natgillin/translations-raw huggingface dataset:
Excipient(s) with known effect 132.33 mg lactose monohydrate per tablet.
Pomožna(e) snov(i) z znanim učinkom 132,33 mg laktoze monohidrat na tableto
Aripiprazole Sandoz 20 mg tablets EU/1/15/1029/043 (14 tablets) EU/1/15/1029/044 (28 tablets) EU/1/15/1029/045 (49 tablets) EU/1/15/1029/046 (56 tablets) EU/1/15/1029/047 (98 tablets)
Aripiprazol Sandoz 20 mg tablete EU/1/15/1029/043 (14 tablet) EU/1/15/1029/044 (28 tablet) EU/1/15/1029/045 (49 tablet) EU/1/15/1029/046 (56 tablet) EU/1/15/1029/047 (98 tablet)
EU/1/15/1029/043 14 tablets EU/1/15/1029/044 28 tablets EU/1/15/1029/045 49 tablets EU/1/15/1029/046 56 tablets EU/1/15/1029/047 98 tablets
EU/1/15/1029/043 14 tablet EU/1/15/1029/044 28 tablet EU/1/15/1029/045 49 tablet EU/1/15/1029/046 56 tablet EU/1/15/1029/047 98 tablet
venlafaxine, St. John's Wort)
paroksetin, venlafaksin, šentjanževka),
In two long term trials with adolescent (13-17 years) schizophrenia and bipolar patients treated with aripiprazole, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 37.0 % and 59.4 %, respectively.
Pri dveh dolgotrajnih preskušanjih pri mladostnikih (starosti od 13 do 17 let) s shizofrenijo in bipolarno motnjo, ki so se zdravili z aripiprazolom, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah 37,0 % (< 3 ng/ml) in pri moških (< 2 ng/ml) 59,4 %.
Aripiprazole Sandoz is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Zdravilo Aripiprazol Sandoz je indicirano za zdravljenje zmernih do hudih maničnih epizod pri bipolarni motnji I pri mladostnikih, starih 13 let in več.
Aripiprazole Sandoz contains lactose
Zdravilo Aripiprazol Sandoz vsebuje laktozo
Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n=99, placebo: n=44) in a randomised, double-blind, placebo controlled, 8 week study using a fixed dose weightbased treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Tiki, povezani s Tourettovim sindromom, pri pediatričnih bolnikih (glejte poglavje 4.2) Učinkovitost aripiprazola je bila raziskana pri pediatrični populaciji s Tourettovo motnjo (aripiprazol: n = 99, placebo: n = 44) v 8-tedenski randomizirani, dvojno slepi, s placebom nadzorovani študiji, zasnovani z zdravljenimi skupinami, ki so prejemale nespremenjen odmerek glede na telesno maso posameznika v razponu od 5 mg/dan do 20 mg/dan, z začetnim odmerkom 2 mg. Bolniki so bili stari od 7 do 17 let, povprečni izhodiščni rezultat njihovega števila tikov po skupni oceni resnosti tikov na lestvici TTS-YYGTSS (angl. Total Tic Severity Score - Yale Global Tic Severity Scale) pa je bil 30.
What Aripiprazole Sandoz tablets look like and contents of the pack´
Izgled zdravila Aripiprazol Sandoz in vsebina pakiranja
Excipient(s) with known effect 71.02 mg lactose monohydrate per tablet.
Pomožna(e) snov(i) z znanim učinkom 71,02 mg laktoze monohidrat na tableto
In the adolescent (13-17 years) schizophrenia population with aripiprazole exposure of 5 to 30 mg up to 72 months, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 25.6% and 45.0%, respectively.
Pri populaciji mladostnikov (starosti od 13 do 17 let) s shizofrenijo, ki so največ 72 mesecev izpostavljeni apriprazolu 5 do 30 mg, je bila pojavnost nizkih vrednosti prolaktina v serumu pri ženskah (< 3 ng/ml) 25,6 % in pri moških (< 2 ng/ml) 45,0 %.
Aripiprazole Sandoz 20 mg tablets Each tablet contains 20 mg aripiprazole.
Aripiprazol Sandoz 20 mg tablete Ena tableta vsebuje 20 mg aripiprazola.
Suicide attempt, suicidal ideation and completed suicide (see section 4.4)
Psihiatrične motnje nespečnost anksioznost nemir depresija hiperseksualnost poskus samomora, misli na samomor in samomor (glejte poglavje 4.4) patološko hazardiranje
Blister packs in cartons: 14, 28, 49, 56, 98 tablets
Aripiprazol Sandoz 20 mg tabletePretisni omoti v škatlah: 14, 28, 49, 56, 98 tablet
• diarrhoea,
sladkorna bolezen,
Excipient(s) with known effect 196.50 mg lactose monohydrate per tablet.
Pomožna(e) snov(i) z znanim učinkom 196,50 mg laktoze monohidrat na tableto
Aripiprazole Sandoz 30 mg tablets Each tablet contains 30 mg aripiprazole.
Aripiprazol Sandoz 30 mg tablete Ena tableta vsebuje 30 mg aripiprazola.
Excipient(s) with known effect 97.75 mg lactose monohydrate per tablet.
Pomožna(e) snov(i) z znanim učinkom 97,75 mg laktoze monohidrat na tableto
In the pooled adolescent schizophrenia population (13-17 years) with exposure up to 2 years, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 29.5% and 48.3%, respectively.
V populaciji mladostnikov s shizofrenijo (13-17 let), ki so se zdravili do 2 leti, je bila pogostnost nizke ravni prolaktina v serumu pri ženskah (< 3 ng/ml) 29,5 % in pri moških (< 2 ng/ml) 48,3 %.
Aripiprazole Sandoz20mg tablets are white coloured, round shaped tablets, with an approximate diameter of 7.8mm, debossed with “SZ” on one side and “448” on the other side.
Tablete Aripiprazol Sandoz 20 mg so bele okrogle tablete s približnim premerom 7,8 mm, z vtisnjeno oznako “SZ” na eni strani in “448” na drugi strani.
In a 26- week, olanzapine-controlled, double-blind, multi-national study of schizophrenia which included 314 adult patients and where the primary end-point was weight gain, significantly less patients had at least 7% weight gain over baseline (i.e. a gain of at least 5.6 kg for a mean baseline weight of ~80.5 kg) on aripiprazole (n= 18, or 13% of evaluable patients), compared to olanzapine (n= 45, or 33% of evaluable patients).
za vsaj 5,6 kg pri povprečni izhodiščni masi ~ 80,5 kg) značilno redkejše pri bolnikih, ki so dobivali aripiprazol, (n = 18 ali 13 % ocenljivih bolnikov) kot pri tistih, ki so dobivali olanzapin (n = 45 ali 33 % ocenljivih bolnikov).
In a short-term placebo-controlled clinical trial involving 302 adolescents (13-17 years) with schizophrenia, the frequency and type of adverse reactions were similar to those in adults except for the following reactions that were reported more frequently in adolescents receiving aripiprazole than in adults receiving aripiprazole (and more frequently than placebo):
V kratkotrajnem, s placebom nadzorovanem kliničnem preskušanju, ki je vključevalo 302 mladostnika (13-17 let) s shizofrenijo, so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih neželenih učinkov, ki so bili pri mladostnikih, ki so prejemali aripiprazol, pogostejši kot pri odraslih, ki so prejemali aripiprazol (in pogostejši kot pri placebu): somnolenca/sedacija in ekstrapiramidne motnje so bili zelo pogosti (≥ 1/10), suha usta, povečan apetit in ortostatska hipotenzija pa pogosti (≥ 1/100, < 1/10) neželeni učinki.
Each tablet contains 20 mg of aripiprazole.
