Fenistil New drops oral (solution)

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

dimetindene (dimetindene maleate)

Available from:

GlaxoSmithKline Consumer Healthcare S.A.

ATC code:

R06AB03 օրիգինալ դեղ

INN (International Name):

dimetindene (dimetindene maleate)

Dosage:

1mg/ml glass bottle 20ml

Pharmaceutical form:

drops oral (solution)

Units in package:

1mg/ml glass bottle 20ml

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-11-26

Summary of Product characteristics

1
GSK Consumer Healthcare S.A.,
Switzerland.
CONFIDENTIAL
Summary of Product Characteristics
Fenistil NEW
Regulatory Affairs
FENISTIL 1 MG/ML ORAL DROPS
Dimethindene maleate
SUMMARY OF PRODUCT CHARACTERISTICS
Document type:
SPC
Document status:
Final
Release date:
10 February, 2020
Number of pages:
7
Property of GSK Consumer Healthcare
S.A. Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of GSK Consumer Healthcare
S.A.
2
GSK Consumer Healthcare S.A.,
Switzerland.
CONFIDENTIAL
Summary of Product Characteristics
Fenistil NEW
CONTENTS
1. NAME OF THE MEDICINAL
PRODUCT
................................................................
3
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
.......................................
3
3. PHARMACEUTICAL
FORM
....................................................................................
3
4. CLINICAL
PARTICULARS
......................................................................................
3
4.1. Therapeutic
indications
....................................................................................
3
4.2. Posology and method of
administration
............................................................
3
4.3.
Contraindications............................................................................................
3
4.4. Special
warnings
and
special
precautions for
use
..............................................
3
4.5. Interactions with other
medicinal
products and other forms of
interaction
.........
3
4.6. Pregnancy and lactation
...................................................................................
3
4.7. Effects on
ability
to drive and use
machines...................................................... 4
4.8.
Undesirable
effects...........................................................................................
4
4.9.
Overdose
.........................................................................................................
4
5.
PHARMACOLOGICAL
PROPERTIES
................................