Serie Generale n. 175 del 27-7-2019
ESTRATTI, SUNTI E COMUNICATI
AGENZIA ITALIANA DEL FARMACO
AGENZIA ITALIANA DEL FARMACO
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) (GU Serie Generale n.175 del 27-07-2019)

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 società
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 già 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 società richiedente.