BISEPTOL

Medicinal product

(Invented) name

BISEPTOL

Active substance (s)

Trimetoprimas/Sulfametoksazolas

Strength

80 mg/400 mg

Pharmaceutical form

tabletės

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

Adamed Pharma S.A., Lenkija

Date of authorisation

1995-10-04

Date of renewal

2010-05-12

Documents

1988 BISEPTOL tab PCS PL 2024 10 03.docx

1988 Pakuotės lapelis 2024 10 03.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Trimetoprimas	80 mg
Sulfametoksazolas	400 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
1240	352	1000352	lizdinė plokštelė	N20		Receptinis	LT/1/95/1988/002	Netiekiama	-	-	No	-	-	Download
60270	74545	1074545	lizdinė plokštelė	N28		Receptinis	LT/1/95/1988/005	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-05-12	Perregistruotas
1995-10-04	Registruotas