natgillin/translations-raw huggingface dataset:
IT - Italy Farmaceutici Caber Spa Viale Città D'Europa, 681
Farmaceutici Caber Spa Viale Città D'Europa, 681 00100 ROMA Italija
Kallithea 176 74
Kallithea 176 74 Attiki
BERLIN CHEMIE AG (MENARINI GROUP) Glienicker Weg 125-127 12489 Berlin Germany
RO - Romunija BERLIN CHEMIE AG (MENARINI GROUP) Glienicker Weg 125-127
S.C.
C.T.
20136 MILANO
20136 MILANO Italija
ES - Spain QUIMIFAR, S.A.Comadran, 37 Barbera del Valles 08210 BARCELONA
ES - Španija QUIMIFAR, S.A.Comadran, 37 Barbera del Valles
FR - France Sandoz 49, av. Pompidou 92300 Levallois-Perret France
FR - Francija Sandoz 49, av. Pompidou 92300 Levallois-Perret Francija
TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven Germany
DE - Nemčija TAD Pharma GmbH Heinz-Lohmann-Str. 5D 27472 Cuxhaven
Bezafibrat 400 ret-1 A Pharma
Bezafibrat 400 ret-1 A Pharma tableta s podaljšanim sproščanjem
D-64295 Darmstadt Germany durafenat MF 200 mg
D-64295 Darmstadt Nemčija durafenat MF 200 mg trda kapsula s prirejenim sproščanjem
AT - Austria G.L.
AT - Avstrija
1 cours du Triangle 92936 Paris la Défense Cedex FRANCE
1 cours du Triangle 92936 Paris La Défense Cedex Francija
Box 313, 3740 AH Baarn, The Netherlands
Actavis BV P.O. Box 313, 3740 AH Baarn, The Nizozemska
2740-298 Porto Salvo Portugal
2740-298 Porto Salvo Portugalska
GEMLIPID-MEDICHROM 600 MG/TAB Film coated tablet
GEMLIPID-MEDICHROM 600 MG/TAB filmsko obložena tableta
2740-299 Porto Salvo Portugal
2740-299 Porto Salvo Portugalska
EL - Greece MED-ONE AFBEE Agiou Petrou 30 and Epameinonda
MED-ONE AFBEE Agiou Petrou 30 and Epameinonda Aharnes 136 75 Grčija
IT - Italy C.T.
IT - Italija
IT - Italy Vecchi & Piam Sapa Via Padre Semeria, 5
Vecchi & Piam Sapa Via Padre Semeria, 5 16131 GENOVA Italija
Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal
Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugalska
FR - France SUBSTIPHARM 8, rue Bellini
SUBSTIPHARM 8, rue Bellini 75116 Paris Francija
Winthrop Farmacêutica Portugal,Lda.
Winthrop Farmacêutica Portugalska,Lda.
Box 313, 3740 AH Baarn The Netherlands
Actavis BV P.O. Box 313, 3740 AH Baarn The Nizozemska
Pfizer Pharma GmbH Linkstr.
DE - Nemčija Pfizer Pharma GmbH Linkstr.
Edifício 5C - 6º 2740-298 Porto Salvo Portugal
Edifício 5C - 6º 2740-298 Porto Salvo Portugalska
33127 Saint Jean d'Illac France
GALENIX DEVELOPPEMENT Les Palanques 33127 Saint Jean d'Illac Francija
68-88, rue Louis Ampère ZI des Chanoux
Laboratoires LEURQUIN MEDIOLANUM 68-88, rue Louis Ampère ZI des Chanoux 93330 Neuilly-sur-Marne Francija
LV - Latvia SIA PharmaSwiss Latvia Gertrudes iela 54-5
SIA PharmaSwiss Latvija Gertrudes iela 54-5 Riga, LV-1011
400 MG/TAB PROLONGED RELEASE TABLETS
400 MG/TAB tableta s podaljšanim sproščanjem
EL - Greece SPECIFAR ABEE 28th October str 1
SPECIFAR ABEE 28th October str 1 Agia Barbara 123 51 Grčija
Hennig Arzneimittel GmbH & Co.KG
DE - Nemčija Hennig Arzneimittel GmbH & Co.KG
FR - France LABORATOIRE RATIOPHARM 19, boulevard Paul Vaillant Couturier
Laboratoire RATIOPHARM 19, boulevard Paul Vaillant Couturier
Empreendimento Lagoas Park Edifício 5C - 6º 2740-298 Porto Salvo Portugal
Empreendimento Lagoas Park Edifício 5C - 6º 2740-298 Porto Salvo Portugalska
Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugal
Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugalska
Bezafibrat "ratiopharm" retard 400 mgFilmtabletten prolonged-release tablet
Bezafibrat "ratiopharm" retard 400 mgFilmtabletten tableta s podaljšanim sproščanjem
145 MG/TAB Film-coated tablet
145 MG/TAB filmsko obložena tableta
Sandoz A/S C.F.Tietgens Boulevard 40
SE - Švedska Sandoz A/S C.F.Tietgens
Sandoz A/S C.F. Tietgens Boulevard 40
SE - Švedska Sandoz A/S C.F. Tietgens
00-308 Warsaw Poland
8 Kruczkowskiego st. 00-308 Warsaw Poljska
CY - Cyprus REMEDICA LTD Aharnon street P.O.Box 51706
REMEDICA LTD Aharnon street P.O.Box 51706 3508 Lemesos Ciper
PL - Poland Sanofi-Aventis France boulevard Romain Rolland 1-13, F-75014 Paris,
PL - Poljska Sanofi-Aventis Francija boulevard Romain Rolland 1-13, F-75014 Paris,
IT - Italy Pfizer Italia Srl Via Isonzo, 71
Pfizer Italia Srl Via Isonzo, 71 04100 - LATINA Italija
S.A. Rue De La Pastorale 26-28 1080 Bruxelles Belgium
S.A. Rue De La Pastorale 26-28 1080 Bruxelles Belgija
Berlin-Chemie AG Glienicker Weg 125 D-12489 Berlin Germany
DE - Nemčija Berlin-Chemie AG Glienicker Weg 125
Empreendimento Lagoas Park, Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugal
Empreendimento Lagoas Park, Edifício 7 - 2º/3º 2740-264 Porto Salvo Portugalska
IT - Italy Teva Italia Srl Via Messina, 38
Teva Italia Srl Via Messina, 38 20154 MILANO Italija
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3
DE - Nemčija ratiopharm GmbH Graf-Arco-Str. 3
FR - France LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf
LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette Francija
Laboratoires Fournier SA 8 Bd Clemenceau F-21000 Dijon France
Laboratoires Fournier SA 8 Bd Clemenceau F-21000 Dijon Francija
FR - France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE
49, avenue Georges Pompidou 92300 Levallois-Perret Francija
Bezalip Retard
Liparison Retard
S.C. TERAPIA S.A. Str. Fabricii Nr. 124, Cluj-Napoca România
Str. Fabricii Nr. 124, Cluj-Napoca România
Alternova A/S Lodhusvej 11 4230 Skælskør Denmark
DK - Danska Alternova A/S Lodhusvej 11
FR - France Biogaran15 bd Charles de Gaulle 92700 Colombes France
FR - Francija Biogaran15 bd Charles de Gaulle 92700 Colombes Francija
S.C. TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca România
Str. Fabricii Nr. 124 Cluj-Napoca România
PannonPharma Kft. Pannonpharma út 1.
