Zessly

Medicinal product

(Invented) name

Zessly

Active substance (s)

Infliksimabas

Strength

100 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AB02, Infliximab

Marketing authorisation holder

Sandoz GmbH, Austrija

Date of authorisation

2018-05-18

Date of renewal

Documents

Zessly paciento kortele.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for concentrate for solution for infusion	1 vnt.
Infliksimabas	100 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
99837	85945	1085945	flakonas	N1		Receptinis	EU/1/18/1280/001	Tiekiama	-	-	No	-	-
99838	85946	1085946	flakonas	N2		Receptinis	EU/1/18/1280/002	Netiekiama	-	-	No	-	-
99839	85947	1085947	flakonas	N3		Receptinis	EU/1/18/1280/003	Netiekiama	-	-	No	-	-
99840	85948	1085948	flakonas	N4		Receptinis	EU/1/18/1280/004	Netiekiama	-	-	No	-	-
99841	85949	1085949	flakonas	N5		Receptinis	EU/1/18/1280/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-05-18	Registruotas