Apremilast Krka

Medicinal product

(Invented) name

Apremilast Krka

Active substance (s)

Apremilastas

Strength

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

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2024-07-24

Date of renewal

Documents

5510-11_pakuotes lapelis_2024-07-24.docx

5510_5511 Apremilast KRKA PCS 2025 07 02.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SK/H/0306/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje 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
114299	100411	1100411	lizdinė plokštelė	N56		Receptinis	LT/1/24/5511/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-07-24	Registruotas