FrancophonIA/ELRC3.0 huggingface dataset:
English: VELMARI 3 MG/0,02 MG 0,02 mg 3 mg
Swedish: VELMARI 3 MG/0,02 MG
English: Ethinylestradiol/Chlormadi non Hexal 0,03 mg/2 mgFilmtabletten
Swedish: Ethinylestradiol/Chlor madinon Hexal 0,03 mg/2 mgFilmtabletten
English: Sanofi Aventis PLC Tó street 1-5.
Swedish: SANOFI AVENTIS FRANCE 1-13 boulevard Romain Rolland
English: Belgium JANSSEN-CILAG N.V. Antwerpseweg 15-17
Swedish: Antwerpseweg 15-17
English: Ethinylestradiol/desogestr el Richter 0,03 mg/0,15 mg filmomhulde tabletten
Swedish: Ethinylestradiol/deso gestrel Richter 0,03 mg/0,15 mg filmomhulde tabletten
English: Slovak Republic mibe GmbH Arzneimittel
Swedish: Slovakien mibe GmbH Arzneimittel Münchener Str. 15
English: 28027 Madrid Spain
Swedish: 28023 Aravaca (Madrid) Spanien
English: NELYA 0,015 MG/0,06 MG 0,06 mg 0,015 mg
Swedish: NELYA 0,015 MG/0,06 MG
English: Ethinylestradiol/Gestodeen Sandoz 0,030/0,075 mg, omhulde tabletten
Swedish: Ethinylestradiol/Gesto deen Sandoz 0,030/0,075 mg, omhulde tabletten
English: Ethinylestradiol/Gestodeen Sandoz 0,020/0,075 mg, omhulde tabletten
Swedish: Ethinylestradiol/Gesto deen Sandoz 0,020/0,075 mg, omhulde tabletten
English: Aneea 3 mg/0,02 mg filmcoated tablets
Swedish: Aneea 3 mg/0,02 mg film-coated tablets
English: AMAROSA CONTINUOUS 3 mg 0,02 mg
Swedish: PYRLA CONTINUOUS 3 mg 0,02 mg
English: FOXINETTE 2 MG/0,03 MG 0,03 mg 2 mg
Swedish: FOXINETTE 2 MG/0,03 MG
English: Sibilla 2 mg/0,03 mg filmcoated tablets
Swedish: Sibilla 2 mg/0,03 mg film-coated tablets
English: SEEGEE 2 mg/0,03 mg 2 mg 0,03 mg
Swedish: SEEGEE 2 mg/0,03 mg
English: Carl-Zeiss-Ring 9 85737 Ismaning Germany
Swedish: 85737 Ismaning
English: 23-25 avenue du Docteur Lannelongue 75668 PARIS Cedex
Swedish: 75668 PARIS Cedex 14 Frankrike
English: Palandra 0,03mg/3mg 3 mg 0,03 mg
Swedish: Palandra 0,03mg/3mg
English: Ethinylestradiol/desogestr el Richter 0,02 mg/0,15 mg filmomhulde tabletten
Swedish: Ethinylestradiol/deso gestrel Richter 0,02 mg/0,15 mg filmomhulde tabletten
English: Desogestrel/Ethinylestradi ol CF 0,15/0,03 mg, tabletten
Swedish: Desogestrel/Ethinyles tradiol CF 0,15/0,03 mg, tabletten
English: RHONYA 3 MG/30 MCG 3 mg 0,03 mg
Swedish: RHONYA 3 MG/30 MCG
English: 28008 Madrid Spain
Swedish: 28108 Alcobendas (Madrid) Spanien
English: 540306 Târgu Mureş România
Swedish: Gedeon Richter România S.A. Str. Cuza-Vodă, nr. 99-105 540306 Târgu Mureş România
English: Angiletta 2 mg / 0,03 mg 2 mg 0,03 mg
Swedish: Angiletta 2 mg / 0,03 mg
English: Desogestrel/Ethinylestradi ol CF 0,15/0,02 mg, tabletten
Swedish: Desogestrel/Ethinyles tradiol CF 0,15/0,02 mg, tabletten
English: 1020 Wien Austria
Swedish: 1070 Wien
English: SUAVURET comprimidos 0,15 mg 0,02 mg
Swedish: Mercilon, tabletten 0,15 mg 0,02 mg
English: VEYANNE 0,02 MG/3 MG 0,02 mg 3 mg
Swedish: VEYANNE 0,02 MG/3 MG
English: Czech Republic mibe GmbH Arzneimittel
Swedish: Tjeckien mibe GmbH Arzneimittel Münchener Str. 15
English: Kylnetta ED film-coated tablets 0.03mg/3mg
Swedish: Kylnetta ED filmcoated tablets 0.03mg/3mg
English: Naiwanel 0,03mg/3mg 3 mg 0,03 mg
Swedish: Naiwanel 0,03mg/3mg
English: MAITALON 20 0,02 mg/3 mg Filmtabletten
Swedish: Sidretella 20 0,02 mg/3 mg Filmtabletten
English: Laboratorios Leon Farma SA
Swedish: LEON FARMA
English: Belgium Gedeon Richter Plc.
Swedish: Storbritannien Gedeon Richter Plc.
English: Drospibel 0,03mg/3mg 3 mg 0,03 mg
Swedish: Drospibel 0,03mg/3mg
English: Pfizer Hungary LTD.
Swedish: Pfizer Hellas S.A.
English: AMMILY 2 MG / 0,03 MG 2 mg 0,03 mg
Swedish: AMMILY 2 MG / 0,03 MG
English: Eslarilla ED Film-coated tablets 0.02mg/3mg
Swedish: Eslarilla ED Filmcoated tablets 0.02mg/3mg
English: MADINELLE 0,03 MG/2 MG 2 mg 0,03 mg
Swedish: MADINELLE 0,03 MG/2 MG
English: Ethinylestradiol/Gestodeen Mylan 0,02/0,075 mg, omhulde tabletten
Swedish: Ethinylestradiol/Gesto deen Mylan 0,02/0,075 mg, omhulde tabletten
English: TEVA SANTE 110 Esplanade du Général de Gaulle 92931 PARIS LA DEFENSE CEDEX FRANCE
Swedish: 92931 Paris la Defense Cedex
English: Lovette ED film-coated tablets 0.02mg/3mg
Swedish: Lovette ED filmcoated tablets 0.02mg/3mg
English: Lucette ED film-coated tablets 0.03mg/3mg
Swedish: Lucette ED filmcoated tablets 0.03mg/3mg
English: Daylette 0,02 mg/3 mg 0,02 mg 3 mg
Swedish: Daylette 0,02 mg/3 mg
English: 0,02 m 0,075 mg
Swedish: GESTODENOL 20 0.02 mg 0.075 mg
English: Ethinylestradiol/Gestodeen Mylan 0,03/0,075 mg, omhulde tabletten
Swedish: Ethinylestradiol/Gesto deen Mylan 0,03/0,075 mg, omhulde tabletten
English: Ethinylestradiol/Desogestr el 0,02/0,15 mg Teva, tabletten
Swedish: Ethinylestradiol/Deso gestrel 0,02/0,15 mg Teva, tabletten
English: RHONYA 3 MG/20 MCG 0,02 mg 3 mg
Swedish: RHONYA 3 MG/20 MCG
English: Ethinylestradiol/Desogestr el 0,03/0,15 mg Teva, tabletten
Swedish: Ethinylestradiol/Deso gestrel 0,03/0,15 mg Teva, tabletten
English: Bayer Pharma AG Müllerstraße 178 D-13353 Berlin Germany
Swedish: Bayer Pharma AG Muellerstrasse 170-178 D-13353 Berlin Tyskland
English: Ethinylestradiol/Drospiren one Gedeon Richter
Swedish: Ethinylestradiol/Dros pirenone Gedeon Richter
English: Desogestrel/Ethinylestradi ol STADA 0,15/0,03 mg, tabletten
Swedish: Desogestrel/Ethinyles tradiol STADA 0,15/0,03 mg, tabletten
English: Naiwanel 0,02mg/3mg 0,02 mg 3 mg
Swedish: Naiwanel 0,02mg/3mg
English: Bayer Portugal, S.A. Rua Quinta do Pinheiro
Swedish: Bayer Portugal, S.A. Rua Quinta do Pinheiro 5 2794-003 Carnaxide Portugal
English: Famina-ratiopharm 20 0,02 mg 0,15 mg
Swedish: Desofemine 20 Nova 0,02 mg 0,15 mg
English: Jamyle 15 Mikrogramm/60 Mikrogramm Filmtabletten
Swedish: Mikrogramm/60 Mikrogramm Filmtabletten
English: Desogestrel/Ethinylestradi ol STADA 0,15/0,02 mg, tabletten
Swedish: Desogestrel/Ethinyles tradiol STADA 0,15/0,02 mg, tabletten
English: Mirelle 15 Mikrogramm/60 MikrogrammFilmtabletten
Swedish: Mikrogramm/60 MikrogrammFilmtabletten
English: 0,05 mg / 0,05 mg 1 mg / 2 mg
Swedish: 0,05 mg / 0,1 mg / 0,15 mg
English: Ady Endre u. 22.
