Cimzia

Medicinal product

(Invented) name

Cimzia

Active substance (s)

Certolizumabas pegolas

Strength

200 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AB05, Certolizumab pegol

Marketing authorisation holder

UCB Pharma S.A., Belgija

Date of authorisation

2009-10-01

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	1 ml
Certolizumabas pegolas	200 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
37959	51600	1051600	užpildytas švirkštas	1 ml N1 (2 užpildyti švirkštai + 2 alkoholiu sumirkyti tamponai)		Receptinis	EU/1/09/544/001	Netiekiama	-	-	No	-	-
37960	51601	1051601	užpildytas švirkštas	1 ml N6 (3 x 2) užpildyti švirkštai + 6 (3x2) alkoholiu sumirkyti tamponai		Receptinis	EU/1/09/544/002	Netiekiama	-	-	No	-	-
57961	72083	1072083	užpildytas švirkštas	1 ml N2 (su adatos apsauga + 2 alkoholiu sumirkyti tamponai (naudoti tik sveikatos priežiūros specialistams))		Receptinis	EU/1/09/544/003	Netiekiama	-	-	No	-	-
61534	75875	1075875	užpildytas švirkštas	1 ml N10 (5x2)+ N10 (5x2) + 2 alkoholiu sumirkyti tamponai		Receptinis	EU/1/09/544/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2009-10-01	Registruotas