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 |
Yes |
D.2.5.1 |
Orphan drug designation number |
EU/3/12/1094 |
D.3 Description of the IMP |
D.3.1 |
Product name |
modified recombinant human C-type natriuretic peptide |
D.3.2 |
Product code |
BMN 111 |
D.3.4 |
Pharmaceutical form |
Lyophilisate for solution for injection |
D.3.4.1 |
Specific paediatric formulation |
Yes |
D.3.7 |
Routes of administration for this IMP |
Subcutaneous use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) |
D.3.8 |
INN – Proposed INN |
TBD |
D.3.9.2 |
Current sponsor code |
BMN 111 |
D.3.9.3 |
Other descriptive name |
MODIFIED RHCNP |
D.3.9.4 |
EV Substance Code |
SUB120857 |
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 |
0.2 to 10 |
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) |
No |
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 |
No |
D.3.11.3.4 |
Combination ATIMP (i.e. one involving a medical device) |
No |
D.3.11.3.5 |
Committee on Advanced therapies (CAT) has issued a classification for this product |
No |
D.3.11.4 |
Combination product that includes a device, but does not involve an Advanced Therapy |
No |
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 |
Yes |
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 |