Cyclophosphamide Accord

Medicinal product

(Invented) name

Cyclophosphamide Accord

Active substance (s)

Ciklofosfamidas

Strength

500 mg

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)

L01AA01, Cyclophosphamide

Marketing authorisation holder

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2021-11-11

Date of renewal

Documents

4848_4849 Cyclophosphamine Accord.docx

4848-4849 pakuotes lapelis_2021-11-11.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5098/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra:	1 vnt.
Ciklofosfamidas	500 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
107521	93626	1093626	flakonas	N1		Receptinis	LT/1/21/4848/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-27	Išregistruotas
2021-11-11	Registruotas