Enbrel

Medicinal product

(Invented) name

Enbrel

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

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2000-02-03

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 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
62003	76376	1076376	užpildytas švirkštiklis	N2 (MYCLIC) (+2 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/99/126/019	Netiekiama	-	-	No	-	-
62004	76377	1076377	užpildytas švirkštiklis	N4 (MYCLIC) (+4 alkoholiu suvilgyti tamponai)		Receptinis	EU/1/99/126/020	Tiekiama	-	-	No	-	-
62005	76378	1076378	užpildytas švirkštiklis	N12 (MYCLIC) (+12 alkoholiu suvilgyti tamponų)		Receptinis	EU/1/99/126/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2000-02-03	Registruotas