D.IMP: 1 |
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 | Clinimix N9G15E 1 litre |
D.3.4 | Pharmaceutical form | Solution for infusion |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-alanine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 11.38 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-arginine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 6.32 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Glycine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.67 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-histidine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.64 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-isoleucine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.30 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-leucine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.02 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-lysine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.19 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-methionine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.20 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-phenylalanine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.08 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-proline |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.74 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-serine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.75 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-threonine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.31 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-tryptophan |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.99 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-tyrosine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.22 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-valine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.19 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Sodium acetate trihydrate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.31 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Dibasic potassium phosphate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.22 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.24 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.02 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | glucose |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 150 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.662 |
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) | Yes |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Yes |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
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 | Yes |
D.3.11.13.1 | Other medicinal product type | Combination of actives substances manufactured by either synthesis/fermentation or extraction (glucose) |
D.IMP: 2 |
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 | Clinimix N9G15E 1 litre |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Clintec Parenteral SAS |
D.2.1.2 | Country which granted the Marketing Authorisation | France |
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 | Clinimix N9G15E 1 litre |
D.3.2 | Product code | DKB6669 |
D.3.4 | Pharmaceutical form | Solution for infusion |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-alanine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 11.38 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-arginine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 6.32 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Glycine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.67 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-histidine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.64 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-isoleucine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.30 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-leucine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.02 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-lysine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.19 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-methionine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.20 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-phenylalanine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.08 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-proline |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.74 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-serine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.75 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-threonine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.31 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-tryptophan |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.99 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-tyrosine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.22 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | L-valine |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3.19 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Sodium acetate trihydrate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4.31 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Dibasic potassium phosphate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5.22 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Sodium chloride |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2.24 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Magnesium chloride hexahydrate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 1.02 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Glucose |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 150 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Calcium chloride dihydrate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.662 |
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) | Yes |
| The IMP is a: |
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
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 | Yes |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
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.3.11.13.1 | Other medicinal product type | Combination of active substances manufactured by either synthesis/fermentation or extraction (glucose) |