Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
paracetamol, pheniramine (pheniramine maleate), phenylephrine (phenylephrine hydrochloride)
Novartis Consumer Health Inc.
N02BE51
paracetamol, pheniramine (pheniramine maleate), phenylephrine (phenylephrine hydrochloride)
325mg+ 20mg+ 10mg
powder for oral solution with forest berries flavour
(10) sachets 11,5g
OTC
Registered
2017-04-25
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 ...................... Прочитать полный документ