XELJANZ

Medicinal product

(Invented) name

XELJANZ

Active substance (s)

Tofacitinibas

Strength

10 mg

Pharmaceutical form

plėvele dengtos tabletės

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 mokomoji medziaga sveikatos prieziuros specialistams.pdf

XELJANZ paciento kortele.pdf

XELJANZ kontrolinis sarasas sveikatos prieziuros specialistams ivadiniam gydymui.pdf

XELJANZ kontrolinis sarasas sveikatos prieziuros specialistams palaikomajam gydymui.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

Film-coated tablet	1 vnt.
Tofacitinibas	10 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
100442	86551	1086551	buteliukas	N60		Receptinis	EU/1/17/1178/005	Netiekiama	-	-	No	-	-
100443	86552	1086552	buteliukas	N168		Receptinis	EU/1/17/1178/006	Netiekiama	-	-	No	-	-
100444	86553	1086553	lizdinė plokštelė	N56		Receptinis	EU/1/17/1178/007	Netiekiama	-	-	No	-	-
100445	86554	1086554	lizdinė plokštelė	N112		Receptinis	EU/1/17/1178/008	Netiekiama	-	-	No	-	-
100446	86555	1086555	lizdinė plokštelė	N182		Receptinis	EU/1/17/1178/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas