Erelzi

Medicinal product

(Invented) name

Erelzi

Active substance (s)

Etanerceptas

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)

L04AB01, Etanercept

Marketing authorisation holder

Sandoz GmbH, Austrija

Date of authorisation

2017-06-23

Date of renewal

Documents

Ezelzi paciento kortele.pdf

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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	1 ml
Etanerceptas	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
68610	83192	1083192	užpildytas švirkštas	N1		Receptinis	EU/1/17/1195/005	Netiekiama	-	-	No	-	-
68611	83193	1083193	užpildytas švirkštas	N2		Receptinis	EU/1/17/1195/006	Netiekiama	-	-	No	-	-
68612	83194	1083194	užpildytas švirkštas	N4		Receptinis	EU/1/17/1195/007	Tiekiama	-	-	No	-	-
68613	83195	1083195	užpildytas švirkštas	N12 (3x4) (sudėtinė)		Receptinis	EU/1/17/1195/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-23	Registruotas