PannonPharma Kft. Pannonpharma út 1. 7720 Pécsvárad Madžarska
EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
ANFARM HELLAS S.A. Perikleous 53-57 Gerakas Attikis 153 44 Grčija
26-28, rue de la Pastorale B- 1080 Bruxelles Belgium
26-28, rue de la Pastorale B- 1080 Bruxelles Belgija
EL - Greece PFIZER HELLAS S.A. Messogion Avenue 243
PFIZER HELLAS S.A. Messogion Avenue 243 Neo Psychiko 154 51 Grčija
PL - Poland ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
PL - Poljska ratiopharm GmbH Graf-Arco-Strasse 3, Ulm, D-89079
Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebuejo zdravilno učinkovino ciprofibrat in imajo dovoljenje za promet v EU
Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour Iceland
Reykjavíkurvegi, 76-78 IS-220 Hafnarfjörour Islandija
FR - France Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Iceland
FR - Francija Actavis Group PTC ehfReykjavikurvegi 76-78220 HafnarfjördurIslande Islandija
Fenolip retard 250 mgKapseln prolonged release capsule, hard
Fenolip retard 250 mgKapseln trda kapsula s podaljšanim sproščanjem
FR - France Biogaran 15, bd Charles de Gaulle 92700 Colombes France
FR - Francija Biogaran 15, bd Charles de Gaulle 92700 Colombes Francija
FENOX 160 mg modified-release filmcoated tablets
FENOX 160 mg filmsko obložena tableta s prirejenim sproščanjem
FENOFIBRATE EG 145 mg, comprimé tablet
FENOFIBRATE EG 145 mg, comprimé tableta
S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Belgium
S.A. 26-28 rue de la Pastorale B-1080 Bruxelles Belgija
26-28 rue de la Pastorale B-1080, Brussels
26-28 rue de la Pastorale B-1080, Brussels Belgija
Reykjavikurvegur 76-78, 220, Hafnarfjordur
Reykjavikurvegur 76-78, 220, Hafnarfjordur Islandija
Apteor modified released tablet
Apteor tableta s prirejenim sproščanjem peroralno
Katalip 250 mg trde kapsule capsule, hard
Katalip 250 mg Trda kapsula
S.C. TERAPIA S.A. Str. Fabricii Nr. 124 Cluj-Napoca Romania
Str. Fabricii Nr. 124 Cluj-Napoca Romunija
FR - France Actavis Group PTC ehf Reykjavikurvegi 76-78
FR - Francija Actavis Group PTC ehf Reykjavikurvegi 76-78
900 MG/TAB Film coated tablet
900 MG/TAB filmsko obložena tableta
Fenofanton 250 mg Hartkapseln, retardiert
Fenofanton 250 mg Hartkapseln, retardiert trda kapsula s podaljšanim sproščanjem
AT - Austria Actavis Group PTC ehf Reykjavikurvegur 76-78
AT - Avstrija Actavis Group PTC ehf Reykjavikurvegur 76-78
SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1C
BE - Belgija SANOFI-AVENTIS BELGIJA N.V.
Fenobrat prolonged-release capsule
Fenoratio Retard kapsula s podaljšanim sproščanjem
Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebuejo zdravilno učinkovino gemfibrozil in imajo dovoljenje za promet v EU
Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Iceland
Actavis Group PLC Reykjavikurvegur 76-78 IS- 220 Hafnarfjordur Islandija
LOPID TABLETS 600 MG 600mg
LOPID TABLETS 600 MG 600mg obložena tableta
Bezafibrat Sandoz 400mg Retardtabletten
Bezafibrat Sandoz 400mg Retardtabletten tableta s podaljšanim sproščanjem
EL - Greece COSMOPHARM EPE P.O.
