Pharmakovigilanz, PV-Systeme und PSURs von Diapharm Dr. Ebeling & Assoc GmbH B.A.H WIDI Dr. Ebeling & Assoc GmbH Pharmakovigilanz, PV-Systeme und PSURs von Diapharm

 

Data Lock Points 2011 für chemische Substanzen

Cave: Die Berechnung der DLPs erfolgte durch Stichtag minus 2 Monate, um eine einheitliche Darstellung zu ermöglichen. Da der Zeitraum zwischen DLP und Abgabetermin des PSURs von (maximal) 60 Tagen jedoch nicht immer exakt 2 Monaten entspricht, ergeben sich ausgehend von dem im Projekt fixierten Stichtag fallweise Abweichungen zum tatsächlichen DLP.

 
Active substance name (INN) EU DLP BfArM / BAH DLP
     
alendronate sodium 201101  
alendronate + colecalciferol (Vitamin D) 201101  
alizapride 201101  
alprostadil (erectile dysfunction) 201101  
altretamine 201101  
bacterial Lysate 201101  
bamifyline 201101  
belladonna alkaloids, ergotamine, phenobarbital 201101  
bromhexine 201101 201210
bromhexine + eucalyptin etheroeum + ainisi aetheroleum + foeniculi etheroleum + levomentholum + menthae piperitae eleum + origani etheroleum 201101  
calcipotriol 201101  
capreomycin 201101  
carbomer (artificial tears) 201101  
carboprost 201101  
cefoperazone 201101  
cefoperazone-sulbactam (sulperazone) 201101  
cyclopenthiazide 201101  
dexamethasone 201101 201305
dexamethasone + framycetin +
gramicidin
201101  
dexamethasone + neomycin 201101  
dexamethasone + neomycin + polymyxin b 201101  
dexamethasone + neomycin+ acetic acid, glacial 201101  
dexamethasone + polymyxin b + trimethoprim 201101  
dibromopropamidine 201101  
diethylstilbestrol 201101  
eletriptan 201101  
enoxolone 201101  
ginkgo biloba extract + heptaminol hydrochloride acid + troxerutin 201101  
ginkgo biloba extract + troxerutin 201101  
haloperidol, haloperidol decanoate, haloperidol buzepide 201101 201210
meglumine 201101  
methyl salicylate + menthol + eugenol 201101  
nalidixic acid 201101  
omega-3 fatty acids 201101 201101
oxatomide (yearly PSURs) 201101  
phenprocoumon 201101 201101
pitofenone 201101  
polyvinyl alcohol + polyethylene glycol 201101  
prenoxdiazine 201101  
protirelin 201101  
pyrrolidone carboxylate sodium 201101  
salbutamol (albuterol) 201101 201107
sertindole (6-monthly PSURs) 201101  
sevoflurane 201101  
sodium bicarbonate + sodium sulphate (sodium sulfate anhydrous) + sodium phosphate 201101  
somatorelin 201101  
spirapril 201101  
zanamivir (yearly PSURs) 201101  
zofenopril 201101  
     
attapulgite + aluminium hydroxide and magnesium carbonate co-dried gel 201102  
bicalutamide 201102  
butoconazole 201102  
cyclopentolate 201102  
cyclophosphamide 201102  
dicycloverine 201102  
dihydroergocristine + esculinum (esculin) + rutoside (rutin) 201102  
doxylamine 201102 201102
estradiol + dydrogesterone 201102  
estradiol + testosterone 201102  
fluprednidene + miconazole 201102  
fructose + glucose + xylitol 201102  
gliclazide 201102  
hydrocortisone acetate + neomycine + centella extract 201102  
lisinopril + HCT 201102 201206
mannitol 201102  
mephenoxalone 201102  
metixene 201102  
mofebutazone 201102 201102
noscapine 201102  
phosphate ( 32P) sodium 201102  
piperazine 201102  
polycarbophil 201102  
proglumetacine 201102  
rocuronium 201102  
salicylamide 201102  
selenium disulfide 201102  
sodium citrate 201102 201102
technetium (Tc-99m) pyrophosphate 201102  
trandolapril 201102  
     
aceclofenac 201103  
amlodipine 201103 201204
benorilate 201103  
bleomycin 201103 201302
carbaethopendecinium 201103  
carteolol 201103  
cephalexin 201103  
chlortetracycline + demeclocycline + tetracycline 201103  
cisapride (yearly PSURs) 201103  
dexamethasone + tobramycin (ophtalmic and otic use) 201103  
diiodohydroxyquinoline 201103  
disulfiram 201103  
esomeprazole 201103  
ethinylestradiol + gestodene 201103  
etoricoxib (yearly PSURs) 201103  
ezetimibe + simvastatin 201103  
fluconazole 201103 201201
hydroquinidine 201103  
hyoscine butylbromide (butylscopolamine bromide, scopolamine butyl bromide) 201103 201310
lauromacrogol 400 201103  
lauromacrogols combinations 201103  
levosulpiride 201103  
microcrystalline hydroxyapatite 201103  
obidoxime 201103  
oxilofrine 201103 201103
pemoline 201103 201103
phenyl(2-hydroxybenzoate) 201103 201103
pimecrolimus (yearly PSURs) 201103  
piribedil 201103  
piritramide 201103  
polyestradiol 201103  
polyestradiol combinations 201103  
poyestradiol 201103  
pravastatin 201103 201110
procyclidine 201103  
proparacaine 201103  
quinfamide 201103  
rifamycin 201103  
risedronate (yearly PSURs) 201103  
sertraline 201103 201210
silver nitrate 201103  
sodium chloride, potassium chloride, calcium chloride dihydrate (+ glucose) (Ringer [+ glucose]), including irrigation 201103  
somatropin 201103  
tacrolimus (6 monthly PSURs) 201103  
thiopental 201103  
tobramycin (ophtalmic drops) 201103  
tropicamide 201103  
     
acexamic Acid 201104  
amiloride 201104 201206
amiloride + chlorthalidone 201104  
amiloride + furosemide 201104  
amiloride + HCT + methyldopa 201104  
amiloride + HCT + timolol 201104  
amiloride + hydrochlorothoaizide (HCT) 201104 201206
amsacrine 201104  
azithromycin 201104 201203
benzoyl peroxide 201104 201104
bupivacaine 201104  
bupivacaine + adrenaline 201104  
ciclopirox + oxolamine 201104  
cinchocaine (dibucaine) 201104  
co-danthrusate 201104  
cytarabine 201104  
dimeticone 201104  
dimeticone combinations 201104  
disopyramide 201104  
dosulepin 201104  
dydrogesterone 201104  
enflurane 201104  
etamsylate 201104  
fenspiride 201104  
fluorescein 201104  
fluorescein + oxybuprocaine 201104  
linezolid (yearly PSURs) 201104  
methyldopa + HCT 201104  
mycophenolate mofetil 201104  
olmesartan + amlodipine (6-monthly PSUR) 201104  
phentolamine 201104  
piroxicam 201104 201204
poly (styrol, divinylbenzol) sulfonic acid 201104 201104
porfimer sodium 201104  
potassium chloride 201104  
quinapril 201104 201206
quinapril + HCT 201104 201206
ramipril + furosemide 201104  
simethicone 201104 201102
simvastatin 201104 201204
sulfasalazine 201104 201012
thymol, levomenthol, salol 201104  
tioconazole 201104  
valsartan (6-monthly PSUR cycles for the paediatric indication only) 201104  
valsartan + HCT 201104  
     
(iso)spagmulate 201105  
apraclonidine 201105  
buflomedil 201105 201301
carisoprodol 201105  
chenodesoxycholic acid 201105  
chloramphenicol + dexamethasone 201105  
chlorpromazine 201105  
clonidine 201105 201212
dextran70 + hydroxypropylmethyl cellulose 201105  
diisopropylamine 201105  
dimethoxanate 201105  
estramustine 201105 201103
formoterol 201105  
goserelin 201105  
indobufen 201105  
irinotecan 201105  
ketobemidone 201105  
lactobacillus LB 201105  
lactulose 201105 201302
lanreotide 201105  
methyl salicylate + clove oil + capsicum oil 201105  
moxifloxacin (yearly PSURs) 201105  
nadifloxacin 201105  
norethisterone (norethindrone) combinations 201105  
pancreas powder (Rizolipase) 201105 201103
pancreatic extracts 201105  
pancreatin 201105 201101
pancreatin combinations 201105  
prasterone 201105  
remifentanil 201105  
technetium (Tc-99m) tiatide 201105  
testosteronenantat 201105  
tetracosactide (cosyntropin) 201105  
tramadol 201105 201310
tramadol + paracetamol 201105  
trimecaine 201105  
xylometazoline 201105 201310
     
acetylcholine 201106  
almotriptan 201106  
barnidipine 201106  
benzocaine + tyrothricin 201106  
benzylpenicillin 201106  
botulinum toxin A (yearly PSURs) 201106  
brivudine 201106  
buclizine 201106  
cefonicid 201106  
chlorhexidine + sodium fluoride 201106  
cilastatin + imipenem 201106  
clebopride 201106  
coal tar + alcoholic extract 201106  
coal tar + soya oil 201106  
coal tar derivative 201106  
dextromethorphan 201106 201011
dextromethorphan combinations (except with chlorphenamine, dexchlorpheniramine or paracetamol) 201106  
dihydralazine + HCT + reserpine 201106  
dihydroergotamine + oxytocin 201106  
dimethyl sulfoxide 201106  
epirubicin 201106 201211
ergometrine + oxytocin 201106  
ethionamide 201106  
flumetasone 201106  
flumetasone + clioquinol 201106  
fluoride sodium + strontium acetate hemihydrate 201106  
latanoprost + timolol 201106  
levobunolol 201106 201012
lonazolac 201106 201106
methotrexate 201106 201203
misoprostol 201106  
octreotide 201106  
ornidazole 201106  
oxeladin 201106  
oxytocin 201106 201201
pipobroman 201106  
procainamide 201106  
propiomazine 201106  
propranolol 201106 201209
prothipendyl 201106  
rupatadine (yearly PSURs) 201106  
solifenacin 201106  
sulindac 201106  
tetryzoline 201106 201106
trazodone 201106 201308
troxerutine 201106 201106
vincamine 201106  
     
acamprosate 201107  
acenocoumarol 201107  
alpha dihydroergocryptine 201107  
amylmetacresol + dichlorobenzyl alcohol 201107  
amylmetacresol + dichlorobenzyl alcohol + levomenthol 201107  
amylmetacresol + dichlorobenzyl alcohol + lidocaine 201107  
astemizole 201107 201107
buprenorphine 201107  
cefpiramide 201107  
certoparin (heparin) 201107  
cloperastine 201107  
deltamethrin 201107  
dropropizine 201107  
fenofibrate 201107 201107
floctafenine 201107  
halothane 201107  
levocetirizine 201107  
lodoxamide 201107  
magaldrate 201107 201107
mesnum (mesna) 201107  
pralidoxime 201107  
propylthiouracil 201107  
quetiapine (yearly PSURs) 201107  
ropinirole (yearly PSUR) 201107  
selenite sodium 201107  
sulfadiazine 201107  
tacalcitol 201107  
tamsulosin 201107 201105
timolol (opthalmic preparations) 201107 201212
tolbutamide 201107  
tropatepine 201107  
vinpocetin 201107  
xipamide 201107 201301
zinc salts 201107 201107
ziprasidone (yearly PSURs) 201107  
     
aquatain 201108  
atropine 201108  
benzylpenicillin combinations 201108  
brompheniramine 201108  
budesonide + formoterol (yearly PSURs) 201108  
buserelin 201108  
butorphanol 201108  
calcium folinate 201108  
carbenicillin 201108  
cefaclor 201108 201111
cetirizine + pseudoephedrine 201108  
chloropyramine 201108  
chloroxine 201108  
citral + terpinol + sylvestre pine oil + serpolet (thyme) oil 201108  
dalteparin (heparin) 201108  
dexibuprofen 201108  
diphemanil (methylsulfate) 201108  
drofenine + propyphenazone 201108  
embramine 201108  
epervudine 201108  
erdosteine 201108  
esketamine 201108  
estradiol (17-beta) 201108 201304
fenbufen 201108  
ferrous fumarate 201108  
ferumoxtran-10 (superparamagnetic ironoxide) 201108  
finasteride (yearly PSURs) 201108 201107
folinic acid 201108 201304
fosphenytoin 201108  
fotemustine 201108  
gliquidone 201108  
glyceryl trinitrate (nitorglycerin) 201108 201307
hyaluronate sodium 201108  
hydrocortisone 201108 201205
hypochlorite sodium 201108  
ibopamine 201108  
iopamidol (oral) 201108  
ioxitalamic acid 201108  
ipecacuanha (ipecac) + combinations 201108  
isotretinoin (yearly PSUR) 201108 201011
lercanidipine 201108  
megestrol 201108 201307
methenamine 201108  
methenamine + phenazopyridine 201108  
methyl butetisalicylate 201108  
methylene diphosphonic acid 201108  
naproxen 201108 201305
naproxen combinations 201108  
neomycin + hydrocortisone 201108  
nicotine 201108  
nifurtoinol 201108  
nitroglycerin (oral) 201108  
nitroglycerin (transdermal) 201108  
oxetorone 201108  
pefloxacin 201108  
penciclovir (topical use only) 201108  
pilocarpine (ophthalmic) 201108  
raltitrexed 201108  
ramipril + piretanide 201108  
rotigotine 201108  
s-ketamine 201108  
sodium chloride (ophtamic) 201108  
sotalol 201108 201208
sulfafurazole (sulfisoxazole) 201108  
sulfamethoxazole 201108  
sulfisoxazole 201108  
suxamethonium 201108  
suxamethonium bromide 201108  
thyroglobulin 201108  
thyrotricine (or tyrothricin) 201108 201108
tiaprofenic acid 201108  
tolazamide 201108  
tretinoin + tocopherols 201108  
triflusal 201108  
viminol 201108  
     
