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 | Information not present in EudraCT |
D.2.1.1.1 | Trade name | Omegaven-Fresenius |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Fresenius-Kabi Deutschland |
D.2.1.2 | Country which granted the Marketing Authorisation | Germany |
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 | Omegaven-Fresenius |
D.3.2 | Product code | Omegaven-Fresenius |
D.3.4 | Pharmaceutical form | Emulsion 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 | Icosapent |
D.3.9.1 | CAS number | 10417-94-4 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 12.5
to
28.2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 | INN - Proposed INN | Doconexent |
D.3.9.1 | CAS number | 6217-54-5 |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 14.4
to
30.9 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 544-63-8 |
D.3.9.3 | Other descriptive name | Myristic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 1
to
6 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 57-10-3 |
D.3.9.3 | Other descriptive name | Palmitic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 2.5
to
10 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 373-49-9 |
D.3.9.3 | Other descriptive name | (Z)-Hexadec-9-enoic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 3
to
9 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 57-11-4 |
D.3.9.3 | Other descriptive name | Stearic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 0.5
to
2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 112-80-1 |
D.3.9.3 | Other descriptive name | Oleic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 6
to
13 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 60-33-3 |
D.3.9.3 | Other descriptive name | Linoleic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 1
to
7 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 463-40-1 |
D.3.9.3 | Other descriptive name | Linolenic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 2 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 119798-44-6 |
D.3.9.3 | Other descriptive name | 6,9,12,15-Octadecatetraenoic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 0.5
to
4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 26764-41-0 |
D.3.9.3 | Other descriptive name | Eicosenoic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 0.5
to
3 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 506-32-1 |
D.3.9.3 | Other descriptive name | Arachidonic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 1
to
4 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 25378-26-1 |
D.3.9.3 | Other descriptive name | Docosenoic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | up to |
D.3.10.3 | Concentration number | 1.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 25448-00-4 |
D.3.9.3 | Other descriptive name | Docosapentaenoic acid |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 1.5
to
4.5 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 59-02-9 |
D.3.9.3 | Other descriptive name | Vitamin E |
D.3.10 | Strength |
D.3.10.1 | Concentration unit | g/l gram(s)/litre |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 0.15
to
0.296 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 56-81-5 |
D.3.9.3 | Other descriptive name | Glycerin |
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 | 25 |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.9.1 | CAS number | 8002-43-5 |
D.3.9.3 | Other descriptive name | Lecithin |
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.3.11 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 | 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 | 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 |