Active substance
Mesalazine
- SFDA 20
- US FDA 46
- Health Canada 19
- US price lines 12
- NHS prices 22
- WHO EML 1
- Safety 12
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ASACOL | 1600 mg | modified-release tablet · Oral use | 60 Blister | SAR 295.55 | NCE · Prescription | Tillotts Pharma GmbH | Valid |
| ASACOL 400MG F.C TAB | 400 mg | Gastro-resistant tablet · Oral use | 50 Blister | SAR 68.20 | NCE · Prescription | TILLOTTS | Valid |
| ASACOL 500MG SUPPOSITORIES | 500 mg | Suppository · Rectal use | 20 Blister | SAR 58.70 | NCE · Prescription | TILLOTTS | Valid |
| ASACOL 800MG GASTRO-RESISTANT TABLETS | 800 mg | Gastro-resistant tablet · Oral use | 50 Blister | SAR 129.60 | NCE · Prescription | TILLOTTS | Valid |
| PENTASA 1 G CONTROLLED RELEASE TABLET | 1 g | Prolonged-release tablet · Oral use | 60 Blister | SAR 167.30 | NCE · Prescription | FERRING | Valid |
| PENTASA 1% ENEMA | 1 g | Enema · Rectal use | 7 Box | SAR 78.50 | Generic · Prescription | FERRING | Valid |
| PENTASA 1GM PROLONGED RELEASE GRANULES | 1 g | Prolonged-release granules · Oral use | 50 Sachet | SAR 166.05 | NCE · Prescription | FERRING | Valid |
| PENTASA 1GM SUPP. | 1 g | Suppository · Rectal use | 14 Box | SAR 107.50 | NCE · Prescription | FERRING | Valid |
| PENTASA 4GM PROLONGED RELEASE GRANULES IN SACHET | 4 g | Granules in sachet · Oral use | 30 Sachet | SAR 292.55 | NCE · Prescription | FERRING | Valid |
| PENTASA 500 MG SLOW RELEASE TABLET | 500 mg | Prolonged-release tablet · Oral use | 50 Blister | SAR 85.70 | NCE · Prescription | FERRING | Valid |
| PENTASA XTEND 2 GM SACHET | 2 g | Oral powder · Oral use | 60 Sachet | SAR 299.75 | Generic · Prescription | FERRING | Valid |
| Rosol | 1 g | Film-coated tablet · Oral use | 100 Blister | SAR 191.50 | Generic · Prescription | FAES FARMA, S.A. | Valid |
| SALOFALK 4GM-60ML ENEMA | 4 g | Rectal suspension · Rectal use | 7 Tube | SAR 138.05 | NCE · Prescription | DR. FALK PHARMA | Valid |
| SALOFALK 500MG TAB | 500 mg | Gastro-resistant tablet · Oral use | 50 Blister | SAR 68.30 | Generic · Prescription | DR. FALK PHARMA | Valid |
| Salofalk | 500 mg | Prolonged-release granules · Oral use | 100 Sachet | SAR 152.30 | NCE · Prescription | DR. FALK PHARMA | Valid |
| Salofalk | 1000 mg | Prolonged-release granules · Oral use | 50 Sachet | SAR 152.30 | NCE · Prescription | DR. FALK PHARMA | Valid |
| Salofalk | 1500 mg | Prolonged-release granules · Oral use | 60 Sachet | SAR 238.15 | NCE · Prescription | DR. FALK PHARMA | Valid |
| Salofalk | 3000 mg | Prolonged-release granules · Oral use | 60 Sachet | SAR 416.35 | NCE · Prescription | DR. FALK PHARMA | Valid |
| MEZACOL 400 MG E.C TABLET | 400 mg | Gastro-resistant tablet · Oral use | 20 Blister | SAR 27.15 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Withdrawn by MAH · Not Marketed |
| MEZACOL 400 MG E.C TABLET | 400 mg | Gastro-resistant tablet · Oral use | 50 Blister | SAR 58.30 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ULCERATIVE COLITIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ROWASA | 4GM/60ML | enema · rectal | MYLAN SPECIALITY LP | Prescription | 24 Dec 1987 |
| PENTASA | 250MG; 500MG | capsule, extended release · oral | TAKEDA PHARMS USA | Prescription | 10 May 1993 |
| CANASA | 1GM | suppository · rectal | ABBVIE | Prescription | 5 Jan 2001 |
| MESALAMINE | 4GM/60ML | enema · rectal | PADAGIS ISRAEL | Prescription | 17 Sep 2004 |
| LIALDA | 1.2GM | tablet, delayed release · oral | TAKEDA PHARMS USA | Prescription | 16 Jan 2007 |
