Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
Samsca 7.5 mg tablets.
Samsca 15 mg tablets.
Samsca 30 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Samsca 7.5 mg tablets: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side. Samsca 15 mg tablets: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side. Samsca 30 mg tablets: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side. |
Samsca 7.5 mg tablets: Each tablet contains 7.5 mg tolvaptan.
Excipient with known effect: 51 mg lactose (as monohydrate) per tablet
Samsca 15 mg tablets: Each tablet contains 15 mg tolvaptan.
Excipient with known effect: 35 mg lactose (as monohydrate) per tablet
Samsca 30 mg tablets: Each tablet contains 30 mg tolvaptan.
Excipient with known effect: 70 mg lactose (as monohydrate) per tablet
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tolvaptan |
Tolvaptan is a selective vasopressin V2-receptor antagonist that specifically blocks the binding of arginine vasopressin (AVP) at the V2-receptor of the distal portions of the nephron. Tolvaptan affinity for the human V2-receptor is 1.8 times that of native AVP. |
| List of Excipients |
|---|
|
Maize starch |
Samsca 7.5 mg tablets:
10 tablets in PP/Alu blisters
30 tablets in PP/Alu blisters
10 × 1 tablet in PVC/Alu perforated unit dose blisters
30 × 1 tablet in PVC/Alu perforated unit dose blisters
Samsca 15 mg and Samsca 30 mg tablets:
10 × 1 tablet in PVC/Alu perforated unit dose blisters
30 × 1 tablet in PVC/Alu perforated unit dose blisters
Not all pack sizes may be marketed.
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
Samsca 7.5 mg tablets:
EU/1/09/539/005 (10 tablets)
EU/1/09/539/006 (30 tablets)
EU/1/09/539/007 (10 × 1 tablet)
EU/1/09/539/008 (30 × 1 tablet)
Samsca 15 mg tablets:
EU/1/09/539/001 (10 × 1 tablet)
EU/1/09/539/002 (30 × 1 tablet)
Samsca 30 mg tablets:
EU/1/09/539/003 (10 × 1 tablet)
EU/1/09/539/004 (30 × 1 tablet)
Date of first authorisation: 03 August 2009
Date of latest renewal: 19 June 2014
| Drug | Countries | |
|---|---|---|
| SAMSCA | Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
