Hefiya

Medicinal product

(Invented) name

Hefiya

Active substance (s)

Adalimumabas

Strength

40 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)

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 pen	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
110835	96946	1096946	užpildytas švirkštiklis	0,4 ml N1 (SensoReady)		Receptinis	EU/1/18/1287/015	Netiekiama	-	-	No	-	-
110836	96947	1096947	užpildytas švirkštiklis	0,4 ml N2 (SensoReady)		Receptinis	EU/1/18/1287/016	Netiekiama	-	-	No	-	-
110837	96948	1096948	užpildytas švirkštiklis	0,4 ml N4 (SensoReady)		Receptinis	EU/1/18/1287/017	Netiekiama	-	-	No	-	-
110838	96949	1096949	užpildytas švirkštiklis	0,4 ml N6 (3×2) (SensoReady)		Receptinis	EU/1/18/1287/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-26	Registruotas