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 | Yes |
D.2.1.1.1 | Trade name | Plasma-Lyte 148 (pH 7.4) Solution for Infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Healthcare Limited |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Plasma-Lyte 148 (pH 7.4) Solution for Infusion |
D.3.2 | Product code | PL 00116/0332 |
D.3.4 | Pharmaceutical form | Intravenous 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 | Magnesium chloride hexahydrate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.03 |
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 | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.526 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Potassium chloride |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.037 |
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 | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.368 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Sodium gluconate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.502 |
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) | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | Information not present in EudraCT |
D.3.11.7 | Plasma derived medicinal product | Information not present in EudraCT |
D.3.11.8 | Extractive medicinal product | Information not present in EudraCT |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | Information not present in EudraCT |
D.3.11.11 | Herbal medicinal product | Information not present in EudraCT |
D.3.11.12 | Homeopathic medicinal product | Information not present in EudraCT |
D.3.11.13 | Another type of medicinal product | Information not present in EudraCT |
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 | 1000 ml Sodium Chloride 0.9% w/v intravenous infusion BP in a Viaflex container |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Healthcare Limited |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | 1000 ml Sodium Chloride 0.9% w/v intravenous infusion BP in a Viaflex container |
D.3.2 | Product code | PL0116/5057R |
D.3.4 | Pharmaceutical form | Intravenous 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 | Sodium chloride |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g gram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 9 |
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) | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | Information not present in EudraCT |
D.3.11.7 | Plasma derived medicinal product | Information not present in EudraCT |
D.3.11.8 | Extractive medicinal product | Information not present in EudraCT |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | Information not present in EudraCT |
D.3.11.11 | Herbal medicinal product | Information not present in EudraCT |
D.3.11.12 | Homeopathic medicinal product | Information not present in EudraCT |
D.3.11.13 | Another type of medicinal product | Information not present in EudraCT |
D.IMP: 3 |
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 | Yes |
D.2.1.1.1 | Trade name | Plasma Volume 6% Solution for Infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Baxter Healthcare Limited |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Plasma Volume 6% Solution for Infusion |
D.3.2 | Product code | PL 00116/0635 |
D.3.4 | Pharmaceutical form | Intravenous 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 | Calcium Chloride Dihydrate |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.0134 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Hydroxyethyl Starch |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 6 |
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 | % (W/V) percent weight/volume |
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.3.8 | INN - Proposed INN | Potassium chloride |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.04 |
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 | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.37 |
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 | % (W/V) percent weight/volume |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 0.6 |
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) | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | Information not present in EudraCT |
D.3.11.7 | Plasma derived medicinal product | Information not present in EudraCT |
D.3.11.8 | Extractive medicinal product | Information not present in EudraCT |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | Information not present in EudraCT |
D.3.11.11 | Herbal medicinal product | Information not present in EudraCT |
D.3.11.12 | Homeopathic medicinal product | Information not present in EudraCT |
D.3.11.13 | Another type of medicinal product | Information not present in EudraCT |
D.IMP: 4 |
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 | Voluven Fresenius 6% Solution for Infusion |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Fresenius Kabi |
D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
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 | Voluven Fresenius 6% Solution for Infusion |
D.3.2 | Product code | PL 08828/0157 |
D.3.4 | Pharmaceutical form | Intravenous 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 | Hydroxyethyl starch |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g gram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 60 |
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 gram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 9 |
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) | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
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 | Information not present in EudraCT |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | Information not present in EudraCT |
D.3.11.7 | Plasma derived medicinal product | Information not present in EudraCT |
D.3.11.8 | Extractive medicinal product | Information not present in EudraCT |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | Information not present in EudraCT |
D.3.11.11 | Herbal medicinal product | Information not present in EudraCT |
D.3.11.12 | Homeopathic medicinal product | Information not present in EudraCT |
D.3.11.13 | Another type of medicinal product | Information not present in EudraCT |