Paracetamolum/Guaifenesinum/Phenylephrini hydrochloridum Perrigo Poland [Paracetamolum/Guaifenesinum/Phenylephrini hydrochloridum Richard Bittner AG]

Medicinal product

(Invented) name

Active substance (s)

Paracetamolis/Gvajfenezinas/Fenilefrino hidrochloridas

Strength

500 mg/100 mg/6,1 mg

Pharmaceutical form

kietosios kapsulės

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

2022-10-17

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10a

Procedure number

IE/H/1029/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra:	1 vnt.
Paracetamolis	500 mg
Gvajfenezinas	100 mg
Fenilefrino hidrochloridas	6,1 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
109625	95731	1095731	lizdinė plokštelė	N8		Nereceptinis	LT/1/22/5051/001	Netiekiama	-	-	No	-	-
109626	95732	1095732	lizdinė plokštelė	N16		Nereceptinis	LT/1/22/5051/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-17	Registruotas