Swedish: Veres Pálné u. 4-6.
English: Freisetzungssystem
Swedish: HarmonetteDragees
English: Ethinylestradiol/Desogestr el Mylan 0,02/0,15 mg, tabletten
Swedish: Ethinylestradiol/Deso gestrel Mylan 0,02/0,15 mg, tabletten
English: Egretta 2 mg/0,03 mg 2 mg 0,03 mg
Swedish: Egretta 2 mg/0,03 mg
English: YAZ 0,02 mg/3 mg filmcoated tablets
Swedish: YAZ 0,02 mg/3 mg film-coated tablets
English: Drospibel 0,02mg/3mg 0,02 mg 3 mg
Swedish: Drospibel 0,02mg/3mg
English: Ethinylestradiol/Drospiren on Sandoz 0,03 mg/3 mg 21+7 Filmtabletten
Swedish: Ethinylestradiol/Dros pirenon Sandoz 0,03 mg/3 mg 21+7
English: Germany mibe GmbH Arzneimittel Münchener Str. 15 06796 Brehna Germany
Swedish: Tyskland mibe GmbH Arzneimittel Münchener Str. 15
English: PYRLA CONTINUOUS
Swedish: ESLARILA CONTINUOUS
English: Balanca 0,03 mg/2 mgFilmtabletten
Swedish: Balanca 0,03 mg/2 mg - Filmtabletten
English: DROSIANELLE 0,03 mg/3 mg comprimidos recubiertos con película EFG
Swedish: DROSIANELLE 0,03 mg/3 mg comprimido recubiertos con película EFG
English: Janssen-Cilag International N.V. Turnhoutseweg 30 B 2340 Beerse Belgium
Swedish: Antwerpseweg 15-17 2340 Beerse Belgien
English: Ethinylestradiol/Desogestr el Mylan 0,03/0,15 mg, tabletten
Swedish: Ethinylestradiol/Deso gestrel Mylan 0,03/0,15 mg, tabletten
English: Waterford Road Clonmel
Swedish: Hertford Road,
English: KYLNETTA CONTINUOUS 3 mg 0,03 mg
Swedish: KATUL CONTINUOUS 3mg 0,03mg
English: DESOGESTREL/ETINILEST RADIOL MYLAN 0,15 mg/0,02 mg comprimidos EFG
Swedish: DESOGESTREL/ETINI LESTRADIOL MYLAN 0,15 mg/0,02 mg comprimidos EFG
English: Ethinylestradiol/Drospiren on Sandoz 0,02 mg/3 mg 21+7 Filmtabletten
Swedish: Ethinylestradiol/Dros pirenon Sandoz 0,02 mg/3 mg 21+7
English: DESOGESTREL/ETINILEST RADIOL MYLAN 0,15 mg/0,03 mg comprimidos EFG
Swedish: DESOGESTREL/ETINI LESTRADIOL MYLAN 0,15 mg/0,03 mg comprimidos EFG
English: 2 mg/2 mg 3 mg /2 mg 1 g
Swedish: 2 mg/2 mg 3 mg/2 mg 1 mg
English: ETINILESTRADIOL/CLORM ADINONA STADA 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Swedish: ETINILESTRADIOL/CL ORMADINONA STADA 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
English: Velvian Germany GmbH
Swedish: Velvian Tyskland GmbH Carl-Zeiss-Ring 9
English: 69007 LYON FRANCE
Swedish: 75009 Paris
English: Generis Farmacêutica, S.A.
Swedish: SANDOZ FARMACÉUTICA, S.A.
English: Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA, United Kingdom
Swedish: Berkshire RG14 1JA Storbritannien
English: Drospirenone/Ethinylestra diol Richter
Swedish: DROSPIRENONE/ETHI NYLESTRADIOL RICHTER
English: ESTINILESTRADIOL/DROS PERINONA ZENTIVA 0,02 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ESTINILESTRADIOL/ DROSPERINONA ZENTIVA 0,02 mg/3 mg comprimidos recubiertos con película EFG
English: Palandra film coated tablets
Swedish: Qlaira film-coated tablets
English: NuvaRing 0,120 mg/0,015 mg pro 24 StundenVaginalring
Swedish: NuvaRing 0,120 mg/0,015 mg pro 24 Stunden - Vaginalring
English: Danseo 0,03 mg/3 mg 21 + 7 Filmtabletten
Swedish: Danseo 0,03 mg/3 mg 21 + 7
English: Belara 0,03 mg/2 mgFilmtabletten
Swedish: Belara 0,03 mg/2 mg - Filmtabletten
English: JANGEE 0,03 MG/3 MG 3 mg 0,03 mg
Swedish: JANGEE 0,03 MG/3 MG
English: MAITALON 30 0,03 mg/3 mg Filmtabletten
Swedish: Sidretella 30 0,03 mg/3 mg Filmtabletten
English: DESOGESTREL/ETINILEST RADIOL FAMYCARE 0,15 mg/0,03 mg comprimidos EFG
Swedish: DESOGESTREL/ETINI LESTRADIOL FAMYCARE 0,15 mg/0,03 mg comprimidos EFG
English: Yirala 0,03 mg/3 mgFilmtabletten
Swedish: Yirala 0,03 mg/3 mg - Filmtabletten
English: 0.020 mg/3 mg Film-coated tablet Oral use
Swedish: 0,03 mg/3 mg Filmdragerad tablett Oral användning
English: DESOGESTREL/ETINILEST RADIOL FAMYCARE 0,15 mg/0,02 mg comprimidos EFG
Swedish: DESOGESTREL/ETINI LESTRADIOL FAMYCARE 0,15 mg/0,02 mg comprimidos EFG
English: Angemin
Swedish: NAVEEN
English: Danselle 0,02 mg/3 mg 21 + 7 Filmtabletten
Swedish: Danselle 0,02 mg/3 mg 21 + 7
English: Ethinylestradiol Dienogest ladonna sanol 2 mg /0,03 mg Filmtabletten
Swedish: Dienogest Ethinylestradiol ladonna sanol 2 mg /0,03 mg
English: Circlet 0,120 mg/0,015 mg pro 24 Stunden vaginales
Swedish: Circlet 0,120 mg/0,015 mg pro 24 Stunden vaginales Freisetzungssystem
English: KATUL CONTINUOUS
Swedish: KYLNETTA CONTINUOUS
English: 0,070mg/0,040mg; 0,100mg/0,030 mg
Swedish: 0.070 mg/0.040 g 0.100 mg/0.030 mg
English: JANGEE 0,02 MG/3 MG 0,02 mg 3 mg
Swedish: JANGEE 0,02 MG/3 MG
English: ETINILESTRADIOL / CLORMADINONA QUASSET 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Swedish: ETINILESTRADIOL/CL ORMADINONA MADAUS 0,03 mg/2 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
English: Circlet 0,120 mg / 0,015 mg pro 24 StundenVaginalring
Swedish: Circlet 0,120 mg / 0,015 mg pro 24
English: ESTINILESTRADIOL/DROS PIRENONA ZENTIVA 0,03 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ESTINILESTRADIOL/ DROSPIRENONA ZENTIVA 0,03 mg/3 mg comprimidos recubiertos con película EFG
English: ESTINILESTRADIOL/DROS PIRENONA STADA 0,03 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ESTINILESTRADIOL/ DROSPIRENONA STADA 0,03 mg/3 mg comprimidos recubiertos con película EFG
English: ESTINILESTRADIOL/DROS PIRENONA DIARIO STADA 0,02 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ESTINILESTRADIOL/ DROSPIRENONA DIARIO STADA 0,02 mg/3 mg comprimidos recubiertos con película EFG
English: ESTINILESTRADIOL/DROS PIRENONA DIARIO STADA 0,03 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ESTINILESTRADIOL/ DROSPIRENONA DIARIO STADA 0,03 mg/3 mg comprimidos recubiertos con película EFG
English: ANTIN 0,03 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ANTIN 0,03 mg/3 mg comprimidos con película EFG
English: Jasminelle continu
Swedish: GYNDORA CONTINUOUS
English: ESTINILESTRADIOL/DROS PIRENONA STADA 0,02 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ESTINILESTRADIOL/ DROSPIRENONA STADA 0,02 mg/3 mg comprimidos recubiertos con película EFG
English: ANTIN DIARIO 0,03 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ANTIN DIARIO 0,03 mg/3 mg comprimidos con película EFG
English: 13000 Praha - 3 Czech Republic
Swedish: U Nákladového nádraží 10 13000 Praha - 3
English: Ethinylestradiol/Drospiren on Sandoz 0,02 mg/3 mg 21 Filmtabletten
Swedish: Ethinylestradiol/Dros pirenon Sandoz 0,02 mg/3 mg 21
English: Slovak Republic Bayer Pharma AG Müllerstraße 178
Swedish: Bayer Pharma AG Müllerstrasse 170-178.
English: E. ép.em
Swedish: N.V.
English: Ethinylestradiol/Drospiren on Sandoz 0,03 mg/3 mg 21 Filmtabletten
Swedish: Ethinylestradiol/Dros pirenon Sandoz 0,03 mg/3 mg 21
English: 1050 Brussels
Swedish: 75014 Paris
English: Aristo Pharma GmbH Wallenroder Straße 8
Swedish: Aristo Pharma GmbH Wallenroder Straße 8-10 13435 Berlin Tyskland
English: JANGEE 3 mg/0.03 mg 3 mg 0,03 mg
Swedish: JANGEE 3 mg/0.03 mg
English: JANGEE 3 mg/0.02 mg 3 mg 0,02 mg
Swedish: JANGEE 3 mg/0.02 mg
English: Regiomedica GmbH Teichstrasse 66
Swedish: Luxemburg Helm AG Nordkanalstrasse 28
English: Alkotás street 53 MOM Park F, Budapest
Swedish: Pfizer Ungern LTD. Alkotás street 53 Budapest 1123 Hunagry
English: Marszałka J.
Swedish: Marszałka J. Piłsudskiego
English: Ethinylestradiol/Drospiren on Bayer 0,03 mg/3 mg Filmtabletten
Swedish: Ethinylestradiol/Dros pirenon Bayer 0,03 mg/3 mg
English: Laboratoire THERAMEX 6 avenue Albert II, BP 59-MC 98007
Swedish: Laboratoires Majorelle 12 Rue de Berri F-75008 Paris Frankrike
English: GRACIAL EX DIMIREL
Swedish: Famina-ratiopharm
English: 07745 Jena
Swedish: ARTIZIA 0,075
English: Stroupežnického 17
Swedish: Pelplińska 19
English: Ethinylestradiol/Drospiren on Richter 0,02 mg/3 mg filmomhulde tabletten 24
Swedish: Ethinylestradiol/Dros pirenon STADA 0,02 mg/3 mg, 24+4 filmomhulde tabletten
English: 89150 Laichingen Germany
Swedish: 85737 Ismaning Tyskland
English: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex BN22 9AG, United Kingdom
Swedish: Storbritannien Teva UK Limited, Brampton Road,
English: ESLARILA CONTINUOUS 3 mg 0,02 mg
Swedish: MISTRAL Continuous 2mg 0,03mg
English: LABORATOIRES GRUNENTHAL 19, rue Ernest Renan Immeuble Eureka 92000 Nanterre FRANCE
Swedish: Nederländerna EFFIK Bâtument le Newton 9-11, rue Jeanne Braconnier 92366 Meudon la Forêt Frankrike
English: Yaz film coted tablets
Swedish: Qlaira filmsko obložene tablete
English: Albert-SchweitzerGasse 3
Swedish: Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-Gasse 3 1140 Wien
English: Via Pavia, 6 20136 Milano Italy
Swedish: Via D. Scarlatti, 31 20124 Milano Italien
English: Aliud Pharma GmbH Gottlieb-Daimler-Str.
Swedish: Aliud Pharma GmbH Gottlieb-Daimler-Str. 19 89150 Laichingen Tyskland
English: 0,02 mg/3 mg comprimidos recubiertos con película EFG
Swedish: PHARMACEUTICALS 0,02 mg/3 mg comprimidos recubiertos con película EFG
English: Clomet
Swedish: CHIFLATON
English: ESTINILESTRADIOL/DROS PIRENONA DIARIO ACTAVIS 0,02 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ESTINILESTRADIOL/ DROSPIRENONA DIARIO QUASSET 0,02 mg/3 mg comprimidos recubiertos con película EFG
English: Gestodene Ethinylestradiol
Swedish: Gestodene Ethinylestradiol EG
English: ESTINILESTRADIOL/DROS PIRENONA ACTAVIS 0,03 mg/3 mg comprimidos recubiertos con película EFG
Swedish: ESTINILESTRADIOL/ DROSPIRENONA CINFA 0,03 mg/3 mg comprimidos recubiertos con película EFG
English: 0.03 mg / 0.04 mg 0.01mg / 0.05mg / 0.07mg
Swedish: 0.03 mg /0.05 mg 0.04 mg /0.07 mg 0.03 mg /0.10 mg
English: A serious under-reporting is suspected.
Swedish: En kraftig underrapportering misstänks.
English: No new safety risk was identified and the safety profile remains overall unchanged for these products.
Swedish: Ingen ny säkerhetsrisk identifierades och säkerhetsprofilen fortsätter totalt sett att vara oförändrad för dessa läkemedel.
English: The CHMP noted that underreporting is probable.
Swedish: CHMP noterade att underrapportering är sannolik.
English: It is noted that serious hypersensitivity reactions may occur.
Swedish: Det konstateras att allvarliga överkänslighetsreaktioner kan uppträda.
English: The MAHs are encouraged to seek scientific advice to the relevant competent authorities to design these studies.
Swedish: Innehavarna av godkännandena för försäljning rekommenderas att söka vetenskapliga råd från de relevanta behöriga myndigheterna för utformningen av dessa studier.
English: No robust study was conducted for Polyvaccinum and no data in adults was identified.
Swedish: Ingen robust studie utfördes för Polyvaccinum och inga data identifierades hos vuxna.
English: A fatal case of allergic drug induced fever was noted after re-exposure.
Swedish: Ett fall av allergisk läkemedelsinducerad feber med dödlig utgång noterades efter förnyad exponering.
English: This included the responses submitted by the marketing authorisation holders in writing and during Oral Explanations, the information submitted by a third party, as well as the views expressed by the scientific advisory group on anti-infectives.
Swedish: I detta ingick de svar som innehavarna av godkännande för försäljning lämnat in skriftligen och under muntliga förklaringar, information som lämnats in av tredje part samt synpunkter från den vetenskapliga rådgivande gruppen för infektionsläkemedel.
English: The minimal age group for which Luivac can be used (from 4 years of age) should be explicitly stated across all EU MS PIs.
Swedish: Den lägsta åldersgrupp som Luivac kan användas till (från 4 år) ska uttryckligen anges på alla produktinformationer i EU:s medlemsstater.
English: The Italian National Competent Authority (AIFA) considered that results of recent studies cast doubt on the efficacy of these products in respiratory infections.
Swedish: Den italienska behöriga myndigheten (AIFA) fann att resultaten av nyligen genomförda studier ifrågasätter effekten av dessa läkemedel vid luftvägsinfektioner.
English: The products have different names in the MS and whilst the most common name is used herein it should be understood as applying to all associated names.
Swedish: För produkterna, som har olika namn i olika medlemsstater, används här de vanligaste namnen, och det bör förstås att det avser samtliga associerade namn.
English: On 8 June 2018 the Italian National Competent Authority (AIFA) therefore triggered a referral under Article 31 of Directive 2001/83/EC and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of bacterial lysates-containing medicinal products for respiratory conditions and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Swedish: Den 8 juni 2018 inledde därför den italienska behöriga myndigheten (AIFA) ett hänskjutningsförfarande i enlighet med artikel 31 i direktiv 2001/83/EG, och begärde att CHMP skulle bedöma de ovanstående farhågornas inverkan på nytta-riskförhållandet för bakteriella lysatinnehållande läkemedel för luftvägsinfektioner, samt utfärda ett yttrande om huruvida de relevanta godkännandena för försäljning bör kvarstå, ändras, tillfälligt upphävas eller återkallas.
English: No patient with COPD or chronic bronchitis appears to have been included in the available studies.
Swedish: Inga patienter med KOL eller kronisk bronkit verkar ha ingått i de tillgängliga studierna.
English: • The Committee for Medicinal Products for Human Use (CHMP) considered the procedure under Article 31 of Directive 2001/83/EC for bacterial lysates based medicinal products for use in respiratory conditions.
Swedish: • Kommittén för humanläkemedel (CHMP) har beaktat förfarandet enligt artikel 31 i direktiv 2001/83/EG för bakteriella lysat-baserade läkemedel för användning vid luftvägssjukdomar.
English: No robust study was conducted for Respivax.
Swedish: Ingen robust studie utfördes för Respivax.
English: Eight medicinal products containing six different combinations of bacterial strains' lysates currently hold marketing authorisations for use in respiratory conditions in EU MS.
Swedish: Åtta läkemedel som innehåller sex olika kombinationer av lysater från bakteriestammar innehar för närvarande godkännanden för försäljning för användning vid luftvägssjukdomar i EU:s medlemsstater.
English: Therefore, the CHMP considered that the treatment indication is not appropriate and should be removed.
Swedish: Därför fann CHMP att behandlingsindikationen inte är lämplig och bör tas bort.
English: It is noted that the authors of a review article on immunomodulators for the prevention of RTI in children (Cardinale, 2015) concluded that no sufficient evidence for the efficacy of Luivac in the paediatric field was available.
Swedish: Det noteras att författarna till en granskningsartikel om immunmodulatorer för förebyggande av luftvägsinfektioner hos barn (Cardinale, 2015) fann att det saknades tillräckliga belägg för Luivacs effekt på det pediatriska området.
English: The safety information from both clinical trials and pharmacovigilance data was in line with the known safety profile, as described in the product information; rare hypersensitivity/allergic reactions have been reported.
Swedish: Säkerhetsinformationen från de båda kliniska prövningarna och farmakovigilansuppgifterna överensstämde med den kända säkerhetsprofilen, som beskrivs i produktinformationen; sällsynta överkänslighetsreaktioner/allergiska reaktioner har rapporterats.
English: Having reviewed the appropriateness of the formulations and pharmaceutical forms for use in the authorised paediatric populations up to 5 years of age, the CHMP considered that acceptability studies in children below the age of 5 years should be performed for Respivax, Buccalin, Ismigen, Polyvaccinum suspension for injection.
Swedish: Efter att ha granskat beredningarnas och läkemedelsformernas lämplighet att användas i de godkända pediatriska populationerna upp till 5 år fann CHMP att acceptansstudier bör utföras på barn under 5 år för Respivax, Buccalin, Ismigen och Polyvaccinum injektionsvätska, suspension.
English: Bacterial lysates-based medicinal products contain several strains of inactivated whole bacteria/bacterial lysates/bacterial fractions claimed to stimulate the immune system to recognise and fight infections.
Swedish: Bakteriella lysat-baserade läkemedel innehåller flera stammar av inaktiverade hela bakterier/bakteriella lysater/bakteriefraktioner som tros stimulera immunsystemet att känna igen och bekämpa infektioner.
English: Of note, the Taskforce of the European Respiratory Society and European Society for Clinical Microbiology and Infectious Diseases does not recommend oral bacterial lysates for the management of adult LRTI (Woodhead, 2011).
Swedish: Värt att notera är att arbetsgruppen för European Respiratory Society och European Society for Clinical Microbiology and Infectious Diseases avråder användning av orala bakteriella lysater för att behandla nedre luftvägsinfektioner hos vuxna (Woodhead, 2011).
English: Respiratory tract infections may be differentiated in upper and lower respiratory tract infections.
Swedish: Luftvägsinfektioner kan indelas i övre och nedre luftvägsinfektioner.
English: In one MS the indication in children is limited to bacterial RURTI, while in five others it is also generally authorised as immunotherapy.
Swedish: I en av medlemsstaterna är indikationen hos barn begränsad till bakteriell återkommande övre luftvägsinfektion, medan den i fem andra medlemsstater även är allmänt godkänd som immunterapi.
English: The analysis of the scientific data concerning bacterial lysates used for the prophylaxis and treatment of RTI was not able to elucidate the mechanism of action of these products.
Swedish: Analysen av de vetenskapliga uppgifterna om bakteriella lysater som används för profylax och behandling av luftvägsinfektioner kunde inte klargöra verkningsmekanismen för dessa produkter.
English: Grounds for CHMP opinion
Swedish: CHMP:s yttrande
English: Only a few ADRs have been collected over the last 12 year which may indicate serious under-reporting.
Swedish: Endast ett fåtal läkemedelsbiverkningar har samlats in under de senaste 12 åren, vilket kan tyda på en kraftig underrapportering.
English: • The CHMP considered that the safety data reviewed was in accordance with the known profile of the products.
Swedish: • CHMP fann att de granskade säkerhetsuppgifterna överensstämde med dessa produkters kända säkerhetsprofil.