ANAVEX2-73-PDD-001
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8 INN - Proposed INN ANAVEX2-73
D.3.9.2 Current sponsor code ANAVEX2-73
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 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) 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 No
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 No
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 ANAVEX2-73
D.3.4 Pharmaceutical form Capsule
D.3.4.1 Specific paediatric formulation No
D.3.7 Routes of administration for this IMP Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8 INN - Proposed INN ANAVEX2-73
D.3.9.2 Current sponsor code ANAVEX2-73
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 20
