Epinephrine Anapen Junior 150 Mikrogramm in 0,3 ml - Injektionslösung (Fertigspritze)
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1 Vedlegg I Liste over navn, legemiddelform (er), legemiddelstyrke(r), administrasjonsmåte (r), innehaver (e) av n i medlemslandene 1
2 Østerrike Østerrike Østerrike Østerrike Meda Pharma GmbH Guglgasse Wien Austria Epinephrine Anapen Junior 150 Mikrogramm in 0,3 - Injektionslösung (Fertigspritze) Epinephrine Anapen 300 Mikrogramm in 0,3 - Injektionslösung (Fertigspritze) Epinephrine Anapen 500 Mikrogramm/0,3 Injektionslösung in einer Fertigspritze Epinephrine EpiPen Junior 150 Mikrogramm Injektionslösung in einem Fertigpen 150 Mikrogramm /0,3 300 Mikrogramm /0,3 500 Mikrogramm /0,3 150 Mikrogramm Østerrike Meda Pharma GmbH Guglgasse Wien Austria Epinephrine EpiPen 300 Mikrogramm Injektionslösung in einem FertigPen 300 Mikrogramm Østerrike Alk Abello A/S Boge Alle Horsholm Epinephrine hydrotartrat Jext 150 Mikrogramm Injektionslösung in einem Fertigpen 150 Mikrogramm 2
3 Østerrike Alk Abello A/S Boge Alle Horsholm Epinephrine hydrotartrat Jext 300 Mikrogramm Injektionslösung in einem Fertigpen 300 Mikrogramm Belgia Meda Pharma sa-nv Chaussée de la Hulpe Brussels Belgium Epinephrine Epipen 300 µg Belgia Meda Pharma sa-nv Chaussée de la Hulpe Brussels Belgium Epinephrine Epipen junior 150 µg Belgia ALK-Abello Boge Alle Horsholm Epinephrine Bitartrate Jext 150 µg Belgia ALK-Abello Boge Alle Horsholm Epinephrine Bitartrate Jext 300 µg Bulgaria Anapen Junior 150 mcg/0,3 3
4 Bulgaria Bulgaria MEDA Pharma GmbH & Co. KG Benzstr. 1 + Bad Homburg Germany Anapen 300 mcg/0,3 EpiPen Jr. 150 mcg/0,3 Bulgaria MEDA Pharma GmbH & Co. KG Benzstr. 1 + Bad Homburg Germany EpiPen 300 mcg/0,3 Kroatia Medical Intertrade d.o.o. Dr. Franje Tuđmana 3 Sveta Nedjelja Croatia Epinephrine EpiPen 0,3 mg otopina za injekciju 0,3 mg Kroatia Medical Intertrade d.o.o. Dr. Franje Tuđmana 3 Sveta Nedjelja Croatia Epinephrine EpiPen Jr 0,15 mg otopina za injekciju 0,15 mg Kypros Epinephrine Anapen 300 mcg/0.3 4
5 Kypros Tsjekkia MEDA Pharma s.r.o. Kodaňská 1441/ Prague 10 Czech Republic Epinephrine Anapen Junior 150 mcg/0.3 Epinephrine Epipen 300 mikrogramů 0,3 mg per dose (0,3 mg/0,3 ) Tsjekkia MEDA Pharma s.r.o. Kodaňská 1441/ Prague 10 Czech Republic Epinephrine Epipen JR. 150 mikrogramů 0,15 mg per dose (0,15 mg/0,3 ) Tsjekkia Tsjekkia Danmark Lincoln Medical Limited Wilton Salisbury Epinephrine Epinephrine Anapen injekční roztok 300 mikrogramů/0,3 (předplněná injekční stříkačka) Anapen Junior injekční roztok 150 mikrogramů/0,3 (předplněná injekční stříkačka) 0,3 mg per dose (0,3 mg/0,3 ) 0,15 mg per dose (0,15 mg/0,3 ) Anapen 300 mcg/0,3 5
6 Danmark Danmark Meda AS Solvang 8 DK-3450 Allerød Anapen Junior 150 mcg/0,3 EpiPen 0,3 mg/dose Danmark Meda AS Solvang 8 DK-3450 Allerød EpiPen Jr. 0,15 mg/dose Danmark ALK-Abello A/S Bøge Alle 6-8 DK-2970 Hørsholm Jext 150 mcg Danmark ALK-Abello A/S Bøge Alle 6-8 DK-2970 Hørsholm Jext 300 mcg Estland Epinephrine ANAPEN 150 mcg/0,3 6
7 Estland Estland SIA Meda Pharma Vienibas gatve 109, Riga LV-1058 Latvia Epinephrine ANAPEN 300 mcg/ 0,3 Epinephrine EPIPEN 150 mcg/ 0,3 Estland SIA Meda Pharma Vienibas gatve 109, Riga LV-1058 Latvia Epinephrine EPIPEN 300 mcg/0,3 Finland Finland Finland Meda Oy Vaisalantie Espoo Finland ANAPEN 0.3 mg / 0.3 ANAPEN JUNIOR 0.15 mg / 0.3 EPIPEN 300 mikrog 7
