Hefiya

Medicinal product

(Invented) name

Hefiya

Active substance (s)

Adalimumabas

Strength

80 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	0.8 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
110841	96952	1096952	užpildytas švirkštiklis	0,8 ml N1 (SensoReady)		Receptinis	EU/1/18/1287/010	Netiekiama	-	-	No	-	-
110842	96953	1096953	užpildytas švirkštiklis	0,8 ml N2 (SensoReady)		Receptinis	EU/1/18/1287/011	Netiekiama	-	-	No	-	-
111580	97693	1097693	užpildytas švirkštiklis	0,8 ml N3 (SensoReady)		Receptinis	EU/1/18/1287/020	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-07-26	Registruotas