Pantozol Control Takeda GmbH · Authorised · authorised 11 Jun 2009 · ATC A02BC02
Therapeutic indication (EMA)
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Active substance
Pantoprazole
- SFDA 58
- US FDA 48
- EMA 5
- Health Canada 39
- US price lines 7
- NHS prices 4
- Safety 14
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Antopaz | 40 mg | powder for solution for injection · Intravenous use | 1 Vial | SAR 22.90 | Generic · Prescription | Advanced Pharmaceutical Industries | Valid |
| Nolpaza | 20 mg | Gastro-resistant tablet · Oral use | 28 Blister | SAR 18.40 | Generic · Prescription | KRKA D.D., NOVO MESTO | Valid |
| Nolpaza | 40 mg | Gastro-resistant tablet · Oral use | 28 Blister | SAR 39.70 | Generic · Prescription | KRKA D.D., NOVO MESTO | Valid |
| PANREST 20 mg Enteric Coated Tablet | 20 mg | Coated tablet · Oral use | 30 Blister | SAR 18.40 | Generic · Prescription | APOTEX INC. (SIGNET SITE) | Valid |
| PANREST 40 mg Enteric Coated Tablet | 40 mg | Coated tablet · Oral use | 30 Blister | SAR 39.70 | Generic · Prescription | APOTEX INC. (SIGNET SITE) | Valid |
| PANTOL | 20 mg | Gastro-resistant coated tablet · Oral use | 28 Blister | SAR 43.45 | Generic · Prescription | Cooper Pharma Arabia | Valid |
| PANTOL 20 mg enteric-coated tablet | 20 mg | Gastro-resistant coated tablet · Oral use | 14 Blister | SAR 18.80 | Generic · Prescription | Cooper Pharma Arabia | Valid |
| PANTOL 40 mg enteric-coated tablet | 40 mg | Gastro-resistant coated tablet · Oral use | 14 Blister | SAR 39.05 | Generic · Prescription | Cooper Pharma Arabia | Valid |
| PANTOL 40 mg enteric-coated tablet | 40 mg | Gastro-resistant coated tablet · Oral use | 28 Blister | SAR 69.75 | Generic · Prescription | Cooper Pharma Arabia | Valid |
| PANTOLOC | 40 mg | Tablet · Oral use | 30 Blister | SAR 57.00 | Generic · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| PANTOLOC | 20 mg | Tablet · Oral use | 30 Bottle | SAR 27.50 | Generic · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| PANTOLOC | 20 mg | Tablet · Oral use | 15 Bottle | SAR 24.35 | Generic · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| PANTOLOC 40MG TABLETS | 40 mg | Tablet · Oral use | 15 Bottle | SAR 28.50 | Generic · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| PANTOMAX 20MG E.C. TABLETS | 20 mg | Gastro-resistant coated tablet · Oral use | 30 Blister | SAR 39.40 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| PANTOMAX 20MG E.C. TABLETS | 20 mg | Gastro-resistant coated tablet · Oral use | 15 Blister | SAR 19.70 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| PANTOMAX 40MG E.C.TABLETS | 40 mg | Gastro-resistant coated tablet · Oral use | 30 Blister | SAR 56.45 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| PANTOMAX 40MG E.C.TABLETS | 40 mg | Gastro-resistant coated tablet · Oral use | 15 Blister | SAR 31.65 | Generic · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| PANTONIX 40 mg powder for infusion | 40 mg | Powder for infusion · Intravenous use | 1 Vial | SAR 28.30 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Valid |
| PANTOVER 40MG E.C. TABLETS | 40 mg | Gastro-resistant coated tablet · Oral use | 30 Child-resistant Closure | SAR 50.80 | Generic · Prescription | JORDAN RIVER PHARMACEUTICAL INDUSTRIES | Valid |
| PANTOVER 40MG E.C. TABLETS | 40 mg | Gastro-resistant coated tablet · Oral use | 14 Child-resistant Closure | SAR 26.60 | Generic · Prescription | JORDAN RIVER PHARMACEUTICAL INDUSTRIES | Valid |
| PANTOVER 40MG E.C. TABLETS | 40 mg | Gastro-resistant coated tablet · Oral use | 15 Child-resistant Closure | SAR 28.50 | Generic · Prescription | JORDAN RIVER PHARMACEUTICAL INDUSTRIES | Valid |
| PANTOZOL 20MG E.C TAB | 20 mg | Gastro-resistant coated tablet · Oral use | 30 Blister | SAR 54.80 | NCE · Prescription | ACINO PHARMA AG | Valid |
| PANTOZOL 20MG E.C TAB | 20 mg | Gastro-resistant coated tablet · Oral use | 15 Blister | SAR 30.70 | NCE · Prescription | ACINO PHARMA AG | Valid |
| PANTOZOL 40MG I.V Powder for injection | 40 mg | powder for solution for injection · Intravenous use | 1 Vial | SAR 26.60 | NCE · Prescription | ACINO PHARMA AG | Valid |
| PANTOZOL 40MG TAB | 40 mg | Gastro-resistant tablet · Oral use | 15 Blister | SAR 49.25 | NCE · Prescription | ACINO PHARMA AG | Valid |
33 more — full table
Indications — CHI Daman Drug Formulary
