Enbrel

Medicinal product

(Invented) name

Enbrel

Active substance (s)

Etanerceptas

Strength

25 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	0.5 ml
Etanerceptas	25 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
25390	27998	1027998	užpildytas švirkštas	N4 (+ 4 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/99/126/013	Netiekiama	-	-	No	-	-
25391	27999	1027999	užpildytas švirkštas	N8 (+ 8 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/99/126/014	Netiekiama	-	-	No	-	-
25392	28000	1028000	užpildytas švirkštas	N24 (+ 24 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/99/126/015	Netiekiama	-	-	No	-	-
99836	85944	1085944	užpildytas švirkštas	N12 (+12 alkoholiu suvilgytų tamponų)		Receptinis	EU/1/99/126/026	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-09-26	Registruotas