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 (III) sulfate hydrate 0.5%, Ointment;
chromium(III) chloride 1%, Ointment;
citral 2%, Ointment;
citronellal 2%, Ointment;
citronellol 1%, Ointment;
clobetasol-17-propionate 0.1%, Solution;
clobetasol-17-propionate 0.25%, 1%, Ointment;
clotrimazole 1%, Ointment;
cobalt (II) sulfate 2.5%, Ointment;
cocamidopropyl betaine 1%, Solution;
cochineal red 1%, Solution;
coconut diethanolamide 0.5%, Ointment;
cod 10%, Ointment;
cold cream 100%, R;
compositae mix 6%, Ointment;
copper(II) sulfate pentahydrate 2%, Ointment;
corticosteroide mix 2.01%, Ointment;
coumarin 5%, Ointment;
cow casein 10%, Ointment;
cyanocobalamin 10%, Ointment;
decyl glucoside 5%, Ointment;
deflazacort 0.1%, Solution;
derma. farinae 10%, Ointment;
derma. mix 10%, Ointment;
derma. ptero 10%, Ointment;
desoximetasone 1%, Ointment;
dexamethasone 0.1%, Solution;
dexamethasone 0.5%, Ointment;
dexamethasone-21-phosphate disodium salt 1%, Ointment;
dexketoprofen 1%, Ointment;
dexpanthenol 5%, Ointment;
diallyl disulfide 1%, Ointment;
diazolidinyl urea 1% e 2%, Ointment;
dichlorophene 0.5 %, Ointment;
diclofenac 2.5%, 5%, Ointment;
diethanolamine (DEA) 2%, Ointment;
diethylhexyl butamido triazone 10%, Ointment;
dimethylaminopropylamine (DMAPA) 1%, Solution;
dimethylaminopropylamine 1%, Ointment;
dimethylfumarate 0.01%, 0.5%, Ointment;
dimethylol dihydroxyethyleneurea 4.5%, Solution;
dioxybenzone 2%, Ointment;
dipentamethylenethiuram tetrasulfide 0.25%, Ointment;
disodium edatate 1%, Ointment;
disodium phenyldibenzimidazole tetrasulfonate 10%, Ointment;
disperse blu mix (124/106) 1%, Ointment;
disperse blu-106 1%, Ointment;
disperse blue-124 1%, Ointment;
disperse red-11 1%, Ointment;
disperse yellow-9 1%, Ointment;
dithiocarbamate mix 2%, Ointment;
diurethane dimethacrylate 2%, Ointment;
dl alpha tocopherol 100%, R;
d-limonene 2% e 3%, Ointment;
DMDM hydantion 1%, 2%, Solution;
dodecyl gallate 0,3%, Ointment;
dodecyl mercaptan 0.1%, Ointment;
egg mix (white/yolk) 10%, Ointment;
egg white 10%, Ointment;
egg yolk 10%, Ointment;
erythromycin 1% e 2%, Ointment;
erythrosin-B 0.25%, Ointment;
erytrosin-B- 0.25%, Solution;
ethyl acrilate 0.1%, Ointment;
ethyl cyanoacrylate 10%, Ointment;
ethyl hexyl glycerol 5%, Ointment;
ethyleneurea, melamine forlmadeyde mix 5%, Ointment;
ethymethacrylate 2%, Ointment;
etofenamate 2%, Ointment;
farnesol 5%, Ointment;
ferric chloride 2%, Solution;
ferrous sulfate 5%, Ointment;
fluticasone propionate 0.1%, Solution;
formic acid 1%, Solution;
fragrance mix II 14%, Ointment;
fusidic acid sodium salt 2%, Ointment;
gallium oxide 1%, Ointment;
germanium(IV) chloride 2%, Ointment;
glyoxal trimeric dihydrate 1%, Ointment;
gold acid chloride trihydrate 0.1%, Ointment;
grass mix 5%, Ointment;
hexylene glucol 10%, Solution;
homosalate 5% e 10%, Ointment;
hydrocortisone 1%, Ointment;
hydrocortisone aceponate 1%, Solution;
hydrocortisone-17-butyrate 0.1%, 1%, Ointment;
hydrocortisone-17-butyrate 0.1%, 1%, Solution;
hydrocortisone-21-acetate 1%, Ointment;
ibuprofen 5%, Ointment;
indium(III) chloride 1%, Ointment;
indometacin 1%, Ointment;
iododeoxyuridine 1%, Ointment;
iodoform 5%, Ointment;
iodopropynyl butylcarbamate 0.2 %, 0.5%, Ointment;
iridium(III) chloride 1%, Ointment;
isopropylmyristate 10%, Ointment;
jasminun officinale oil (jasminun grandiflorum) 2% e 5%,
Ointment;
ketoprofen 1%, 2.5%, 5%, Ointment;
lauryl glycoside 3%, Ointment;
lavandula angustifolia oil (lavanderoil) 2%, Ointment;
lichen acid mix 0.3%, Ointment;
lilial 10%, Ointment;
linalool 10%, Ointment;
lyral 5%, Ointment;
mafenide 10%, Ointment;
magnesium chloride 2%, Ointment;
maize meal 10%, Ointment;
majantol 5%, Ointment;
manganese oxide 10%, Ointment;
manganese(II) chloride 0.5%, Ointment;
melamine formaldeyde resin 7%, Ointment;
menthyl anthranilate (Meradimate) 5%, Ointment;
mepivacaine-HCI 1%, Ointment;
mercapto mix [C] 2%, Ointment;
mercury-(II) chloride 0.1%, Ointment;
metamizol 1%, Ointment;
metanil yellow 1%, Ointment;
methyl violet 0.5%, Ointment;
methylchloroisothiazolinone/methylisothiazolinone 0.01%,
Solution;
methyldibromo glutaronitrile 0.3%, 0,5%, Ointment;
methylene-bis(methyloxazolidine) 1%, Ointment;
methylisothiazolinone 0.05%, 0.2%, Solution;
methylprednisolone aceponate 0.1%, Solution;
methylprednisolone hemisuccinate 0.1%, Solution;
metronidazole 1%, Ointment;
mixed dialkyl thioureas 1%, Ointment;
molybdenum(V) chloride 0.5%, Ointment;
mometasone furoate 0.1%, Solution;
monoethanolamine 2%, Ointment;
naphthol AS 1%, Ointment;
naproxen 5%, Ointment;
neodymium(III) chloride 1%, Ointment;
niobium(V) chloride 0.2%, Ointment;
N-phenyl-B-naphthylamine 1%, Ointment;
nystatin 2%, Ointment;
oat meal 10%, Ointment;
octisalate 5% e 10%, Ointment;
octocrylene 1%, 10%, Ointment;
octyl gallate 0.3%, Ointment;
octyl triazone 10%, Ointment;
octylisothiazolinone 0.025%, Ointment;
oil of bergamot 2%, Ointment;
oil of cinnamon 0,5%, Ointment;
oil of patchouli 10%, Ointment;
oil of rose 0.5%, Ointment;
oil of rosemary 0.5%, Ointment;
olaquindox 1%, Ointment;
oleamidopropyl dimethylamine 0.1%, Solution;
oxytetracycline 3%, Ointment;
papain 1%, Ointment;
paracetamol 10%, Ointment;
parthenolide 0.1%, Ointment;
patent blue-VF 0.25%, Solution;
peanut 10%, Ointment;
pectin 1%, Solution;
penicillamine 1%, Ointment;
pentaerythritoltriacrylat (PETA) 0.1%, Ointment;
phenacetine 10%, Ointment;
phenazone 5%, Ointment;
phenolphthalein 0.5 %, Ointment;
phenoxyethanol 1%, Ointment;
phenylbenzimidazole-5-sulfonic acid 10%, Ointment;
phenylbutazone 10%, Ointment;
phenylephrine hydrochloride 10%, Solution;
piketoprofen 1%, Ointment;
pilocarpine hydrochloride 1%, Solution;
pindolol 2%, Ointment;
piroxicam 1%, Ointment;
polidocanol 3%, Ointment;
polyethylene glycol ointment 100%, R;
polyethylene glycol-400 100%, R;
polymyxin B sulfate 3%, Ointment;
potassium chromium(III) sulfate 2%, Solution;
povidone iodine 10%, Solution;
prednicarbate 1%, Solution;
prednisolone 1%, Ointment;
prednisone 0.1%, Solution;
propanolol-HCl 2%, Ointment;
propyl gallate 0.5%, Ointment;
propylene glycol 100%, R;
propyphenazone 1%, Ointment;
p-toluenediamine 1%, Ointment;
quinidine sulfate 1%, Ointment;
resorcinol-formaldehyde-resin 5%, Ointment;
rhodium chloride 2%, Ointment;
rice meal 10%, Ointment;
ruthenium 0.1%, Ointment;
saccharin 0.1%, Solution;
salicylamide 2%, Ointment;
salicylic acid 5%, Ointment;
samarium(III) chloride 1.5%, Ointment;
shellac 20%, Solution;
silver colloidal 0.1%, Ointment;
silver nitrate 1%, Solution;
sodium alginate 1%, Solution;
sodium benzoate 2%, 5%, Ointment;
sodium cromoglycate 2%, Ointment;
sodium diphosphate 1%, Solution;
sodium disulfite 1%, Ointment;
sodium formate 2%, Solution;
sodium glutamate 1%, Solution;
sodium lauryl sulfate 0.25%, Solution;
sodium lauryl sulfate 0.5%, Ointment;
sodium nitrite 2%, Solution;
sodium-2-pyridinethiol-1-oxide (Sodium-Omadine) 0.1%, Solution;
sorbic acid 2%, Solution;
sorbitan monooleate 5%, Ointment;
soya meal 10%, Ointment;
stearyl alcohol 30%, Ointment;
strontium chloride 2%, Ointment;
sulphur, precipitated 10%, Ointment;
tantal 1%, Ointment;
tartrazine 1%, Solution;
tea tree oil, oxidized 5%, Ointment;
tellurium chloride 2%, Ointment;
tetrahydrofurfuryl methacrylate 2%, Ointment;
textile dye mix (A) 6.6% (B) 5.6%, Ointment;
tert.-butyl methoxydibenzoyl methane 5%, Ointment;
thiamin nitrate 10%, Ointment;
thymol 1%, Ointment;
tin(II) chloride 0.5%, Ointment;
tinosorb (methylene-bis- benzotriazolyl tetramethylbutylphenol)
10%, Ointment;
titanium 1%, Ointment;
titanium(IV) oxide 0.1%, Ointment;
tixocortolo-21-pivalete 0.1%, 1%, Ointment;
tobramycin 20%, Ointment;
tomato 20%, Ointment;
tree moss 1%, Ointment;
triamcinolone acetonide 0.1%, 1%, Ointment;
triamcinolone acetonide 0.1%, Solution;
trimethylhexane-1,6-diamine (mix of isomers) 0.5%, Ointment;
trolamine salicylate 5%, Ointment;
tungstic acid, sodium salt dihydrate 2%, Solution;
turpentine peroxide 0.3%, Ointment;
vanadium pentoxide 10%, Ointment;
wheat meal 10%, Ointment;
whole milk 20%, Ointment;
wolfram 5%, Ointment;
wool fat 30%, Ointment;
ytterbium sulfate 2%, Ointment;
yttrium oxide 2%, Ointment;
zinc chloride 1%, Ointment;
zinc powder 1%, Ointment;
zinc pyrithione 0.1%, Ointment;
zinc sulfate 1%, Ointment;
zirconium (IV) oxide 0.1%, Ointment;
platinum tetrachloride 1%, Ointment;
propylene glycol 10%, 20%, 30%, Solution;
ammonium thioglycolate 1%, Solution;
quinoline yellow 0.1%, Solution;
Sandalwood oil 10%, Ointment;
tert-butylhydroquinone 1%, Ointment.
Smaltimento scorte
I lotti gia' prodotti dei medicinali sopra elencati possono
essere mantenuti in commercio per un termine massimo di sei mesi a
decorrere dalla data di notifica della determina.
Decorrenza di efficacia della determina: dalla data di notifica
alla societa' richiedente.