Calysclera

Medicinal product

(Invented) name

Calysclera

Active substance (s)

Kladribinas

Strength

10 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AA40, cladribine

Marketing authorisation holder

PharOS Pharmaceutical Oriented Services Limited, Graikija

Date of authorisation

2026-10-15

Date of renewal

Documents

6167_Calysclera.docx

6167_pakuotes lapelis_2026-10-15.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/6663/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Kladribinas	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
122567	108677	1108677	lizdinė plokštelė	N1		Receptinis	LT/1/26/6167/001	Netiekiama	-	-	No	-	-
122568	108678	1108678	lizdinė plokštelė	N4		Receptinis	LT/1/26/6167/002	Netiekiama	-	-	No	-	-
122569	108679	1108679	lizdinė plokštelė	N6		Receptinis	LT/1/26/6167/003	Netiekiama	-	-	No	-	-
122570	108680	1108680	dalomoji lizdinė plokštelė	N4×1		Receptinis	LT/1/26/6167/004	Netiekiama	-	-	No	-	-
122571	108681	1108681	dalomoji lizdinė plokštelė	N6×1		Receptinis	LT/1/26/6167/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-10-15	Registruotas