XELJANZ

Medicinal product

(Invented) name

XELJANZ

Active substance (s)

Tofacitinibas

Strength

1 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AF01, Tofacitinib

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2017-03-22

Date of renewal

Documents

XELJANZ paciento kortele.pdf

XELJANZ kontrolinis sarasas sveikatos prieziuros specialistams ivadiniam gydymui.pdf

XELJANZ kontrolinis sarasas sveikatos prieziuros specialistams palaikomajam gydymui.pdf

XELJANZ mokomoji medziaga sveikatos prieziuros specialistams.pdf

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

Oral solution	1 ml
Tofacitinibas	1 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
107190	93294	1093294	buteliukas	240 ml, buteliuko adapteris ir dozavimo švirkštas N1		Receptinis	EU/1/17/1178/015	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas