COMUNICATO - Diniego delle domande di autorizzazione all'immissione in commercio presentate dalla societa' Smartpractice Europe GmbH ai sensi della determina Aifa n. DG 2130/2017 del 22 dicembre 2017 e successive modifiche ed integrazioni, concernente i medicinali allergeni gia' utilizzati in Italia anteriormente al 1° ottobre 1991. (19A04827)

Estratto determina n. DG/1156/2019 del 5 luglio 2019 Con la determina n. DG/1156/2019 del 5 luglio 2019, notificata alla richiedente in data 8 luglio 2019, sono diniegate le domande di autorizzazione all'immissione in commercio, depositate dalla societa' Smartpractice Europe GmbH, Steuer-Nr.: 337/5032/1276, con sede legale in Veghestrasse 19 - 48149 Münster, Germania, afferenti al procedimento avviato con determina AIFA n. DG 2130/2017 e successive modificazioni ed integrazioni, relative ai medicinali di seguito elencati: Bioban P 1487 (nitrobutyl)morpholine/(ethylnitro- trimethylene)dimorpholine 1%, Ointment;

Bioban CS 1135 4,4-dimethyl-1,3-oxazolidine/3,4,4- trimethyl-1,3-oxazolidine 1%, Ointment;

Bioban CS 1246 7-ethylbicyclooxazolidine 1%, Ointment;

1,2- benzisothiazoline -3- one, sodium salt 0.1%, Ointment;

1,3-butandiol-dimethacrylate 2%, Ointment;

1,4-butandioldimethacrylat (BUDMA) 2%, Ointment;

1,4-butanediol diglycidyl ether 0.25%, Ointment;

1,6-hexanediol diglycidyl ether 0.25%, Ointment;

2-(2´-hydroxy-5´-methylphenyl)benzotriazole (Drometrizole) 10%, Ointment;

2-(2-aminoethoxy)ethanol 1%, Ointment;

2,2,4,4-tetrahydroxybenzophenone (benzophenone-2) 1%, Ointment;

2-ethylhexyl acrylate 0.1%, Ointment;

2-hydroxy-4-methoxy-4-methyl benzophenone 10%, Ointment;

2-hydroxyethyl methacrylate (HEMA) 1%, 2%, Ointment;

2-hydroxy-ethylacrylate 0.1%, Ointment;

2-hydroxymethyl-2-nitro-1,3%-propanediol 1%, Ointment;

2-hydroxypropyl-methacrylate 2%, Ointment;

2-mercaptobenzimidazole 1%, Ointment;

3-aminophenol 1%, Ointment;

3,4´-methyl benzylidene camphor 2%, Ointment;

4-aminoazobenzene 1%, Ointment;

4-diethylamino-2-hydroxybenzoyl-benzoic acid hexyl ester 10%, Ointment;

acetylsalicylic acid 10%, Ointment;

alpha-amylcinnamic alcohol 1%, Ointment;

alpha-hexylcinnamic aldehyde 10%, Ointment;

alpha-isomethylionone 1%, Ointment;

aluminium hydroxide 10%, Ointment;

amalgam 5%, Ointment;

amalgam alloy metals 20%, Ointment;

amaranth 0.1%, Solution;

amcinonide 0.1%, Ointment;

amidoamine (stearamidopropyl dimethylamine) 0.1%, Solution;

aminophenazone 10%, Ointment;

ammonium heptamolybdate 2%, Solution;

ammonium heptamolybdate(VI) 1%, Ointment;

aniline 1%, Ointment;

anisyl alcohol 1%, Ointment;

antimony chloride 1%, Ointment;

articane hydrochloride 1%, Ointment;

aspartame 0.1%, Solution;

atropine sulfate 1%, Solution;

azorubine 0.1%, Solution;

barley meal 10%, Ointment;

basic red 46 1%, Ointment;

beclomethasone dipropionate 0.1%, Solution;

benzisothiazolinone 0.1%, Ointment;

benzoic acid 1%, Solution;

benzoic acid 5%, Ointment;

benzydamine hydrochloride 1% e 2%, Ointment;

benzyl alcohol 1%, Ointment;

benzyl benzoate 1%, Ointment;

benzylhemiformal 1%, Ointment;

benzyl-p-hydroxybenzoate 3%, Ointment;

beryllium(II) sulfat 1%, Solution;

betamethasone 0.1%, Solution;

betamethasone-17,21 dipropionate 0.5%, Ointment;

betamethasone-17,21-dipropionate 0.1%, Solution;

betamethasone-17-valerate 0.1%, Solution;

betamethasone-17-valerate 0.12%, 1%, Ointment;

bis(dibenzyldithiocarbamato)zinc 1%, Ointment;

bis-ethylhexyloxyphenol-methoxyphenyl triazine 10%, Ointment;

bismarck brown R 0.5%, Ointment;

bisphenol A-diglycidyl-methacrylate (BIS-GMA) 2%, Ointment;

bisphenol F 1%, Ointment;

brilliant black 0.1%, Solution;

budesonide 0.01%, 0.1%, Ointment;

bufexamac 5%, Ointment;

butylhydroxyanisole (BHA) 2%, Solution;

butylhydroxytoluene (BHT) 1%, Solution;

cadmium chloride 0.5%, Ointment;

cadmium sulfate 2%, Ointment;

caine mix [A] 7%, [C] 7%, Ointment;

camphor 1%, Ointment;

cananga odorata 2% e 10%, Ointment;

carba mix 3%, Ointment;

carboxymethyl cellulose sodium 2%, Ointment;

carmine 0.5%, Solution;

carmine 2.5%, Ointment;

carvone 5%, Ointment;

cereals mix 10%, Ointment;

cesium chloride 2%, Ointment;

cetalkonium chloride 0.1%, Ointment;

Cetrimide 0.05 %, Solution;

cetylpyridinium chloride 0.1%, Ointment;

chlorhexidine diacetate 0.5%, Solution;

chlorotetracycline-HCl 1%, Ointment;

chlorphenamine maleate 5%, Ointment;

chromium...