Hefiya

Medicinal product

(Invented) name

Hefiya

Active substance (s)

Adalimumabas

Strength

40 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)

L04AB04, Adalimumab

Marketing authorisation holder

Sandoz GmbH, Austrija

Date of authorisation

2018-07-26

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

Solution for injection in pre-filled syringe	0.4 ml
Adalimumabas	40 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
110832	96943	1096943	užpildytas švirkštas	0,4 ml N1		Receptinis	EU/1/18/1287/012	Netiekiama	-	-	No	-	-
110833	96944	1096944	užpildytas švirkštas	0,4 ml N2		Receptinis	EU/1/18/1287/013	Netiekiama	-	-	No	-	-
110834	96945	1096945	užpildytas švirkštas	0,4 ml N6 (3×2)		Receptinis	EU/1/18/1287/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-26	Registruotas