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 | Adapt 232 |
D.3.4 | Pharmaceutical form | Capsule* |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Oral use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | p-hydroxyphenylethyl-O-β-D-glucopyranoside |
D.3.9.2 | Current sponsor code | SP.EX-006 |
D.3.9.3 | Other descriptive name | Rhodiola rosea root dry extract |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 45mg dry extract |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | 5,6,7,8-tetrahydro-1,2,3,10,11, 12-hexamethoxy-6,7dimethyldibenzo (a,c)cycklo-octen-6-ol |
D.3.9.2 | Current sponsor code | SP.EX-005 |
D.3.9.3 | Other descriptive name | schisandra chinesis fruit, dry extract |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 175mg dry extract |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | 3-[4-(1-O-β-D-Glucopyranosyl)-oxy-3,5-dimethoxyphenyl)-2-propen-1-ol,E-form and 2,6-Bis[1-O-β-Glucopyranosyl)-oxy-3,5-dimethoxyphenyl)-3,7–dioxabicycl |
D.3.9.2 | Current sponsor code | SP.EX-003 |
D.3.9.3 | Other descriptive name | Eleutherococcus senticosus root dry extraxt, eleutheroside E, eleutheroside B |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 55mg dry extract |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
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) | 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 | No |
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 | Yes |
D.3.11.12 | Homeopathic medicinal product | No |
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 | 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.2.1.2 | Country which granted the Marketing Authorisation | Sweden |
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 | Artcic root |
D.3.4 | Pharmaceutical form | Capsule, hard |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Oral use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | p-hydroxyphenylethyl-O-β-D-glucopyranoside |
D.3.9.2 | Current sponsor code | SP.EX.006 |
D.3.9.3 | Other descriptive name | Rhodiola rosea root dry extract |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 180mg dry extract |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
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) | 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 | No |
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 | Yes |
D.3.11.12 | Homeopathic medicinal product | No |
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 | 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 | 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 | Panax Ginseng Dry Extract/IDB |
D.3.2 | Product code | 9033921 |
D.3.4 | Pharmaceutical form | Capsule, hard |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Oral use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | 3beta,12beta)-20-[(6-O-beta-D-Glucopyranosyl-beta-D-glucopyranosyl)oxy]-12-hydroxydammar-24-en-3-yl2-O-beta-D-glucopyranosyl-beta-D-glucopyranoside |
D.3.9.1 | CAS number | 41753-43-9 |
D.3.9.3 | Other descriptive name | Panax ginseng root dry extract |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg milligram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 55mg dry extract |
D.3.11 The IMP contains an: |
D.3.11.1 | Active substance of chemical origin | No |
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) | 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 | No |
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 | Yes |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Information not present in EudraCT |