PRODUCT DETAIL

Ponvory 2 mg filmom obalené tablety, Ponvory 3 mg filmom obalené tablety, Ponvory 4 mg filmom obalené tablety ,Ponvory 5 mg filmom obalené tablety, Ponvory 6 mg filmom obalené tablety, Ponvory 7 mg filmom obalené tablety, Ponvory 8 mg filmom obalené tablety, Ponvory 9 mg filmom obalené tablety ,Ponvory 10 mg filmom obalené tablety

Code

7795D

MA number

EU/1/21/1550/001

Product Form:

tbl flm 14x(2x2 mg+2x3 mg+2x4 mg+1x5 mg+1x6 mg+1x7 mg+1x8 mg+1x9 mg+3x10 mg) (blis.OPA/alu/PE+DES/PET/alu/PE)

MA Status:

E - Valid centralised marketing authorisation

Type of procedure:

MAH, country:

LABORATOIRES JUVISE PHARMACEUTICALS, France

Therapeutic Class:

59 - IMMUNOPRAEPARATA

ATC:

L	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
L04	Immunosuppressants
L04A	Immunosuppressants
L04AA	Selective immunosuppressants
L04AA50	Ponesimod

Shelf life:

Route of admin.:

Oral use

Prescription Status:	Medicinal product subject to restricted medical prescription.
Legal basis:	Article 8(3) application - new active substance
MA issued:	19.05.2021
Validity:	19.05.2026
SmPC + PL:	European Medicines Agency's database
Dokument:	Ponvory_Kontrolny zoznam pre predpisujuceho lekara.pdf
Dokument:	Ponvory_Karta pacienta.pdf
Dokument:	Ponvory_Prirucka pre pacienta.pdf
Safety feature	Yes
Data update:	14.07.2023