Ena tableta vsebuje 20 mg aripiprazola.
Excipient(s) with known effect 65.97 mg lactose monohydrate per tablet.
Pomožna(e) snov(i) z znanim učinkom 65,97 mg laktoze monohidrat na tableto
Pathological gambling Impulse-control disorders Binge eating
Neznana pogostnost motnje nadzora impulzov kompulzivno prenajedanje kompulzivno nakupovanje poriomanija agresija agitacija živčnost
Musculoskeletal and connective tissue disorders
Neznana pogostnost in vezivnega tkiva togost
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
• Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat, rdeči železov oksid (E172).
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.
• Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat, indigotin (E132).
White coloured, round shaped tablet, with an approximate diameter of 7.8 mm, debossed with “SZ” on one side and “448” on the other side.
Bele, okrogle, tablete s približnim premerom 7,8 mm, z vtisnjeno oznako “SZ” na eni strani in “448” na drugi strani.
Rhabdomyolysis Myalgia Stiffness
Bolezni mišičnoskeletnega sistema rabdomioliza mialgija
Blue coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Modre, lisaste, okrogle tablete s približnim premerom 6,0 mm, z vtisnjeno oznako “SZ” na eni strani in “444” na drugi strani.
Aripiprazole Sandoz 5 mg tablets Each tablet contains 5 mg aripiprazole.
Aripiprazol Sandoz 5 mg tablete Ena tableta vsebuje 5 mg aripiprazola.
Yellow coloured, mottled, round shaped tablet, with an approximate diameter of 7.0 mm, debossed with “SZ” on one side and “447” on the other side.
Rumene, lisaste, okrogle tablete s približnim premerom 7,0 mm, z vtisnjeno oznako “SZ” na eni strani in “447” na drugi strani.
OUTER CARTON FOR BOTTLE AND LABEL FOR BOTTLE
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ZUNANJA OVOJNINA ZA PLASTENKO IN NALEPKA ZA PLASTENKO
Pink coloured, mottled, round shaped tablet, with an approximate diameter of 9.0 mm, debossed with “SZ” on one side and “449” on the other side.
Rožnate, lisaste, okrogle tablete s približnim premerom 9,0 mm, z vtisnjeno oznako “SZ” na eni strani in “449” na drugi strani.
Aripiprazole Sandoz30mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 9.0mm, debossed with “SZ” on one side and “449” on the other side.
Tablete Aripiprazol Sandoz 30 mg so rožnate lisaste okrogle tablete s približnim premerom 9,0 mm, z vtisnjeno oznako “SZ” na eni strani in “449” na drugi strani.
Aripiprazole Sandoz 5 mg tablets are blue coloured, mottled, round shaped tablets, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “444” on the other side.
Tablete Aripiprazol Sandoz 5 mg so modre lisaste okrogle tablete s približnim premerom 6,0 mm, z vtisnjeno oznako “SZ” na eni strani na eni strani in “444” na drugi strani.
Aripiprazole Sandoz15mg tablets are yellow coloured, mottled, round shaped tablets, with an approximate diameter of 7.0mm, debossed with “SZ” on one side and “447” on the other side.
Tablete Aripiprazol Sandoz 15 mg so rumene lisaste okrogle tablete s približnim premerom 7,0 mm, z vtisnjeno oznako “SZ” na eni strani in “447” na drugi strani.
In the paediatric bipolar population (10-17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (<3 ng/ml) and males (<2 ng/ml) was 28.0% and 53.3%, respectively.
V pediatrični populaciji z bipolarno motnjo (10-17 let), ki so se zdravili do 30 tednov, je bila pogostnost nizke ravni prolaktina v serumu pri deklicah (< 3 ng/ml) 28,0 %, pri dečkih (< 2 ng/ml) pa
Aripiprazole Sandoz 15 mg tablets Each tablet contains 15 mg aripiprazole.
