Theraflu powder for oral solution with forest berries flavour

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

paracetamol, pheniramine (pheniramine maleate), phenylephrine (phenylephrine hydrochloride)

Disponible depuis:

Novartis Consumer Health Inc.

Code ATC:

N02BE51

DCI (Dénomination commune internationale):

paracetamol, pheniramine (pheniramine maleate), phenylephrine (phenylephrine hydrochloride)

Dosage:

325mg+ 20mg+ 10mg

forme pharmaceutique:

powder for oral solution with forest berries flavour

Unités en paquet:

(10) sachets 11,5g

Type d'ordonnance:

OTC

Statut de autorisation:

Registered

Date de l'autorisation:

2017-04-25

Résumé des caractéristiques du produit

07-Feb-2014
0900c35380339304
1.0
Effective
Novartis Consumer Health
Global Regulatory Affairs
Global Labeling
NEOCITRAN / THERAFLU EXTRA STRENGTH COLD AND FLU
Paracetamol 650 mg, pheniramine maleate 20 mg, phenylephrine
hydrochloride 10 mg
Powder for oral solution
THERAFLU / THERAFLU COLD AND FLU
Paracetamol 325 mg, pheniramine maleate 20 mg, phenylephrine
hydrochloride 10 mg
Powder for oral solution
REGIONAL SUMMARY OF PRODUCT CHARACTERISTICS (R-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: Gaurav Jayant Kukade
Document status: Final
GLC approval date:
06 February 2014
GLC
tracking
ID:
2014-Feb-06/03-S
Amendment dates: NA
Effective date:
07 February 2014
Next Update date:
January 2017
Number of pages:
15
Property of Novartis Consumer Health
Confidential
May not be used, divulged, published or otherwise disclosed
without the consent of Novartis Consumer Health
Novartis Consumer Health
r-SmPC
CONFIDENTIAL
Page 2
Neocitran / Theraflu Extra Strength Cold and Flu
Neocitran / Theraflu Berry / Theraflu Cold and Flu
07-Feb-2014
0900c35380339304
1.0
Effective
TABLE OF CONTENTS
1
NAME OF THE MEDICINAL PRODUCT
........................................................................
3
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
.............................................. 3
3
PHARMACEUTICAL FORM
............................................................................................
3
4
CLINICAL PARTICULARS
..............................................................................................
4
4.1
Therapeutic indications
......................