drospirenone + ethinylestradiol (yearly PSURs) 201109  
vigabatrin (yearly PSURs) 201109  
ambroxol 201109 201205
ambroxol + doxycycline 201109 201205
atenolol + chlorthalidone 201109 201208
baclofen (oral) 201109 201307
brimonidine 201109 201112
brimonidine + timolol 201109  
bromazepam 201109 201112
caffeine + phenazone 201109  
canrenoate 201109 201106
capsaicin 201109  
codeine 201109 201302
codeine + chlorpheniramine + ephedrine 201109  
codeine + creosote 201109  
codeine + diphenhydramine 201109  
codeine + erysimum (erythromycin) 201109  
codeine + guaifenesin + ephedrine hydrochloride 201109  
codeine + ibuprofen 201109  
codeine polysulfonate + phenyltoloxamine + guaifenesin 201109  
codeine polysulfonate + phenyltoloxamine + guaifenesin + thyme 201109  
codeine polysulfonate + phenyltoloxamine polysulfonate 201109  
codeine polysulfonate resin 201109  
dopexamine 201109  
famotidine 201109 201212
fluindione 201109  
ibuprofen 201109 201212
ibuprofen + lysine 201109  
idebenone 201109  
imidapril 201109  
iodide (131I) sodium 201109  
maprotiline 201109 201303
melphalan 201109  
mercaptopurine 201109  
nonivamide 201109  
oxamniquine 201109  
phenazone (antipyridine) 201109 201109
phenolphtalein 201109  
pramocaine 201109  
pramoxine (pramocaine) 201109  
pravastatin + acetylsalicylic acid 201109  
pravastatin + acetylsalicylic acid (aspirin) 201109  
procaine 201109  
propylene glycol 201109  
serrapeptase 201109  
sulfabenzamide + sulfacetamide + sulfathiazole 201109  
sulfinpyrazone 201109  
sumatriptan 201109  
trapidil 201109  
triclorcarban 201109  
trospium 201109  
valganciclovir 201109  
     
methylphenidate (yearly PSURs) 201110 201011
fluticasone + salmeterol (yearly PSURs) 201110  
salmeterol (yearly PSURs) 201110  
acemetacin 201110 201110
aminoglutethimide 201110  
antazoline 201110  
antazoline + naphazoline 201110  
antazoline + tetryzoline (tetrahydrozoline) 201110  
antazoline + xylometazoline 201110  
atorvastatin 201110  
bamipine 201110 201110
benzalkonium chloride (incl ocular) 201110  
benzalkonium chloride + benzyl alcohol + chlorhexedine 201110  
benzalkonium chloride + cetrimide 201110  
benzalkonium chloride + chloroxylenol + disodium edetate 201110  
benzalkonium chloride + dequalinium chloride 201110  
benzalkonium chloride + dimethicone 201110  
benzalkonium chloride + hexylresorcinol 201110  
benzalkonium chloride + tolnaftate 201110  
benzbromarone 201110 201201
cefotiam 201110 201209
cefsulodin 201110  
clomipramine 201110 201212
corticorelin 201110  
cyanocobalamin (57Co) 201110  
dopamine 201110 201306
ethinylestradiol + norgestimate 201110  
hexylresorcinol 201110  
insulin human 201110 201310
isoflurane 201110  
ketotifen (all formulations except eye drops) 201110 201201
lacidipine 201110  
letrozole 201110  
mexiletine 201110  
mitomycin 201110 201102
olmesartan 201110  
olmesartan + hydrochlorothiazide 201110  
picloxydine 201110  
pivampicillin 201110  
polystyrene sulfonate (polystyrene sulfonate acid) 201110  
polythiazide 201110  
polythiazide + reserpine 201110  
proscillaridin 201110  
prulifloxacin 201110  
pseudoephedrine 201110  
pseudoephedrine + triprolidine 201110  
sultopride 201110  
tertatol 201110  
tetrabenazine 201110  
tiotropium 201110  
tobramycin 201110  
trimipramine 201110 201202
vinblastine 201110 201110
     