COSMOPHARM EPE P.O. Box 42
100 MG/CAP HARD CAPSULES ORAL
100 MG/CAP trda kapsula
LIPANTHYL SUPRA 160 mg 160 mg modified-release filmcoated tablets
LIPANTHYL SUPRA 160 mg 160 mg filmsko obložena tableta s prirejenim sproščanjem
600 MG/TAB Film coated tablet
600 MG/TAB filmsko obložena tableta
Prolonged-released tablet
tableta s podaljšanim sproščanjem
D-64295 Darmstadt Germany durafenat retard
D-64295 Darmstadt Nemčija durafenat retard trda kapsula s podaljšanim sproščanjem
Bezafibrat HEXAL 400mg retard Retardtabletten
Bezafibrat HEXAL 400mg retard Retardtabletten tableta s podaljšanim sproščanjem
Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Iceland
Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Islandija
IT - Italy Doc Generici Srl Via Manuzio, 7
Doc Generici Srl Via Manuzio, 7 20124 MILANO Italija
FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
FR - Francija Sanofi Aventis Francija 1-13 Bd Romain Rolland 75014 Paris
160 MG/CAP HARD CAPSULES ORAL
160 MG/CAP trda kapsula
Fenofibrat STADA 250 mg Hartkapseln, retardiert
Fenofibrat STADA 250 mg Hartkapseln, retardiert trda kapsula s podaljšanim sproščanjem
FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
FR - Francija Mylan SAS 117, allée des Parcs 69800 Saint Priest Francija
Actavis Group PTC ehf, Reykjavíkurvegi 76-78 220 Hafnarfjördur Iceland
Actavis Group PTC ehf, Reykjavíkurvegi 76-78 220 Hafnarfjördur Islandija
Fenofibrat-ratiopharm 250 mg Retardkapseln
Fenofibrat-ratiopharm 250 mg Retardkapseln trda kapsula s podaljšanim sproščanjem
Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Iceland
Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Islandija
CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
200 MG/CAP HARD CAPSULES ORAL
200 MG/CAP trda kapsula
FR - France Qualimed 117, allée des Parcs 69800 Saint Priest France
FR - Francija Qualimed 117, allée des Parcs 69800 Saint Priest Francija
Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Zdravila, ki vsebujejo zdravilno učinkovino fenofibrat in imajo dovoljenje za promet v EU
200 mg coated tablet
200 mg filmsko obložena tableta
Lipsin retard 250 mgKapseln prolonged release capsule, hard
Lipsin retard 250 mgKapseln trda kapsula s podaljšanim sproščanjem
CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
400 mg Prolonged release coated tablet
400 mg, comprimé enrobé à libération prolongée tableta s podaljšanim sproščanjem
SKSlovakia
PTPortugalskaska
Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
DE - Nemčija Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA Greschbachstr.
DE - Nemčija DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA
Fenofibrat-CT 250mg Retardkapseln
Fenofibrat-CT 250mg Retardkapseln trda kapsula s podaljšanim sproščanjem
FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
15, boulevard Charles de Gaulle 92700 Colombes Francija
DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm
DE - Nemčija ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Nemčija
11-15 Quai Dion Bouton 92800 Puteaux
92800 Puteaux
Bezafibrat-ratiopharm 400 mg Retardtabletten
Bezafibrat-ratiopharm 400 mg Retardtabletten tableta s podaljšanim sproščanjem
FENOFIBRATE MYLAN 160 mg, comprimé pelliculé
FENOFIBRATE MYLAN 160 mg, comprimé pelliculé 160 mg
IT - Italy Solvay Pharma Spa Via della Libertà 30
Solvay Pharma Spa Via della Libertà 30 100 95 Grugliasco Italija
ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78 220 Hafnarfjordur Iceland
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Islandija
RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
RO - Romunija sanofi-aventis Francija 1-13, boulevard Romain Rolland 75014 Paris
Lopid filmcoated tablet
Lopid obložena tableta
Lipox Bezafibrat 400 mg Retardtabletten
Lipox Bezafibrat 400 mg Retardtabletten tableta s podaljšanim sproščanjem
Innogem hard capsule
trda kapsula s prirejenim sproščanjem
Prolonged-release capsules
Fenobrat trda kapsula s podaljšanim sproščanjem
Prolonged-release tablet
Bezalip Retard tableta s podaljšanim sproščanjem
FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Francija
FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
QUALIMED 117, allée des Parcs 69800 Saint-Priest Francija
FR - France RANBAXY PHARMACIE GENERIQUES
FR - Francija Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton
Lipox Bezafibrat 400mg Retardtabletten
Lipox Bezafibrat 400mg Retardtabletten tableta s podaljšanim sproščanjem
400 mg tablet
400 mg filmsko obložena tableta
Prolonged release coated tablet
Bezalip obložena tableta s podaljšanim sproščanjem
FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE
SANOFI AVENTIS Francija 1-13, boulevard Romain Rolland 75014 Paris Francija
FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
SANOFI AVENTIS Francija 1-13, boulevard Romain Rolland 75014 Paris
filmcoated tablets
Fibrocit tableta
The European Commission issued a decision on 11 September 2012.
