Imaplix

Medicinal product

(Invented) name

Imaplix

Active substance (s)

Apremilastas+Apremilastas+Apremilastas

Strength

10 mg + 20 mg + 30 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AA32, Apremilast

Marketing authorisation holder

UAB Norameda, Lietuva

Date of authorisation

2024-01-19

Date of renewal

Documents

5325_5326 Imaplix PCS 2025 04 29.docx

5325_5326_pakuotes lapelis_2024-01-19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IS/H/0584/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje (10 mg) yra:	1 vnt.
Apremilastas	10 mg
Tabletėje (20 mg) yra:	1 vnt.
Apremilastas	20 mg
Tabletėje (30 mg) yra:	1 vnt.
Apremilastas	30 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
112585	98705	1098705	lizdinė plokštelė	N27 (N4×10 mg + N4×20 mg + N19×30 mg)	pakuotė gydymui pradėti	Receptinis	LT/1/24/5325/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-19	Registruotas