JINARC Tablet Ref.[10510] Active ingredients: Tolvaptan

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Product name and form

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.

Qualitative and quantitative composition

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
Hydroxypropylcellulose
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Indigo carmine aluminium lake

Pack sizes and marketing

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.

Marketing authorization holder

Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Marketing authorization dates and numbers

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

Drugs

Drug Countries
JINARC Austria, Australia, Canada, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom

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