Tremfya

Medicinal product

(Invented) name

Tremfya

Active substance (s)

Guselkumabas

Strength

100 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)

L04AC16, Guselkumab

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2017-11-10

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 in pre-filled pen	1 ml
Guselkumabas	100 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
100033	86141	1086141	užpildytas švirkštiklis	1 ml N1		Receptinis	EU/1/17/1234/002	Tiekiama	-	-	No	-	-
101830	87932	1087932	užpildytas švirkštiklis	1 ml N2 (2x1)		Receptinis	EU/1/17/1234/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-11-10	Registruotas