Aripiprazol Sandoz 15 mg tablete Ena tableta vsebuje 15 mg aripiprazola.
• seizure,
Pri odmerkih,
Pink coloured, mottled, round shaped tablet, with an approximate diameter of 6.0 mm, debossed with “SZ” on one side and “446” on the other side.
Rožnate, lisaste, okrogle tablete s približnim premerom 6,0 mm, z vtisnjeno oznako “SZ” na eni strani in “446” na drugi strani.
Renal impairment
Jeterna okvara
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.
• Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat, rumen železov oksid.
These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Sandoz; if you get any unusual symptom taking any of these medicines together with Aripiprazole Sandoz you should see your doctor.
Ta zdravila lahko povečajo tveganje za neželene učinke ali zmanjšajo učinek zdravila Aripiprazol Sandoz.
Aripiprazole Sandoz 10 mg tablets Each tablet contains 10 mg aripiprazole.
Aripiprazol Sandoz 10 mg tablete Ena tableta vsebuje 10 mg aripiprazola.
Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section
Tudi pri aripiprazolu se lahko pojavijo preobčutljivostne reakcije v obliki simptomov alergije (glejte poglavje 4.8).
Aripiprazole Sandoz 10 mg tablets are pink coloured, mottled, round shaped tablets, with an approximate diameter of 6.0mm, debossed with “SZ” on one side and “446” on the other side.
Tablete Aripiprazol Sandoz 10 mg so rožnate lisaste okrogle tablete s približnim premerom 6,0 mm, z vtisnjeno oznako “SZ” na eni strani in “446” na drugi strani.
Pancreatitis Dysphagia Diarrhoea
Očesne bolezni zamegljen vid diplopija okulogirna kriza
INFORMATION IN BRAILLE Aripiprazole Sandoz 20 mg
PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 20 mg
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.
• Druge sestavine zdravila so laktoza monohidrat, koruzni škrob, mikrokristalna celuloza, hidroksipropilceluloza, magnezijev stearat.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of aripiprazole.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 20 mg aripiprazola.
INFORMATION IN BRAILLE Aripiprazole Sandoz 30 mg
PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 30 mg
Other medicines and Aripiprazole Sandoz
Shranjevanje zdravila Aripiprazol Sandoz
INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 5 mg
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole
IME ZDRAVILA Aripiprazol Sandoz 30 mg tablete aripiprazol
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 30 mg
PODATKI V BRAILLOVI PISAVI Zunanji ovoj: Aripiprazol Sandoz 30 mg
Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Aripiprazol Sandoz 5 mg tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat indigotin (E132)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1029/042
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole
IME ZDRAVILA Aripiprazol Sandoz 20 mg tablete aripiprazol