ANESTHESIA-SUPPORTIVE AGENTS/ ASPIRATION PNEUMONIA PROPHYLAXIS; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-EVIDENCE BASED FIRST LINE TREATMENT STRATEGY; BACTRIAL INFECTIONS OF THE GASTROINTESTINAL TRACT- H-PYLORI ERADICATION-SALVAGE THERAPIES; BARIATRIC SURGERY; CORONARY ARTERY DISEASE; DYSPEPSIA; GASTROESOPHAGEAL REFLUX DISEASE (GERD); MIGRAINE/ HEADACHE; NON-ST WAVE ELEVATED MYOCARDIAL INFARCTION (NSTEMI); Septic Shock; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); THROMBOTIC THROMBOCYTOPENIC PURPURA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROTONIX | EQ 40MG BASE; EQ 20MG BASE | tablet, delayed release · oral | WYETH PHARMS | Prescription | 2 Feb 2000 |
| PROTONIX IV | EQ 40MG BASE/VIAL | injectable · intravenous | WYETH PHARMS | Prescription | 22 Mar 2001 |
| PROTONIX | EQ 40MG BASE | for suspension, delayed release · oral | WYETH PHARMS | Prescription | 14 Nov 2007 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | DR REDDYS LABS LTD | Prescription | 19 Jan 2011 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | TORRENT PHARMS | Prescription | 19 Jan 2011 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | MYLAN PHARMS INC | Prescription | 19 Jan 2011 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | APOTEX | Prescription | 19 Jan 2011 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | LANNETT CO INC | Prescription | 20 Jan 2011 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | RUBICON RESEARCH | Prescription | 2 May 2012 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | AUROBINDO PHARMA LTD | Prescription | 28 Sep 2012 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | injectable · intravenous | EPIC PHARMA LLC | Prescription | 8 Nov 2012 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | HETERO LABS LTD V | Prescription | 10 Sep 2014 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | ORBION PHARMS | Prescription | 2 Dec 2014 |
| PANTOPRAZOLE SODIUM | EQ 20MG BASE; EQ 40MG BASE | tablet, delayed release · oral | AMNEAL PHARMS | Prescription | 26 Jan 2016 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | injectable · intravenous | EUGIA PHARMA | Prescription | 30 Mar 2016 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | powder · intravenous | HIKMA | Prescription | 30 Jun 2017 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE | for suspension, delayed release · oral | SUN PHARM | Prescription | 30 Jun 2020 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | injectable · intravenous | HANGZHOU ZHONGMEI | Prescription | 30 Aug 2021 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | injectable · intravenous | GLAND | Prescription | 18 May 2022 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | injectable · intravenous | ASPIRO | Prescription | 18 May 2022 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | injectable · intravenous | BE PHARMS | Prescription | 18 May 2022 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | injectable · intravenous | KNACK | Prescription | 19 May 2022 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE | tablet, delayed release · oral | MANKIND PHARMA | Prescription | 26 Jul 2022 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | injectable · intravenous | MEITHEAL | Prescription | 29 Aug 2022 |
| PANTOPRAZOLE SODIUM | EQ 40MG BASE | for suspension, delayed release · oral | AJANTA PHARMA LTD | Prescription | 9 Feb 2023 |
23 more — full table
EMA European Union — centrally authorised medicines
Controloc Control Takeda GmbH · Authorised · authorised 11 Jun 2009 · ATC A02BC02
Therapeutic indication (EMA)
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Somac Control Takeda GmbH · Authorised · authorised 12 Jun 2009 · ATC A02BC02
Therapeutic indication (EMA)
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Pantoloc Control Takeda GmbH · Withdrawn · authorised 11 Jun 2009 · ATC A02BC02
Therapeutic indication (EMA)
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Pantecta Control Takeda GmbH · Withdrawn · authorised 12 Jun 2009 · ATC A02BC02
Therapeutic indication (EMA)
Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AG-PANTOPRAZOLE SODIUM | 02481588 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | ANGITA PHARMA INC. |
| ALTA-PANTOPRAZOLE | 02469138 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | ALTAMED PHARMA |
| APO-PANTOPRAZOLE | 02292912 | 20 MG | TABLET (DELAYED-RELEASE) · ORAL | APOTEX INC |
| APO-PANTOPRAZOLE | 02292920 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | APOTEX INC |
| AURO-PANTOPRAZOLE | 02415208 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | AURO PHARMA INC |
| BIO-PANTOPRAZOLE | 02445867 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | BIOMED PHARMA |
| JAMP PANTOPRAZOLE SODIUM | 02392615 | 20 MG | TABLET (DELAYED-RELEASE) · ORAL | JAMP PHARMA CORPORATION |
| JAMP PANTOPRAZOLE SODIUM | 02392623 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | JAMP PHARMA CORPORATION |
