Reagila Gedeon Richter · Authorised · authorised 13 Jul 2017 · ATC N05AX15
Therapeutic indication (EMA)
Reagila is indicated for the treatment of schizophrenia in adult patients.
Active substance
Cariprazine
- SFDA 4
- US FDA 4
- EMA 1
- Health Canada 4
- US price lines 6
- NHS prices 4
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Reagila | 1.5 mg | Capsule, hard · Oral use | 28 Blister | SAR 225.70 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Reagila | 3 mg | Capsule, hard · Oral use | 28 Blister | SAR 225.70 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Reagila | 4.5 mg | Capsule, hard · Oral use | 28 Blister | SAR 225.70 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Reagila | 6 mg | Capsule, hard · Oral use | 28 Blister | SAR 225.70 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
Indications — CHI Daman Drug Formulary
SCHIZOPHRENIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| VRAYLAR | EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE; EQ 0.5MG BASE; EQ 0.75MG BASE | capsule · oral | ABBVIE | Prescription | 17 Sep 2015 |
| CARIPRAZINE HYDROCHLORIDE | EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE | capsule · oral | ZYDUS | Discontinued | 9 Sep 2022 |
| CARIPRAZINE HYDROCHLORIDE | EQ 1.5MG BASE; EQ 3MG BASE; EQ 4.5MG BASE; EQ 6MG BASE | capsule · oral | SUN PHARM | Discontinued | 30 Sep 2022 |
| CARIPRAZINE HYDROCHLORIDE | EQ 1.5MG BASE; EQ 3MG BASE; EQ 6MG BASE | capsule · oral | AUROBINDO PHARMA LTD | Discontinued | 16 Dec 2025 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | VRAYLAR 0.5 MG CAPSULE | $50.77868 | per EA | 23 Sep 2026 |
| US NADAC | VRAYLAR 0.75 MG CAPSULE | $50.83865 | per EA | 23 Sep 2026 |
| US NADAC | VRAYLAR 1.5 MG CAPSULE | $50.84237 | per EA | 23 Sep 2026 |
| US NADAC | VRAYLAR 3 MG CAPSULE | $50.88385 | per EA | 23 Sep 2026 |
| US NADAC | VRAYLAR 4.5 MG CAPSULE | $50.78615 | per EA | 23 Sep 2026 |
| US NADAC | VRAYLAR 6 MG CAPSULE | $50.77591 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Cariprazine 1.5mg capsules | £80.36 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Cariprazine 3mg capsules | £80.36 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Cariprazine 4.5mg capsules | £80.36 | 28 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Cariprazine 6mg capsules | £80.36 | 28 capsule | 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 18 Dec 2025 VRAYLAR — 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
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.