| APRISO | 375MG | capsule, extended release · oral | SALIX | Prescription | 31 Oct 2008 |
| MESALAMINE | 1GM | suppository · rectal | QUAGEN | Prescription | 24 Nov 2015 |
| MESALAMINE | 1.2GM | tablet, delayed release · oral | ZYDUS PHARMS | Prescription | 5 Jun 2017 |
| MESALAMINE | 800MG | tablet, delayed release · oral | ZYDUS PHARMS | Prescription | 21 Jul 2017 |
| MESALAMINE | 1.2GM | tablet, delayed release · oral | ACTAVIS LABS FL | Prescription | 23 Mar 2018 |
| MESALAMINE | 1.2GM | tablet, delayed release · oral | SUN PHARM | Prescription | 25 Jan 2019 |
| MESALAMINE | 1GM | suppository · rectal | RISING | Prescription | 19 Apr 2019 |
| MESALAMINE | 400MG | capsule, delayed release · oral | TEVA PHARMS USA | Prescription | 9 May 2019 |
| MESALAMINE | 1GM | suppository · rectal | SANDOZ | Prescription | 12 Jun 2019 |
| MESALAMINE | 1GM | suppository · rectal | J MOLNER | Prescription | 21 Jun 2019 |
| MESALAMINE | 375MG | capsule, extended release · oral | MYLAN | Prescription | 20 Nov 2019 |
| MESALAMINE | 1GM | suppository · rectal | ZYDUS PHARMS | Prescription | 12 Feb 2020 |
| MESALAMINE | 1GM | suppository · rectal | ANNORA PHARMA | Prescription | 19 Mar 2020 |
| MESALAMINE | 1GM | suppository · rectal | ACTAVIS MID ATLANTIC | Prescription | 14 Aug 2020 |
| MESALAMINE | 375MG | capsule, extended release · oral | ALKEM LABS LTD | Prescription | 15 Jul 2021 |
| MESALAMINE | 375MG | capsule, extended release · oral | ZYDUS PHARMS | Prescription | 12 Aug 2021 |
| MESALAMINE | 500MG | capsule, extended release · oral | SUN PHARM | Prescription | 11 May 2022 |
| MESALAMINE | 375MG | capsule, extended release · oral | ALEMBIC | Prescription | 28 Oct 2022 |
| MESALAMINE | 375MG | capsule, extended release · oral | AUROBINDO PHARMA LTD | Prescription | 31 Mar 2023 |
| MESALAMINE | 1.2GM | tablet, delayed release · oral | SINOTHERAPEUTICS INC | Prescription | 12 May 2023 |
21 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MEZAVANT | 02297558 | 1.2 G | TABLET (DELAYED- AND EXTENDED-RELEASE) · ORAL | TAKEDA CANADA INC |
| MEZERA | 02474018 | 1 G | SUPPOSITORY · RECTAL | AVIR PHARMA INC. |
| MEZERA | 02474026 | 1 G / ACT | FOAM · RECTAL | AVIR PHARMA INC. |
| MEZERA | 02524481 | 500 MG | TABLET (DELAYED-RELEASE) · ORAL | AVIR PHARMA INC. |
| MEZERA | 02545012 | 1 G | TABLET (DELAYED-RELEASE) · ORAL | AVIR PHARMA INC. |
| OCTASA | 02465752 | 800 MG | TABLET (DELAYED-RELEASE) · ORAL | TILLOTTS PHARMA AG |
| OCTASA | 02529610 | 1600 MG | TABLET (DELAYED-RELEASE) · ORAL | TILLOTTS PHARMA AG |
| PENTASA | 02099683 | 500 MG | TABLET (EXTENDED-RELEASE) · ORAL | FERRING INC |
| PENTASA | 02153521 | 1 G / 100 ML | SUSPENSION · RECTAL | FERRING INC |
| PENTASA | 02153556 | 4 G / 100 ML | SUSPENSION · RECTAL | FERRING INC |
| PENTASA | 02153564 | 1 G | SUPPOSITORY · RECTAL | FERRING INC |
| PENTASA | 02399466 | 1 G | TABLET (EXTENDED-RELEASE) · ORAL | FERRING INC |
| SALOFALK | 02112760 | 500 MG | SUPPOSITORY · RECTAL | ABBVIE CORPORATION |
| SALOFALK | 02112787 | 500 MG | TABLET (DELAYED-RELEASE) · ORAL | ABBVIE CORPORATION |
| SALOFALK | 02112795 | 2 G / 60 G | SUSPENSION · RECTAL | ABBVIE CORPORATION |
| SALOFALK | 02112809 | 4 G / 60 G | SUSPENSION · RECTAL | ABBVIE CORPORATION |
| SALOFALK | 02242146 | 1000 MG | SUPPOSITORY · RECTAL | ABBVIE CORPORATION |
| TEVA-5 ASA | 02171929 | 400 MG | TABLET (ENTERIC-COATED) · ORAL | TEVA CANADA LIMITED |
| ZDS-MESALAMINE SUPPOSITORIES | 02562367 | 1000 MG | SUPPOSITORY · RECTAL | ZYDUS LIFESCIENCES LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CANASA 1,000 MG SUPPOSITORY | $37.10967 | per EA | 23 Sep 2026 |
