BISEPTOL

Medicinal product

(Invented) name

BISEPTOL

Active substance (s)

Sulfametoksazolas/Trimetoprimas

Strength

80 mg/16 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J01EE01, Sulfamethoxazole and trimethoprim

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

1995-04-05

Date of renewal

2009-04-24

Documents

1531 Pakuotės lapelis 2024 03 01.docx

1531 BISEPTOL konc inf RPP 2024 03 01.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Mililitre yra	1 ml
Sulfametoksazolas	80 mg
Trimetoprimas	16 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
1243	7041	1007041	ampulė	5 ml N10		Receptinis	LT/1/94/1531/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-04-24	Perregistruotas
1995-04-05	Registruotas