Tammex

Medicinal product

(Invented) name

Tammex

Active substance (s)

Loperamido hidrochloridas

Strength

2 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A07DA03, Loperamide

Marketing authorisation holder

Farmaceutica Biochem International S.R.L., Rumunija

Date of authorisation

2014-10-16

Date of renewal

2019-06-20

Documents

Tammex_LT_107_DC_AR.pdf

3643 Pakuotės lapelis 2023 10 26.docx

3643 Tammex RPP 2023 10 26.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0107/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Vienoje kietojoje kapsulėje 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
56233	70329	1070329	lizdinė plokštelė	N10		Nereceptinis	LT/1/14/3643/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-07-12	Išregistruotas
2019-06-20	Perregistruotas
2014-10-16	Registruotas