Hefiya

Medicinal product

(Invented) name

Hefiya

Active substance (s)

Adalimumabas

Strength

80 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	0.8 ml
Adalimumabas	80 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
110839	96950	1096950	užpildytas švirkštas	0,8 ml N1		Receptinis	EU/1/18/1287/008	Netiekiama	-	-	No	-	-
110840	96951	1096951	užpildytas švirkštas	0,8 ml N2		Receptinis	EU/1/18/1287/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-26	Registruotas