Nucala

Medicinal product

(Invented) name

Nucala

Active substance (s)

Mepolizumabas

Strength

100 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)

R03DX09, Mepolizumab

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited, Airija

Date of authorisation

2015-12-02

Date of renewal

Documents

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
Mepolizumabas	100 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
102223	88323	1088323	užpildytas švirkštiklis	1 ml N1		Receptinis	EU/1/15/1043/003	Tiekiama	-	-	No	-	-
102224	88324	1088324	užpildytas švirkštiklis	1 ml N3 (3x1)		Receptinis	EU/1/15/1043/004	Netiekiama	-	-	No	-	-
108571	94675	1094675	užpildytas švirkštiklis	1 ml N9 (9×1)		Receptinis	EU/1/15/1043/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-12-02	Registruotas