PONVORY Film-coated tablet Ref.[27995] Active ingredients: Ponesimod

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

Ponvory 2 mg film-coated tablets.
Ponvory 3 mg film-coated tablets.
Ponvory 4 mg film-coated tablets.
Ponvory 5 mg film-coated tablets.
Ponvory 6 mg film-coated tablets.
Ponvory 7 mg film-coated tablets.
Ponvory 8 mg film-coated tablets.
Ponvory 9 mg film-coated tablets.
Ponvory 10 mg film-coated tablets.
Ponvory 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Ponvory 2 mg film-coated tablets:

White, round, biconvex, film-coated tablet of 5 mm diameter with “2” on one side and an arch on the other side.

Ponvory 3 mg film-coated tablets:

Red, round, biconvex, film-coated tablet of 5 mm diameter with “3” on one side and an arch on the other side.

Ponvory 4 mg film-coated tablets:

Purple, round, biconvex, film-coated tablet of 5 mm diameter with “4” on one side and an arch on the other side.

Ponvory 5 mg film-coated tablets:

Green, round, biconvex, film-coated tablet of 8.6 mm diameter with “5” on one side and an arch and an “A” on the other side.

Ponvory 6 mg film-coated tablets:

White, round, biconvex, film-coated tablet of 8.6 mm diameter with “6” on one side and an arch and an “A” on the other side.

Ponvory 7 mg film-coated tablets:

Red, round, biconvex, film-coated tablet of 8.6 mm diameter with “7” on one side and an arch and an “A” on the other side.

Ponvory 8 mg film-coated tablets:

Purple, round, biconvex, film-coated tablet of 8.6 mm diameter with “8” on one side and an arch and an “A” on the other side.

Ponvory 9 mg film-coated tablets:

Brown, round, biconvex, film-coated tablet of 8.6 mm diameter with “9” on one side and an arch and an “A” on the other side.

Ponvory 10 mg film-coated tablets:

Orange, round, biconvex, film-coated tablet of 8.6 mm diameter with “10” on one side and an arch and an “A” on the other side.

Ponvory 20 mg film-coated tablets:

Yellow, round, biconvex, film-coated tablet of 8.6 mm diameter with “20” on one side and an arch and an “A” on the other side.

Qualitative and quantitative composition

Ponvory 2 mg film-coated tablets

Each film-coated tablet contains 2 mg of ponesimod.

Excipient with known effect: Each tablet contains 23 mg of lactose.

Ponvory 3 mg film-coated tablets

Each film-coated tablet contains 3 mg of ponesimod.

Excipient with known effect: Each tablet contains 22 mg of lactose.

Ponvory 4 mg film-coated tablets

Each film-coated tablet contains 4 mg of ponesimod.

Excipient with known effect: Each tablet contains 21 mg of lactose.

Ponvory 5 mg film-coated tablets

Each film-coated tablet contains 5 mg of ponesimod.

Excipient with known effect: Each tablet contains 118 mg of lactose.

Ponvory 6 mg film-coated tablets

Each film-coated tablet contains 6 mg of ponesimod.

Excipient with known effect: Each tablet contains 117 mg of lactose.

Ponvory 7 mg film-coated tablets

Each film-coated tablet contains 7 mg of ponesimod.

Excipient with known effect: Each tablet contains 117 mg of lactose.

Ponvory 8 mg film-coated tablets

Each film-coated tablet contains 8 mg of ponesimod.

Excipient with known effect: Each tablet contains 116 mg of lactose.

Ponvory 9 mg film-coated tablets

Each film-coated tablet contains 9 mg of ponesimod.

Excipient with known effect: Each tablet contains 115 mg of lactose.

Ponvory 10 mg film-coated tablets

Each film-coated tablet contains 10 mg of ponesimod.

Excipient with known effect: Each tablet contains 114 mg of lactose.

Ponvory 20 mg film-coated tablets

Each film-coated tablet contains 20 mg of ponesimod.

Excipient with known effect: Each tablet contains 104 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ponesimod

Ponesimod is a sphingosine 1-phosphate (S1P) receptor 1 modulator. Ponesimod binds with high affinity to S1P receptor 1 located on lymphocytes. It blocks the capacity of lymphocytes to egress from lymph nodes reducing the number of lymphocytes in peripheral blood. The mechanism by which it exerts therapeutic effects in multiple sclerosis may involve reduction of lymphocyte migration into the central nervous system.

List of Excipients

Tablet core:

Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Povidone K30
Silica colloidal anhydrous
Sodium laurilsulfate

Tablet coating:

Hypromellose 2910
Lactose monohydrate
Macrogol 3350
Titanium dioxide
Triacetin

Ponvory 3 mg film-coated tablets:

Iron oxide red (E172)
Iron oxide yellow (E172)

Ponvory 4 mg film-coated tablets:

Iron oxide red (E172)
Black iron oxide (E172)

Ponvory 5 mg film-coated tablets:

Black iron oxide (E172)
Iron oxide yellow (E172)

Ponvory 7 mg film-coated tablets:

Iron oxide red (E172)
Iron oxide yellow (E172)

Ponvory 8 mg film-coated tablets:

Iron oxide red (E172)
Black iron oxide (E172)

Ponvory 9 mg film-coated tablets:

Iron oxide red (E172)
Black iron oxide (E172)
Iron oxide yellow (E172)

Ponvory 10 mg film-coated tablets:

Iron oxide red (E172)
Iron oxide yellow (E172)

Ponvory 20 mg film-coated tablets:

Iron oxide yellow (E172)

Pack sizes and marketing

The Alu/alu blister with desiccant consists of a laminated Alu cold form film with integrated desiccant and a laminated Alu push-through lidding film.

Treatment initiation pack:

Each blister pack of 14 film-coated tablets for a 2-week treatment schedule contains:

2 film-coated tablets of 2 mg
2 film-coated tablets of 3 mg
2 film-coated tablets of 4 mg
1 film-coated tablet of 5 mg
1 film-coated tablet of 6 mg
1 film-coated tablet of 7 mg
1 film-coated tablet of 8 mg
1 film-coated tablet of 9 mg
3 film-coated tablets of 10 mg

Ponvory 20 mg film-coated tablets (maintenance pack):

Pack of 28 film-coated tablets or multipack containing 84 (3 packs of 28) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

EU/1/21/1550/001
EU/1/21/1550/002
EU/1/21/1550/003

Date of first authorisation: 19 May 2021

Drugs

Drug Countries
PONVORY Estonia, Finland, Ireland, Lithuania, Poland, Romania

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