FrancophonIA/ELRC3.0 huggingface dataset:
English: 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)
Danish: Aripiprazole Sandoz 20 mg tabletter EU/1/15/1029/043 (14 tabletter) EU/1/15/1029/044 (28 tabletter) EU/1/15/1029/045 (49 tabletter) EU/1/15/1029/046 (56 tabletter) EU/1/15/1029/047 (98 tabletter)
English: 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
Danish: EU/1/15/1029/043 14 tabletter EU/1/15/1029/044 28 tabletter EU/1/15/1029/045 49 tabletter EU/1/15/1029/046 56 tabletter EU/1/15/1029/047 98 tabletter
English: In one 3-week, fixed-dose, placebo-controlled monotherapy trial involving patients with a manic or mixed episode of Bipolar I Disorder, aripiprazole failed to demonstrate superior efficacy to placebo.
Danish: I et 3-ugers, placebokontrolleret enkeltstof-forsøg med fast dosis til patienter med manisk eller blandet episode med bipolær lidelse type 1, havde aripiprazol ikke bedre effekt end placebo.
English: 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.
Danish: Hos den unge population (13-17 år) med skizofreni, der blev eksponeret for 5 til 30 mg aripiprazol i op til 72 måneder, var incidensen af lavt serumprolaktin hos pigerne (< 3 ng/ml) og drengene (< 2 ng/ml) henholdsvis 25,6 % og 45,0 %.
English: Excipient(s) with known effect 71.02 mg lactose monohydrate per tablet.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på 71,02 mg lactosemonohydrat pr. tablet.
English: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Red iron oxide (E172)
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Magnesiumstearat Rød jernoxid (E172)
English: Microcrystalline cellulose Hydroxypropyl cellulose Magnesium stearate Yellow iron oxide (E172)
Danish: Mikrokrystallinsk cellulose Hydroxypropylcellulose Magnesiumstearat Gul jernoxid (E172)
English: Excipient(s) with known effect 97.75 mg lactose monohydrate per tablet.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på 97,75 mg lactosemonohydrat per tablet.
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.
Danish: • Øvrige indholdsstoffer: lactosemonohydrat, majsstivelse, mikrokrystallinsk cellulose,
English: 2D barcode carrying the unique identifier included.
Danish: Kun ydre karton til flaske: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Excipient(s) with known effect 196.50 mg lactose monohydrate per tablet.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på 196,50 mg lactosemonohydrat per tablet.
English: Aripiprazole Sandoz 20 mg tablets Each tablet contains 20 mg aripiprazole.
Danish: Aripiprazole Sandoz 20 mg tabletter Hver tablet indeholder 20 mg aripiprazol.
English: What Aripiprazole Sandoz tablets contain
Danish: Aripiprazole Sandoz-tabletter indeholder
English: Tel: +420 225 775 111 office.cz@sandoz.com
Danish: CZ-140 00 Praha 4 - Nusle Tel: +420 225 775 111 office.cz@sandoz.com
English: Excipient(s) with known effect 65.97 mg lactose monohydrate per tablet.
Danish: Hjælpestof(fer), som behandleren skal være opmærksom på 65,97 mg lactosemonohydrat per tablet.
English: Blister packs in cartons: 14, 28, 49, 56, 98 tablets
Danish: Aripiprazole Sandoz 20 mg tabletter Blisterpakninger i æsker: 14, 28, 49, 56, 98 tabletter
English: 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.
Danish: Lyserød, plettet, rund tablet, med en omtrentlig diameter på 9,0 mm, præget med ”SZ” på den ene side og med ”449” på den anden side.
English: The efficacy of aripiprazole in paediatric subjects with Tourette's syndrome (aripiprazole: n=32, placebo: n=29) was also evaluated over a flexible dose range of 2 mg/day to 20 mg/day and a starting dose of 2 mg, in a 10 week, randomised, double blind, placebo-controlled study conducted in South-Korea.
Danish: I et randomiseret, dobbeltblindet, placebokontrolleret 10-ugers studie gennemført i Sydkorea blev aripiprazols virkning hos pædiatriske patienter med Tourettes syndrom (aripiprazol: n = 32, placebo: n = 29) undersøgt inden for et fleksibelt dosisområde på 2-20 mg/dag med en startdosis på 2 mg.
English: 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.
Danish: Gul, plettet, rund tablet, med en omtrentlig diameter på 7,0 mm, præget med ”SZ” på den ene side og med ”447” på den anden side.
English: Aripiprazole Sandoz 30 mg tablets Each tablet contains 30 mg aripiprazole.
Danish: Aripiprazole Sandoz 30 mg tabletter Hver tablet indeholder 30 mg aripiprazol.
English: 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.
Danish: Aripiprazole Sandoz 20 mg tabletter er hvide, runde tabletter med en omtrentlig diameter på 7,8 mm, præget med ”SZ” på den ene side og med ”448” på den anden side.
English: 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.
Danish: Blå, plettet, rund tablet, med en omtrentlig diameter på 6,0 mm, præget med ”SZ” på den ene side og med”444” på den anden side.
English: Each tablet contains 20 mg of aripiprazole.
Danish: Hver tablet indeholder 20 mg aripiprazol.
English: 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.
Danish: I den pædiatriske population (10-17 år) med bipolær lidelse, som fik behandling i op til 30 uger, var incidensen af lav serum-prolaktin hos piger (< 3 ng/ml) og drenge (< 2 ng/ml) henholdsvis 28,0 % og
English: 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.
Danish: Aripiprazole Sandoz 30 mg tabletter er lyserøde, plettede, runde tabletter med en omtrentlig diameter på 9,0 mm, præget med ”SZ” på den ene side og med ”449” på den anden side.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of aripiprazole.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 20 mg aripiprazol.
English: Musculoskeletal and connective tissue disorders
Danish: Ikke almindelig Ikke kendt muskler og bindevæv
English: 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.
Danish: Aripiprazole Sandoz 5 mg tabletter er blå, plettede, runde tabletter med en omtrentlig diameter på 6,0 mm, præget med ”SZ” på den ene side og med ”444” på den anden side.
English: Aripiprazole Sandoz 5 mg tablets Each tablet contains 5 mg aripiprazole.
Danish: Aripiprazole Sandoz 5 mg tabletter Hver tablet indeholder 5 mg aripiprazol.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of aripiprazole
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 30 mg aripiprazol
English: 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.
Danish: Lyserød, plettet, rund tablet, med en omtrentlig diameter på 6,0 mm, præget med ”SZ” på den ene side og med ”446” på den anden side.
English: Aripiprazole Sandoz 10 mg tablets Each tablet contains 10 mg aripiprazole.
Danish: Aripiprazole Sandoz 10 mg tabletter Hver tablet indeholder 10 mg aripiprazol.
English: 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.
Danish: Disse typer medicin kan øge risikoen for bivirkninger eller reducere virkningen af Aripiprazole Sandoz.
English: 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.
Danish: Aripiprazole Sandoz 15 mg tabletter er gule, plettede, runde tabletter med en omtrentlig diameter på 7,0 mm, præget med ”SZ” på den ene side og med ”447” på den anden side.
English: Aripiprazole Sandoz 30 mg tablets
Danish: Aripiprazole Sandoz 30 mg tabletter
English: Aripiprazole Sandoz 20 mg tablets
Danish: Aripiprazole Sandoz 20 mg tabletter
English: Aripiprazole Sandoz 15 mg tablets Each tablet contains 15 mg aripiprazole.
Danish: Aripiprazole Sandoz 15 mg tabletter Hver tablet indeholder 15 mg aripiprazol.
English: What Aripiprazole Sandoz tablets are and what they are used for What you need to know before you take Aripiprazole Sandoz tablets How to take Aripiprazole Sandoz tablets Possible side effects
Danish: Det skal du vide, før du begynder at tage Aripiprazole Sandoz Sådan skal du tage Aripiprazole Sandoz Bivirkninger
English: stroke or "mini" stroke, abnormal blood pressure
Danish: • hjerte-kar-sygdom, hjerte-kar-sygdom i familien, slagtilfælde eller mini-slagtilfælde, unormalt blodtryk
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of aripiprazole
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 15 mg aripiprazol
English: 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.
Danish: Aripiprazole Sandoz 10 mg tabletter er lyserøde, plettede, runde tabletter med en omtrentlig diameter på 6,0 mm, præget med ”SZ” på den ene side og med ”446” på den anden side.
English: Aripiprazole Sandoz 10 mg tablets
Danish: Aripiprazole Sandoz 10 mg tabletter
English: Aripiprazole Sandoz 5 mg tablets
Danish: Aripiprazole Sandoz 5 mg tabletter
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigo carmine (E132) aluminium lake.
Danish: hydroxypropylcellulose, magnesiumstearat, indigotin aluminiumlak (E132).
