Meropenem Accord

Medicinal product

(Invented) name

Meropenem Accord

Active substance (s)

Meropenemas

Strength

1 g

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DH02, Meropenem

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2018-01-24

Date of renewal

Documents

4186 Meropenem Accord milt inj_inf PCS PL 2021 08 10.docx

4186 Pakuotės lapelis 2021 08 10.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

IE/H/0457/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Meropenemas	1 g

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
61723	76066	1076066	flakonas	N1		Receptinis	LT/1/18/4186/004	Netiekiama	-	-	No	-	-
98791	84895	1084895	flakonas	N5		Receptinis	LT/1/18/4186/005	Netiekiama	-	-	No	-	-
98792	84896	1084896	flakonas	N10		Receptinis	LT/1/18/4186/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-30	Išregistruotas
2018-01-24	Registruotas