Enbrel

Medicinal product

(Invented) name

Enbrel

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

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2006-09-26

Date of renewal

Documents

Enbrel paciento kortele.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection in a 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
25393	28001	1028001	užpildytas švirkštas	N2 (+ 2 tamponai, suvilgyti spiritu)		Receptinis	EU/1/99/126/016	Netiekiama	-	-	No	-	-
25394	28002	1028002	užpildytas švirkštas	N4 (+ 4 tamponai, suvilgyti spiritu)		Receptinis	EU/1/99/126/017	Netiekiama	-	-	No	-	-
25395	28003	1028003	užpildytas švirkštas	N12 (+ 12 tamponų, suvilgytų spiritu)		Receptinis	EU/1/99/126/018	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-09-26	Registruotas