natgillin/translations-raw huggingface dataset:
When used on its own, Lyxumia reduced Hb1Ac levels by 0.6% more than placebo. 
Ainuravimina kasutamisel vähendas Lyxumia Hb1Ac sisaldust 0,6% võrra enam kui platseebo.
The active substance in Lyxumia, lixisenatide, is a ‘GLP-1 receptor agonist'. 
Lyxumia toimeaine liksisenatiid on GLP-1 retseptori agonist.
This is a summary of the European public assessment report (EPAR) for Lyxumia. 
See on ravimi Lyxumia Euroopa avaliku hindamisaruande kokkuvõte.
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. 
Inimravimite komitee järeldas, et Lyxumia on II tüüpi diabeediga patsientide vere glükoosisisalduse vähendamisel efektiivne nii kasutamisel ainuravimina kui ka koos teiste diabeediravimitega.
HbA1c gives an indication of how well the blood glucose is controlled. 
HbA1c sisaldus veres näitab vere glükoosisisalduse reguleeritavust.
When used in combination with other diabetes medicines, Lyxumia reduced Hb1Ac levels by 0.4 up to 0.9% more than placebo. 
Kasutamisel koos teiste diabeediravimitega vähendas Lyxumia HbA1c sisaldust 0,4-0,9% võrra enam kui platseebo.
What benefit has Lyxumia shown during the studies? 
Milles seisneb uuringute põhjal Lyxumia kasulikkus?
Lyxumia was more effective than placebo at controlling blood glucose. 
Lyxumia oli vere glükoosisisalduse reguleerimisel platseebost efektiivsem.
In addition, beneficial weight loss was seen in patients treated with Lyxumia. 
Lyxumiaga ravitavatel patsientidel täheldati ka kasulikku kehakaalu vähenemist.
How has Lyxumia been studied? 
Kuidas Lyxumiat uuriti?
Lyxumia is used in adults who have type 2 diabetes to control their blood glucose (sugar) level. 
Lyxumiat kasutatakse II tüüpi diabeediga täiskasvanud patsientide vere glükoosisisalduse reguleerimiseks.
How is Lyxumia used? 
Kuidas Lyxumiat kasutatakse?
What is Lyxumia used for? 
Milleks Lyxumiat kasutatakse?
How does Lyxumia work? 
Kuidas Lyxumia toimib?
It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh. 
Ravimit manustatakse nahaaluse süstina kõhuseina, õlavarre või reie piirkonda.
Hexal AG, Germany 
Hexal AG, Saksamaa
ZYDUS France 
Prantsusmaa ZYDUS France
United Kingdom Kinedexe UK Limited (previously 
Ühendkuningriik Kinedexe UK Limited (previously
Teva Sante 
Prantsusmaa Teva Sante
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 
IA lisa: ravimid, mille müügiluba soovitatakse säilitada, ja nende ravimite müügiloa taotlused, mille bioekvivalentsus Euroopa Liidu võrdlusravimiga on tõestatud
Annex Ib: Products for which the marketing authorisations are recommended for suspension and marketing authorisation applications which do not satisfy the criteria for authorisation 
IB lisa: ravimid, mille müügiluba soovitatakse peatada, ja müügiloa taotlused, mis ei vasta müügiloa nõuetele Liikmesriik
Sanofi Aventis France 
Prantsusmaa Sanofi Aventis
United Kingdom Dawa Limited 
Ühendkuningriik Dawa Limited
United Kingdom Medreich PLC 
Ühendkuningriik Medreich PLC
LABORATORIOS COMBIX, SLU 
LABORATORI OS COMBIX, SLU
SUBSTIPHARM DEVELOPPEMENT 
SUBSTIPHARM DEVELOPPEMEN T
Carbocisteine 375 mg Capsules, Hard carbocisteine 
Carbocisteine 375 mg Capsules, Hard karbotsüsteiin
Belgium Sandoz n.v./s.a. 
Sandoz n.v./s.a.
