Theraflu SN

Medicinal product

(Invented) name

Theraflu SN

Active substance (s)

Paracetamolis/Pseudoefedrino hidrochloridas

Strength

500 mg/30 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

N02BE51, Paracetamol, combinations excl. psycholeptics

Marketing authorisation holder

Haleon Hungary Kft. , Vengrija

Date of authorisation

2014-04-09

Date of renewal

2018-12-14

Documents

Pseudoephedrine_DHPC.pdf

3541 Pakuotės lapelis 2025 02 17.docx

3541 Theraflu SN PCS PL 2025 02 17.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

DE/H/3727/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Paketėlyje yra	1 vnt.
Paracetamolis	500 mg
Pseudoefedrino hidrochloridas	30 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
53826	67810	1067810	paketėlis	N6		Nereceptinis	LT/1/14/3541/001	Netiekiama	-	-	No	-	-
58800	73015	1073015	paketėlis	N8		Nereceptinis	LT/1/14/3541/002	Netiekiama	-	-	No	-	-
58801	73016	1073016	paketėlis	N10		Nereceptinis	LT/1/14/3541/003	Tiekiama	-	-	No	-	-	Download
58802	73017	1073017	paketėlis	N12		Nereceptinis	LT/1/14/3541/004	Netiekiama	-	-	No	-	-
58803	73018	1073018	paketėlis	N14		Nereceptinis	LT/1/14/3541/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-12-14	Perregistruotas
2014-04-09	Registruotas