Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
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 |
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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. |
Each film-coated tablet contains 2 mg of ponesimod.
Excipient with known effect: Each tablet contains 23 mg of lactose.
Each film-coated tablet contains 3 mg of ponesimod.
Excipient with known effect: Each tablet contains 22 mg of lactose.
Each film-coated tablet contains 4 mg of ponesimod.
Excipient with known effect: Each tablet contains 21 mg of lactose.
Each film-coated tablet contains 5 mg of ponesimod.
Excipient with known effect: Each tablet contains 118 mg of lactose.
Each film-coated tablet contains 6 mg of ponesimod.
Excipient with known effect: Each tablet contains 117 mg of lactose.
Each film-coated tablet contains 7 mg of ponesimod.
Excipient with known effect: Each tablet contains 117 mg of lactose.
Each film-coated tablet contains 8 mg of ponesimod.
Excipient with known effect: Each tablet contains 116 mg of lactose.
Each film-coated tablet contains 9 mg of ponesimod.
Excipient with known effect: Each tablet contains 115 mg of lactose.
Each film-coated tablet contains 10 mg of ponesimod.
Excipient with known effect: Each tablet contains 114 mg of lactose.
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 |
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Tablet core: Croscarmellose sodium Tablet coating: Hypromellose 2910 Ponvory 3 mg film-coated tablets: Iron oxide red (E172) Ponvory 4 mg film-coated tablets: Iron oxide red (E172) Ponvory 5 mg film-coated tablets: Black iron oxide (E172) Ponvory 7 mg film-coated tablets: Iron oxide red (E172) Ponvory 8 mg film-coated tablets: Iron oxide red (E172) Ponvory 9 mg film-coated tablets: Iron oxide red (E172) Ponvory 10 mg film-coated tablets: Iron oxide red (E172) Ponvory 20 mg film-coated tablets: Iron oxide yellow (E172) |
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.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
EU/1/21/1550/001
EU/1/21/1550/002
EU/1/21/1550/003
Date of first authorisation: 19 May 2021
| Drug | Countries | |
|---|---|---|
| PONVORY | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom |
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