XELJANZ

Medicinal product

(Invented) name

XELJANZ

Active substance (s)

Tofacitinibas

Strength

11 mg

Pharmaceutical form

pailginto atpalaidavimo 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 kontrolinis sarasas sveikatos prieziuros specialistams ivadiniam gydymui.pdf

XELJANZ paciento kortele.pdf

XELJANZ kontrolinis sarasas sveikatos prieziuros specialistams palaikomajam gydymui.pdf

XELJANZ mokomoji medziaga sveikatos prieziuros specialistams.pdf

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Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Prolonged-release tablet	1 vnt.
Tofacitinibas	11 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
103043	89144	1089144	buteliukas	N30		Receptinis	EU/1/17/1178/010	Netiekiama	-	-	No	-	-
103044	89145	1089145	buteliukas	N90		Receptinis	EU/1/17/1178/011	Netiekiama	-	-	No	-	-
103045	89146	1089146	lizdinė plokštelė	N28		Receptinis	EU/1/17/1178/012	Netiekiama	-	-	No	-	-
103046	89147	1089147	lizdinė plokštelė	N91		Receptinis	EU/1/17/1178/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-22	Registruotas