Aripiprazole Sandoz 5 mg tablets EU/1/15/1029/001 (10 tablets) EU/1/15/1029/002 (14 tablets) EU/1/15/1029/003 (16 tablets) EU/1/15/1029/004 (28 tablets) EU/1/15/1029/005 (30 tablets) EU/1/15/1029/006 (35 tablets) EU/1/15/1029/007 (56 tablets) EU/1/15/1029/008 (70 tablets) EU/1/15/1029/009 (14 x 1 tablets) EU/1/15/1029/010 (28 x 1 tablets) EU/1/15/1029/011 (49 x 1 tablets) EU/1/15/1029/012 (56 x 1 tablets) EU/1/15/1029/013 (98 x 1 tablets) EU/1/15/1029/014 (100 tablets)
Aripiprazol Sandoz 5 mg tablete EU/1/15/1029/001 (10 tablet) EU/1/15/1029/002 (14 tablet) EU/1/15/1029/003 (16 tablet) EU/1/15/1029/004 (28 tablet) EU/1/15/1029/005 (30 tablet) EU/1/15/1029/006 (35 tablet) EU/1/15/1029/007 (56 tablet) EU/1/15/1029/008 (70 tablet) EU/1/15/1029/009 (14 x 1 tablet) EU/1/15/1029/010 (28 x 1 tablet) EU/1/15/1029/011 (49 x 1 tablet) EU/1/15/1029/012 (56 x 1 tablet) EU/1/15/1029/013 (98 x 1 tablet) EU/1/15/1029/014 (100 tablet)
INFORMATION IN BRAILLE Aripiprazole Sandoz 10 mg
PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 10 mg
INFORMATION IN BRAILLE Aripiprazole Sandoz 15 mg
PODATKI V BRAILLOVI PISAVI Aripiprazol Sandoz 15 mg
Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Red iron oxide (E172)
Aripiprazol Sandoz 10 mg tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat rdeči železov oksid (E172)
What Aripiprazole Sandoz tablets contain
Kaj vsebuje zdravilo Aripiprazol Sandoz
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/061
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1029/061
Aripiprazole Sandoz 10 mg tablets EU/1/15/1029/015 (10 tablets) EU/1/15/1029/016 (14 tablets) EU/1/15/1029/017 (16 tablets) EU/1/15/1029/018 (28 tablets) EU/1/15/1029/019 (30 tablets) EU/1/15/1029/020 (35 tablets) EU/1/15/1029/021 (56 tablets) EU/1/15/1029/022 (70 tablets) EU/1/15/1029/023 (14 x 1 tablets) EU/1/15/1029/024 (28 x 1 tablets) EU/1/15/1029/025 (49 x 1 tablets) EU/1/15/1029/026 (56 x 1 tablets) EU/1/15/1029/027 (98 x 1 tablets) EU/1/15/1029/028 (100 tablets)
Aripiprazol Sandoz 10 mg tablete EU/1/15/1029/015 (10 tablet) EU/1/15/1029/016 (14 tablet) EU/1/15/1029/017 (16 tablet) EU/1/15/1029/018 (28 tablet) EU/1/15/1029/019 (30 tablet) EU/1/15/1029/020 (35 tablet) EU/1/15/1029/021 (56 tablet) EU/1/15/1029/022 (70 tablet) EU/1/15/1029/023 (14 x 1 tablet) EU/1/15/1029/024 (28 x 1 tablet) EU/1/15/1029/025 (49 x 1 tablet) EU/1/15/1029/026 (56 x 1 tablet) EU/1/15/1029/027 (98 x 1 tablet) EU/1/15/1029/028 (100 tablet)
INFORMATION IN BRAILLE Outer carton:Aripiprazole Sandoz 5 mg
PODATKI V BRAILLOVI PISAVI Zunanji ovoj: Aripiprazol Sandoz 5 mg
EU/1/15/1029/015 10 tablets EU/1/15/1029/016 14 tablets EU/1/15/1029/017 16 tablets EU/1/15/1029/018 28 tablets EU/1/15/1029/019 30 tablets EU/1/15/1029/020 35 tablets EU/1/15/1029/021 56 tablets EU/1/15/1029/022 70 tablets EU/1/15/1029/023 14 x 1 tablets EU/1/15/1029/024 28 x 1 tablets EU/1/15/1029/025 49 x 1 tablets EU/1/15/1029/026 56 x 1 tablets EU/1/15/1029/027 98 x 1 tablets
