Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
azelaic acid
Bayer Healthcare Manufacturing S.r.l.
D10AX03
azelaic acid
150mg/g
gel for external use
5g and 30g aluminium tube
OTC
Registered
2016-02-04
I r;i \,, i::' f {cal tlrcare Summary o f Produc t Char acteri stics Skinoren Gel. Azelaic Acid 15 % gel * This medicinal product is fegisterecl / marketed undel the followilrg trade namgs: skinof€n, Finacea, Azelainsaeure Schering, Azclan' Finel'in, Zelaika 7"r'f ,o<- l, 2. TABLE OF CONTENTS NAME OF THE MEDICINAL PRODUCT """""""""""""""""""" """"""""" 4 OUALITATIVE AND QUANTITATIVE COMPOSITION IN TERMS OF irlii ,rCiivp iussrANcBts) .. """"""" 4 PHARMACEUTICAL FORM........' """"""""""""""""""""' 4 CLINICAL PARTICULARS '.".......'. """""""""""" """"""" 4 Indication(si ......'. Dosase and method of administration Contraindications """""""""""""""""""" 4 Special warnings and precautions fot' use""""""'--" """"""' 4 Interaction with other medicinal products and other forms of interaction """"' 5 Pregnancy and lactation..".',.' Undesirable effects.."..'....'.-""'----- 3. 4, 4.1 4.2 4.3 4,4 4.6 4.6.1 4.6.2 4.7 4.8 4.9 5. 5,1 . Pharmacodynamic properties" 5.2 Pharmacoklnetic Properties"" """ """"""' / -1 5,3 Preclinicalsafetydata.....""'-"-""'--' 6, PHARMACEUTICALPARTICULARS.. 6.1 6.2 6.3 6.4 6.5 6.6 7. List of excipients Incompatlbilities Shelf life Special precautions for storage Nature and contents ofcontainer Instl.uctions for use / handling OWNER OFTHE PRODUCT ffi 1. NA]VIE OF THE MEDICINAL PRODUCT Skinoren 15 % gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TI{D ACTIVE SUBSTANCE(S) I g Skinoren gel contains 150 mg (15 %) azelaic actd' For a full List ofexcipients, see section 6 l 3. PHARMACEUTICAL FORM Gel (white to yellowish-whrte opaque gerJ IN TERMS OF 4.1 Indications Acne: rnild ancl moderale case of papulopttstular acne on facial skin' papulopustular Iosac€a 4,2 Dosage and method of administration For extemal use. Adults and children above 12 years of age:.gel 'should be applied to tbe ,ir"*o "ti"*itr.tn twice aday (momine ancl evening) and mbbed in€enlYskinor"n g"t i. ;;;;;t r.icm of get is sufficieni for the entire facial area ! "Tji"i,'i* tir" ,rro.,to u"it'oro'gt'lv cleaned with plain water or mild Lees het volledige document