English: Aripiprazole Sandoz 30 mg tablets Lactose monohydrate Maize starch
Danish: Aripiprazole Sandoz 30 mg tabletter Lactosemonohydrat Majsstivelse
English: Aripiprazole Sandoz 15 mg tablets
Danish: Aripiprazole Sandoz 15 mg tabletter
English: 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)
Danish: Aripiprazole Sandoz 5 mg tabletter EU/1/15/1029/001 (10 tabletter) EU/1/15/1029/002 (14 tabletter) EU/1/15/1029/003 (16 tabletter) EU/1/15/1029/004 (28 tabletter) EU/1/15/1029/005 (30 tabletter) EU/1/15/1029/006 (35 tabletter) EU/1/15/1029/007 (56 tabletter) EU/1/15/1029/008 (70 tabletter) EU/1/15/1029/009 (14 x 1 tabletter) EU/1/15/1029/010 (28 x 1 tabletter) EU/1/15/1029/011 (49 x 1 tabletter) EU/1/15/1029/012 (56 x 1 tabletter) EU/1/15/1029/013 (98 x 1 tabletter) EU/1/15/1029/014 (100 tabletter)
English: Aripiprazole Sandoz 20 mg tablets Lactose monohydrate Maize starch
Danish: Aripiprazole Sandoz 20 mg tabletter Lactosemonohydrat Majsstivelse
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/061
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/061
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 20 mg
Danish: INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 20 mg
English: Hydroxypropyl cellulose
Danish: hydroxypropylcellulose, magnesiumstearat.
English: Domaniewska 50C 02-672 Warszawa Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Danish: Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/042
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/042
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 30 mg
Danish: INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 30 mg
English: indinavir, ritonavir)
Danish: Nyrer og urinveje
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 30 mg
Danish: INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 30 mg
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 20 mg tablets aripiprazole
Danish: LÆGEMIDLETS NAVN Aripiprazole Sandoz 20 mg tabletter aripiprazol
English: Aripiprazole Sandoz 10 mg tablets Lactose monohydrate Maize starch
Danish: Aripiprazole Sandoz 10 mg tabletter Lactosemonohydrat Majsstivelse
English: Aripiprazole Sandoz 15 mg tablets Lactose monohydrate Maize starch
Danish: Aripiprazole Sandoz 15 mg tabletter Lactosemonohydrat Majsstivelse
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 5 mg
Danish: INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 5 mg
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 30 mg tablets aripiprazole
Danish: LÆGEMIDLETS NAVN Aripiprazole Sandoz 30 mg tabletter aripiprazol
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 15 mg
Danish: INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 15 mg
English: 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
Danish: EU/1/15/1029/015 10 tabletter EU/1/15/1029/016 14 tabletter EU/1/15/1029/017 16 tabletter EU/1/15/1029/018 28 tabletter EU/1/15/1029/019 30 tabletter EU/1/15/1029/020 35 tabletter EU/1/15/1029/021 56 tabletter EU/1/15/1029/022 70 tabletter EU/1/15/1029/023 14 x 1 tabletter EU/1/15/1029/024 28 x 1 tabletter EU/1/15/1029/025 49 x 1 tabletter EU/1/15/1029/026 56 x 1 tabletter EU/1/15/1029/027 98 x 1 tabletter
English: 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)
Danish: Aripiprazole Sandoz 15 mg tabletter EU/1/15/1029/029 (10 tabletter) EU/1/15/1029/030 (14 tabletter) EU/1/15/1029/031 (16 tabletter) EU/1/15/1029/032 (28 tabletter) EU/1/15/1029/033 (30 tabletter) EU/1/15/1029/034 (35 tabletter) EU/1/15/1029/035 (56 tabletter) EU/1/15/1029/036 (70 tabletter) EU/1/15/1029/037 (14 x 1 tabletter) EU/1/15/1029/038 (28 x 1 tabletter) EU/1/15/1029/039 (49 x 1 tabletter) EU/1/15/1029/040 (56 x 1 tabletter) EU/1/15/1029/041 (98 x 1 tabletter) EU/1/15/1029/042 (100 tabletter)
English: 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)
Danish: Aripiprazole Sandoz 30 mg tabletter EU/1/15/1029/048 (10 tabletter) EU/1/15/1029/049 (14 tabletter) EU/1/15/1029/050 (16 tabletter) EU/1/15/1029/051 (28 tabletter) EU/1/15/1029/052 (30 tabletter) EU/1/15/1029/053 (35 tabletter) EU/1/15/1029/054 (56 tabletter) EU/1/15/1029/055 (70 tabletter) EU/1/15/1029/056 (14 x 1 tabletter) EU/1/15/1029/057 (28 x 1 tabletter) EU/1/15/1029/058 (49 x 1 tabletter) EU/1/15/1029/059 (56 x 1 tabletter) EU/1/15/1029/060 (98 x 1 tabletter) EU/1/15/1029/061 (100 tabletter)
