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 2013 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
     
123I-hippuran (o-Iodohippurate sodium) 201301  
123I-MIBG 201301  
algeldrate 201301 201105
aluminium +/or calcium +/or magnesium antacids 201301  
amlodipine + atorvastatin 201301  
amphetamine 201301  
amphetamine + dextroamphetamine 201301  
calcium +/or aluminium +/or magnesium antacids 201301  
carbachol 201301  
carboplatin 201301 201310
ciprofloxacin 201301 201211
ciprofloxacin + fluocinolone acetonide 201301  
cyclizine 201301  
ethyl esters of iodised fatty acids from poppyseed oil 201301  
exametazime 201301  
fenoprofen 201301  
gadodiamide 201301  
gemcitabine 201301  
gestrinone 201301  
glipizide 201301  
heparinoid (sodium alginate sulfate) 201301  
heparinoid + ibuprofen 201301  
interferon gamma-1b 201301  
isradipine 201301  
lofepramine 201301  
magnesium +/or calcium +/or aluminium antacids 201301  
mephenesin 201301  
mivacurium 201301  
niflumic acid (morniflumate) 201301  
oxacillin 201301  
potassium bicarbonate + sodium alginate 201301  
potassium bicarbonate + sodium bicarbonate 201301  
protamine 201301  
quinidine 201301  
stannousfluoride + medronate 201301  
sulfaguanidine 201301  
tauroselcholic acid [75Se] 201301  
tranexamic acid 201301  
tridecanamine undecylenate 201301  
triethanolamine salicylate 201301  
verapamil 201301 201202
     
acetylsalicylic acid 201302 201302
acetylsalicylic acid combinations 201302 201302
alverine 201302  
alverine + simethicone 201302  
aminohippurate 201302  
atenolol 201302 201208
atenolol + indapamide 201302  
benzylbenzoate 201302  
caffeine 201302 201302
carbolevure 201302  
chlornitrofenol 201302  
chlortalidone + reserpine 201302  
clobazam 201302  
clobetasol 201302  
clonixin 201302  
dacarbazine 201302  
etoposide 201302 201209
fenoterol + ipratropium 201302  
gabapentin 201302 201208
gadoteridol 201302  
ioxaglic acid 201302  
ispaghula husk + mebeverine 201302  
labetalol 201302  
lithium 201302 201101
losartan + HCT 201302  
mebeverine 201302  
mesalazine (mesalamine) 201302 201101
nafarelin 201302  
nicorandil 201302  
nifuratel 201302  
nitrofurantoin 201302 201103
paracetamol combinations (including those with acetyl salicylic acid) 201302 201302
perphenazine 201302  
phenylbutazone 201302 201104
pilocarpine + timolol 201302  
pimozide 201302  
pyrazinamide 201302  
technetium (99mTc) macrosalb 201302  
thioridazine 201302  
thyrotropin releasing hormone (synthetic) 201302  
tinzaparine 201302  
urea (13C) 201302  
     
alprazolam 201303 201301
ampicillin 201303 201306
ampicillin + cloxacillin 201303  
aureomycin (chlortetracycline) 201303  
benzatropine (benztrophine) 201303  
benzylnicotine + campher (camphora) + dimethyl sulphate + turpentine oil 201303  
calcium levofolinate 201303  
cefoxitin 201303  
cetalkonium + choline salicylate 201303  
chloramphenicol + amino acids + Vit A 201303  
chlorprothixene 201303  
choline salicylate 201303  
dienogest + ethinyl estradiol 201303  
dihydroergotamine + etilefrine 201303  
dihydrotachysterol 201303  
enalapril 201303 201206
ethynylestradiol + lynestrenol 201303 201108
felodipine + ramipril 201303  
hydralazine 201303  
hydrotalcite 201303 201203
ifenprodil 201303  
itopride 201303  
lynestrenol 201303  
lynestrenol + ethinyl estradiol 201303  
mepivacaine 201303 201108
mepivacaine + adrenaline (Epinephrine) 201303  
methionine 201303 201201
methylphenobarbital 201303  
neostigmine 201303 201303
nifuratel nystatin 201303  
nitrazepam 201303 201102
nortriptyline 201303  
panthenol 201303 201303
pethidine (meperidine) 201303  
phendimetrazine 201303  
pipotiazine 201303  
pirenzepine 201303 201103
pristinamycin (virginiamycin) 201303  
secnidazole 201303  
sodium iodide [l123] 201303  
stibogluconate 201303  
technetium (99mTc) oxidronate 201303  
thiocolchicoside 201303  
tosylchloramide 201303  
trandolapril + verapamil 201303  
trifluridine 201303  
vincristine 201303 201304
     
aceclidine 201304  
ademetionine (S-adenosylmethionine) 201304  
almitrine 201304  
barium sulphate + combninations 201304 201011
bemiparin 201304  
beta-carotene 201304 201304
bisacodyl 201304  
bisacodyl combinations 201304  
budesonide 201304 201208
buspirone 201304 201308
captopril 201304 201206
captopril + HCT 201304 201206
carbutamide 201304  
chloroxylenol 201304  
chloroxylenol + dibucaine 201304  
chloroxylenol + disodium edetate 201304  
chloroxylenol + edetic acid + triclosan 201304  
clobutinol 201304 201304
clofazimine 201304  
clomiphene 201304 201104
cod liver oil 201304  
cod liver oil + zinc oxide 201304  
cortivazol 201304  
dantrone + poloxamer 201304  
desoxycortone acetate 201304  
dexamphetamine (dextroamphetamine) 201304  
diazoxide 201304  
dornase alfa (deoxyribonuclease I) + fibrinolysin 201304  
dornase alfa (deoxyribonuclease I) + fibrinolysin + chloramphenicol 201304  
droperidol 201304  
droperidol + fentanyl 201304  
ethinylestradiol + levonorgestrel 201304  
horse chestnut seed extract (escin) 201304  
iobitridol 201304  
iomeprol 201304  
ivermectin 201304  
naloxone 201304 201305
naloxone combinations 201304 201307
oxycodone 201304  
oxycodone + naloxone 201304  
patent Blue V sodium 201304  
phenol 201304  
probenecid 201304  
promethazine 201304 201308
reboxetine 201304  
streptomycin 201304  
sulprostone 201304  
teniposide 201304  
tilidine 201304 201307
urea 201304  
     
adrenaline (ephinephrine) 201305  
amylsalicylate + methylnicotinate + levomenthol 201305  
benazepril + HCT 201305 201206
bendrofluazide (bendroflumethiazide) 201305  
benzethonium chloride 201305  
cyproterone 201305  
cyproterone + ethinyl estradiol 201305 201108
dapsone 201305  
dapsone + ferrous oxalate 201305  
dinoprost trometamol (tromethamine) 201305  
diosmin 201305 201305
dorzolamide 201305  
doxycycline 201305 201205
ebastine 201305  
estrogens, conjugated 201305  
ferumoxsil (siloxane coated superparamagnetic ironoxide) 201305  
hydrocortisone + oxytetracycline 201305  
isoniazide + pyrazinamide + rifampin (rifampicin) 201305  
isoniazide + rifampin (rifampicin) 201305  
macrogol 3350 201305  
macrogol 4000 201305  
macrogol 4000 and combinations 201305  
mebendazole 201305  
metipamide 201305  
nalbuphine 201305  
nicardipine 201305 201103
oxytetracycline 201305  
oxytetracycline combinations 201305  
pamidronate 201305 201308
petrolatum, mineral oil (ophthalmic) 201305  
pheniramine 201305  
prednisone 201305 201308
rifampicin (rifampin) 201305  
ticlopidine 201305 201201
tirofiban 201305  
undecylenic acid + zinc undecylenate 201305  
zuclopenthixol 201305  
     
alfoscerate olamine 201306  
alpha amylase 201306  
alpha amylase + bacitracine 201306  
benzododecinium bromide 201306  
chloramphenicol 201306  
chloramphenicol + combinations not further specified 201306  
chlortalidone 201306 201208
cinitapride 201306  
clonazepam 201306  
colestipol 201306  
decamethrin (deltamethin) + piperonyl (pipamperone) 201306  
dehydrocholic acid 201306  
dexbrompheniramine combinations 201306  
dexchlorpheniramine + chlorphenamine + pseudoephedrine 201306  
dexchlorpheniramine + dextromethorphan + coffein 201306  
dextropropoxyphene 201306  
dienogest + estradiol 201306  
etofenamate 201306  
ganciclovir 201306  
human chorionic gonadotropin (HCG) 201306  
hyprolose 201306  
inosine 201306  
lomustine 201306  
magnesium combinations (excluding antacids) 201306 201107
mitoxantrone 201306 201310
nafcillin 201306  
pentosane polyester + phenylephrine 201306  
phentermine 201306  
prednisolone 201306 201208
prochlorperazine 201306  
rizatriptan 201306  
vasopressin 201306  
zolpidem 201306 201209
     
acetazolamide 201307  
adapalene (topical) 201307  
albendazole 201307  
amitriptyline + amitriptylinoxide 201307  
amitriptyline + perphenazine 201307  
amitriptylinoxide 201307  
aurothiomalate 201307  
calcium salts not used in antacids or vitamin preparations 201307  
carbasalate calcium 201307  
carbasalate calcium+ metoclopramide 201307  
cisatracurium 201307  
colchicine 201307  
colchicine + tiemonium + opium 201307  
crotamiton 201307  
desogestrel 201307  
dobesilate calcium 201307  
dorzolamide + timolol 201307  
fluorometholone 201307  
fosfomycin 201307  
gadoteric acid (intraarticular) 201307  
glibornuride 201307  
glycine 201307 201307
griseofulvin 201307  
hexetidine 201307 201307
hymecromone 201307  
ibuprofen + pseudoephedrine 201307  
ifosfamide 201307  
lovastatin 201307 201212
meloxicam 201307  
minerals and combinations (excl. with vitamins) 201307 201306
monmectite 201307  
pentosane (elmiron) 201307  
pizotifen (pizotyline) 201307  
sodium aurothiomalate (aurothiomalate; sodium thiomalate) 201307  
thiamazole (methimazole) 201307 201208
valpromide 201307  
     
