2.2.1.1 Product: RO7234292
Type
Product
Excluded MSCs
2.2.1.1.1 Product details
Medicinal product name:
RO7234292
EU medicinal product number/medicinal product unique ID:
PRD10384563
Pharmaceutical form:
SOLUTION FOR INJECTION
Strength:
Medicinal product other name:
Tominersen
Is this a specific paediatric formulation:
No
Product authorisation status:
Not Authorised
Medicinal product role in trial:
Test
Sponsors product code:
RO 723-4292/F02-01
2.2.1.1.2 Products characteristics
Medicinal product characteristics:
Other
Other medicinal product:
antisense oligonucleotide
2.2.1.1.3 Dosage and administration Details
Route of administration:
I.T. BOLUS INJECTION TO THE INTRATHECAL SPACE
Maximum duration of treatment:
1 Day(s)
Maximum daily dose allowed:
0
Daily dose unit of measure:
DF dosage form
Maximum total dose allowed:
0
Total dose unit of measure:
DF dosage form
2.2.1.1.4 Information about the modification of the medicinal product
Has the medicinal product been modified in relation to its Marketing Authorisation:
No
Description of the modification:
2.2.1.1.5 Product classification
Anatomical Therapeutic Chemical (ATC) Codes:
ATC name:
ATC level:
2.2.1.1.6 Product authorisation details
MA holder
F. HOFFMANN-LA ROCHE LTD
MA authorisation country
Marketing authorisation number
Centralised procedure/MRP/DCP/registration procedure number
2.2.1.1.7 Orphan designation
Does this product have an orphan drug designation:
No
Designation number for orphan drug:
2.2.1.1.8 Active substance
Classification:
Nucleic Acid
Active Substance name:
TOMINERSEN
Active substance name synonyms:
Active Substance other descriptive name:
EU Active Substance Code:
SUB198185
Strength:
Status:
Not Authorised
2.2.1.1.9 Advanced therapy medicinal product
2.2.1.1.10 Device associated with medicinal product
| Product used in combination with a device |
Product ID |
Device trade name |
Description of the device |
Type of device |
Device has CE mark |
Device notified body |
2.2.1.1 Compliance with (GMP) for the medicinal product
Authorisation number of manufacturing and import:
2.2.2.1 Product: RO7234292 Placebo
Type
Product
Excluded MSCs
2.2.2.1.1 Product details
Medicinal product name:
RO7234292 Placebo
EU medicinal product number/medicinal product unique ID:
N/A
Pharmaceutical form:
N/A
Strength:
Medicinal product other name:
N/A
Is this a specific paediatric formulation:
No
Product authorisation status:
Medicinal product role in trial:
Placebo
Sponsors product code:
2.2.2.1.2 Products characteristics
Medicinal product characteristics:
Other medicinal product:
2.2.2.1.3 Dosage and administration Details
Route of administration:
Maximum duration of treatment:
undefined Week(s)
Maximum daily dose allowed:
Daily dose unit of measure:
Maximum total dose allowed:
Total dose unit of measure:
2.2.2.1.4 Information about the modification of the medicinal product
Has the medicinal product been modified in relation to its Marketing Authorisation:
No
Description of the modification:
2.2.2.1.5 Product classification
Anatomical Therapeutic Chemical (ATC) Codes:
N/A
ATC name:
N/A
ATC level:
N/A
2.2.2.1.6 Product authorisation details
MA holder
N/A
MA authorisation country
Iceland
Marketing authorisation number
N/A
Centralised procedure/MRP/DCP/registration procedure number
2.2.2.1.7 Orphan designation
Does this product have an orphan drug designation:
No
Designation number for orphan drug:
2.2.2.1.8 Active substance
Classification:
Active Substance name:
Active substance name synonyms:
Active Substance other descriptive name:
N/A
EU Active Substance Code:
N/A
Strength:
Status:
2.2.2.1.9 Advanced therapy medicinal product
2.2.2.1.10 Device associated with medicinal product
| Product used in combination with a device |
Product ID |
Device trade name |
Description of the device |
Type of device |
Device has CE mark |
Device notified body |
2.2.2.1 Compliance with (GMP) for the medicinal product
Authorisation number of manufacturing and import: