natgillin/translations-raw huggingface dataset:
Maximum daily dose taking valproate is 30 mg (0.75 ml) for each kilogram of body weight, each day. 
Maksimalna dnevna doza ako uzimate valproat je 30 mg (0,75 ml) za svaki kilogram tjelesne težine, svaki dan.
For this patient population, the maximum recommended dose is 30 mg/kg/day. 
Za ovu populaciju bolesnika, maksimalna preporučena doza je 30 mg/kg na dan.
3,200 mg/day or 80 ml/day 
3200 mg na dan ili 80 ml na dan
Children 4 years of age or older weighing less than 30 kg 
Djeca u dobi od 4 ili više godina, tjelesne težina manje od 30 kg
2,400 mg/day or 60 ml/day 
2400 mg na dan ili 60 ml na dan
1,200 mg/day or 30 ml/day 
1200 mg na dan ili 30 ml na dan
Nasogastric tube (NG): Polyvinyl chloride (PVC) tube of not greater than 40 cm in length and diameter of tube 5 Fr. To ensure adequate dosing, after administration of the oral suspension, the enteral feeding tube must be flushed at least once with 1 ml of water. 
Nazogastrična sonda (NG): sonda od polivinil klorida (PVC) ne veća od 40 cm dužine i promjera sonde 5 Fr.
Physicians should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate, based on the individual patients clinical situation (see sections 4.5 and 4.6). 
Liječnici trebaju pokušati osigurati da se koristi odgovarajuća kontracepcija i na temelju kliničke procjene odlučiti jesu li oralni kontraceptivi ili doze komponenti oralnih kontraceptiva odgovarajući za pojedinu bolesnicu, s obzirom na njezinu kliničku situaciju (vidjeti dijelove 4.5 i 4.6).
EXPIRY DATE EXP (MM/YYYY) 
ROK VALJANOSTI Rok valjanosti (MM/GGGG)
Physicians should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see sections 4.4 and 4.5). 
Liječnici bi trebali pokušati osigurati da se koristi odgovarajuća kontracepcija i na temelju kliničke procjene odlučiti jesu li oralni kontraceptivi ili doze komponenti oralnih kontraceptiva odgovarajući za pojedinu bolesnicu s obzirom na njezinu kliničku situaciju (vidjeti dijelove 4.4 i 4.5).
For this patient population, the maximum recommended dose is 45 mg/kg/day. 
Za ovu populaciju bolesnika, maksimalna preporučena doza je 45 mg/kg na dan.
As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate. 
Budući da valproat značajno smanjuje klirens rufinamida, u bolesnika s tjelesnom težinom < 30 kg kojima se istodobno daje valproat preporučuje se niža maksimalna doza Inovelona.
1,800 mg/day or 45 ml/day 
1800 mg na dan ili 45 ml na dan
Oligomenorrhoea 
Oligomenoreja
According to clinical response and tolerability, the dose may be increased by 400 mg/day increments, as frequently as every other day, up to a maximum recommended dose as indicated in the table below. 
Sukladno kliničkom odgovoru i podnošljivosti, doza se može postupno povećavati za 400 mg na dan, najviše svaki drugi dan, do maksimalne preporučene dnevne doze, kako je navedeno u tablici niže.
How to store Inovelon 
Kako čuvati Inovelon
The dose will be calculated for you by the doctor and may be increased by 400 mg every other day. 
Dozu će izračunati liječnik i može je povećavati za 400 mg svaki dan.
The dose will be calculated for you by the doctor and may be increased by 10 mg for each kilogram of body weight, every third day. 
Liječnik će vam izračunati dozu i može je povećati svaki treći dan za 10 mg za svaki kilogram tjelesne težine.
- If you get any side effects, talk to the doctor or pharmacist. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
The cap fits properly when the PIBA is in place. 
Zatvarač točno pristaje ako je nastavak pravilno umetnut.
Maximum daily dose not taking valproate is 45 mg for each kilogram of body weight, each day. 
Maksimalna dnevna doza ako ne uzimate valproat je 45 mg za svaki kilogram tjelesne težine, svaki dan.
The dose will be calculated for you by the doctor and may be increased by 10 mg (0.25 ml) for each kilogram of body weight, every third day. 
Liječnik će vam izračunati dozu i može je povećati svaki treći dan za 10 mg (0,25 ml) za svaki kilogram tjelesne težine.
Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silica colloidal, anhydrous 
Jezgra laktoza hidrat celuloza, mikrokristalična kukuruzni škrob karmelozanatrij, umrežena hipromeloza magnezijev stearat natrijev laurilsulfat silicijev dioksid, koloidni, bezvodni
According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/day, to the maximum recommended dose of 600 mg/day (15 ml/day). 
Sukladno kliničkom odgovoru i podnošljivosti, nakon najmanje 2 dana doza se može povećavati za 200 mg na dan do maksimalne preporučene doze od 600 mg na dan (15 ml na dan).
2,400 mg/day 
2400 mg na dan
Each 200 mg film-coated tablet contains 40 mg lactose (as monohydrate). 
Jedna filmom obložena tableta od 200 mg sadrži 40 mg laktoze (u obliku laktoza hidrata).
Use in children 4 years of age or older and less than 30 kg 
Primjena u djece u dobi od 4 ili više godina i tjelesne težine manje od 30 kg
Maximum daily dose taking valproate is 30 mg for each kilogram of body weight, each day. 
Maksimalna dnevna doza ako uzimate valproat je 30 mg za svaki kilogram tjelesne težine, svaki dan.
Insert adaptor into the neck of the bottle until a tight seal is made Push plunger of syringe completely down 
Umetnite nastavak u vrat boce tako da bude čvrsto spojen.
Each 100 mg film-coated tablet contains 20 mg lactose (as monohydrate). 
Jedna filmom obložena tableta od 100 mg sadrži 20 mg laktoze (u obliku laktoza hidrata).
Maximum daily dose taking valproate is no more than 2,200 mg (55 ml), depending on body weight. 
Maksimalna dnevna doza ako uzimate valproat nije viša od 2200 mg (55 ml), ovisno o tjelesnoj težini.
According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/day, to the maximum recommended dose of 600 mg/day. 
Sukladno kliničkom odgovoru i podnošljivosti, nakon najmanje 2 dana doza se može povećavati za 200 mg na dan, do maksimalne preporučene doze od 600 mg na dan.
Maximum daily dose not taking valproate is no more than 3,200 mg (80 ml), depending on body weight. 
Maksimalna dnevna doza ako ne uzimate valproat nije viša od 3200 mg (80 ml), ovisno o tjelesnoj težini.
According to clinical response and tolerability, the dose may be increased by 200 mg/day increments, as frequently as every third day, up to a maximum recommended dose of 1,000 mg/day (25 ml/day). 
Sukladno kliničkom odgovoru i podnošljivosti, doza se može postupno povećavati za 200 mg na dan, najviše svaki treći dan, do maksimalne preporučene doze od 1000 mg na dan (25 ml na dan).
Each 400 mg film-coated tablet contains 80 mg lactose (as monohydrate). 
Jedna filmom obložena tableta od 400 mg sadrži 80 mg laktoze (u obliku laktoza hidrata).
Common (more than 1 in a 100 patients) side effects of Inovelon are: 
Česte nuspojave Inovelona (u više od 1 na 100 bolesnika):
INFORMATION IN BRAILLE Inovelon 200 mg tablets 
16. PODACI NA BRAILLEOVOM PISMU Inovelon 200 mg tablete
1,600 mg/day or 40 ml/day 
1600 mg na dan ili 40 ml na dan
Gait disturbance* 
Konvulzije omaglica*
INFORMATION IN BRAILLE Inovelon 400 mg tablets 
16. PODACI NA BRAILLEOVOM PISMU Inovelon 400 mg tablete
According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day (0.25 ml/kg/day) every third day to a target dose of 45 mg/kg/day (1.125 ml/kg/day) administered in two equally divided doses separated by approximately 12 hours. 
Sukladno kliničkom odgovoru i podnošljivosti, svaki treći dan doza se može povećati za najviše 10 mg/kg na dan (0,25 ml/kg na dan) do ciljne doze od 45 mg/kg na dan (1,125 ml/kg na dan), koja se daje podijeljeno u dvije jednake doze u razmaku od približno 12 sati.
Simeticone emulsion, 30% containing benzoic acid, cyclotetrasiloxane, dimethicone, glycol stearate and glyceryl distearate, methylcellulose, PEG-40 stearate (polyethylene glycol stearate), polysorbate 65, silica gel, sorbic acid, sulphuric acid and water. 
Simetikon emulzija, 30%-tna, koja sadrži benzoatnu kiselinu, ciklotetrasiloksan, dimetikon, glikolstearat i glicerildistearat, metilcelulozu, PEG-40 stearat (polietilenglikolstearat), polisorbat 65, gel silicijevog dioksida, sorbatnu kiselinu, sulfatnu kiselinu i vodu. poloksamer 188 metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) propilenglikol (E1520) kalijev sorbat (E202) sorbitol (E420), tekući (nekristalizirajući) aroma naranče voda
INFORMATION IN BRAILLE Inovelon 100 mg tablets 
16. PODACI NA BRAILLEOVOM PISMU Inovelon 100 mg tablete
Patients > 30 kg not receiving valproate: 
Bolesnici s tjelesnom težinom > 30 kg koji ne primaju valproat:
Patients < 30 kg not receiving valproate: 
Bolesnici s tjelesnom težinom < 30 kg koji ne primaju valproat:
Inovelon 400 mg film-coated tablets 
Inovelon 400 mg filmom obložene tablete rufinamid
1,800 mg/day 
1800 mg na dan
According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day (0.25 ml/kg/day) every third day to a target dose of 30 mg/kg/day (0.75 ml/kg/day) administered in two equally divided doses separated by approximately 12 hours. 
Sukladno kliničkom odgovoru i podnošljivosti, svaki treći dan doza se može povećati za najviše 10 mg/kg na dan (0,25 ml/kg na dan) do ciljne doze od 30 mg/kg na dan (0,75 ml/kg na dan), koja se daje podijeljeno u dvije jednake doze u razmaku od približno 12 sati.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/011-016 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/378/011-016
2,200 mg/day 
2200 mg na dan
Each 200 mg film-coated tablet contains 200 mg of rufinamide. 
Jedna 200 mg filmom obložena tableta sadrži 200 mg rufinamida.
Inovelon 200 mg film-coated tablets 
Inovelon 200 mg filmom obložene tablete rufinamid
Each 400 mg film-coated tablet contains 400 mg of rufinamide. 
Jedna 400 mg filmom obložena tableta sadrži 400 mg rufinamida.
According to clinical response and tolerability, the dose may be increased by 200 mg/day increments, as frequently as every third day, up to a maximum recommended dose of 1,000 mg/day. 
Sukladno kliničkom odgovoru i podnošljivosti, doza se može postupno povećavati, za 200 mg na dan, najviše svaki treći dan, do maksimalne preporučene doze od 1000 mg na dan.
Each 100 mg film-coated tablet contains 100 mg of rufinamide. 
Jedna 100 mg filmom obložena tableta sadrži 100 mg rufinamida.
400 mg: Pink, ‘ovaloid', slightly convex, approximately 18.2 mm in length, scored on both sides, embossed ‘Є263' on one side and blank on the other side. 
400 mg: ružičasta, izduženo ovalna, blago konveksna tableta, duljine približno 18,2 mm, s razdjelnim urezom na obje strane i utisnutom oznakom ‘Є263' na jednoj strani i bez oznake na drugoj.
Constipation Dyspepsia 
Zatvor Dispepsija
MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/001-005 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/378/001-005
1,200 mg/day 
1200 mg na dan
Cytochrome P450-mediated metabolism is very minor. 
Jako mali dio metabolizma posredovan je citokromom P450.
Maximum daily dose not taking valproate is no more than 3,200 mg, depending on body weight. 
Maksimalna dnevna doza ako ne uzimate valproat nije viša od 3200 mg, ovisno o tjelesnoj težini.
- Inovelon 400 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є263' on one side and blank on the other side. 
- Inovelon 400 mg tablete su ružičaste, ovalne, blago konveksne filmom obložene tablete s razdjelnim urezom na obje strane i utisnutom oznakom ‘Є263' na jednoj strani i bez oznake na drugoj.
100 mg: Pink, ‘ovaloid', slightly convex, approximately 10.2 mm in length, scored on both sides, embossed ‘Є261' on one side and blank on the other side. 
100 mg: ružičasta, izduženo ovalna, blago konveksna tableta, duljine približno 10,2 mm, s razdjelnim urezom na obje strane i utisnutom oznakom ‘Є261' na jednoj strani i bez oznake na drugoj.
200 mg: Pink, ‘ovaloid', slightly convex, approximately 15.2 mm in length, scored on both sides, embossed ‘Є262' on one side and blank on the other side. 
200 mg: ružičasta, izduženo ovalna, blago konveksna tableta, duljine približno 15,2 mm, s razdjelnim urezom na obje strane i utisnutom oznakom ‘Є262' na jednoj strani i bez oznake na drugoj.
- Inovelon 100 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є261' on one side and blank on the other side. 
- Inovelon 100 mg tablete su ružičaste, ovalne, blago konveksne filmom obložene tablete s razdjelnim urezom na obje strane i utisnutom oznakom ‘Є261' na jednoj strani i bez oznake na drugoj.
According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day every third day to a target dose of 30 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. 
Sukladno kliničkom odgovoru i podnošljivosti, svaki treći dan doza se može povećati za najviše 10 mg/kg na dan do ciljne doze od 30 mg/kg na dan, koja se daje podijeljeno u dvije jednake doze u razmaku od približno 12 sati.
Patients > 30 kg also receiving valproate: 
Bolesnici s tjelesnom težinom > 30 kg koji primaju i valproat:
Maximum daily dose taking valproate is no more than 2,200 mg, depending on body weight. 
Maksimalna dnevna doza ako uzimate valproat nije više od 2200 mg, ovisno o tjelesnoj težini.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/006-010 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/378/006-010
Citric acid, anhydrous (E330) 
6.1 Popis pomoćnih tvari celuloza, mikrokristalična (E460) karmelozanatrij (E466) hidroksietilceluloza citratna kiselina, bezvodna (E330)
- Inovelon 200 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є262' on one side and blank on the other side. 
- Inovelon 200 mg tablete su ružičaste, ovalne, blago konveksne filmom obložene tablete s razdjelnim urezom na obje strane i utisnutom oznakom ‘Є262' na jednoj strani i bez oznake na drugoj.
Each film-coated tablet contains 200 mg rufinamide. 
Jedna filmom obložena tableta sadrži 200 mg rufinamida.
Each film-coated tablet contains 100 mg rufinamide. 
Jedna filmom obložena tableta sadrži 100 mg rufinamida.
3,200 mg/day 
3200 mg na dan
According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day every third day to a target dose of 45 mg/kg/day administered in two equally divided doses separated by approximately 12 hours. 
Sukladno kliničkom odgovoru i podnošljivosti, svaki treći dan doza se može povećati za najviše 10 mg/kg na dan do ciljne doze od 45 mg/kg na dan, koja se daje podijeljeno u dvije jednake doze u razmaku od približno 12 sati.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg rufinamide. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 100 mg rufinamida.
Abdominal pain upper 
Epistaksa mučnina bol u gornjem dijelu abdomena povraćanje
1,600 mg/day 
1600 mg na dan
Each film-coated tablet contains 400 mg rufinamide. 
Jedna filmom obložena tableta sadrži 400 mg rufinamida.
MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/017 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/06/378/017
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 200 mg rufinamide. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 200 mg rufinamida.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 400 mg rufinamide. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 400 mg rufinamida.
Patients < 30 kg also receiving valproate: 
Bolesnici s tjelesnom težinom < 30 kg koji primaju i valproat:
The cap should be replaced after each use. 
Nakon svake uporabe treba vratiti zatvarač na bocu.
Musculoskeletal and connective tissue and bone disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u leđima
NAME OF THE MEDICINAL PRODUCT Inovelon 100 mg film-coated tablets Rufinamide 
Inovelon 100 mg filmom obložene tablete rufinamid
Very common (more than 1 in 10 patients) side effects of Inovelon are: 
Obavijestite liječnika ako imate nešto od navedenog: Vrlo česte nuspojave Inovelona (u više od 1 na 10 bolesnika):
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
POSEBNE OBVEZE ZA PROVEDBEMJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France 
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Francuska
1/12 - Queluz de Baixo 
3Armz. 1/12 - Queluz de Baixo
FI-13500 Tavastehus Finland 
FI-13500 Tavastehus Finska
Luxembourg Hexal AG Industriestrasse 25 
Luksemburg Hexal AG Industriestrasse 25
00101 HELSINKI Finland 
00101 HELSINKI Finska
1495-139 Algés 
1495-139 Algés Portugal
Luxembourg Will-Pharma S.A. Rue du Manil 80 
Luksemburg Will-Pharma S.A. Rue du Manil 80
Luxembourg Johnson & Johnson Consumer SA/NV 
Luksemburg Johnson & Johnson Consumer SA/NV
18b 82152 Planegg-Martinsried Germany 
18b 82152 PlaneggMartinsried Germany
DK-4230 Skælskør Denmark 
DK-4230 Skælskør Danska
Abbott Oy Pihatörmä 1 B 02240 ESPOO Finland 
Abbott Oy Pihatörmä 1 B 02240 ESPOO Finska
Şoseaua Alexandriei nr. 145 A, Bragadiru judeţul Ilfov 
Şoseaua Alexandriei nr. 145 A, Bragadiru, Ilfov Romania
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. 
Aziende Chimiche Riunite Angelini Francuskasco A.C.R.A.F.
2770-229 Paço de Arcos Portugal 
2770-229 Paço de Arcos
PANNONPHARMA Gyógyszergyártó Kft. 7720 Pécsvárad Pannonpharma út 1. 
PANNONPHARMA Gyógyszergyártó Kft. 7720 Pécsvárad Pannonpharma út 1. Hungary
WYETH SANTE FAMILIALE Coeur Défense - Tour A - La Défense 4 
Coeur Défense - Tour A - La Défense 4
G. M. Dimitrov Blvd Sofia, 1172 
M. Dimitrov Blvd Sofia, 1172
Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark 
Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Danska
Polígono Industrial de Alcobendas 28108 ALCOBENDAS Spain 
Industrial de Alcobendas 28108 ALCOBENDAS Spain
38123 Frazione Ravina - Trento Italy 
38123 Frazione Ravina - Trento
Iceland ratiopharm Oy Keilaranta 10 02150 Espoo Finland 
Island ratiopharm Oy Keilaranta 10 02150 Espoo Finska
EVOLUPHARM rue Irène Caron Zone Industrielle d'Auneuil 60390 Auneuil France 
EVOLUPHARM rue Irène Caron Zone Industrielle d'Auneuil 60390 Auneuil Francuska
McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road 
McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate Grange Road Dublin 13
P.O.Box 6733 Etterstad NO-0609 Oslo Norway 
Weifa AS P.O.Box 6733 Etterstad NO-0609 Oslo Norway
Str. Dr.Victor Babeş Nr. 50 Baia Mare 
Dr.Victor Babeş Nr. 50
Solution for injection Parenteral use 
Otopina za injekciju Parenteralnu uporabu
Irún, km.26,200 San Sebastián de los Reyes (Madrid) 28700 
Irún, km.26,200 San Sebastián de los Reyes (Madrid) 28700 Spain
Aspire Pharma Limited 102 High Street GB-GU7 1DS GODALMING, SURREY 
Aspire Pharma Limited 102 High Street GB-GU7 1DS GODALMING, SURREY United Kingdom
Rijeka 10000 
Rijeka 10000 Croatia
INTERNATIONAL DRUG DEVELOPMENT 5, rue Simonet 75013 Paris France 
INTERNATIONAL DRUG DEVELOPMENT 5, rue Simonet 75013 Paris Francuska
IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. 
IOUL & EIR TSETI FAR/KA ERGASTIRIA ABEE D.T. "INTERMED ABEE"
CRISTERS 22 quai Gallieni 92150 Suresnes France 
CRISTERS 22 quai Gallieni 92150 Suresnes Francuska
Estrada Marco do GriloZemouto 
Estrada Marco do Grilo - Zemouto
FIN-02200 Espoo Finland 
FIN-02200 Espoo Finska
00040 Santa PalombaPomezia (RM) - Italy 
00040 Santa Palomba - Pomezia (RM) - Italy
Pipera Nr. 42, Etajele 1, 
Pipera Nr. 42, Etajele 1, 16, 17 Sector 2,
Via Nocera Umbra 75 Roma 
Angenerico S.P.A. Via Nocera Umbra 75 Roma
Luxembourg Socobom nv/sa Avenue Louise 149b24 
Luksemburg Socobom nv/sa Avenue Louise 149b24
Borgartúni 26 105 Reykjavík Iceland 
Portfarma ehf. Borgartúni 26 105 Reykjavík Iceland
Distrifarma - Companhia de Distribuição Farmacêutica, S.A. Estrada Consiglieri Pedroso, 80 - Lt. 3 - Armz. 
