Remsima

Medicinal product

(Invented) name

Remsima

Active substance (s)

Infliksimabas

Strength

120 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AB02, Infliximab

Marketing authorisation holder

Celltrion Healthcare Hungary Kft., Vengrija

Date of authorisation

2013-09-10

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in pre-filled pen	1 ml
Infliksimabas	120 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
102933	89034	1089034	užpildytas švirkštiklis	ir 2 alkoholiu suvilgyti tamponai N1		Receptinis	EU/1/13/853/012	Netiekiama	-	-	No	-	-
102934	89035	1089035	užpildytas švirkštiklis	ir alkoholiu suvilgyti tamponai N2		Receptinis	EU/1/13/853/013	Netiekiama	-	-	No	-	-
102935	89036	1089036	užpildytas švirkštiklis	ir alkoholiu suvilgyti tamponai N4		Receptinis	EU/1/13/853/014	Netiekiama	-	-	No	-	-
104222	90326	1090326	užpildytas švirkštiklis	ir alkoholiu suvilgyti tamponai N6		Receptinis	EU/1/13/853/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-09-10	Registruotas