| JAMP-PANTOPRAZOLE | 02357054 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | JAMP PHARMA CORPORATION |
| M-PANTOPRAZOLE | 02467372 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | MANTRA PHARMA INC |
| MAR-PANTOPRAZOLE | 02416565 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | MARCAN PHARMACEUTICALS INC |
| MINT-PANTOPRAZOLE | 02417448 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | MINT PHARMACEUTICALS INC |
| MYLAN-PANTOPRAZOLE T | 02408570 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | MYLAN PHARMACEUTICALS ULC |
| NB-PANTOPRAZOLE | 02557304 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | NB PHARMA INC. |
| NRA-PANTOPRAZOLE | 02471825 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | NORA PHARMA INC |
| PANTOLOC | 02229453 | 40 MG | TABLET (ENTERIC-COATED) · ORAL | TAKEDA CANADA INC |
| PANTOLOC | 02241804 | 20 MG | TABLET (ENTERIC-COATED) · ORAL | TAKEDA CANADA INC |
| PANTOPRAZOLE | 02318695 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | PRO DOC LIMITEE |
| PANTOPRAZOLE | 02370808 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | SANIS HEALTH INC |
| PANTOPRAZOLE | 02428172 | 20 MG | TABLET (DELAYED-RELEASE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| PANTOPRAZOLE | 02428180 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | SIVEM PHARMACEUTICALS ULC |
| PANTOPRAZOLE | 02431327 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | LABORATOIRE RIVA INC. |
| PANTOPRAZOLE | 02536137 | 20 MG | TABLET (DELAYED-RELEASE) · ORAL | SANIS HEALTH INC |
| PANTOPRAZOLE | 02547368 | 40 MG | TABLET (DELAYED-RELEASE) · ORAL | 10445517 CANADA INC / NORTH PHARMACEUTICALS / DAC PHARMACEUTICALS |
| PANTOPRAZOLE FOR INJECTION | 02352214 | 40 MG / VIAL | POWDER FOR SOLUTION · INTRAVENOUS | FRESENIUS KABI CANADA LTD |
14 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | PANTOPRAZOLE DR 40 MG SUSP PKT | $3.84903 | per EA | 30 Sep 2026 |
| US NADAC | PANTOPRAZOLE SOD DR 20 MG TAB | $0.04262 | per EA | 23 Sep 2026 |
| US NADAC | PANTOPRAZOLE SOD DR 40 MG TAB | $0.03577 | per EA | 23 Sep 2026 |
| US NADAC | PANTOPRAZOLE SODIUM 40 MG VIAL | $2.374 | per EA | 18 Mar 2026 |
| US NADAC | PROTONIX 40 MG SUSPENSION | $14.06629 | per EA | 23 Sep 2026 |
| US NADAC | PROTONIX DR 20 MG TABLET | $14.31343 | per EA | 1 Jan 2026 |
| US NADAC | PROTONIX DR 40 MG TABLET | $14.23539 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Pantoprazole 20mg gastro-resistant tablets | £0.86 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Pantoprazole 40mg gastro-resistant tablets | £0.91 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Pantoprazole 40mg powder for solution for injection vials | £5.00 | 1 vial | 1 Oct 2026 |
| NHS Drug Tariff | Pantoprazole 40mg powder for solution for injection vials | £22.50 | 5 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.
Safety signals and safety-related labeling changes
- US FDA 12 Aug 2024 PROTONIX IV — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Jul 2023 PANTOPRAZOLE SODIUM — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Jul 2023 PROTONIX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Jul 2023 PROTONIX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 16 May 2019 PRAC signal: Colitis microscopic
Action for MAH: update of the product information: Yes - EMA PRAC 17 Jan 2019 PRAC signal: Colitis microscopic
Action for MAH: update of the product information: No - EMA PRAC 12 Jan 2017 PRAC signal: Incident chronic kidney disease (CKD) and progression to end stage renal disease (ESRD)
Action for MAH: update of the product information: No - EMA PRAC 1 Dec 2016 PRAC signal: Gastric polyps
Action for MAH: update of the product information: Yes - EMA PRAC 2 Sep 2016 PRAC signal: Incident chronic kidney disease (CKD) and progression to end stage renal disease (ESRD)
Action for MAH: update of the product information: No - EMA PRAC 8 Jul 2016 PRAC signal: Elevated circulating levels of chromogranin A
Action for MAH: update of the product information: Yes - EMA PRAC 17 Mar 2016 PRAC signal: Elevated circulating levels of chromogranin A
Action for MAH: update of the product information: No - EMA PRAC 9 Jul 2015 PRAC signal: Subacute cutaneous lupus erythematosus (SCLE)
Action for MAH: update of the product information: Yes - EMA PRAC 10 Apr 2015 PRAC signal: Subacute cutaneous lupus erythematosus (SCLE)
Action for MAH: update of the product information: No - EMA PRAC 6 Nov 2014 PRAC signal: Subacute cutaneous lupus erythematosus (SCLE)
Action for MAH: update of the product information: No
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.