Fenistil New drops oral (solution)

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

dimetindene (dimetindene maleate)

Disponible depuis:

GlaxoSmithKline Consumer Healthcare SARL

Code ATC:

R06AB03 օրիգինալ դեղ

DCI (Dénomination commune internationale):

dimetindene (dimetindene maleate)

Dosage:

1mg/ml glass bottle 20ml

forme pharmaceutique:

drops oral (solution)

Unités en paquet:

1mg/ml glass bottle 20ml

Type d'ordonnance:

OTC

Statut de autorisation:

Registered

Date de l'autorisation:

2022-12-08

Résumé des caractéristiques du produit

1
GSK Consumer Healthcare SARL,
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
Number of pages:
7
Property of GSK Consumer Healthcare
SARL Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of GSK Consumer Healthcare
SARL
2
GSK Consumer Healthcare SARL,
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
................................................................