Evropska komisija je odločbo izdala dne 11. septembra 2012.
The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Družba je želela, da dovoljenje za promet z zdravilom priznajo tudi v Franciji in Združenem kraljestvu („zadevni državi članici“).
In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
Poleg tega razpoložljivi podatki o varnosti in učinkovitosti zdravila niso zadostovali, da bi nadomestili neobstoj biološke enakovrednosti.
However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.
Vendar pa države članice niso uspele doseči soglasja, zato je francoska regulatorna agencija za zdravila 23. februarja 2012 zadevo napotila na CHMP v arbitražo.
Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Zdravilo Mifepristone Linepharma je bilo po decentraliziranem postopku že odobreno na Danskem, Finskem, v Islandiji, na Norveškem in Švedskem.
On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mifepristone Linepharma.
Evropska agencija za zdravila je 21. junija 2012 končala arbitražni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Mifepristone Linepharma.
It contains the active substance mifepristone, which works by blocking the effects of the hormone progesterone, which plays an important role in the maintenance of pregnancy.
Vsebuje zdravilno učinkovino mifepriston, ki deluje tako, da zavira učinke hormona progesterona, ki ima pomembno vlogo pri vzdrževanju nosečnosti.
In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Poleg tega je priporočil, da se izvede prospektivna opazovalna študija za spremljanje predpisovanja zdravila Mifepristone Linepharma.
This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
To pomeni, da je podobno referenčnemu zdravilu Mifegyne, ki vsebuje isto zdravilno učinkovino.
However, the difference was not considered to be of concern as the safety and effectiveness of mifepristone at much higher doses of up to 600 mg is well established and has been confirmed by the supportive studies with Mifepristone Linepharma.
Vendar pa ta razlika ni bila ocenjena kot zaskrbljujoča, saj sta varnost in učinkovitost mifepristona dokazani v veliko večjih odmerkih, vse do 600 mg, in potrjeni s podpornimi študijami z zdravilom Mifepristone Linepharma.
The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Zaključil je tudi, da morajo informacije o zdravilu vsebovati opozorilo, da se odmerki, večji od 200 mg, ne smejo predpisovati.
Why was Mifepristone Linepharma reviewed?
Zakaj je bilo zdravilo Mifepristone Linepharma pregledano?
Mifepristone Linepharma is a medicine used for terminating pregnancy.
Zdravilo Mifepristone Linepharma je zdravilo, ki se uporablja za prekinitev nosečnosti.
Mifepristone Linepharma is given as a single dose of 200 mg, followed 36 - 48 hours later by a dose of another medicine called gemeprost.
Zdravilo Mifepristone Linepharma se daje v enkratnem odmerku 200 mg, ki mu čez 36 do 48 ur sledi odmerek drugega zdravila, imenovanega gemeprost.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mifepristone Linepharma outweigh its risks, and recommended that the marketing authorisation granted in Sweden be recognised in other Member States of the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Mifepristone Linepharma odtehtajo njegova tveganja, in priporočil, da se dovoljenje za promet z zdravilom, ki je bilo odobreno na Švedskem, prizna tudi v drugih državah članicah EU.
Therefore, based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Mifepristone Linepharma outweigh its risks and recommended that the marketing authorisation for Mifepristone Linepharma be granted in all concerned Member States.
Tako je na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru ta zaključil, da koristi zdravila Mifepristone Linepharma odtehtajo z njim povezana tveganja, in priporočil, da se dovoljenje za promet z zdravilom Mifepristone Linepharma odobri v vseh zadevnih državah članicah.
