CINQAERO

Medicinal product

(Invented) name

CINQAERO

Active substance (s)

Reslizumabas

Strength

10 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R03DX08, Reslizumab

Marketing authorisation holder

Teva B.V., Nyderlandai

Date of authorisation

2016-08-16

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

Concentrate for solution for infusion	1 ml
Reslizumabas	10 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
66276	80800	1080800	flakonas	10 ml N1		Receptinis	EU/1/16/1125/001	Netiekiama	-	-	No	-	-
68569	83149	1083149	flakonas	2,5 ml N1		Receptinis	EU/1/16/1125/002	Netiekiama	-	-	No	-	-
98883	84987	1084987	flakonas	10 ml N2		Receptinis	EU/1/16/1125/003	Netiekiama	-	-	No	-	-
98884	84988	1084988	flakonas	2,5 ml N2		Receptinis	EU/1/16/1125/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-08-16	Registruotas