| Asacolon 1000 mg Suppository PA2018/005/001 |
Mesalazine |
Tillotts Pharma GmbH |
Marketed |
| Asacolon 1600 mg modified-release tablets PA2018/004/001 |
Mesalazine |
Tillotts Pharma GmbH |
Marketed |
| Asacolon 400mg Gastro-Resistant Tablets PA2018/001/001 |
Mesalazine |
Tillotts Pharma GmbH |
Marketed |
| Asacolon 500 mg Suppositories PA2018/001/003 |
Mesalazine |
Tillotts Pharma GmbH |
Marketed |
| Asacolon 800 mg Gastro-resistant Tablets PPA0465/465/001 |
Mesalazine |
PCO Manufacturing Ltd. |
— |
| Asacolon 800mg Gastro-resistant Tablets PA2018/001/002 |
Mesalazine |
Tillotts Pharma GmbH |
Marketed |
| Galtasa 1000 mg gastro-resistant tablets PA0864/001/003 |
Mesalazine |
Faes Farma S.A. |
Not marketed |
| Galtasa 500 mg gastro-resistant tablets PA0864/001/001 |
Mesalazine |
Faes Farma S.A. |
Not marketed |
| Galtasa 500 mg suppositories PA0864/001/002 |
Mesalazine |
Faes Farma S.A. |
Not marketed |
| Mezavant XL 1200 mg gastro-resistant, prolonged release tablets PA23211/004/001 |
Mesalazine |
Takeda Pharmaceuticals International AG Ireland Branch |
Marketed |
| Mezavant XL 1200 mg gastro-resistant, prolonged release tablets PPA0465/289/001 |
Mesalazine |
PCO Manufacturing Ltd. |
— |
| Mezavant XL 1200 mg gastro-resistant, prolonged release tablets PPA1463/093/001 |
Mesalazine |
IMED Healthcare Ltd., |
— |
| Mezavant XL 1200 mg gastro-resistant, prolonged release tablets PPA2306/023/001 |
Mesalazine |
Originalis B.V. |
— |
| Pentasa 1 g prolonged-release tablets PA1009/006/007 |
Mesalazine |
Ferring Ireland Ltd |
Marketed |
| Pentasa 1 g prolonged-release tablets PPA1463/110/002 |
Mesalazine |
IMED Healthcare Ltd. |
— |
| Pentasa 1 g prolonged-release tablets PPA0465/450/003 |
Mesalazine |
PCO Manufacturing Ltd. |
— |
| Pentasa 1 g suppositories PPA2306/010/001 |
Mesalazine |
Originalis B.V. |
— |
| Pentasa 1 g Suppositories PPA1463/190/003 |
Mesalazine |
IMED Healthcare Ltd., |
— |
| Pentasa 10 mg/ml Rectal Suspension PA1009/006/003 |
Mesalazine |
Ferring Ireland Ltd |
Marketed |
| Pentasa 1g Suppositories PA1009/006/002 |
Mesalazine |
Ferring Ireland Ltd |
Marketed |
| Pentasa 1g Suppositories PPA0465/450/005 |
Mesalazine |
PCO Manufacturing Ltd. |
— |
| Pentasa 500 mg prolonged-release tablets PA1009/006/005 |
Mesalazine |
Ferring Ireland Ltd |
Marketed |
| Pentasa 500 mg prolonged-release tablets PPA1463/110/001 |
Mesalazine |
IMED Healthcare Ltd., |
— |
| Pentasa Sachet 1g prolonged-release granules PA1009/006/001 |
Mesalazine |
Ferring Ireland Ltd |
Marketed |
| Pentasa Sachet 1g prolonged-release granules PPA0465/450/006 |
Mesalazine |
PCO Manufacturing Ltd. |
— |
| Pentasa Sachet 2 g prolonged-release granules PPA0465/450/001 |
Mesalazine |
PCO Manufacturing Ltd. |
— |
| Pentasa Sachet 2 g prolonged-release granules PPA1463/190/001 |
Mesalazine |
IMED Healthcare Ltd., |
— |
| Pentasa Sachet 2g prolonged-release granules PA1009/006/006 |
Mesalazine |
Ferring Ireland Ltd |
Marketed |
| Pentasa Sachet 2g prolonged-release granules PPA2306/010/002 |
Mesalazine |
Originalis B.V. |
— |
| Pentasa Sachet 4 g prolonged-release granules PPA0465/450/004 |
Mesalazine |
PCO Manufacturing Ltd. |
— |
| Pentasa Sachet 4 g prolonged-release granules PPA1463/190/002 |
Mesalazine |
IMED Healthcare Ltd., |
— |
| Pentasa Sachet 4 g Prolonged-release granules PA1009/006/008 |
Mesalazine |
Ferring Ireland Ltd |
Marketed |
| Salofalk 1.5g prolonged-release granules PA0573/003/007 |
Mesalazine |
Dr. Falk Pharma GmbH |
Marketed |
| Salofalk 1000mg prolonged-release granules PA0573/003/002 |
Mesalazine |
Dr. Falk Pharma GmbH |
Marketed |
| Salofalk 1g Suppositories PA0573/004/004 |
Mesalazine |
Dr. Falk Pharma GmbH |
Marketed |
| Salofalk 1g Suppositories PPA1463/212/001 |
Mesalazine |
IMED Healthcare Ltd., |
— |
| Salofalk 1g/Actuation Rectal Foam PA0573/004/005 |
Mesalazine |
Dr. Falk Pharma GmbH |
Marketed |
| Salofalk 250 mg Suppositories PA0573/004/002 |
Mesalazine |
Dr. Falk Pharma GmbH |
Marketed |
| Salofalk 3g prolonged-release granules PA0573/003/006 |
Mesalazine |
Dr. Falk Pharma GmbH |
Marketed |
| Salofalk 4g/60ml Enema PA0573/004/001 |
Mesalazine |
Dr. Falk Pharma GmbH |
Marketed |
| Salofalk 500 mg prolonged-release granules PA0573/003/001 |
Mesalazine |
Dr. Falk Pharma GmbH |
Marketed |