DistrifarmaCompanhia de Distribuição Farmacêutica, S.A. Estrada Consiglieri Pedroso, 80 - Lt.
Via Cavriana 14 Milano 
S.P.A. Via Cavriana 14 Milano
EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex 
EG LABOLABORATOIRES EUROGENERICS "Le Quintet"bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex Francuska
Place Lucien-Auvert 77020 Melun Cedex France 
Place Lucien-Auvert 77020 Melun Cedex Francuska
GIBAUD PHARMA 73, rue de la Tour 42002 Saint-Etienne Cedex 1 France 
GIBAUD PHARMA 73, rue de la Tour 42002 Saint-Etienne Cedex 1
Rue de la Rochefoucauld 6 16000 Angoulême France 
AJC INVEST Rue de la Rochefoucauld 6 16000 Angoulême Francuska
Laboratórios Basi - Indústria Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal 
Farmacêutica, S.A Parque Industrial Manuel Lourenço Ferreira, Lote 15 3450-232 Mortágua Portugal
RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex France 
RECKITT BENCKISER HEALTHCARE FRANCE 15, rue Ampère 91748 Massy Cedex Francuska
Avenida D. João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal 
João II, Lote 1.06.2.2.C - 1º B 1990-095 Lisboa Portugal
Luxembourg Reckitt Benckiser Healthcare nv/sa 
Luksemburg Reckitt Benckiser Healthcare nv/sa
S.C. ANTIBIOTICE S.A. Str. Valea Lupului nr.1, Iaşi 
S.C. ANTIBIOTICE S.A. Str. Valea Lupului nr.1,
02101 ESPOO Finland 
02101 ESPOO Finska
Carretera de Castellvell, 24 43206 Reus (Tarragona) Spain 
Korhispana, S.L. Carretera de Castellvell, 24 43206 Reus (Tarragona) Spain
Wałbrzyska st. 13 60-198 Poznan Poland 
Biofarm Sp. z o.o. Wałbrzyska st. 13 60-198 Poznan Poland
ZAMBON FRANCE 13, rue René Jacques 92138 Issy-les-Moulineaux Cedex 
ZAMBON FRANCE 13, rue René Jacques 92138 Issy-lesMoulineaux Cedex Francuska
Unit 2A Sefton Business Park Aintree, Liverpool L30 1RD 
Unit 2A, Olympic Way, Sefton Business Park Bootle, Liverpool L30 1RD
92931 Paris La Défense Cedex France 
92931 Paris La Défense Cedex Francuska
Bristol Myers Squibb 3, rue Joseph Monier 92500 Rueil-Malmaison France 
Bristol Myers Squibb 3, rue Joseph Monier 92500 RueilMalmaison Francuska
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for ibuprofen-containing medicinal products and dexibuprofen-containing medicinal products (systemic formulations) 
Popis naziva, farmaceutskog(ih) oblika, jačine(a) lijek(ov)a, put(ev)a primjene, nositelj(a) odobrenja u državama članicama
ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre France 
ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers
00144 Roma 
00144 ROMA Italy
Boumpoulinas Street 11 PO Box 27783 Nicosia CY-2433 
PO Box 27783 Nicosia CY-2433
Viale Amelia 70, Rome 00181, Italy 
S.p.A. Viale Amelia 70 00181 Rome Italy
Postepu st. 21B 02-676 Warsaw Poland 
21B 02-676 Warsaw Poland
Reckitt Benckiser Healthcare International Limited Bath Road 103-105 
Reckitt Benckiser Healthcare International Limited Bath Road 103-105 Berkshire
GALENICA A.E. Eleftherias 4, 14564, Kifissia, Greece 
Eleftherias 4, 14564, Kifissia, Greece
Teva Denmark A/S Parallelvej 10-12, DK-2800 Kongens Lyndby Denmark 
Teva Danska A/S Parallelvej 10-12, DK-2800 Kongens Lyndby
Alkaloid d.o.o., Ulica grada Vukovara 226f Zagreb 10000 
Alkaloid d.o.o., Ulica grada Vukovara 226f
Laboratórios AzevedosIndústria Farmacêutica, S.A. Edifícios Azevedos - Estrada Nacional 117-2, Alfragide 2614-504 Amadora Portugal 
Farmacêutica, S.A. Edifícios AzevedosEstrada Nacional 1172, Alfragide 2614-504 Amadora Portugal