Fenistil New drops oral (solution)

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Valmisteyhteenveto Valmisteyhteenveto (SPC)
08-12-2022

Aktiivinen ainesosa:

dimetindene (dimetindene maleate)

Saatavilla:

GlaxoSmithKline Consumer Healthcare SARL

ATC-koodi:

R06AB03 օրիգինալ դեղ

INN (Kansainvälinen yleisnimi):

dimetindene (dimetindene maleate)

Annos:

1mg/ml glass bottle 20ml

Lääkemuoto:

drops oral (solution)

Kpl paketissa:

1mg/ml glass bottle 20ml

Prescription tyyppi:

OTC

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2022-12-08

Valmisteyhteenveto

                                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
................................................................
                                
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