Hotex

Medicinal product

(Invented) name

Hotex

Active substance (s)

Paracetamolis/Gvajfenezinas/Fenilefrino hidrochloridas

Strength

500 mg/200 mg/10 mg

Pharmaceutical form

milteliai geriamajam tirpalui

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

ATC code (s)

N02BE51, Paracetamol, combinations excl. psycholeptics

Marketing authorisation holder

Perrigo Poland Sp. z o.o., Lenkija

Date of authorisation

2021-10-01

Date of renewal

2024-04-24

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(3)

Procedure number

PT/H/2372/001

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Paketėlyje yra:	1 vnt.
Paracetamolis	500 mg
Gvajfenezinas	200 mg
Fenilefrino hidrochloridas	10 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
107284	93388	1093388	paketėlis	N5	Nereceptinis	LT/1/21/4816/001	Netiekiama	-	-	No	-	-
107285	93389	1093389	paketėlis	N6	Nereceptinis	LT/1/21/4816/002	Netiekiama	-	-	No	-	-
107286	93390	1093390	paketėlis	N10	Nereceptinis	LT/1/21/4816/003	Netiekiama	-	-	No	-	-
107287	93391	1093391	paketėlis	N14	Nereceptinis	LT/1/21/4816/004	Netiekiama	-	-	No	-	-
107288	93392	1093392	paketėlis	N15	Nereceptinis	LT/1/21/4816/005	Netiekiama	-	-	No	-	-
107289	93393	1093393	paketėlis	N20	Nereceptinis	LT/1/21/4816/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-04-24	Perregistruotas
2021-10-01	Registruotas