Recarbrio

Medicinal product

(Invented) name

Recarbrio

Active substance (s)

Imipenemas/Cilastatinas/Relebaktamas

Strength

500 mg/500 mg/250 mg

Pharmaceutical form

milteliai infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DH56, imipenem, cilastatin and beta-lactamase inhibitor

Marketing authorisation holder

Merck Sharp & Dohme B.V., Nyderlandai

Date of authorisation

2020-02-13

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

Powder for solution for infusion	1 vnt.
Imipenemas	500 mg
Cilastatinas	500 mg
Relebaktamas	250 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
103311	89413	1089413	flakonas	N25		Receptinis	EU/1/19/1420/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-02-13	Registruotas