EU/1/15/1029/015 10 tablet EU/1/15/1029/016 14 tablet EU/1/15/1029/017 16 tablet EU/1/15/1029/018 28 tablet EU/1/15/1029/019 30 tablet EU/1/15/1029/020 35 tablet EU/1/15/1029/021 56 tablet EU/1/15/1029/022 70 tablet EU/1/15/1029/023 14 x 1 tablet EU/1/15/1029/024 28 x 1 tablet EU/1/15/1029/025 49 x 1 tablet EU/1/15/1029/026 56 x 1 tablet EU/1/15/1029/027 98 x 1 tablet
Aripiprazole Sandoz 20 mg tablets Lactose monohydrate Maize starch
Aripiprazol Sandoz 20 mg tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1029/028
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
IME ZDRAVILA Aripiprazol Sandoz 10 mg tablete aripiprazol
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 10 mg
PODATKI V BRAILLOVI PISAVI Zunanji ovoj: Aripiprazol Sandoz 10 mg
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
IME ZDRAVILA Aripiprazol Sandoz 5 mg tablete aripiprazol
INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
PODATKI V BRAILLOVI PISAVI Zunanji ovoj: Aripiprazol Sandoz 15 mg
Aripiprazole Sandoz 30 mg tablets EU/1/15/1029/048 (10 tablets) EU/1/15/1029/049 (14 tablets) EU/1/15/1029/050 (16 tablets) EU/1/15/1029/051 (28 tablets) EU/1/15/1029/052 (30 tablets) EU/1/15/1029/053 (35 tablets) EU/1/15/1029/054 (56 tablets) EU/1/15/1029/055 (70 tablets) EU/1/15/1029/056 (14 x 1 tablets) EU/1/15/1029/057 (28 x 1 tablets) EU/1/15/1029/058 (49 x 1 tablets) EU/1/15/1029/059 (56 x 1 tablets) EU/1/15/1029/060 (98 x 1 tablets) EU/1/15/1029/061 (100 tablets)
Aripiprazol Sandoz 30 mg tablete EU/1/15/1029/048 (10 tablet) EU/1/15/1029/049 (14 tablet) EU/1/15/1029/050 (16 tablet) EU/1/15/1029/051 (28 tablet) EU/1/15/1029/052 (30 tablet) EU/1/15/1029/053 (35 tablet) EU/1/15/1029/054 (56 tablet) EU/1/15/1029/055 (70 tablet) EU/1/15/1029/056 (14 x 1 tablet) EU/1/15/1029/057 (28 x 1 tablet) EU/1/15/1029/058 (49 x 1 tablet) EU/1/15/1029/059 (56 x 1 tablet) EU/1/15/1029/060 (98 x 1 tablet) EU/1/15/1029/061 (100 tablet)
EU/1/15/1029/001 10 tablets EU/1/15/1029/002 14 tablets EU/1/15/1029/003 16 tablets EU/1/15/1029/004 28 tablets EU/1/15/1029/005 30 tablets EU/1/15/1029/006 35 tablets EU/1/15/1029/007 56 tablets EU/1/15/1029/008 70 tablets EU/1/15/1029/009 14 x 1 tablets EU/1/15/1029/010 28 x 1 tablets EU/1/15/1029/011 49 x 1 tablets EU/1/15/1029/012 56 x 1 tablets EU/1/15/1029/013 98 x 1 tablets
EU/1/15/1029/001 10 tablet EU/1/15/1029/002 14 tablet EU/1/15/1029/003 16 tablet EU/1/15/1029/004 28 tablet EU/1/15/1029/005 30 tablet EU/1/15/1029/006 35 tablet EU/1/15/1029/007 56 tablet EU/1/15/1029/008 70 tablet EU/1/15/1029/009 14 x 1 tablet EU/1/15/1029/010 28 x 1 tablet EU/1/15/1029/011 49 x 1 tablet EU/1/15/1029/012 56 x 1 tablet EU/1/15/1029/013 98 x 1 tablet
Aripiprazole Sandoz 15 mg tablets EU/1/15/1029/029 (10 tablets) EU/1/15/1029/030 (14 tablets) EU/1/15/1029/031 (16 tablets) EU/1/15/1029/032 (28 tablets) EU/1/15/1029/033 (30 tablets) EU/1/15/1029/034 (35 tablets) EU/1/15/1029/035 (56 tablets) EU/1/15/1029/036 (70 tablets) EU/1/15/1029/037 (14 x 1 tablets) EU/1/15/1029/038 (28 x 1 tablets) EU/1/15/1029/039 (49 x 1 tablets) EU/1/15/1029/040 (56 x 1 tablets) EU/1/15/1029/041 (98 x 1 tablets) EU/1/15/1029/042 (100 tablets)
