Nucala

Medicinal product

(Invented) name

Nucala

Active substance (s)

Mepolizumabas

Strength

100 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)

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 syringe	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
102225	88325	1088325	užpildytas švirkštas	1 ml N1		Receptinis	EU/1/15/1043/005	Netiekiama	-	-	No	-	-
102226	88326	1088326	užpildytas švirkštas	1 ml N3 (3x1)		Receptinis	EU/1/15/1043/006	Netiekiama	-	-	No	-	-
108572	94676	1094676	užpildytas švirkštas	1 ml N9 (9x1)		Receptinis	EU/1/15/1043/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-12-02	Registruotas