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 | MIRCERA |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Roche Registration Limited |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
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.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 30 mcg / 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 40 mcg/0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µl/ml microlitre(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 50 mcg/0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µl/ml microlitre(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 60 mcg/0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 75 mcg/0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 100 mcg/ 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 120 mcg/ 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 150 mcg/0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 200 mcg/ 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 250 mcg/0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | methoxy polyethylene glycol-epoetin beta |
D.3.9.2 | Current sponsor code | RO0503821 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 360 mcg/0.6 ml |
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) | 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 | 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 | 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 | 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 | Aranesp |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Amgen Europe B.V. |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
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.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | darbepoetin alfa |
D.3.9.2 | Current sponsor code | RO4910910 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 20 mcg / 0.5 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | darbepoetin alfa |
D.3.9.2 | Current sponsor code | RO4910910 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 30 mcg / 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | darbepoetin alfa |
D.3.9.2 | Current sponsor code | RO4910910 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 50 mcg / 0.5 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | darbepoetin alfa |
D.3.9.2 | Current sponsor code | RO4910910 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 100 mcg / 0.5 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | darbepoetin alfa |
D.3.9.2 | Current sponsor code | RO4910910 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg/ml microgram(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 300 mcg / 0.6 ml |
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) | 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 | 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 | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
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 | Yes |
D.2.1.1.1 | Trade name | Eprex/Erypo |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Janssen Cilag Ltd |
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.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin alfa |
D.3.9.2 | Current sponsor code | RO4910905 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3000 IU / 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin alfa |
D.3.9.2 | Current sponsor code | RO4910905 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 5000 IU / 0.5 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin alfa |
D.3.9.2 | Current sponsor code | RO4910905 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 6000 IU / 0.6 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin alfa |
D.3.9.2 | Current sponsor code | RO4910905 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 8000 IU / 0.8 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin alfa |
D.3.9.2 | Current sponsor code | RO4910905 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10000 IU / 1.0 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin alfa |
D.3.9.2 | Current sponsor code | RO4910905 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 30000IU / 0.75 ml |
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) | 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 | 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 | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |
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 | NeoRecormon |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Roche Registration Limited |
D.2.1.2 | Country which granted the Marketing Authorisation | European Union |
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.3.4 | Pharmaceutical form | Solution for injection |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Intravenous use Subcutaneous use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin beta |
D.3.9.2 | Current sponsor code | RO2053859 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 2000 IU / 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin beta |
D.3.9.2 | Current sponsor code | RO2053859 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3000 IU / 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin beta |
D.3.9.2 | Current sponsor code | RO2053859 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 6000 IU / 0.3 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin beta |
D.3.9.2 | Current sponsor code | RO2053859 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 10000 IU / 0.6 ml |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | epoetin beta |
D.3.9.2 | Current sponsor code | RO2053859 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | IU/ml international unit(s)/millilitre |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 20000 IU / 0.6 ml |
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) | 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 | 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 | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | No |