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 | AMCHAFIBRIN 500 mg inyectable |
D.2.1.1.2 | Name of the Marketing Authorisation holder | ROTTAPHARM, S.L. |
D.2.1.2 | Country which granted the Marketing Authorisation | Spain |
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 | 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 | TRANEXAMICO ACIDO |
D.3.9.1 | CAS number | 1197-18-8 |
D.3.9.3 | Other descriptive name | TRANEXAMIC ACID |
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 | 500 |
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) | 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 | 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 | TISSUCOL DUO 2,0 ml |
D.2.1.1.2 | Name of the Marketing Authorisation holder | BAXTER, S.L. |
D.2.1.2 | Country which granted the Marketing Authorisation | Spain |
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 | Periarticular use
|
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | FIBRONECTINA |
D.3.9.3 | Other descriptive name | FIBRONECTINA |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 2
to
9 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PROTEINAS |
D.3.9.3 | Other descriptive name | PROTEINS NOS |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 100
to
130 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TROMBINA HUMANA |
D.3.9.3 | Other descriptive name | TROMBINA HUMANA |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | EID50/dose 50% Embryo Infective Dose/dose |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 500 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CALCIO CLORURO |
D.3.9.1 | CAS number | 10035-04-8 |
D.3.9.3 | Other descriptive name | CALCIO CLORURO |
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 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | FIBRINOGENO HUMANO |
D.3.9.1 | CAS number | 9001-31-4 |
D.3.9.3 | Other descriptive name | FIBRINOGEN, HUMAN |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | mg/ml milligram(s)/millilitre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 70
to
110 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PLASMINOGENO |
D.3.9.1 | CAS number | 9001-91-6 |
D.3.9.3 | Other descriptive name | PLASMINOGENO |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | µg microgram(s) |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 40
to
120 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | APROTININA |
D.3.9.1 | CAS number | 9004-04-0 |
D.3.9.3 | Other descriptive name | APROTININ |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | EID50 50% Embryo Infective Dose |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 3000 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | FACTOR XIII |
D.3.9.1 | CAS number | 9013-56-3 |
D.3.9.3 | Other descriptive name | FACTOR XIII |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | EID50 50% Embryo Infective Dose |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 10
to
50 |
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 | Yes |
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 |