Both medicines are available as 200 mg tablets but whereas Mifegyne was authorised to be given at doses of 600 mg and 200 mg, Mifepristone Linepharma was only authorised at the 200 mg dose.
Obe zdravili sta na voljo v obliki 200miligramskih tablet, vendar je bilo zdravilo Mifegyne odobreno v odmerkih 600 mg in 200 mg, zdravilo Mifepristone Linepharma pa le v odmerku 200 mg.
The CHMP noted that the data submitted by the company showed a small deviation of Mifepristone Linepharma from the acceptable range for bioequivalence with the reference medicine, with Mifepristone Linepharma 200 mg producing slightly higher levels of active substance in the body than Mifegyne 200 mg.
CHMP je ugotovil, da podatki, ki jih je predložila družba, kažejo na majhno odstopanje zdravila Mifepristone Linepharma od sprejemljivega razpona za biološko enakovrednost z referenčnim zdravilom, pri čemer privede zdravilo Mifepristone Linepharma 200 mg do rahlo višje ravni zdravilne učinkovine v telesu kot zdravilo Mifegyne 200 mg.
Mifepristone Linepharma is a ‘hybrid medicine'.
Zdravilo Mifepristone Linepharma je „hibridno zdravilo“.
Linepharma France submitted an application for Mifepristone Linepharma for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 December 2010.
Družba Linepharma France je predložila vlogo za medsebojno priznavanje zdravila Mifepristone Linepharma na podlagi prvotnega dovoljenja za promet z zdravilom, odobrenega na Švedskem dne stran 2/2
What is Mifepristone Linepharma?
Kaj je zdravilo Mifepristone Linepharma?
The grounds for the referral were that Mifepristone Linepharma had not been shown to be bioequivalent to the reference medicine, Mifegyne 200 mg.
Razlog za napotitev je bilo dejstvo, da za zdravilo Mifepristone Linepharma ni bila dokazana biološka enakovrednost zdravilu Mifegyne 200 mg.
28 February 2014
28. februar 2014
The final opinion was converted into a Decision by the European Commission on 28 February 2014.
Končno mnenje je bilo spremenjeno v sklep Evropske komisije dne 28. februarja 2014.
The referral started on 7 November 2012.
Napotitveni postopek se je začel dne 7. novembra 2012.
The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.
Odbor je za poročevalko imenoval H. Jukes, za soporočevalko pa E-M. Vestergaard.
Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Predlagatelji in imetniki dovoljenja za promet z zdravilom so 15. februarja 2013 in 9. septembra 2013 predložili pisna pojasnila.
The condition on the marketing authorisations is in Annex IV.
Pogoji dovoljenj za promet z zdravili so v Prilogi IV.
International non-proprietary name (INN): enrofloxacin
Mednarodno nelastniško ime (INN): enrofloksacin
It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Deluje antibakterijsko na širok spekter gramnegativnih in grampozitivnih bakterij.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v Prilogi III.
Veterinary Medicines
Zdravila za uporabo v veterinarski medicini
Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Enrofloksacin je sintetično kemoterapevtsko sredstvo iz skupine derivatov fluorokinolon karboksilne kisline.
Enrofloxacin is for veterinary use only.
Enrofloksacin je namenjen le za uporabo v veterinarski medicini.
The CVMP was requested to consider the indications, dosage regimens and withdrawal periods for chickens and turkeys in order to ensure consumer safety, efficacious treatment in chickens and turkeys, as well as lower the risk of development of antimicrobial resistance to enrofloxacin.
Odbor CVMP so prosili, naj preveri indikacije, režime odmerjanja in karence za piščance in purane, da bi zagotovili varnost potrošnikov, učinkovito zdravljenje piščancev in puranov ter zmanjšali tveganje razvoja odpornosti mikroorganizmov proti enrofloksacinu.
Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information and conditions of the marketing authorisations.
Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP menil, da je splošno razmerje med tveganji in koristmi za ta zdravila še vedno pozitivno, če se upoštevajo spremembe informacij o zdravilu in pogojev dovoljenj za promet z zdravili.