8 Finland Meda Oy Vaisalantie Espoo Finland EPIPEN JR. 150 mikrog Finland ALK-Abello A/S Bøge Alle 6-8 B.O.BOX Horsholm tartrate JEXT 150 mikrog Finland ALK-Abello A/S Bøge Alle 6-8 B.O.BOX Horsholm tartrate JEXT 300 mikrog Frankrike BIOPROJET PHARMA 9 Rue Rameau Paris France ANAPEN 150 microgrammes/0,3, pre-filled syringe 150 µg/0,3 Frankrike BIOPROJET PHARMA 9 Rue Rameau Paris France ANAPEN 300 microgrammes/0,3, pre-filled syringe 300 µg/0,3 Frankrike Meda Pharma 25 boulevard de l Amiral Bruix Paris France EPIPEN 0,15 mg/0,3, pre-filled pen 0,15 mg/0,3 8
9 Frankrike Meda Pharma 25 boulevard de l Amiral Bruix Paris France EPIPEN 0,30 mg/0,3, pre-filled pen 0,30 mg/0,3 Frankrike ALK-Abelló A/S Boge Allé Horsholm JEXT 150 microgrammes, pre-filled pen 150 µg Frankrike ALK-Abelló A/S Boge Allé Horsholm JEXT 300 microgrammes, pre-filled pen 300 µg Tyskland ALK-ABELLO A/S Boge Alle Horsholm Epinephrine JEXT 300 Mikrogramm Injektionslösung in einem Fertigpen 0,3 mg /0,3 Tyskland ALK-ABELLO A/S Boge Alle Horsholm Epinephrine JEXT 150 Mikrogramm Injektionslösung in einem Fertigpen 0,15 mg /0,15 Tyskland. Unit 8 Wilton Buisiness Epinephrine Anapen 300 Mikrogramm Injektionslösung 300 µg/ 0,3 9
10 Tyskland Tyskland. Unit 8 Wilton Buisiness MEDA Pharma GmbH & Co. KG Benzstr Bad Homburg Germany Epinephrine Anapen Junior 150 Mikrogramm Injektionslösung 150 µg/ 0,3 Epinephrine Fastjekt 2 mg/ 2 Tyskland MEDA Pharma GmbH & Co. KG Benzstr Bad Homburg Germany Epinephrine FASTJEKT Junior 0,5 mg/ 1 Tyskland PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic Epinephrine Emerade 150 Mikrogramm Injektionslösung in einem Fertigpen 0,5 mg/ 0,5 Tyskland PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic Epinephrine Emerade 300 Mikrogramm Injektionslösung in einem Fertigpen 0,5 mg/ 0,5 10
11 Tyskland PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic Epinephrine Emerade 500 Mikrogramm Injektionslösung in einem Fertigpen 0,5 mg/ 0,5 Hellas Hellas Epinephrine ANAPEN 300 mcg/ 0,3 Epinephrine ANAPEN 150 mcg/0,3 Hellas DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E., 1st Km Leof. Paianias- Markopoulou, Paiania, Greece Hellas DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E., 1st Km Leof. Paianias- Markopoulou, Paiania, Greece Epinephrine FASTPEN 0,15 mg/3 Epinephrine FASTPEN 0,30 mg/0,3 11
12 Ungarn Ungarn Ungarn Unit 8, Wilton Business Wilton,Salisbury Unit 8, Wilton Business Wilton,Salisbury Meda Pharma Hungary Kft. Váci út 91. Budapest H-1139 Hungary ANAPEN 300 mikrogramm/0,3 oldatos injekció előretöltött fecskendőben ANAPEN JUNIOR 150 mikrogramm/0,3 oldatos injekció előretöltött fecskendőben EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban 300 microgramm /0,3 150 microgramm /0,3 300 microgramm /0,3 Ungarn Meda Pharma Hungary Kft. Váci út 91. Budapest H-1139 Hungary EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban 150 microgramm /0,3 Iceland Adrenalinum (Epinephrinum) Anapen 300 microg/0,3 Island Adrenalinum (Epinephrinum) Anapen Junior 150 microg/0,3 12
13 Island Meda AB Pipers väg 2A, Box 906 SE , Solna Sweden Adrenalinum (Epinephrinum) EpiPen 300 microg Island Meda AB Pipers väg 2A, Box 906 SE , Solna Sweden Adrenalinum (Epinephrinum) EpiPen Junior 150 microg Island ALK-Abelló A/S Böge Alle 6-8, 2970 Horsholm Adrenalinum bítartrat (Epinephrinum bítartrat) Jext 150 microg Island ALK-Abelló A/S, Böge Alle 6-8, 2970 Horsholm Adrenalinum bítartrat (Epinephrinum bítartrat) Jext 300 microg Irland, (epinephrine) BP Anapen 300 micrograms in 0.3 a pre-filled syringe 300 micrograms in 0.3 solution Irland, (epinephrine) BP (epinephrine) BP 150 micrograms in 0.3 solution 13
14 Irland Irland Irland Meda Health Sales Ireland Limited Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland Meda Health Sales Ireland Limited Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland ALK-Abello A/S Boge Alle 6-8 DK-2970 Horsholm Ph. Eur. Epipen 300 micrograms pre-filled pen Ph. Eur. Epipen Junior 150 micrograms solution for injection in pre-filled pen (as adrenaline tartrate) Jext 300 micrograms pre-filled pen 300 micrograms in 0.3 solution 150 micrograms 300 micrograms Irland ALK-Abello A/S Boge Alle 6-8 DK-2970 Horsholm (as adrenaline tartrate) Jext 150 micrograms pre-filled pen 150 micrograms Italia MEDA PHARMA S.P.A. Viale Brenta Milano Italy FASTJEKT 330 mcg Løsning for injeksjon i en forhåndsfylt injektor Italia MEDA PHARMA S.P.A. Viale Brenta Milano Italy FASTJEKT 165 mcg Løsning for injeksjon i en forhåndsfylt injektor 14
15 Italia ALK-ABELLÓ A/S Boge Alle 6-8 DK-2970 Horsholm tartrate JEXT 300 mcg Italia ALK-ABELLÓ A/S Boge Alle 6-8 DK-2970 Horsholm tartrate JEXT 150 mcg Italia CHENPEN 300 mcg Parenteralt bruk Italia CHENPEN 150 mcg Parenteralt bruk Latvia Epinephrine Anapen 150 micrograms/0,3 pre-filled syringe 150 micrograms/ 0,3 15
16 Latvia Latvia Meda Pharma SIA Vienibas gatve 109 Riga, LV-1058 Latvia Epinephrine Anapen 300 micrograms/0,3 pre-filled syringe Epinephrine Epipen 150 micrograms pre-filled pen 300 micrograms/ 0,3 150 micrograms Latvia Meda Pharma SIA Vienibas gatve 109 Riga, LV-1058 Latvia Epinephrine Epipen 300 micrograms pre-filled pen 300 micrograms Litauen Litauen Litauen Unit 8, Wilton Business Wilton Salisbury Unit 8, Wilton Business Wilton Salisbury SIA Meda Pharma Vienibas gatve 109 Riga LV-1058 Latvia Epinephrine Anapen 300 microgram/ 0,3 Epinephrine Anapen 150 microgram/ 0,3 Epinephrine Epipen 300 microgram/ 0,3 16
17 Litauen SIA Meda Pharma Vienibas gatve 109 Riga LV-1058 Latvia Epinephrine Epipen 150 microgram/ 0,3 Luxembourg Luxembourg Luxembourg. Unit 8, Wilton Business, Wilton Salisbury SP2 OAH United kingdom. Unit 8, Wilton Business, Wilton Salisbury SP2 OAH United kingdom Meda Pharma GmbH&Co.KG Benzstrasse Bad Homburg Germany Adrenalin Anapen 150 µg Adrenalin Anapen 300 µg Adrenalin (hydrochloride) Fastjekt 300 µg Luxembourg Meda Pharma GmbH&Co.KG Benzstrasse Bad Homburg Germany Adrenalin (hydrochloride) Fastjekt junior 150 µg Luxembourg Alk Abello A/S Boge Alle Horsholm Adrenalin (tartrate) Jext 150 µg 17
18 Luxembourg Alk Abello A/S Boge Alle Horsholm Adrenalin (tartrate) Jext 300 µg Malta Malta Norge Lincoln Medical Limited Wilton Salisbury Lincoln Medical Limited Wilton Salisbury Lincoln Medical limited Unit 8 Wilton Business Wilton Salisbury Great Britain Adrenalin Anapen 300 micrograms in 0.3 a pre-filled syringe Adrenalin Anapen Junior 150 micrograms in 0.3 a pre-filled syringe 300 micrograms/ micrograms/ 0.3 Anapen 300 microg/0,3 Norge Lincoln Medical limited Unit 8 Wilton Business Wilton Salisbury Great Britain Anapen Junior 150 microg/0,3 Norge Meda AS Askerveien 61 Postboks Asker Norway EpiPen 300 microg 18
19 Norge Meda AS Askerveien 61 Postboks Asker Norway EpiPen Jr 150 microg Norge ALK-Abelló AS Bøge Alle 6-8 DK-2970 Hørsholm tartrate Jext 150 microg Norge ALK-Abelló AS Bøge Alle 6-8 DK-2970 Hørsholm tartrate Jext 300 microg Polen Polen Polen Warszawskie Zakłady Farmaceutyczne POLFA S.A. ul. Karolkowa 22/ Warszawa Lincoln Medical Limited Unit 8, Wilton Business, Lincoln Medical Limited Unit 8, Wilton Business, Adrenalina WZF 300 mcg/0,3 Infusjonsvæske, /penn Anapen 300 mcg Infusjonsvæske, Anapen Junior 150 mcg Infusjonsvæske, 19
20 Polen Meda Pharma GmbH & Co. KG Benzstrasse Bad Homburg Germany EpiPen Jr. 150 mcg / dose Infusjonsvæske, Polen Meda Pharma GmbH & Co. KG Benzstrasse Bad Homburg Germany EpiPen Senior 300 mcg / dose Infusjonsvæske, Portugal. Unit 8, Wilton Business, Wilton Salisbury Anapen 0,15 mg/0, mg/0.3 Portugal. Unit 8, Wilton Business, Wilton Salisbury Anapen 0,3 mg/0,3 0.3 mg/0.3 Portugal Meda Pharma - Produtos Farmacêuticos, S.A. Rua do Centro Cultural, Lisboa Portugal Epipen 0.15 mg/0.3 Portugal Meda Pharma - Produtos Farmacêuticos, S.A. Rua do Centro Cultural, Lisboa Portugal Epipen 0.3 mg/0.3 20
21 Romania MEDA Pharma GmbH & Co. KG Benzstr. 1, Bad Homburg v.d. Höhe Germany Adrenalină (epinefrină) EpiPen 150 micrograme 150 micrograms/ dose Romania MEDA Pharma GmbH & Co. KG Benzstr. 1, Bad Homburg v.d. Höhe Germany Adrenalină (epinefrină) EpiPen 300 micrograme 300 micrograms/ dose Slovakia Meda Pharma spol. s r. o. Trnavská cesta Bratislava Slovak Republic Epinephrine EpiPen 300 µg/dose Slovakia Meda Pharma spol. s r. o. Trnavská cesta Bratislava Slovak Republic Epinephrine EpiPen Jr. 150 µg/dose Slovakia ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm Epinephrine Jext 150 mikrogramov 150 µg/dose Slovakia ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm Epinephrine Jext 300 mikrogramov 300 µg/dose 21
22 Slovenia Slovenia Slovenia United kingdom United kingdom Meda Pharma GmbH & Co. KG, Benzstrasse Bad Homburg Germany Anapen 300 mikrogramov/0,3 raztopina za injiciranje v napolnjeni injekcijski brizgi Anapen za otroke 150 mikrogramov/0,3 raztopina za injiciranje v napolnjeni injekcijski brizgi Epipen 300 mikrogramov/0,3 raztopina za injiciranje v napolnjenem injekcijskem peresniku 300 mcg/0,3 150 mcg/0,3 300 mcg/0,3 Slovenia Meda Pharma GmbH & Co. KG, Benzstrasse Bad Homburg Germany Epipen za otroke 150 mikrogramov/0,3 raztopina za injiciranje v napolnjenem injekcijskem peresniku 150 mcg/0,3 Spania MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2ª planta Parque Empresarial San Fernando San Fernando de Henares (Madrid) Spain Altellus 150 microgramos niños, solución inyectable en pluma precargada 0.15 mg/0.3 22
23 Spania Spania Spania Spania MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2ª planta Parque Empresarial San Fernando San Fernando de Henares (Madrid) Spain ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Altellus 300 microgramos adultos solución inyectable en pluma precargada tartrate Anapen 0,15 mg/0,3 solución inyectable en jeringa precargada Anapen 0,30 mg/0,3 solución inyectable en jeringa precargada Jext 150 microgramos solución inyectable en pluma precargada 0.30 mg/ mg/ mg/ mg/0.3 Spania ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm tartrate Jext 300 microgramos solución inyectable en pluma precargada 0.30 mg/0.3 23
24 Sverige Meda AB Box Solna Sweden EpiPen 300 mikrogram Parenteralt bruk Sverige Meda AB Box Solna Sweden EpiPen jr 150 mikrogram Parenteralt bruk Sverige Wilton Salisbury SP20AH Anapen 0,3 mg/dose Parenteralt bruk Sverige Wilton Salisbury SP20AH Anapen Junior 0,15 mg/dose Parenteralt bruk Sverige ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm tartrate Jext 300 mikrogram Parenteralt bruk Sverige ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm tartrate Jext 150 mikrogram Parenteralt bruk 24
25 Sverige PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic tartrate Emerade 500 mikrogram Parenteralt bruk Sverige PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic tartrate Emerade 300 mikrogram Parenteralt bruk Sverige PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic tartrate Emerade 150 mikrogram Parenteralt bruk Sverige Meda AB Box Solna Sweden Nepipe 300 mikrogram Parenteralt bruk Sverige Meda AB Box Solna Sweden Nepipe Junior 150 mikrogram Parenteralt bruk Nederland. Anapen, oplossing voor injectie 0,3 microgram/ dosis 25
26 Nederland Nederland. Meda Pharma B.V. Krijgsman DM Amstelveen The Netherlands Anapen junior, oplossing voor injectie EpiPen Junior 150 microgram/dosis 0,15 microgram/ dosis 0,15 microgram/ dosis Nederland Meda Pharma B.V. Krijgsman DM Amstelveen The Netherlands EpiPen 300 microgram/dosis 0,3 microgram/ dosis Nederland ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horshlom Jext 150 microgram, oplossing voor injectie 0,15 microgram/ dosis Nederland ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horshlom Jext 300 microgram, oplossing voor injectie 0,3 microgram/ dosis Storbritannia Alk Abello A-S Boge Alle 6-8 Hersholm 2970 tartrate Jext 150 micrograms pre-filled pen 150 micrograms Storbritannia Alk Abello A-S Boge Alle 6-8. Hersholm 2970 tartrate Jext 300 micrograms pre-filled pen 300 micrograms 26
27 Storbritannia Storbritannia Storbritannia Storbritannia Aurum Pharmaceuticals Limited, Bampton Road Harold Hill Romford Essex RM3 8UG Meda Pharmaceuticals Limited, Skyway House Parsonage Road, Takeley Bishops Stortford CM22 6PU Meda Pharmaceuticals Limited Skyway House, Parsonage Road, Takeley Bishops Stortford CM22 6PU PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic acid tartrate (epinephrine) 1 in 1000 solution for injection BP auto-injector Epipen auto-injecto 0.3mg Epipen auto-injector 0.15mg tartrate Emerade 150 micrograms solution for injection in pre-filled pen 1 in mg 0.15 mg 150 micrograms Intramuskulær/Subku tan bruk Storbritannia PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic tartrate Emerade 300 micrograms solution for injection in pre-filled pen 300 micrograms 27
28 Storbritannia PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic tartrate Emerade 500 micrograms solution for injection in pre-filled pen 500 micrograms 28
INN Invented name Strength Pharmaceutical form. Epinephrine Anapen Junior 150 Mikrogramm in 0,3 ml - Injektionslösung (Fertigspritze)
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