Biseptol

Medicinal product

(Invented) name

Biseptol

Active substance (s)

Sulfametoksazolas/Trimetoprimas

Strength

200 mg/40 mg/5 ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

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

1994-06-22

Date of renewal

2009-05-13

Documents

1565 Biseptol geriam susp II PL 2022 08 05.docx

1565 Pakuotės lapelis 2022 08 05.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

5 ml suspensijos yra	5 ml
Sulfametoksazolas	200 mg
Trimetoprimas	40 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
28	356	1000356	buteliukas	80 ml N1		Receptinis	LT/1/94/1565/001	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2009-05-13	Perregistruotas
1994-06-22	Registruotas