Otrivin

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

xylometazoline (xylometazoline hydrochloride)

Available from:

Novartis Consumer Health S.A.

INN (International Name):

xylometazoline (xylometazoline hydrochloride)

Dosage:

0,5mg/ml

Pharmaceutical form:

drops nasal

Prescription type:

OTC

Summary of Product characteristics

Novartis Consumer Health SA
CH-1260, Nyon, Switzerland Global Regulatory Affairs
GlobalLabelling&
Compliance
OTRIVIN
_®_
0.05%
MOISTURISING FORMULA (F.5)
Nasal Drops (F.5)
Xylometazoline hydrochloride 0.05%
SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
The Core Data Sheet displays the company’s current position on
important characteristics of the
product, including the Core Safety Information (4.3-4.9 and 5.3)
according to ICH E2C.
The National Product Information (and Regional Product Information) is
based on the CDS.
However, because national regulatory requirements and medical
practices vary between countries,
the National (and Regional) Product Information may differ in several
respects, including but not
limited to the Core Safety Information.
Author(s): Paul Labbas, Parul Shukla
Document status: Final
GLC approval date:
24
Oct 2013
GLC tracking ID: 2013-Oct-24/01-S
Amendment date(s): 24 Oct 2013
Effective date: 31 Oct 2013
Next Update date: Oct 2016
Property of NovartisConsumer Health SA
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis Consumer Health SA
Novartis Consumer Health SA
Core SmPC
Page 2
Otrivin® 0.05% F.5
1.
NAME OF THE MEDICINAL
PRODUCT..................................................................3
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION.........................................3
3.
PHARMACEUTICAL
FORMS.....................................................................................3
4.
CLINICAL
PARTICULARS.........................................................................................3
4.1.
Therapeutic
indications.......................................................................................3
4.2.
Posology and method of
administration.............................................................3
4.3.
Contra-indications..............................................................................................4
4.4.
Special warnings and special precautions for
use..............................................4