[18 F] fludeoxyglucose (injection) 201111  
acriflavinium chloride (acriflavine hydrochloride) + menthol + resorcinol 201111  
atovaquone 201111  
cefazolin 201111 201304
cephradine (cefradine) 201111  
chlormadinone acetate + ethinyl estradiol 201111  
chondroitin 201111  
chondroitin + glucosamine 201111  
chromium (51 Cr) EDTA 201111  
cimetidine 201111 201201
cimetidine + sodium alginate 201111  
cinoxacin 201111  
clopamide + pindolol 201111  
detajmium 201111  
diethylamine salicylic acid combinations 201111  
dihydrocodeine 201111 201302
dihydrocodeine combinations 201111  
donepezil 201111  
epitizide (epithiazide) + triamterene 201111  
ergometrine 201111  
fenoterol 201111  
fluocinolone + metronidazole + nystatin 201111  
gelatin Absorbable 201111  
glatiramer 201111  
idoxuridine 201111  
iotrolan 201111  
isoniazide 201111  
lisuride 201111  
methyl salicylate + menthol 201111  
methylprednisolone aceponate 201111  
metronidazole (topical) 201111  
metronidazole + minocycline + nystatine 201111  
nitroprusside 201111  
povidone 201111  
quinine 201111  
quinine combinations 201111  
teicoplanin 201111  
temazepam 201111  
ursodeoxycholic acid 201111 201111
     
aldesleukin 201112  
ambenonium 201112  
ambroxol + clenbuterol 201112  
amcinonide + neomycin 201112  
amilomer 201112  
amiodarone 201112 201308
amyl nitrite 201112  
androstanolone 201112  
azathioprine 201112 201305
bacitracin 201112  
bacitracin + chlorhexidine 201112  
bacitracin + colistimethate sodium + hydrocortisone acetate 201112  
bacitracin + neomycin 201112  
bacitracin + neomycin + prednisolone 201112  
beclomethasone 201112 201110
betahistine 201112 201112
bufexamac + lidocaine 201112 201112
catalase + neomycin 201112  
celecoxib 201112  
chlorhexidine + neomycin 201112  
chlorocresol 201112  
chlorocresol combinations 201112  
cilazapril 201112  
cilazapril + HCT 201112  
ciprofibrate 201112  
citalopram 201112 201204
citicoline 201112  
comfrey extract + methylnicotinate 201112  
comfrey root liquid extract (symphytum officinalis) 201112  
cyproheptadine 201112  
deferoxamine 201112  
desmopressin 201112  
drospirenone + estradiol 201112  
escitalopram 201112  
esmolol 201112  
estradiol (17-beta) + gestodene 201112  
fludrocortisone + gramicidin + neomycin 201112  
fluorouracil 201112 201203
gramicidin 201112  
gramicidin + neomycin 201112  
gramicidin, neomycin, naphazoline, phenylephrine 201112  
granisetron 201112  
hydroxysine, hydroxysine chloride; hydroxysine pamoate and all fixed combination products containing hydroxyzine 201112  
iopamidol (intravascular, intrathecal) 201112 201301
isosorbide mononitrate 201112 201208
lansoprazole 201112  
lormetazepam 201112 201104
methadone 201112 201302
neomycin 201112  
pergolide 201112 201204
pimethixene 201112  
pipemidic acid 201112  
prajmalium 201112  
prilocaine 201112  
prilocaine + adrenaline 201112  
roxithromycin 201112 201109
sodium chromate ( 51Cr) 201112  
tazarotene 201112  
tegafur 201112  
terbutaline 201112 201306
terfenadine 201112 201112
thiethylperazine 201112  
tobramycin (for inhalation) 201112  

 

 

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