Erelzi

Medicinal product

(Invented) name

Erelzi

Active substance (s)

Etanerceptas

Strength

50 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)

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 pen	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
68614	83196	1083196	užpildytas švirkštiklis	N1 (SensoReady)		Receptinis	EU/1/17/1195/009	Netiekiama	-	-	No	-	-
68615	83197	1083197	užpildytas švirkštiklis	N2 (SensoReady)		Receptinis	EU/1/17/1195/010	Netiekiama	-	-	No	-	-
68616	83198	1083198	užpildytas švirkštiklis	N4 (SensoReady)		Receptinis	EU/1/17/1195/011	Tiekiama	2025-02-10	-	No	-	-
68617	83199	1083199	užpildytas švirkštiklis	N12 (3x4) (sudėtinė) (SensoReady)		Receptinis	EU/1/17/1195/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-06-23	Registruotas