natgillin/translations-raw huggingface dataset:
The study comparing Lyxumia with exenatide (added to metformin) showed reduced HbA1c levels by 0.79% after 24 weeks treatment with Lyxumia compared to 0.96% with exenatide twice daily. 
Ispitivanje koje je uspoređivalo lijek Lyxumia s eksenatidom (koji je dodan metforminu) pokazalo je smanjene razine HbA1c za 0,79 % nakon 24-tjedne terapije Lyxumiom u usporedbi s 0,96 % s eksenatidom dva puta na dan.
Lyxumia should not be given with a combination of both, basal insulin and a sulphonylurea. 
Lijek Lyxumia ne smije se davati u kombinaciju s oba lijeka, bazalnim inzulinom i sulfonilurejom.
The CHMP concluded that Lyxumia was shown to be effective at lowering blood glucose levels in patients with type 2 diabetes, when given alone or in combination with other diabetes medicines. 
CHMP je zaključio da se pokazalo da je lijek Lyxumia učinkovit u snižavanju razina glukoze u krvi u bolesnika s dijabetesom tipa 2 kada se daje sam ili u kombinaciji s drugim lijekovima protiv dijabetesa.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lyxumia, including the appropriate precautions to be followed by healthcare professionals and patients. 
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Lyxumia nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
When used on its own, Lyxumia reduced Hb1Ac levels by 0.6% more than placebo. 
Kada se koristila nasamo, Lyxumia je reducirala razine Hb1Ac za 0,6 % više od placeba.
HbA1c gives an indication of how well the blood glucose is controlled. 
Razine HbA1c pokazuju kako se dobro kontrolira razina glukoze u krvi.
Why has Lyxumia been approved? 
Zašto je Lyxumia odobren?
Regarding its safety, most side effects are comparable to those of other similar diabetes medicines with side effects affecting the gut being the most common ones. 
Što se tiče sigurnosti, većina nuspojava usporediva s onima kod sličnih lijekova protiv dijabetesa dok su im najčešće nuspojave one koje zahvaćaju probavni sustav.
Six of the studies compared Lyxumia with placebo (a dummy treatment), used alone or when added to metformin, a sulphonylurea, basal insulin, or a combination of two of these medicines, in patients in whom previous treatment had failed. 
Šest ispitivanja uspoređivalo je Lyxumiu s placebom (prividnim liječenjem) koje se koristilo samo ili uz dodatak metformina, sulfonilureje, bazalnog inzulina ili kombinacije ova dva lijeka kod bolesnika kod kojih prethodno liječenje nije uspjelo.
Lyxumia is a diabetes medicine that contains the active substance lixisenatide. 
Lyxumia je lijek protiv dijabetesa koji sadrži djelatnu tvar liksisenatid.
HbA1c levels were measured after 12 weeks when Lyxumia was used alone and after 24 weeks when it was used in combination with other diabetes medicines. 
Razine HbA1c mjerene su 12 tjedana nakon što se Lyxumia primjenjivala sama te 24 tjedna nakon što je primjenjivana u kombinaciji s drugim antidijabeticima.
Lyxumia is used in adults who have type 2 diabetes to control their blood glucose (sugar) level. 
Lyxumia se koristi kod odraslih osoba s dijabetesom mellitusom tipa 2 za kontrolu razine njihove glukoze u krvi (šećera).
It is used together with diabetes medicines taken by mouth and/or basal insulin (long-acting insulin) in patients whose blood glucose levels are not adequately controlled by these medicines together with diet and exercise. 
Koristi se skupa s lijekovima protiv dijabetesa koji se uzimaju kroz usta i/ili bazalnim inzulinom (inzulinom dugog djelovanja) kod bolesnika čije razine glukoze u krvi nisu kontrolirane na odgovarajući način ovim lijekovima skupa s dijetom i tjelovježbom.
What is Lyxumia? 
Što je Lyxumia?
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 Lyxumia. 
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek Lyxumia da bi preporučio njegovo odobrenje za stavljanje na tržište te uvjete za njegovu primjenu.
When used in combination with other diabetes medicines, Lyxumia reduced Hb1Ac levels by 0.4 up to 0.9% more than placebo. 
Kada se koristila u kombinaciji s drugim lijekovima protiv dijabetesa, Lyxumia je smanjila razine Hb1Ac za 0,4 do 0,9 % više nego placebo.
When used together with a sulphonylurea or basal insulin, the most common side effect (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). 
Kada se koristi skupa sa sulfonilurejom ili bazalnim inzulinom najčešća nuspojava (može se javiti kod više od 1 na 10 bolesnika) bila je hipoglikemija (niske razine glukoze u krvi).
In one study, Lyxumia was compared with another diabetes medicine called exenatide when added to metformin in patients whose blood sugar levels were not adequately controlled by metformin. 
U jednom je ispitivanju Lyxumia uspoređena s drugim lijekom protiv dijabetesa zvanim eksenatid kad se dodavao metforminu kod bolesnika čije razine glukoze u krvi nisu bile na odgovarajući način kontrolirane metforminom.
This causes the release of insulin and helps to reduce blood glucose levels and control type 2 diabetes. 
To uzrokuje otpuštanje inzulina, pomaže u smanjenju razine glukoze u krvi te kontrolira dijabetes tipa 2.
The CHMP concluded that the benefits of Lyxumia outweigh its risks and recommended that it be granted marketing authorisation. 
Odbor za lijekove za primjenu kod ljudi (CHMP) odlučio je da koristi od lijeka Lyxumia nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za stavljanje u promet.
For the full list of all side effects and restrictions with Lyxumia, see the package leaflet. 
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Lyxumia, potražite u uputi o lijeku.
What benefit has Lyxumia shown during the studies? 
Koje su koristi lijeka Lyxumia utvrđene u ispitivanjima?
What is Lyxumia used for? 
Za što se Lyxumia koristi?
In addition, beneficial weight loss was seen in patients treated with Lyxumia. 
Pored toga, kod bolesnika liječenih lijekom Lyxumia uočen je koristan gubitak tjelesne težine.
How is Lyxumia used? 
Kako se koristi Lyxumia?
How does Lyxumia work? 
Kako djeluje Lyxumia?
How has Lyxumia been studied? 
Kako je Lyxumia ispitivana?
QUALIGEN, SL 
Španjolska QUALIGEN, SL
Baclofeno Generis baclofen 
Baclofeno Generis baklofen
Hexal AG, Germany 
Hexal AG, Njemačka
Laboratórios Basi - Indústria Farm 
Laboratórios BasiIndústria Farm
Annex Ib: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation 
Prilog I.b: Lijekovi za koje se preporučuje obustava odobrenja za stavljanje lijeka u promet i zahtjevi za odobrenje za stavljanje lijeka u promet koji ne udovoljavaju kriterijima za izdavanje odobrenja
BRADEX AEBE DUTASTERIDE/BRADEX 
BRADEX AEBE DUTASTERIDE/BRADEX dutasterid
Annex Ia: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established 
Prilog I.a: Lijekovi za koje se preporučuje zadržavanje odobrenja za stavljanje lijeka u promet i zahtjevi za odobrenje za stavljanje lijeka u promet za koje je utvrđena bioekvivalencija u odnosu na referentni lijek odobren u EU-u
tianeptine 
tianeptin
Corporation Orion Pharma, Finland 
Orion Corporation Orion Pharma, Finska
Carbocisteine 375 mg Capsules, Hard carbocisteine 
Carbocisteine 375 mg Capsules, Hard karbocistein
Belfada aripiprazole 
Belfada aripiprazol
Sandoz A/S, Denmark 
Sandoz A/S, Danska
Prednisolon Alternova prednisolone 
Prednisolon Alternova prednisolon
The Netherlands Sandoz B.V. 
Nizozemska Sandoz B.V.
LABORATORIOS COMBIX, SLU 
Španjolska LABORATORIOS COMBIX, SLU
Loperamid Apofri loperamide 
Loperamid Apofri loperamid
Metoklopramid Alternova metoclopramide 
Metoklopramid Alternova metoklopramid
Loperamid Orifarm loperamide 
Loperamid Orifarm loperamid
United Kingdom Strides Arcolab International 
Španjolska Strides Arcolab International
Alternova A/S Hydrokortison Alternova hydrocortisone 
Alternova A/S Hydrokortison Alternova hidrokortizon
Bendro-flumetiazid Alternova bendro-flumethiazide 2.5 mg Tablet 
Bendro-flumetiazid Alternova bendroflumetiazid 2,5 mg tableta
Alternova A/S Baklofen Alternova baclofen 
Alternova A/S Baklofen Alternova baklofen
ΦΑΡΜΑΖΑΚ ΑΝΩΝΥΜΗ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΜΠΟΡΙΚΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΤΑΙΡΕΙΑ Δ.Τ. 
ΦΑΡΜΑΖΑΚ ΑΝΩΝΥΜΗ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΜΠΟΡΙΚΗ ΒΙΟΜΗΧΑΝΙΚΗ ΕΤΑΙΡΕΙΑ Δ.Τ. PHARMAZAC AE
Sodium Cromoglicate 100mg hard Capsules sodium cromoglicate 100 mg Capsule, hard Oral use 
Sodium Cromoglicate 100mg hard Capsules natrijev kromoglikat 100 mg kapsula, tvrda peroralna primjena
Clindamycin Alternova clindamycin 
Clindamycin Alternova klindamicin
AUROVITAS SPAIN, SAU 
Španjolska AUROVITAS SPAIN, SAU
ethinylestradiol / levonorgestrel 
etinilestradiol/levonor gestrel
hydrocortisone 
hidrokortizon
FarmozSociedade Técnico Medicinal, S.A. 
Farmoz - Sociedade Técnico Medicinal, S.A.
LABORATORIOS AUROBINDO, SLU 
Španjolska LABORATORIOS AUROBINDO, SLU
Morysa memantine 
Morysa memantin
SANDOZ FARMACEUTICA, SA 
Španjolska SANDOZ FARMACEUTICA, SA
Maexeni 30 0,03 mg/0,15 mg Filmtabletten ethinylestradiol / levonorgestrel mg/0.15 mg neuraxpharm Arzneimittel GmbH 
Maexeni 30 0,03 mg/0,15 mg Filmtabletten etinilestradiol/levonor gestrel mg/0,15 mg neuraxpharm Arzneimittel GmbH
United Kingdom Dawa Limited 
Dawa Limited
Memantine Pharmascope memantine 
Memantine Pharmascope memantin
1 A Pharma GmbH, Germany 
1 A Pharma GmbH, Njemačka
LARCIA 125 MIKROGRAMŮ/30 MIKROGRAMŮ 
MIKROGRAMŮ/30 MIKROGRAMŮ
United Kingdom Kinedexe UK Limited (previously 
Kinedexe UK Limited (prethodno NRIM Limited)
Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-acid-ethyl esters 90 
Omega 3-acid-ethyl esters 1000mg soft capsules etilni[90]esteri omega-3 kiselina
Corporation, Finland 
Orion Corporation, Finska
dutasteride 
dutasterid
voriconazol 
vorikonazol
Speciality Pharma Limited 
Generic Speciality Pharma Limited
Naproxen Orion 
Naproxen Orion naproksen
Medreich PLC Gliclazide 40 mg tablets gliclazide 
Medreich PLC Gliclazide 40 mg tablets gliklazid
memantine 
memantin
Biogaran hydroxyzine BIOGARAN hydroxyzine 
Biogaran hydroxyzine BIOGARAN hidroksizin
Beta-histina Bluefish 
Beta-histina Bluefish betahistin
loperamide 
loperamid
Gliclazide 80mg Tablets gliclazide 
Gliclazide 80mg Tablets gliklazid
Loperamid Evolan loperamide 
Evolan Pharma AB Loperamid Evolan loperamid
Beta- histina Bluefish betahistine dihydrochloride 
Beta- histina Bluefish betahistin dihidroklorid
Gliclazide 40mg Tablets gliclazide 
Gliclazide 40mg Tablets gliklazid
The Netherlands Aurobindo Pharma B.V. 
Nizozemska Aurobindo Pharma B.V.
Hydroxyzine hydrochloride 25mg film-coated tablets hydroxyzine hydrochloride 
Hydroxyzine hydrochloride 25mg film-coated tablets hidroksizin hidroklorid 25 mg filmom obložena tableta
Irbesartan 75 mg Film-coated Tablets irbesartan 
Irbesartan 75 mg Filmcoated Tablets irbesartan
Omega 3 Strides Arcolab International omega-3-acid-ethyl esters 90 
Omega 3 Strides Arcolab International etilni[90]esteri omega-3 kiselina
Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (in Germany) 
Amlodipin/Valsartan PUREN (u Njemačkoj)
1000 mg Capsule, soft Oral use 
1 000 mg kapsula, meka peroralna primjena
Naproxen 500 mg tablets naproxen 
Naproxen 500 mg tablets naproksen
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 4 mg / 1.25 mg 
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 4 mg/1,25 mg
Slovak Republic Proenzi s.r.o. 
Rumunjska Proenzi s.r.o.
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 2 mg/ 0.625 mg 
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 2 mg/0,625 mg
Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung bupropion 
Bupropion-neuraxpharm 300 mg Tabletten mit veränderter
Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol / levonorgestrel 
Levonorgestrel/Ethinylestr adiol Famy Care 125 mikrogramů/30 mikrogramů etinilestradiol/levonor gestrel
0.5 mg Capsule, soft Oral use 
0,5 mg kapsula, meka peroralna primjena
Carbimazole 5mg Tablets carbimazole 
Carbimazole 5mg Tablets karbimazol
Betahistyna Bluefish betahistine dihydrochloride 
Betahistyna Bluefish betahistin dihidroklorid
Hydroxyzine CRISTERS 
Hydroxyzine CRISTERS hidroksizin
Hydroxyzine ZENTIVA 
Hydroxyzine ZENTIVA hidroksizin
Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol / levonorgestrel 
Maexeni 150/30 microgram Film Coated Tablets etinilestradiol/levonor gestrel mg/0,125 mg
Dawa Limited Carbimazole 5mg Tablets carbimazole 
Dawa Limited Carbimazole 5mg Tablets karbimazol
Dicloxacillin Alternova dicloxacillin 
Dicloxacillin Alternova dikloksacilin
Voriconazol Glob voriconazol 
Voriconazol Glob vorikonazol
Bupropion 1A Pharma 300 mg - Tablette mit veränderter Wirkstofffreisetzung bupropion 
Bupropion 1A Pharma 300 mg - Tablette mit veränderter
Naproxen Aurobindo 250 mg, tabletten 
Naproxen Aurobindo 250 mg, tabletten naproksen
Hydroxyzine ARROW hydroxyzine 
Hydroxyzine ARROW hidroksizin
Bupropion Sandoz 300 mgTablette mit veränderter Wirkstofffreisetzung bupropion 
Bupropion Sandoz 300 mg - Tablette mit veränderter Wirkstofffreisetzung bupropion
Betahistina Bluefish betahistine dihydrochloride 
Betahistina Bluefish betahistin dihidroklorid
Vzole 200 mg film-coated tablets voriconazol 
Vzole 200 mg film-coated tablets vorikonazol
Vzole 50 mg film-coated tablets voriconazol 
Vzole 50 mg film-coated tablets vorikonazol
Evolan Pharma AB 
Evolan Pharma AB Loperamid ABECE
Naproxeno Aurobindo 
Naproxeno Aurobindo naproksen
Voriconazolo Aurobindo voriconazol 
Voriconazolo Aurobindo vorikonazol
Voriconazole Milpharm 200 mg film-coated tablets voriconazol 
Voriconazole Milpharm 200 mg film-coated tablets vorikonazol
Naproxen Aurobindo 500 mg, tabletten 
Naproxen Aurobindo 500 mg, tabletten naproksen
Voriconazole Milpharm 50 mg film-coated tablets voriconazol 
Voriconazole Milpharm 50 mg film-coated tablets vorikonazol
Hydroxyzinhydrochlorid EQL Pharma hydroxyzine 
Hydroxyzinhydrochlorid EQL Pharma hidroksizin
Voriconazol Aurobindo 200 mg, filmomhulde tabletten voriconazol 
Voriconazol Aurobindo 200 mg, filmomhulde tabletten vorikonazol
Carbimazole 20 mg Tablets carbimazole 
Carbimazole 20 mg Tablets karbimazol
Voriconazol PUREN 200 mg Filmtabletten voriconazol 
Voriconazol PUREN 200 mg Filmtabletten vorikonazol
voriconazole Arrow voriconazol 
voriconazole Arrow vorikonazol
Esters ethyliques d'acides omega-3 Strides omega-3-acid-ethyl esters 90 
ELC Group s.r.o. Esters ethyliques d'acides omega-3 Strides etilni[90]esteri omega-3 kiselina
Voriconazol PUREN 50 mg Filmtabletten voriconazol 
Voriconazol PUREN 50 mg Filmtabletten vorikonazol
Voriconazol Aurobindo 50 mg, filmomhulde tabletten voriconazol 
Voriconazol Aurobindo 50 mg, filmomhulde tabletten vorikonazol
4 mg /1.25 mg 
perindopril/indapamid 4 mg/1,25 mg
Hydroxyzine MYLAN 
Hydroxyzine MYLAN hidroksizin
Naproxen 250 mg tablets naproxen 
Naproxen 250 mg tablets naproksen
Hydroxyzine EQL Pharma hydroxyzine 
Hydroxyzine EQL Pharma hidroksizin
Betahistin Sandoz 8 mg betahistine 
Betahistin Sandoz 8 mg betahistin
Ethinylestradiol / Levonorgeshel Famy Care 30 mikrogramm 125 mikrogramm tablette ethinylestradiol / levonorgestrel 
Ethinylestradiol/Levonorge shel Famy Care 30 mikrogramm 125 mikrogramm tablette etinilestradiol/levonor gestrel mg/0,125 mg
Metformin 1000 mg Filmcoated tablet metformin hydrochloride 
Metformin 1000 mg Filmcoated tablet metformin hidroklorid 1 000 mg filmom obložena tableta
375 mg Capsule, hard Oral use 
375 mg kapsula, tvrda peroralna primjena
Memantine Dawa 20mg filmcoated tablets memantine 
Memantine Dawa 20mg filmcoated tablets memantin
Dawa Limited Carbimazole 20mg Tablets carbimazole 
Dawa Limited Carbimazole 20mg Tablets karbimazol
Betahistin Sandoz 16 mg betahistine 
Betahistin Sandoz 16 mg betahistin
Metformin 850 mg Film-coated tablet metformin hydrochloride 
Metformin 850 mg Filmcoated tablet metformin hidroklorid 850 mg filmom obložena tableta
Voriconazol Aurovitas voriconazol 
Voriconazol Aurovitas vorikonazol
Carbimazole 20mg Tablets carbimazole 
Carbimazole 20mg Tablets karbimazol
Aripiprazole 30 mg tablets aripiprazole 
Aripiprazole 30 mg tablets aripiprazol
Memantine Dawa 10mg filmcoated tablets memantine 
Memantine Dawa 10mg filmcoated tablets memantin
Metformin 500 mg Film-coated tablet metformin hydrochloride 
Metformin 500 mg Filmcoated tablet metformin hidroklorid 500 mg filmom obložena tableta
Naproxen Aurobindo 
Naproxen Aurobindo naproksen
Etrixenal 250 mg tabletes naproxen 
ETRIXENAL 250 MG TABLETY
20 mg Oro-dispersible tablet 
20 mg raspadljiva tableta za usta
150 mg Capsule, hard Oral use 
150 mg kapsula, tvrda peroralna primjena
Tadalafil Milpharm 20 mg filmcoated tablets 
Tadalafil Milpharm 20 mg film-coated tablets
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 8 mg / 2.5 mg 
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamid 8 mg/2,5 mg tableta
15 mg Oro-dispersible tablet 
15 mg raspadljiva tableta za usta
Aripiprazole 5 mg tablets aripiprazole 
Aripiprazole 5 mg tablets aripiprazol
Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 10 mg/160 mg 
Arrow Génériques amlodipine/valsartan Arrow amlodipin/valsartan 10 mg/160 mg
250 mg Capsule, hard Oral use 
250 mg kapsula, tvrda peroralna primjena
300 mg modified-release tablet 
300 mg tableta s prilagođenim oslobađanjem
Aripiprazole 10 mg tablets aripiprazole 
Aripiprazole 10 mg tablets aripiprazol
10 mg Oro-dispersible tablet 
10 mg raspadljiva tableta za usta
Betahistine Sandoz 24 mg betahistine 
Betahistine Sandoz 24 mg betahistin
Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/160 mg 
Arrow Génériques amlodipine/valsartan Arrow amlodipin/valsartan 5 mg/160 mg
2 mg /0.625 mg 
perindopril/indapamid 2 mg/0,625 mg
Amlodipina + Valsartan Aurovitas amlodipine / valsartan 10 mg/160 mg 
Amlodipina + Valsartan Aurovitas amlodipin/valsartan 10 mg/160 mg
Betahistin Sandoz 24 mg betahistine 
Betahistin Sandoz 24 mg betahistin
500 mg Capsule, hard Oral use 
500 mg kapsula, tvrda peroralna primjena
Hydroxyzine Sandoz hydroxyzine 
Hydroxyzine SANDOZ hidroksizin
Amlodipine-Valsartan AB amlodipine / valsartan 10 mg/160 mg 
Amlodipine-Valsartan AB amlodipin/valsartan 10 mg/ 160 mg
Memantin Pharmascope 20 mg Filmtabletten memantine 
Memantin Pharmascope 20 mg Filmtabletten memantin
Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /160 mg 
Amlodipina + Valsartan Aurovitas amlodipin/valsartan 5 mg/160 mg
Amlodipine-Valsartan AB amlodipine / valsartan 5 mg/160 mg 
Amlodipine-Valsartan AB amlodipin/valsartan 5 mg/ 160 mg
metformin hydrochloride 
betahistin dihidroklorid
Tadalafil Milpharm 10 mg filmcoated tablets 
Tadalafil Milpharm 10 mg film-coated tablets
Sarpin amlodipine / valsartan 10 mg /160 mg 
Sarpin amlodipin/valsartan 10 mg/160 mg
Memantin Pharmascope 10 mg Filmtabletten memantine 
Memantin Pharmascope 10 mg Filmtabletten memantin
Aripiprazole 15 mg tablets aripiprazole 
Aripiprazole 15 mg tablets aripiprazol
Memantine Pharmascope 10 mg filmomhulde tabletten memantine 
Memantine Pharmascope 10 mg filmomhulde tabletten memantin
Memantine Pharmascope 20 mg filmomhulde tabletten memantine 
Memantine Pharmascope 20 mg filmomhulde tabletten memantin
Pharmaceuticals AB 
Bluefish Pharmaceuticals AB
Hydroxyzine SANDOZ 
Hydroxyzine Sandoz hidroksizin
Tadalafil Milpharm 5 mg filmcoated tablets 
Tadalafil Milpharm 5 mg film-coated tablets
8 mg/2.5 mg 
perindopril/indapamid 8 mg/2,5 mg tableta
Tablet 
naproksen
Atyxine hydroxyzine 
Atyxine hidroksizin
300 mg Modified-release tablet 
300 mg tablete s prilagođenim oslobađanjem
Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine / valsartan 10 mg /160 mg 
Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipin/valsartan 10 mg/160 mg
Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipine / valsartan 10 mg/160 mg 
Amlodipina/Valsartan Aurobindo 10 mg/160 mg comprimate filmate amlodipin/valsartan 10 mg/160 mg
Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /160 mg 
Amlodipine/ Valsartan Aurobindo 5/160 mg, filmomhulde tabletten amlodipin/valsartan 5 mg/160 mg
Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipine / valsartan 5 mg /80 mg 
Amlodipine/ Valsartan Aurobindo 5/80 mg, filmomhulde tabletten amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine / valsartan 5 mg /160 mg 
Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipin/valsartan 5 mg/160 mg
Napritum 
Napritum naproksen
amlodipine / valsartan 5 mg /160 mg 
amlodipin/valsartan 5 mg/160 mg
NRIM Limited) 
BCM Limited
Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine / valsartan 5 mg /80 mg 
Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
amlodipine / valsartan 10 mg /160 mg 
amlodipin/valsartan 10 mg/160 mg
Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/80 mg 
Arrow Génériques amlodipine/valsartan Arrow amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
The Netherlands Pharmascope Ltd. 
Nizozemska Pharmascope
acide ursodesoxycholique Inopharm ursodeoxycholic acid 500 mg Film-coated tablet 
acide ursodesoxycholique Inopharm ursodeoksikolatna kiselina
Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /80 mg 
Amlodipina + Valsartan Aurovitas amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
Metformine Almus metformin hydrochloride 
Metformine Almus metformin hidroklorid 500 mg tableta
ursodeoxycholic acid 500 mg Film-coated tablet 
Metformina Almus metformin hidroklorid 500 mg filmom obložena tableta
Amlodipine-Valsartan AB amlodipine / valsartan 5 mg/80 mg 
Amlodipine-Valsartan AB amlodipin/valsartan 5 mg/80 mg filmom obložena tableta
0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled pens (multipack) 
6 (3x2) napunjenih brizgalica (višestruko pakovanje)
0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled syringes with needle safety device (multipack) 
6 (3x2) napunjenih štrcaljki sa sigurnosnom zaštitom igle (višestruko pakovanje)
0.8 ml (40 mg/0.8ml) 2 pre-filled syringes with needle safety device 
2 napunjene štrcaljke sa sigurnosnom zaštitom igle
0.8 ml (40 mg/0.8ml) 1 pre-filled syringe with needle safety device 
1 napunjena štrcaljka sa sigurnosnom zaštitom igle
Other changes 
Ostale promjene
The areas harmonised include: 
Područja usklađivanja uključuju:
21 March 2014 
21. ožujka 2014.
The European Commission issued a decision on 21 March 2014. 
Europska komisija usvojila je odluku dana 21. ožujka 2014.
What is Rocephin? 
Što je Rocephin?
Rocephin is marketed in the following EU Member States: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and the United Kingdom, as well as Iceland. 
Rocephin je stavljen na tržište u sljedećim državama članicama EU: Belgiji, Danskoj, Finskoj, Francuskoj, Njemačkoj, Grčkoj, Mađarskoj, Irskoj, Italiji, Latviji, Luksemburgu, Malti, Nizozemskoj, Portugalu, Rumunjskoj, Švedskoj i Ujedinjenom Kraljevstvu, kao i na Islandu.
Why was Rocephin reviewed? 
Zašto je Rocephin pregledan?
Rocephin is authorised in the EU via national procedures. 
Rocephin je odobren u EU putem nacionalnih postupaka.
This prevents the bacteria from building their cell walls, and eventually kills them. 
Ovo sprječava bakterije da izgrade svoje stanične stjenke, te ih naposljetku ubija.
• bacterial meningitis; 
• bakterijski meningitis;
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) 
Pitanja i odgovori o lijeku Rocephin i povezanim nazivima (ceftriakson, 250 mg, 500 mg, 1 g, 2 g, prašak za otopinu za injekciju ili infuziju)