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 | TAURAMIN 10% , Solución para perfusión |
D.2.1.1.2 | Name of the Marketing Authorisation holder | LABORATORIOS GRIFOLS, S.A. |
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 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 | TAURINA |
D.3.9.1 | CAS number | 107-35-7 |
D.3.9.3 | Other descriptive name | TAURINE |
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 | 1.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | PROLINA |
D.3.9.1 | CAS number | 147-85-3 |
D.3.9.3 | Other descriptive name | 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 | 8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CISTEINA |
D.3.9.1 | CAS number | 52-90-4 |
D.3.9.3 | Other descriptive name | CYSTEINE |
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 | 0.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | GLICINA |
D.3.9.1 | CAS number | 56-40-6 |
D.3.9.3 | Other descriptive name | 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 | 8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ALANINA |
D.3.9.1 | CAS number | 56-41-7 |
D.3.9.3 | Other descriptive name | 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 | 9 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | SERINA |
D.3.9.1 | CAS number | 56-45-1 |
D.3.9.3 | Other descriptive name | 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 | 5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ASPARTICO ACIDO |
D.3.9.1 | CAS number | 56-84-8 |
D.3.9.3 | Other descriptive name | ASPARTIC ACID |
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 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | GLUTAMICO ACIDO |
D.3.9.1 | CAS number | 56-86-0 |
D.3.9.3 | Other descriptive name | GLUTAMIC ACID |
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 | 8.7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | METIONINA |
D.3.9.1 | CAS number | 59-51-8 |
D.3.9.3 | Other descriptive name | 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 | 3.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TIROSINA |
D.3.9.1 | CAS number | 60-18-4 |
D.3.9.3 | Other descriptive name | 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 | 0.35 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | LEUCINA |
D.3.9.1 | CAS number | 61-90-5 |
D.3.9.3 | Other descriptive name | 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 | 8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | FENILALANINA |
D.3.9.1 | CAS number | 63-91-2 |
D.3.9.3 | Other descriptive name | 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 | 5.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | LISINA HIDROCLORURO |
D.3.9.1 | CAS number | 657-27-2 |
D.3.9.3 | Other descriptive name | LYSINE HYDROCHLORIDE |
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 | 7.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CISTEINA HIDROCLORURO HIDRATADO |
D.3.9.1 | CAS number | 7048-04-6 |
D.3.9.3 | Other descriptive name | CISTEINA HIDROCLORURO HIDRATADO |
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 | 0.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HISTIDINA |
D.3.9.1 | CAS number | 71-00-1 |
D.3.9.3 | Other descriptive name | 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 | 4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | VALINA |
D.3.9.1 | CAS number | 72-18-4 |
D.3.9.3 | Other descriptive name | 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 | 7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TREONINA |
D.3.9.1 | CAS number | 72-19-5 |
D.3.9.3 | Other descriptive name | 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 | 4.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TRIPTOFANO |
D.3.9.1 | CAS number | 73-22-3 |
D.3.9.3 | Other descriptive name | 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 | 1.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ISOLEUCINA |
D.3.9.1 | CAS number | 73-32-5 |
D.3.9.3 | Other descriptive name | 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 | 5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ARGININA |
D.3.9.1 | CAS number | 74-79-3 |
D.3.9.3 | Other descriptive name | 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 | 10 |
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 | 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 | VAMIN 14 SIN ELECTROLITOS inyectable |
D.2.1.1.2 | Name of the Marketing Authorisation holder | FRESENIUS KABI ESPAÑA, S.A. |
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 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 | PROLINA |
D.3.9.1 | CAS number | 147-85-3 |
D.3.9.3 | Other descriptive name | 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 | 5.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CISTEINA |
D.3.9.1 | CAS number | 52-90-4 |
D.3.9.3 | Other descriptive name | CYSTEINE |
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 | 0.42 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | GLICINA |
D.3.9.1 | CAS number | 56-40-6 |
D.3.9.3 | Other descriptive name | 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 | 5.9 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ALANINA |
D.3.9.1 | CAS number | 56-41-7 |
D.3.9.3 | Other descriptive name | 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 | 12 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | SERINA |
D.3.9.1 | CAS number | 56-45-1 |
D.3.9.3 | Other descriptive name | 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 | 3.4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ASPARTICO ACIDO |
D.3.9.1 | CAS number | 56-84-8 |
D.3.9.3 | Other descriptive name | ASPARTIC ACID |
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 | 2.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | GLUTAMICO ACIDO |
D.3.9.1 | CAS number | 56-86-0 |
D.3.9.3 | Other descriptive name | GLUTAMIC ACID |
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 | 4.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | LISINA |
D.3.9.1 | CAS number | 56-87-1 |
D.3.9.3 | Other descriptive name | 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 | 6.8 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | CISTINA |
D.3.9.1 | CAS number | 56-89-3 |
D.3.9.3 | Other descriptive name | CYSTINE |
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 | 0.42 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | METIONINA |
D.3.9.1 | CAS number | 59-51-8 |
D.3.9.3 | Other descriptive name | 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 | 4.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TIROSINA |
D.3.9.1 | CAS number | 60-18-4 |
D.3.9.3 | Other descriptive name | 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 | 0.17 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | LEUCINA |
D.3.9.1 | CAS number | 61-90-5 |
D.3.9.3 | Other descriptive name | 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 | 5.9 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | FENILALANINA |
D.3.9.1 | CAS number | 63-91-2 |
D.3.9.3 | Other descriptive name | 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 | 5.9 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | HISTIDINA |
D.3.9.1 | CAS number | 71-00-1 |
D.3.9.3 | Other descriptive name | 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 | 5.1 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | VALINA |
D.3.9.1 | CAS number | 72-18-4 |
D.3.9.3 | Other descriptive name | 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 | 5.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TREONINA |
D.3.9.1 | CAS number | 72-19-5 |
D.3.9.3 | Other descriptive name | 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 | 4.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | TRIPTOFANO |
D.3.9.1 | CAS number | 73-22-3 |
D.3.9.3 | Other descriptive name | 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 | 1.4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ISOLEUCINA |
D.3.9.1 | CAS number | 73-32-5 |
D.3.9.3 | Other descriptive name | 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 | 4.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | ARGININA |
D.3.9.1 | CAS number | 74-79-3 |
D.3.9.3 | Other descriptive name | 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 | 8.4 |
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 |