Remsima

Medicinal product

(Invented) name

Remsima

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

Abacus Medicine A/S, Danija

Date of authorisation

Date of renewal

Documents

Initial notice for Remsima_100mg_EU001.docx

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

CR-Lygiagretus platinimas

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
108973	95079	1095079	flakonas	N1		Receptinis	EU/1/13/853/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Registruotas