Loperamid Orifarm loperamide 
Loperamid Orifarm loperamiid
Corporation, Finland 
Corporation, Soome
Morysa memantine 
Morysa memantiin
Metoklopramid Alternova metoclopramide 
Metoklopramid Alternova metoklopramiid
Loperamid Evolan loperamide 
Loperamid Evolan loperamiid
United Kingdom Lupin (Europe) Limited 
Ühendkuningriik Lupin (Europe)
Bupropion Orion bupropion 
Bupropion Orion bupropioon
Buproprionhydrochlorid Hexal 300 mg bupropion 
Buproprionhydrochlorid Hexal 300 mg bupropioon
Alternova A/S Etodolac Alternova etodolac 
Alternova A/S Etodolac Alternova etodolak
EG LABOLaboratoires Eurogenerics 
Prantsusmaa EG LABOLaboratoires
loperamide 
loperamiid
United Kingdom Milpharm Limited 
Ühendkuningriik Milpharm Limited
Bendro-flumetiazid Alternova bendro-flumethiazide 2.5 mg Tablet 
Bendro-flumetiazid Alternova bendroflumetiasiid 2,5 mg Tablett
ethinylestradiol / levonorgestrel 
etinüülöstradiool/ levonorgestreel
Prednisolon Alternova prednisolone 
Prednisolon Alternova prednisoloon
bupropion 
bupropioon
Alternova A/S Baklofen Alternova baclofen 
Alternova A/S Baklofen Alternova baklofeen
SANDOZ FARMACEUTICA, SA 
SANDOZ FARMACEUTI CA, SA
Bupropion 1 A Pharma 300 mg bupropion 
Bupropion 1 A Pharma 300 mg bupropioon
Miofen ibuprofen 
Miofen ibuprofeen
Alternova A/S Hydrokortison Alternova hydrocortisone 
Alternova A/S Hydrokortison Alternova hüdrokortisoon
1 A Pharma GmbH, Germany 
1 A Pharma GmbH, Saksamaa
Sodium Cromoglicate 100mg hard Capsules sodium cromoglicate 100 mg Capsule, hard Oral use 
Sodium Cromoglicate 100mg hard Capsules naatriumkromoglükaat 100 mg Kõvakapsel
Czech Republic SVUS Pharma a.s. 
Tšehhi Vabariik SVUS Pharma a.s.
Memantine Pharmascope memantine 
Memantine Pharmascope memantiin
Baclofeno Generis baclofen 
Baclofeno Generis baklofeen
Paracetamol Almus Pharma paracetamol 
Paracetamol Almus Pharma paratsetamool
dutasteride 
dutasteriid
Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte bupropion 
Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte bupropioon
The Netherlands Sandoz B.V. 
Madalmaad Sandoz B.V.
Omega 3-acid-ethyl esters 1000mg soft capsules omega-3-acid-ethyl esters 90 
Omega 3-acid-ethyl esters 1000mg soft capsules oomega-3 rasvhappe etüülestrid 90
Dicloxacillin Alternova dicloxacillin 
Dicloxacillin Alternova dikloksatsilliin
Arrow Génériques 
Prantsusmaa Arrow Génériques
Loperamid Apofri loperamide 
Apofri AB Loperamid Apofri loperamiid
Mylan SAS 
Prantsusmaa Mylan SAS
Czech Republic Proenzi s.r.o. 
Tšehhi Vabariik Proenzi s.r.o.
Bupropion 1A Pharma 300 mg - Tablette mit veränderter Wirkstofffreisetzung bupropion 
Bupropion 1A Pharma 300 mg - Tablette mit veränderter Wirkstofffreisetzung bupropioon
Clindamycin Alternova clindamycin 
Clindamycin Alternova klindamütsiin
memantine 
memantiin
Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (in Germany) 
Amlodipina + Valsartan Aurovitas, Amlodipin/Valsartan PUREN (Saksamaa)
PUREN Pharma GmbH & Co. KG 
PUREN Pharma GmbH & Co.
Bupropion Sandoz 300 mg tablete s prirejenim sproščanjem bupropion 
Bupropion Sandoz 300 mg tablete s prirejenim sproščanjem bupropioon
Medreich PLC Gliclazide 40 mg tablets gliclazide 
Medreich PLC Gliclazide 40 mg tablets gliklasiid
ibuprofen 
ibuprofeen
Bupropion Sandoz 300 mgTablette mit veränderter Wirkstofffreisetzung bupropion 
Bupropion Sandoz 300 mgTablette mit veränderter Wirkstofffreisetzung bupropioon
Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung bupropion 
Bupropion-neuraxpharm 300 mg Tabletten mit veränderter Wirkstofffreisetzung bupropioon
Irbesartan 75 mg Film-coated Tablets irbesartan 
Irbesartan 75 mg Film-coated Tablets irbesartaan
BBS Consult ApS Loperamid BBS 
BBS Consult ApS
Gliclazide 80mg Tablets gliclazide 
Gliclazide 80mg Tablets gliklasiid
tianeptine 
tianeptiin
United Kingdom HEC Pharm GmbH 
Ühendkuningriik HEC Pharm GmbH
LABORATORIOS AUROBINDO, SLU 
AUROBINDO, SLU
Bupropion HCl Sandoz bupropion 
Bupropion HCl Sandoz bupropioon
Esters ethyliques d'acides omega-3 Strides omega-3-acid-ethyl esters 90 
Esters ethyliques d'acides omega-3 Strides oomega-3 rasvhappe etüülestrid 90
Gliclazide 40mg Tablets gliclazide 
Gliclazide 40mg Tablets gliklasiid
Biogaran hydroxyzine BIOGARAN hydroxyzine 
Prantsusmaa Biogaran hydroxyzine BIOGARAN hüdroksüsiin
Naproxen Orion 
Naproxen Orion naprokseen
acide ursodesoxycholique Inopharm ursodeoxycholic acid 500 mg Film-coated tablet 
acide ursodesoxycholique Inopharm ursodeoksükoolhape 500 mg Õhukese polümeerikattega tablett
Maexeni 150/30 microgram Film Coated Tablets ethinylestradiol / levonorgestrel 
Maexeni 150/30 microgram Film Coated Tablets etinüülöstradiool/levonor gestreel
Irbesartan HEC Pharm 75 mg Filmtabletten irbesartan 
Irbesartan HEC Pharm 75 mg Filmtabletten irbesartaan
Omega 3 Strides Arcolab International omega-3-acid-ethyl esters 90 
Omega 3 Strides Arcolab International oomega-3 rasvhappe etüülestrid 90
Irbesartan HEC Pharm 300 mg Filmtabletten irbesartan 
Irbesartan HEC Pharm 300 mg Filmtabletten irbesartaan
Hydroxyzine hydrochloride 25mg film-coated tablets hydroxyzine hydrochloride 
Hydroxyzine hydrochloride 25mg film-coated tablets hüdroksüsiinhüdrokloriid 25 mg Õhukese polümeerikattega tablett
Irbesartan 300 mg Filmcoated tablets irbesartan 
Irbesartan 300 mg Film-coated tablets irbesartaan
Carbimazole 5mg Tablets carbimazole 
Carbimazole 5mg Tablets karbimasool
Dawa Limited Carbimazole 5mg Tablets carbimazole 
Dawa Limited Carbimazole 5mg Tablets karbimasool
Paracetamol 1000mg Tablets paracetamol 
Paracetamol 1000mg Tablets paratsetamool
Laboratórios Basi - Indústria Farm 
Indústria Farm
Belgium Aurobindo Pharma BV 
Aurobindo Pharma BV
Irbesartan HEC Pharm 150 mg Filmtabletten irbesartan 
Irbesartan HEC Pharm 150 mg Filmtabletten irbesartaan
Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů ethinylestradiol / levonorgestrel 
Levonorgestrel/Ethinylestradiol Famy Care 125 mikrogramů/30 mikrogramů etinüülöstradiool/ levonorgestreel
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 etinüülöstradiool/levonor gestreel
Cristers 
Prantsusmaa Cristers
Paracetamol 1000 mg Film Coated Tablets paracetamol 
Paracetamol 1000 mg Film Coated Tablets paratsetamool
The Netherlands Pharmascope Ltd. 
Prantsusmaa Pharmascope Ltd.
Naproxen 500 mg tablets naproxen 
Naproxen 500 mg tablets naprokseen
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 4 mg / 1.25 mg 
Prantsusmaa ZYDUS France perindopril/Indapamide Zydus France perindopriil/indapamiid 4 mg / 1,25 mg
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 8 mg / 2.5 mg 
Prantsusmaa ZYDUS France perindopril/Indapamide Zydus France perindopriil/indapamiid 8 mg / 2,5 mg
ZYDUS France perindopril/Indapamide Zydus France perindopril/indapamide 2 mg/ 0.625 mg 
Prantsusmaa ZYDUS France perindopril/Indapamide Zydus France perindopriil/indapamiid 2 mg / 0,625 mg
Paracetamol 500 mg Film Coated Tablets paracetamol 
Paracetamol 500 mg Film Coated Tablets paratsetamool
Irbesartan 150 mg Filmcoated tablets irbesartan 
Irbesartan 150 mg Film-coated tablets irbesartaan
Belfada aripiprazole 
Belfada aripiprasool
Ethinylestradiol / Levonorgeshel Famy Care 30 mikrogramm 125 mikrogramm tablette ethinylestradiol / levonorgestrel 
Ethinylestradiol / Levonorgeshel Famy Care 30 mikrogramm 125 mikrogramm tablette etinüülöstradiool/levonor gestreel
Paracetamol 500mg Tablets paracetamol 
Paracetamol 500mg Tablets paratsetamool
300 mg Modified-release tablet 
300 mg Toimeainet modifitseeritult vabastav tablett
Naproxen Aurobindo 250 mg, tabletten 
Naproxen Aurobindo 250 mg, tabletten naprokseen
Oralcon 30 Microgramm/125 Microgramm Tabletten ethinylestradiol / levonorgestrel 
Oralcon 30 Microgramm/125 Microgramm Tabletten etinüülöstradiool/levonor gestreel
Carbimazole 20 mg Tablets carbimazole 
Carbimazole 20 mg Tablets karbimasool
Voriconazole Milpharm 200 mg film-coated tablets voriconazol 
Voriconazole Milpharm 200 mg film-coated tablets vorikonasool
Hydroxyzinhydrochlorid EQL Pharma hydroxyzine 
Hydroxyzinhydrochlorid EQL Pharma hüdroksüsiin
Voriconazole Milpharm 50 mg film-coated tablets voriconazol 
Voriconazole Milpharm 50 mg film-coated tablets vorikonasool
Vzole 50 mg film-coated tablets voriconazol 
Vzole 50 mg film-coated tablets vorikonasool
Voriconazolo Aurobindo voriconazol 
Voriconazolo Aurobindo vorikonasool
Voriconazol Glob voriconazol 
Voriconazol Glob vorikonasool
Naproxen Aurobindo 500 mg, tabletten 
Naproxen Aurobindo 500 mg, tabletten naprokseen
Vzole 200 mg film-coated tablets voriconazol 
Vzole 200 mg film-coated tablets vorikonasool
Naproxeno Aurobindo 
Naproxeno Aurobindo naprokseen
1000 mg Capsule, soft Oral use 
1000 mg Pehmekapsel
Bupropion Sandoz bupropion 
Bupropion Sandoz bupropioon
United Kingdom Strides Arcolab International 
Ühendkuningriik Strides Arcolab
Bupropione Sandoz bupropion 
Bupropione Sandoz bupropioon
Voriconazol Aurobindo 200 mg, filmomhulde tabletten voriconazol 
Voriconazol Aurobindo 200 mg, filmomhulde tabletten vorikonasool
Metformin 1000 mg Filmcoated tablet metformin hydrochloride 
Metformin 1000 mg Filmcoated tablet metformiinhüdrokloriid 1000 mg Õhukese polümeerikattega tablett
Voriconazol PUREN 200 mg Filmtabletten voriconazol 
Voriconazol PUREN 200 mg Filmtabletten vorikonasool
Metformin 850 mg Film-coated tablet metformin hydrochloride 
Metformin 850 mg Film-coated tablet metformiinhüdrokloriid 850 mg Õhukese polümeerikattega tablett
Dawa Limited Carbimazole 20mg Tablets carbimazole 
Dawa Limited Carbimazole 20mg Tablets karbimasool
Carbimazole 20mg Tablets carbimazole 
Carbimazole 20mg Tablets karbimasool
