D.IMP: 1 |
D.1.2 and D.1.3 | IMP Role | Comparator |
D.2 | Status of the IMP to be used in the clinical trial |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Custodiol® |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Dr. Franz Köhler Chemie GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP |
D.3.1 | Product name | Custodiol® |
D.3.4 | Pharmaceutical form | Solution for organ preservation |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intraarterial use Intracardiac use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | SODIUM CHLORIDE |
D.3.9.4 | EV Substance Code | SUB12581MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 15 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | POTASSIUM CHLORIDE |
D.3.9.4 | EV Substance Code | SUB12559MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 9,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | MAGNESIUM CHLORIDE HEXAHYDRATE |
D.3.9.4 | EV Substance Code | SUB12526MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | HISTIDINE HYDROCHLORIDE MONOHYDRATE |
D.3.9.4 | EV Substance Code | SUB12023MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 18,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 71-00-1 |
D.3.9.3 | Other descriptive name | HISTIDINE |
D.3.9.4 | EV Substance Code | SUB08045MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 180,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TRYPTOPHAN |
D.3.9.1 | CAS number | 73-22-3 |
D.3.9.4 | EV Substance Code | SUB12377MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | D-MANNITOL |
D.3.9.4 | EV Substance Code | SUB20970 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 30,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | CALCIUM CHLORIDE DIHYDRATE |
D.3.9.4 | EV Substance Code | SUB12664MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0,015 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | POTASSIUM HYDROGEN-2-OXOGLUTARAAT |
D.3.9.4 | EV Substance Code | SUB99979 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | POTASSIUM HYDROXIDE SOLUTION 50% |
D.3.9.4 | EV Substance Code | SUB78161 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | WATER FOR INJECTION |
D.3.9.4 | EV Substance Code | SUB12398MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | l litre(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1,0 |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
D.IMP: 2 |
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial |
D.2.1 | IMP to be used in the trial has a marketing authorisation | No |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP |
D.3.1 | Product name | Custodiol-N® |
D.3.4 | Pharmaceutical form | Solution for organ preservation |
D.3.4.1 | Specific paediatric formulation | No |
D.3.7 | Routes of administration for this IMP | Intracardiac use Infiltration
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | SODIUM CHLORIDE |
D.3.9.4 | EV Substance Code | SUB12581MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3,2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | POTASSIUM CHLORIDE |
D.3.9.4 | EV Substance Code | SUB12559MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | MAGNESIUM CHLORIDE HEXAHYDRATE |
D.3.9.4 | EV Substance Code | SUB12526MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 8,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 71-00-1 |
D.3.9.3 | Other descriptive name | HISTIDINE |
D.3.9.4 | EV Substance Code | SUB08045MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 124 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | CALCIUM CHLORIDE DIHYDRATE |
D.3.9.4 | EV Substance Code | SUB12664MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0,02 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | GLYCINE |
D.3.9.4 | EV Substance Code | SUB12000MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 56-41-7 |
D.3.9.3 | Other descriptive name | ALANINE |
D.3.9.4 | EV Substance Code | SUB05290MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg/l milligram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TRYPTOPHAN |
D.3.9.1 | CAS number | 73-22-3 |
D.3.9.4 | EV Substance Code | SUB12377MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | ARGININE |
D.3.9.4 | EV Substance Code | SUB05560MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | DEFEROXAMINE MESILATE |
D.3.9.1 | CAS number | 138-14-7 |
D.3.9.4 | EV Substance Code | SUB01571MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0,0250 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 56-84-8 |
D.3.9.3 | Other descriptive name | ASPARTIC ACID |
D.3.9.4 | EV Substance Code | SUB11721MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | WATER FOR INJECTION |
D.3.9.4 | EV Substance Code | SUB12398MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | l litre(s) |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 1,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | SODIUM HYDROXIDE SOLUTION |
D.3.9.4 | EV Substance Code | SUB20366 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 12,8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | OXOGLURIC ACID |
D.3.9.4 | EV Substance Code | SUB36364 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2,0 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Saccharose |
D.3.9.3 | Other descriptive name | SUCROSE |
D.3.9.4 | EV Substance Code | SUB12600MIG |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 33 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | LK 614 |
D.3.9.3 | Other descriptive name | 3,4 DIMETHOXY-N-METHYLBENZHYDROXAM ACID |
D.3.9.4 | EV Substance Code | SUB169610 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0,0075 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.3 | Other descriptive name | N-ACETYL-L-HISTIDINE MONOHYDRATE |
D.3.9.4 | EV Substance Code | SUB169536 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mmol/l millimole(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 57,0 |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | No |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | No |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | No |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | No |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | No |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | No |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |