Loperamidum PPH [LOPERAMIDUM WZF Polfa]

Medicinal product

(Invented) name

Loperamidum PPH [LOPERAMIDUM WZF Polfa]

Active substance (s)

Loperamido hidrochloridas

Strength

2 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis/Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07DA03, Loperamide

Marketing authorisation holder

Zakłady Farmaceutyczne POLPHARMA S.A., Lenkija

Date of authorisation

1995-04-05

Date of renewal

2008-11-24

Documents

1336 Pakuotės lapelis Rp 2024 12 19.docx

1336 Pakuotės lapelis OTC 2024 12 19.docx

1336 Loperamidum PPH OTC II PL 2024 12 19.docx

1336 Loperamidum PPH Rp II PL 2024 12 19.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.
Loperamido hidrochloridas	2 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
1146	6972	1006972	lizdinė plokštelė	N10		Nereceptinis	LT/1/95/1336/001	Tiekiama	-	-	No	-	-	Download
1147	6973	1006973	lizdinė plokštelė	N30		Receptinis	LT/1/95/1336/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2008-11-24	Perregistruotas
1995-04-05	Registruotas