voriconazole Arrow voriconazol 
voriconazole Arrow vorikonasool
Napritum 
naprokseen
Voriconazol PUREN 50 mg Filmtabletten voriconazol 
Voriconazol PUREN 50 mg Filmtabletten vorikonasool
Memantine Dawa 20mg filmcoated tablets memantine 
Memantine Dawa 20mg filmcoated tablets memantiin
Voriconazol Aurobindo 50 mg, filmomhulde tabletten voriconazol 
Voriconazol Aurobindo 50 mg, filmomhulde tabletten vorikonasool
Hydroxyzine ARROW hydroxyzine 
Hydroxyzine ARROW hüdroksüsiin
Naproxen 250 mg tablets naproxen 
Naproxen 250 mg tablets naprokseen
paracetamol 
paratsetamool
Memantine Dawa 10mg filmcoated tablets memantine 
Memantine Dawa 10mg filmcoated tablets memantiin
20 mg Oro-dispersible tablet 
20 mg Suus dispergeeruv tablett
0.5 mg Capsule, soft Oral use 
0,5 mg Pehmekapsel
Naproxen Aurobindo 
Naproxen Aurobindo naprokseen
Aripiprazole 30 mg tablets aripiprazole 
Aripiprazole 30 mg tablets aripiprasool
Metformin 500 mg Film-coated tablet metformin hydrochloride 
Metformin 500 mg Film-coated tablet metformiinhüdrokloriid 500 mg Õhukese polümeerikattega tablett
Voriconazol Aurovitas voriconazol 
Voriconazol Aurovitas vorikonasool
The Netherlands Aurobindo Pharma B.V. 
Madalmaad Aurobindo Pharma B.V.
Betahistin Sandoz 16 mg betahistine 
Betahistin Sandoz 16 mg beetahistiin
Etrixenal 250 mg tabletes naproxen 
Etrixenal 250 mg tabletes naprokseen
Tadalafil Milpharm 2.5 mg film-coated tablets 
Tadalafil Milpharm 2.5 mg filmcoated tablets
Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/80 mg 
Arrow Génériques amlodipine / valsartan Arrow amlodipiin/valsartaan 5 mg / 80 mg
voriconazol 
vorikonasool
ETRIXENAL 250 MG TABLETY naproxen 
ETRIXENAL 250 MG TABLETY naprokseen
Capsule, soft Oral use 
Väljamõeldud nimetus Toimeaine
Beta- histina Bluefish betahistine dihydrochloride 
Beta- histina Bluefish beetahistiindihüdrokloriid 24 mg Tablett
hydrocortisone 
hüdroksüsiin
amlodipine / valsartan 5 mg/80 mg 
amlodipiin/valsartaan 5 mg / 80 mg
Aripiprazole 5 mg tablets aripiprazole 
Aripiprazole 5 mg tablets aripiprasool
Hydroxyzine Sandoz hydroxyzine 
Hydroxyzine Sandoz hüdroksüsiin
Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 10 mg/160 mg 
Arrow Génériques amlodipine / valsartan Arrow amlodipiin/valsartaan 10 mg / 160 mg
Sarpin amlodipine / valsartan 10 mg /160 mg 
Sarpin amlodipiin/valsartaan 10 mg / 160 mg
5 mg Oro-dispersible tablet 
5 mg Suus dispergeeruv tablett
Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /80 mg 
Amlodipina + Valsartan Aurovitas amlodipiin/valsartaan 5 mg / 80 mg
Memantine Pharmascope 20 mg filmomhulde tabletten memantine 
Memantine Pharmascope 20 mg filmomhulde tabletten memantiin
Aripiprazole 10 mg tablets aripiprazole 
Aripiprazole 10 mg tablets aripiprasool
Memantine Pharmascope 10 mg filmomhulde tabletten memantine 
Memantine Pharmascope 10 mg filmomhulde tabletten memantiin
Amlodipine-Valsartan AB amlodipine / valsartan 5 mg/80 mg 
Amlodipine-Valsartan AB amlodipiin/valsartaan 5 mg / 80 mg
15 mg Oro-dispersible tablet 
15 mg Suus dispergeeruv tablett
Memantin Pharmascope 20 mg Filmtabletten memantine 
Memantin Pharmascope 20 mg Filmtabletten memantiin
Betahistin Sandoz 8 mg betahistine 
Betahistin Sandoz 8 mg
Aripiprazole 15 mg tablets aripiprazole 
Aripiprazole 15 mg tablets aripiprasool
Sandoz 
Prantsusmaa Sandoz
Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipine / valsartan 5 mg /80 mg 
Amlodipina/Valsartan Aurobindo 5 mg/80 mg comprimate filmate amlodipiin/valsartaan 5 mg / 80 mg
Arrow Génériques amlodipine / valsartan Arrow amlodipine / valsartan 5 mg/160 mg 
Arrow Génériques amlodipine / valsartan Arrow amlodipiin/valsartaan 5 mg / 160 mg
Memantin Pharmascope 10 mg Filmtabletten memantine 
Memantin Pharmascope 10 mg Filmtabletten memantiin
Hydroxyzine EQL Pharma hydroxyzine 
Hydroxyzine EQL Pharma hüdroksüsiin
Betahistine Sandoz 24 mg betahistine 
Betahistine Sandoz 24 mg beetahistiin
Amlodipina + Valsartan Aurovitas amlodipine / valsartan 10 mg/160 mg 
Amlodipina + Valsartan Aurovitas amlodipiin/valsartaan 10 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 amlodipiin/valsartaan 5 mg / 80 mg
10 mg Oro-dispersible tablet 
10 mg Suus dispergeeruv tablett
Amlodipine-Valsartan AB amlodipine / valsartan 10 mg/160 mg 
Amlodipine-Valsartan AB amlodipiin/valsartaan 10 mg / 160 mg
Betahistin Sandoz 24 mg betahistine 
Betahistin Sandoz 24 mg beetahistiin
Amlodipine-Valsartan AB amlodipine / valsartan 5 mg/160 mg 
Amlodipine-Valsartan AB amlodipiin/valsartaan 5 mg / 160 mg
Amlodipina + Valsartan Aurovitas amlodipine / valsartan 5 mg /160 mg 
Amlodipina + Valsartan Aurovitas amlodipiin/valsartaan 5 mg / 160 mg
Corporation Orion Pharma, Finland 
Pharma, Soome
Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipine / valsartan 10 mg /160 mg 
Amlodipine/ Valsartan Aurobindo 10/160 mg, filmomhulde tabletten amlodipiin/valsartaan 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 amlodipiin/valsartaan 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 amlodipiin/valsartaan 5 mg / 160 mg
Olanzapin HEC Pharm 20 mg Schmelztabletten olanzapin 
Olanzapin HEC Pharm 20 mg Schmelztabletten olansapiin
Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipine / valsartan 5 mg /160 mg 
Amlodipina/Valsartan Aurobindo 5 mg/160 mg comprimate filmate amlodipiin/valsartaan 5 mg / 160 mg
amlodipine / valsartan 5 mg /160 mg 
amlodipiin/valsartaan 5 mg / 160 mg
Olanzapin HEC Pharm 5 mg Schmelztabletten olanzapin 
Olanzapin HEC Pharm 5 mg Schmelztabletten olansapiin
Olanzapin HEC Pharm 10 mg Schmelztabletten olanzapin 
Olanzapin HEC Pharm 10 mg Schmelztabletten olansapiin
Olanzapin HEC Pharm 15 mg Schmelztabletten olanzapin 
Olanzapin HEC Pharm 15 mg Schmelztabletten olansapiin
NRIM Limited) 
Limited)
amlodipine / valsartan 10 mg/160 mg 
amlodipiin/valsartaan 10 mg / 160 mg
omega-3-acid-ethyl esters 90 
oomega-3 rasvhappe etüülestrid 90
Betahistyna Bluefish betahistine dihydrochloride 
Betahistyna Bluefish beetahistiindihüdrokloriid 24 mg Tablett
Betahistin Sandoz 8 mg tablete 
Betahistin Sandoz 8 mg tablete beetahistiin
Metformine Almus metformin hydrochloride 
Metformine Almus metformiinhüdrokloriid 500 mg Tablett
0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled pens (multipack) 
6 (3 x 2) pensüstlit (mitmikpakend)
0.8 ml (40 mg/0.8ml) 6 (3 x2) pre-filled syringes with needle safety device (multipack) 
6 (3 x 2) süstlit nõelakaitsega (mitmikpakend)
21 March 2014 
21. märts 2014
Outcome of a procedure under Article 30 of Directive 2001/83/EC 
Direktiivi 2001/83/EÜ artikli 30 kohase menetluse tulemus
The amended information to doctors and patients is available here. 