Aripiprazol Sandoz 15 mg tablete EU/1/15/1029/029 (10 tablet) EU/1/15/1029/030 (14 tablet) EU/1/15/1029/031 (16 tablet) EU/1/15/1029/032 (28 tablet) EU/1/15/1029/033 (30 tablet) EU/1/15/1029/034 (35 tablet) EU/1/15/1029/035 (56 tablet) EU/1/15/1029/036 (70 tablet) EU/1/15/1029/037 (14 x 1 tablet) EU/1/15/1029/038 (28 x 1 tablet) EU/1/15/1029/039 (49 x 1 tablet) EU/1/15/1029/040 (56 x 1 tablet) EU/1/15/1029/041 (98 x 1 tablet)
NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
IME ZDRAVILA Aripiprazol Sandoz 15 mg tablete aripiprazol
EU/1/15/1029/029 10 tablets EU/1/15/1029/030 14 tablets EU/1/15/1029/031 16 tablets EU/1/15/1029/032 28 tablets EU/1/15/1029/033 30 tablets EU/1/15/1029/034 35 tablets EU/1/15/1029/035 56 tablets EU/1/15/1029/036 70 tablets EU/1/15/1029/037 14 x 1 tablets EU/1/15/1029/038 28 x 1 tablets EU/1/15/1029/039 49 x 1 tablets EU/1/15/1029/040 56 x 1 tablets EU/1/15/1029/041 98 x 1 tablets
EU/1/15/1029/029 10 tablet EU/1/15/1029/030 14 tablet EU/1/15/1029/031 16 tablet EU/1/15/1029/032 28 tablet EU/1/15/1029/033 30 tablet EU/1/15/1029/034 35 tablet EU/1/15/1029/035 56 tablet EU/1/15/1029/036 70 tablet EU/1/15/1029/037 14 x 1 tablet EU/1/15/1029/038 28 x 1 tablet EU/1/15/1029/039 49 x 1 tablet EU/1/15/1029/040 56 x 1 tablet EU/1/15/1029/041 98 x 1 tablet
Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Yellow iron oxide (E172)
Aripiprazol Sandoz 15 mg tablete laktoza monohidrat koruzni škrob mikrokristalna celuloza hidroksipropilceluloza magnezijev stearat rumen železov oksid (E172)
MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/15/1029/014
EU/1/15/1029/048 10 tablets EU/1/15/1029/049 14 tablets EU/1/15/1029/050 16 tablets EU/1/15/1029/051 28 tablets EU/1/15/1029/052 30 tablets EU/1/15/1029/053 35 tablets EU/1/15/1029/054 56 tablets EU/1/15/1029/055 70 tablets EU/1/15/1029/056 14 x 1 tablets EU/1/15/1029/057 28 x 1 tablets EU/1/15/1029/058 49 x 1 tablets EU/1/15/1029/059 56 x 1 tablets EU/1/15/1029/060 98 x 1 tablets
EU/1/15/1029/048 10 tablet EU/1/15/1029/049 14 tablet EU/1/15/1029/050 16 tablet EU/1/15/1029/051 28 tablet EU/1/15/1029/052 30 tablet EU/1/15/1029/053 35 tablet EU/1/15/1029/054 56 tablet EU/1/15/1029/055 70 tablet EU/1/15/1029/056 14 x 1 tablet EU/1/15/1029/057 28 x 1 tablet EU/1/15/1029/058 49 x 1 tablet EU/1/15/1029/059 56 x 1 tablet EU/1/15/1029/060 98 x 1 tablet
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 30 mg aripiprazola.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 15 mg aripiprazola.
The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Evropska komisija je dovoljenje za promet z zdravilom PegIntron, veljavno po vsej Evropski uniji, odobrila dne 25. maja 2000.