TEMPIER

Medicinal product

(Invented) name

TEMPIER

Active substance (s)

Paracetamolis/Pseudoefedrino sulfatas/Dekstrometorfano hidrobromidas

Strength

500 mg/30 mg/15 mg

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

R05X, Other cold preparations

Marketing authorisation holder

UAB NVT, Lietuva

Date of authorisation

2018-11-12

Date of renewal

2023-10-10

Documents

4293 TEMPIER PCS PL 2025 07 01.docx

Tempier_NP_NPS_viesas_AR.pdf

4293 Pakuotės lapelis 2025 07 01.docx

Pseudoephedrine_DHPC.pdf

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10a

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Paketėlyje yra	1 vnt.
Paracetamolis	500 mg
Pseudoefedrino sulfatas	30 mg
Dekstrometorfano hidrobromidas	15 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
100469	86577	1086577	paketėlis	N6		Nereceptinis	LT/1/18/4293/001	Tiekiama	-	-	No	-	-	Download
100470	86578	1086578	paketėlis	N10		Nereceptinis	LT/1/18/4293/002	Netiekiama	-	-	No	-	-
100471	86579	1086579	paketėlis	N20		Nereceptinis	LT/1/18/4293/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-10-10	Perregistruotas
2018-11-12	Registruotas