Ponvory

Medicinal product

(Invented) name

Ponvory

Active substance (s)

Ponezimodas+Ponezimodas+Ponezimodas+Ponezimodas+Ponezimodas+Ponezimodas+Ponezimodas+Ponezimodas+Ponezimodas

Strength

2 mg + 3 mg + 4 mg + 5 mg + 6 mg + 7 mg + 8 mg + 9 mg + 10 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

L04AE04, ponesimod

Marketing authorisation holder

Laboratoires Juvisé Pharmaceuticals, Prancūzija

Date of authorisation

2021-05-19

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Each film-coated tablet (2 mg) contains	1 vnt.
Ponezimodas	2 mg
Each film-coated tablet (3 mg) contains	1 vnt.
Ponezimodas	3 mg
Each film-coated tablet (4 mg) contains	1 vnt.
Ponezimodas	4 mg
Each film-coated tablet (5 mg) contains	1 vnt.
Ponezimodas	5 mg
Each film-coated tablet (6 mg) contains	1 vnt.
Ponezimodas	6 mg
Each film-coated tablet (7 mg) contains	1 vnt.
Ponezimodas	7 mg
Each film-coated tablet (8 mg) contains	1 vnt.
Ponezimodas	8 mg
Each film-coated tablet (9 mg) contains	1 vnt.
Ponezimodas	9 mg
Each film-coated tablet (10 mg) contains	1 vnt.
Ponezimodas	10 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
106304	92405	1092405	lizdinė plokštelė	N14 (2×2 mg+2×3 mg+2×4 mg+1×5 mg+1×6 mg+1×7 mg+1×8 mg+1×9 mg+3×10 mg)	pakuotė gydymui pradėti	Receptinis	EU/1/21/1550/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-05-19	Registruotas