English: INFORMATION IN BRAILLE Outer carton:Aripiprazole Sandoz 5 mg
Danish: INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 5 mg
English: INFORMATION IN BRAILLE Aripiprazole Sandoz 10 mg
Danish: INFORMATION I BRAILLESKRIFT Aripiprazole Sandoz 10 mg
English: 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
Danish: EU/1/15/1029/001 10 tabletter EU/1/15/1029/002 14 tabletter EU/1/15/1029/003 16 tabletter EU/1/15/1029/004 28 tabletter EU/1/15/1029/005 30 tabletter EU/1/15/1029/006 35 tabletter EU/1/15/1029/007 56 tabletter EU/1/15/1029/008 70 tabletter EU/1/15/1029/009 14 x 1 tabletter EU/1/15/1029/010 28 x 1 tabletter EU/1/15/1029/011 49 x 1 tabletter EU/1/15/1029/012 56 x 1 tabletter EU/1/15/1029/013 98 x 1 tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/028
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/028
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 5 mg tablets aripiprazole
Danish: LÆGEMIDLETS NAVN Aripiprazole Sandoz 5 mg tabletter aripiprazol
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 10 mg
Danish: INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 10 mg
English: INFORMATION IN BRAILLE Outer carton: Aripiprazole Sandoz 15 mg
Danish: INFORMATION I BRAILLESKRIFT Ydre karton: Aripiprazole Sandoz 15 mg
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 15 mg tablets aripiprazole
Danish: LÆGEMIDLETS NAVN Aripiprazole Sandoz 15 mg tabletter aripiprazol
English: NAME OF THE MEDICINAL PRODUCT Aripiprazole Sandoz 10 mg tablets aripiprazole
Danish: LÆGEMIDLETS NAVN Aripiprazole Sandoz 10 mg tabletter aripiprazol
English: 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
Danish: EU/1/15/1029/029 10 tabletter EU/1/15/1029/030 14 tabletter EU/1/15/1029/031 16 tabletter EU/1/15/1029/032 28 tabletter EU/1/15/1029/033 30 tabletter EU/1/15/1029/034 35 tabletter EU/1/15/1029/035 56 tabletter EU/1/15/1029/036 70 tabletter EU/1/15/1029/037 14 x 1 tabletter EU/1/15/1029/038 28 x 1 tabletter EU/1/15/1029/039 49 x 1 tabletter EU/1/15/1029/040 56 x 1 tabletter EU/1/15/1029/041 98 x 1 tabletter
English: Aripiprazole Sandoz 5 mg tabletsLactose monohydrate Maize starch
Danish: Aripiprazole Sandoz 5 mg tabletter Lactosemonohydrat Majsstivelse
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1029/014
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1029/014
English: 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
Danish: EU/1/15/1029/048 10 tabletter EU/1/15/1029/049 14 tabletter EU/1/15/1029/050 16 tabletter EU/1/15/1029/051 28 tabletter EU/1/15/1029/052 30 tabletter EU/1/15/1029/053 35 tabletter EU/1/15/1029/054 56 tabletter EU/1/15/1029/055 70 tabletter EU/1/15/1029/056 14 x 1 tabletter EU/1/15/1029/057 28 x 1 tabletter EU/1/15/1029/058 49 x 1 tabletter EU/1/15/1029/059 56 x 1 tabletter EU/1/15/1029/060 98 x 1 tabletter
English: UNIQUE IDENTIFIER - 2D BARCODE [Only Carton for bottle:]
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE
English: If you have the impression that the effect of Aripiprazole Sandozis too strong or too weak, talk to your doctor or pharmacist.
Danish: Kontakt lægen eller apoteket, hvis du mener, virkningen af Aripiprazole Sandoz er for kraftig eller for svag.
English: 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)
Danish: EU/1/15/1029/019 (30 tabletter) EU/1/15/1029/020 (35 tabletter) EU/1/15/1029/021 (56 tabletter) EU/1/15/1029/022 (70 tabletter) EU/1/15/1029/023 (14 x 1 tabletter) EU/1/15/1029/024 (28 x 1 tabletter) EU/1/15/1029/025 (49 x 1 tabletter) EU/1/15/1029/026 (56 x 1 tabletter) EU/1/15/1029/027 (98 x 1 tabletter) EU/1/15/1029/028 (100 tabletter)
English: The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E172).
Danish: hydroxypropylcellulose, magnesiumstearat, rød jernoxid (E172).
English: The European Commission granted a marketing authorisation valid throughout the EU for PegIntron on 25 May 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for PegIntron den 25. maj 2000.
English: This document is a summary of the European Public Assessment Report (EPAR) for PegIntron.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for PegIntron.
English: The full EPAR for PegIntron can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for PegIntron findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for PegIntron.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for PegIntron.