Biotum

Medicinal product

(Invented) name

Biotum

Active substance (s)

Ceftazidimas pentahidratas

Strength

1 g

Pharmaceutical form

milteliai injekciniam ar infuziniam tirpalui

Route (s) of administration

leisti į veną, leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01DD02, Ceftazidime

Marketing authorisation holder

Pharmaceutical Works POLPHARMA S.A., Lenkija

Date of authorisation

1998-09-17

Date of renewal

2010-06-15

Documents

2044 Pakuotės lapelis 2025 02 11.docx

2044 Biotum RPP 2025 02 11, PZ 2025 05 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Ceftazidimas pentahidratas	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
4731	2941	1002941	flakonas	N1		Receptinis	LT/1/98/2044/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2010-06-15	Perregistruotas
1998-09-17	Registruotas