| US NADAC | LIALDA DR 1.2 GM TABLET | $8.94652 | per EA | 23 Sep 2026 |
| US NADAC | MESALAMINE 1,000 MG SUPP | $1.28382 | per EA | 23 Sep 2026 |
| US NADAC | MESALAMINE 4 GM/60 ML ENEMA | $0.09843 | per ML | 23 Sep 2026 |
| US NADAC | MESALAMINE 4 GM/60 ML ENEMA | $0.17585 | per ML | 23 Sep 2026 |
| US NADAC | MESALAMINE 4 GM/60 ML KIT | $134.90444 | per EA | 23 Sep 2026 |
| US NADAC | MESALAMINE 800 MG DR TABLET | $4.02045 | per EA | 23 Sep 2026 |
| US NADAC | MESALAMINE DR 1.2 GM TABLET | $0.7809 | per EA | 23 Sep 2026 |
| US NADAC | MESALAMINE DR 400 MG CAPSULE | $2.69898 | per EA | 23 Sep 2026 |
| US NADAC | MESALAMINE ER 0.375 GRAM CAP | $0.47798 | per EA | 23 Sep 2026 |
| US NADAC | PENTASA 250 MG CAPSULE | $2.90086 | per EA | 23 Sep 2026 |
| US NADAC | PENTASA 500 MG CAPSULE | $5.82619 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Mesalazine 1.2g gastro-resistant modified-release tablets | £42.95 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1.5g gastro-resistant modified-release granules sachets sugar free | £48.85 | 60 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1.6g gastro-resistant tablets | £30.08 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1g gastro-resistant modified-release granules sachets sugar free | £28.74 | 50 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1g gastro-resistant tablets | £58.50 | 90 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1g modified-release granules sachets sugar free | £30.74 | 50 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1g modified-release tablets | £36.89 | 60 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1g suppositories | £27.44 | 28 suppository | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1g/100ml enema | £17.73 | 7 enema | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 1g/application foam enema | £30.17 | 14 actuation | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 2g modified-release granules sachets sugar free | £73.78 | 60 sachet | 1 Oct 2026 |
| NHS Drug Tariff | Mesalazine 2g/59ml enema | £29.92 | 7 enema | 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)
- 17.3. Anti-inflammatory medicines · core
Therapeutic equivalent to sulfasalazine for Crohn disease site; Therapeutic equivalent to sulfasalazine for Ulcerative colitis
Safety signals and safety-related labeling changes
- US FDA 30 Jul 2024 PENTASA — 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 30 Jul 2024 ROWASA — 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 24 Oct 2023 APRISO — 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 24 Oct 2023 CANASA — 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 24 Oct 2023 LIALDA — 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 24 Oct 2023 DELZICOL — 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 16 Nov 2022 ASACOL HD — 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 1 Oct 2020 ASACOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 11 Jul 2019 PRAC signal: Nephrolithiasis
Action for MAH: update of the product information: Yes - EMA PRAC 16 May 2019 PRAC signal: Nephrolithiasis
Action for MAH: update of the product information: No - EMA PRAC 1 Sep 2017 PRAC signal: Risk of photosensitivity reactions
Action for MAH: update of the product information: Yes - EMA PRAC 6 Apr 2017 PRAC signal: Risk of photosensitivity reactions
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.