Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
Jinarc 15 mg tablets.
Jinarc 30 mg tablets.
Jinarc 45 mg tablets.
Jinarc 60 mg tablets.
Jinarc 90 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Jinarc 15 mg tablets: Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side. Jinarc 30 mg tablets: Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side. Jinarc 45 mg tablets: Blue, square (6.8 mm on a side, major axis 8.2 mm), shallow-convex, debossed with “OTSUKA” and “45” on one side. Jinarc 60 mg tablets: Blue, modified rectangular (major axis 9.9 mm, minor axis 5.6 mm), shallow-convex, debossed with “OTSUKA” and “60” on one side Jinarc 90 mg tablets: Blue, pentagonal (major axis 9.7 mm, minor axis 9.5 mm), shallow-convex, debossed with “OTSUKA” and “90” on one side. |
Jinarc 15 mg tablets: Each tablet contains 15 mg of tolvaptan.
Excipient(s) with known effect: Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate).
Jinarc 30 mg tablets: Each tablet contains 30 mg of tolvaptan.
Excipient(s) with known effect: Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate).
Jinarc 45 mg tablets: Each tablet contains 45 mg of tolvaptan.
Excipient(s) with known effect: Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Jinarc 60 mg tablets: Each tablet contains 60 mg of tolvaptan.
Excipient(s) with known effect: Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Jinarc 90 mg tablets: Each tablet contains 90 mg of tolvaptan.
Excipient(s) with known effect: Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
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 |
Jinarc 15 mg tablets:
7 or 28 tablets in PVC/aluminium foil blister
Jinarc 30 mg tablets:
7 or 28 tablets in PVC/aluminium foil blister
Jinarc 15 mg tablets + Jinarc 45 mg tablets:
14 tablets in 1 PVC/aluminium foil blister with 7 × 15 mg and 7 × 45 mg tablets
28 tablets in 2 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets
56 tablets in 4 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets
14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 15 mg and 7 × 45 mg tablets
28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets
56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets
Jinarc 30 mg tablets + Jinarc 60 mg tablets:
14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 60 mg tablets
28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets
56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets
14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 60 mg tablets
28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets
56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets
Jinarc 30 mg tablets + Jinarc 90 mg tablets:
14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 90 mg tablets
28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets
56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets
14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 90 mg tablets
28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets
56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets
Not all pack sizes may be marketed.
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
Jinarc 15 mg tablets:
EU/1/15/1000/001-002 (blister)
Jinarc 30 mg tablets:
EU/1/15/1000/003-004 (blister)
Jinarc 15 mg tablets + Jinarc 45 mg tablets:
EU/1/15/1000/005-007 (blister)
EU/1/15/1000/014-016 (blister in wallet card)
Jinarc 30 mg tablets + Jinarc 60 mg tablets:
EU/1/15/1000/008-010 (blister)
EU/1/15/1000/017-019 (blister in wallet card)
Jinarc 30 mg tablets + Jinarc 90 mg tablets:
EU/1/15/1000/011-013 (blister)
EU/1/15/1000/020-022 (blister in wallet card)
Date of first authorisation: 27 May 2015
| Drug | Countries | |
|---|---|---|
| JINARC | Austria, Australia, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom |
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