ROWATINEX

Medicinal product

(Invented) name

ROWATINEX

Active substance (s)

alfa ir beta pinenai/Kamfenas/Cineolas/Fenchonas/Borneolis/Anetolis

Strength

31 mg/15 mg/3 mg/4 mg/10 mg/4 mg

Pharmaceutical form

skrandyje neirios minkštosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Nereceptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G04BC, Urinary concrement solvents

Marketing authorisation holder

Rowa Pharmaceuticals Ltd., Airija

Date of authorisation

1997-04-09

Date of renewal

2010-09-08

Documents

2156 PAKUOTĖS LAPELIS 2025 08 19.docx

2156 ROWATINEX PCS PL 2025 08 19.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Nacionalinė procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
alfa ir beta pinenai	31 mg
Kamfenas	15 mg
Cineolas	3 mg
Fenchonas	4 mg
Borneolis	10 mg
Anetolis	4 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
4882	10208	1010208	lizdinė plokštelė	N50		Nereceptinis	LT/1/97/2156/001	Tiekiama	-	-	No	-	-	Download
4883	10209	1010209	lizdinė plokštelė	N100		Nereceptinis	LT/1/97/2156/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-09-08	Perregistruotas
1997-04-09	Registruotas