Arstidele ja patsientidele ettenähtud muudetud teave on siin.
The European Commission issued a decision on 21 March 2014. 
Euroopa Komisjon tegi otsuse 21. märtsil 2014.
What is Rocephin? 
Mis on Rocephin?
Why was Rocephin reviewed? 
Miks Rocephin läbi vaadati?
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. 
Rocephini turustatakse järgmistes Euroopa Liidu liikmesriikides: Belgia, Iirimaa, Itaalia, Kreeka, Luksemburg, Läti, Madalmaad, Malta, Portugal, Prantsusmaa, Rootsi, Rumeenia, Saksamaa, Soome, Taani, Ungari ja Ühendkuningriik ning lisaks veel Island.
The areas harmonised include: 
Ühtlustada tuleb järgmised osad.
It is also available in the EU under other trade names: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine. 
Seda turustatakse Euroopa Liidus ka teiste kaubanduslike nimede all: Rocefin, Rocephalin, Rocephalin cum lidocain, Rocephine.
Rocephin is authorised in the EU via national procedures. 
Rocephinile on Euroopa Liidus müügiluba antud riiklike menetluste kaudu.
• bacterial meningitis; 
• bakteriaalne meningiit;
On 23 January 2014, the European Medicines Agency completed a review of Rocephin. 
23. jaanuaril 2014 lõpetas Euroopa Ravimiamet (EMA) Rocephini läbivaatamise.
The CHMP concluded that Rocephin should be used to treat the following infections in adults and children, which were already approved in several but not all EU Member States: 
Inimravimite komitee otsustas, et Rocephini tuleb täiskasvanutel ja lastel kasutada järgmiste infektsioonide raviks, mis olid juba mitmes Euroopa Liidu liikmesriigis, kuid mitte kõigis, heaks kiidetud:
Questions and answers on Rocephin and associated names (ceftriaxone, 250 mg, 500 mg, 1 g, 2 g, powder for solution for injection or infusion) 
Rocephini ja sarnaste nimetuste teave (tseftriaksoon, 250 mg, 500 mg, 1 g, 2 g, süste- või infusioonilahuse valmistamise pulber)
In adults and children over 12 years of age, the recommended dose varies between 1 and 4 g of Rocephin once daily depending on the condition it is used to treat. 
Täiskasvanutel ja üle 12-aastastel lastel on soovituslik annus 1 kuni 4 g Rocephini kord ööpäevas olenevalt haigusest, mida sellega ravitakse.
The CHMP also harmonised other sections of the SmPC including section 4.3 (contraindications), 4.4 (special warnings and precautions for use) and 4.6 (pregnancy and lactation). 
Inimravimite komitee ühtlustas ka ravimi omaduste kokkuvõtte lõigud 4.3 (Vastunäidustused), 4.4 (Erihoiatused ja ettevaatusabinõud kasutamisel) ja 4.6 (Fertiilsus, rasedus ja imetamine).
• bacterial endocarditis (an infection in the heart). 
• bakteriaalne endokardiit (südame infektsioon).
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed. 
Seetõttu kasutatakse ravimit liikmesriikides erinevalt ja seda on näha ravimi omaduste kokkuvõtte, märgistuse ja pakendi infolehtede erinevustest riikides, kus ravimit turustatakse.
On 9 December 2011, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Rocephin in the EU. 
9. detsembril 2011 suunas Euroopa Komisjon küsimuse Rocephini müügilubade ühtlustamisest Euroopa Liidus edasi inimravimite komiteele.
The company that markets these medicines is Roche. 
Neid ravimeid turustab Roche.
It may also be used to treat disseminated Lyme borreliosis (a bacterial infection spread to humans by infected ticks) in adults and children including neonates from 15 days of age. 
Seda võib kasutada ka dissemineerunud Lyme'i borrelioosi (bakterinfektsioon, mis levib inimestele nakatunud puukide kaudu) raviks täiskasvanutel ja lastel, sh 15 päeva vanustel vastsündinutel.