ciclesonide 201308  
ferric hydroxide sucrose complex 201308  
mecillinam 201308  
meldonium 201308  
paricalcitol 201308  
pivmecillinam 201308  
tricoflos 201308  
ajmaline 201308  
amyleine (amylocaine) + chlorhexidine 201308  
benzalkonium chloride + oxymetazoline 201308  
bile acids and salts 201308  
biperiden 201308 201309
borax/boric acid (opthalmic bath) 201308  
cefatrizine 201308  
cetrimide + chlorhexidine 201308  
chlorhexidine 201308 201301
chlorhexidine + cetrimonium 201308  
delorazepam 201308  
desonide 201308  
dextran (40, 60 and 70) 201308  
dextran 1 201308  
eflornithine 201308  
meclozine (meclizine) 201308  
meclozine hydrochloride, fixed combinations 201308  
medazepam 201308  
miconazole 201308 201303
miconazole combinations 201308  
naftifine 201308  
oxcarbazepine 201308  
oxymetazoline 201308  
oxymetazoline combinations 201308  
phenylsalicylate 201308  
phytoestrol 201308  
pyrvinium 201308  
     
adapalene + benzoyl peroxide 201309  
ciclopirox olamine (shampoo only) 201309  
etonogestrel 201309  
fucidic acid 201309  
indoramin 201309  
testosterone, testosterone undecanoate (oral) 201309  
atropine + diphenoxylate 201309  
bisoprolol 201309 201209
bisulepin 201309  
chlorambucil 201309  
ciclopirox olamine (all formulations except shampoo) 201309  
clavulanic acid 201309 201309
clenbuterol 201309  
dextranomer 201309  
dinoprostone 201309  
dipivefrin 201309  
esbiothrin 201309  
felbamate 201309  
gadoteric acid (IV and intravascular) 201309  
guanfacine 201309  
hydroxycobalamin 201309  
ichthyol (ammonium ichthosulfonate (ichthosulfol)) 201309  
isosorbide dinitrate 201309 201205
levosimendan 201309  
lidocaine (inj. + cardio inj.) 201309 201112
lidocaine + adrenaline (Epinephrine) 201309  
lisinopril 201309 201206
losartan 201309  
meprobamate + aceprometazine 201309  
mirtazapine 201309 201109
nefazodone 201309  
noradrenaline (norepinephrine) 201309  
omoconazole 201309  
papaverine 201309  
papaverine + combinations 201309  
papaverine + homatropine + dehydrocholic acid
201309  
silver sulfadiazine 201309  
silver sulfadiazine + cerous nitrate (cerium nitrate) 201309  
spartocin 201309  
testosterone (implants) 201309  
testosterone propionate, testosterone phenyl propionate and testosterone iso hexanoate and testosteronedecanoate 201309  
ticarcillin 201309  
ticarcillin + clavulanate 201309  
tolterodine 201309  
     
acetyldigoxin 201310 201110
acetyldigoxin combinations 201310  
alibendole 201310  
atenolol + nifedipine 201310 201208
barbexaclone 201310  
beractant (beta cardone) 201310  
betamethyl digoxin 201310  
buformin 201310  
chlorhexidine + dexpanthenol 201310  
chlorphenamine (chlorpheniramine) 201310  
chlorphenamine combinations (except with dexchlorpheniramine) 201310  
cholecalciferol + calcium 201310  
clemastine 201310  
desogestrel + ethinyl estradiol 201310 201108
dexetimide 201310  
diacetylmorphine 201310  
digoxin 201310 201110
fluanisone 201310  
fludrocortisone 201310  
flunitrazepam 201310 201304
fluorometholone + tetryzoline 201310  
furazolidone 201310  
hyoscyamine 201310  
lenograstim 201310  
lomefloxacin (ophtalmic preparations) 201310  
meprobamate 201310  
methylprednisolone 201310 201105
methylprednisolone acetate, lidocaine hydrochloride 201310  
methylprednisolone acetate, neomycin Sulfate 201310  
minoxidil 201310  
nitrofural 201310  
oxitropium 201310  
paraffin 201310  
paraffin combinations 201310  
pidotimod 201310  
pipamperone 201310  
povidone iodine 201310 201207
rimexolone 201310  
rimexolone (ophtalmic) 201310  
rutoside (rutin) 201310  
talinolol 201310  
trifluoperazine 201310  
colecalciferol + calcium 201310  
perindopril 201310  
technetium (99mTc) bicisate 201310  

 

 

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