Gotenfia

Medicinal product

(Invented) name

Gotenfia

Active substance (s)

Golimumabas

Strength

50 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)

L04AB06, Golimumab

Marketing authorisation holder

STADA Arzneimittel AG, Vokietija

Date of authorisation

2026-02-10

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Užpildytame švirkšte (0,5 ml) yra:	0.5 ml
Golimumabas	50 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
120083	106188	1106188	užpildytas švirkštas	N1		Receptinis	EU/1/25/2009/001	Netiekiama	-	-	No	-	-
120084	106189	1106189	užpildytas švirkštas	N3		Receptinis	EU/1/25/2009/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-02-10	Registruotas