Ogivri

Medicinal product

(Invented) name

Ogivri

Active substance (s)

Trastuzumabas

Strength

420 mg

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FD01, trastuzumab

Marketing authorisation holder

Biosimilar Collaborations Ireland Limited, Airija

Date of authorisation

2018-12-12

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for concentrate for solution for infusion	1 vnt.
Trastuzumabas	420 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
102229	88329	1088329	flakonas	N1		Receptinis	EU/1/18/1341/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-12-12	Registruotas