INN Invented name Strength Pharmaceutical form. Epinephrine Anapen Junior 150 Mikrogramm in 0,3 ml - Injektionslösung (Fertigspritze)

Transcription

1 Annex I List of the names, pharmaceutical (s), strength(s) of the medicinal product(s), route(s) of, marketing authorisation (s) in the Member s 1

2 Austria Austria Austria Austria 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 Austria Meda Pharma GmbH Guglgasse Wien Austria Epinephrine EpiPen 300 Mikrogramm Injektionslösung in einem FertigPen 300 Mikrogramm Austria Alk Abello A/S Boge Alle Horsholm Epinephrine hydrotartrat Jext 150 Mikrogramm Injektionslösung in einem Fertigpen 150 Mikrogramm 2

3 Austria Alk Abello A/S Boge Alle Horsholm Epinephrine hydrotartrat Jext 300 Mikrogramm Injektionslösung in einem Fertigpen 300 Mikrogramm Belgium Meda Pharma sa-nv Chaussée de la Hulpe Brussels Belgium Epinephrine Epipen 300 µg Belgium Meda Pharma sa-nv Chaussée de la Hulpe Brussels Belgium Epinephrine Epipen junior 150 µg Belgium ALK-Abello Boge Alle Horsholm Epinephrine Bitartrate Jext 150 µg Belgium 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 Anapen 300 mcg/0,3 EpiPen Jr. 150 mcg/0,3 Bulgaria MEDA Pharma GmbH & Co. KG Benzstr. 1 + Bad Homburg EpiPen 300 mcg/0,3 Croatia Medical Intertrade d.o.o. Dr. Franje Tuđmana 3 Sveta Nedjelja Croatia Epinephrine EpiPen 0,3 mg otopina za injekciju 0,3 mg Croatia Medical Intertrade d.o.o. Dr. Franje Tuđmana 3 Sveta Nedjelja Croatia Epinephrine EpiPen Jr 0,15 mg otopina za injekciju 0,15 mg Cyprus Epinephrine Anapen 300 mcg/0.3 4

5 Cyprus Czech Republic 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 ) Czech Republic 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 ) Czech Republic Czech Republic 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 Meda AS Solvang 8 DK-3450 Allerød Anapen Junior 150 mcg/0,3 EpiPen 0,3 mg/dose Meda AS Solvang 8 DK-3450 Allerød EpiPen Jr. 0,15 mg/dose ALK-Abello A/S Bøge Alle 6-8 DK-2970 Hørsholm Jext 150 mcg, prefilled pen ALK-Abello A/S Bøge Alle 6-8 DK-2970 Hørsholm Jext 300 mcg, prefilled pen Estonia Epinephrine ANAPEN 150 mcg/0,3 6

7 Estonia Estonia SIA Meda Pharma Vienibas gatve 109, Riga LV-1058 Latvia Epinephrine ANAPEN 300 mcg/ 0,3 Epinephrine EPIPEN 150 mcg/ 0,3 Estonia 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 France BIOPROJET PHARMA 9 Rue Rameau Paris France ANAPEN 150 microgrammes/0,3, pre-filled syringe 150 µg/0,3 France BIOPROJET PHARMA 9 Rue Rameau Paris France ANAPEN 300 microgrammes/0,3, pre-filled syringe 300 µg/0,3 France 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 France Meda Pharma 25 boulevard de l Amiral Bruix Paris France EPIPEN 0,30 mg/0,3, pre-filled pen 0,30 mg/0,3 France ALK-Abelló A/S Boge Allé Horsholm JEXT 150 microgrammes, pre-filled pen 150 µg France ALK-Abelló A/S Boge Allé Horsholm JEXT 300 microgrammes, pre-filled pen 300 µg ALK-ABELLO A/S Boge Alle Horsholm Epinephrine JEXT 300 Mikrogramm Injektionslösung in einem Fertigpen 0,3 mg /0,3 ALK-ABELLO A/S Boge Alle Horsholm Epinephrine JEXT 150 Mikrogramm Injektionslösung in einem Fertigpen 0,15 mg /0,15. Unit 8 Wilton Buisiness Epinephrine Anapen 300 Mikrogramm Injektionslösung 300 µg/ 0,3 9

10 . Unit 8 Wilton Buisiness MEDA Pharma GmbH & Co. KG Benzstr Bad Homburg MEDA Pharma GmbH & Co. KG Benzstr Bad Homburg Epinephrine Anapen Junior 150 Mikrogramm Injektionslösung 150 µg/ 0,3 Epinephrine Fastjekt 2 mg/ 2 Epinephrine FASTJEKT Junior 0,5 mg/ 1 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 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 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 Greece Greece Epinephrine ANAPEN 300 mcg/ 0,3 Epinephrine ANAPEN 150 mcg/0,3 Greece DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E., 1st Km Leof. Paianias- Markopoulou, Paiania, Greece Greece 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 Hungary Hungary Hungary 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 Hungary 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 Iceland Adrenalinum (Epinephrinum) Anapen Junior 150 microg/0,3 12

13 Iceland Meda AB Pipers väg 2A, Box 906 SE , Solna Adrenalinum (Epinephrinum) EpiPen 300 microg Iceland Meda AB Pipers väg 2A, Box 906 SE , Solna Adrenalinum (Epinephrinum) EpiPen Junior 150 microg Iceland ALK-Abelló A/S Böge Alle 6-8, 2970 Horsholm Adrenalinum bítartrat (Epinephrinum bítartrat) Jext 150 microg Iceland ALK-Abelló A/S, Böge Alle 6-8, 2970 Horsholm Adrenalinum bítartrat (Epinephrinum bítartrat) Jext 300 microg Ireland, (epinephrine) BP Anapen 300 micrograms in 0.3 a pre-filled syringe 300 micrograms in 0.3 solution in a pre-filled syringe Ireland, (epinephrine) BP (epinephrine) BP 150 micrograms in 0.3 solution in a pre- filled syringe 13

14 Ireland Ireland Ireland 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 in a pre-filled pen in a pre-filled pen Ireland ALK-Abello A/S Boge Alle 6-8 DK-2970 Horsholm (as adrenaline tartrate) Jext 150 micrograms pre-filled pen 150 micrograms Italy MEDA PHARMA S.P.A. Viale Brenta Milano Italy FASTJEKT 330 mcg in a prefilled injector Italy MEDA PHARMA S.P.A. Viale Brenta Milano Italy FASTJEKT 165 mcg in a prefilled injector 14

15 Italy ALK-ABELLÓ A/S Boge Alle 6-8 DK-2970 Horsholm tartrate JEXT 300 mcg in a prefilled pen Italy ALK-ABELLÓ A/S Boge Alle 6-8 DK-2970 Horsholm tartrate JEXT 150 mcg in a prefilled pen Italy CHENPEN 300 mcg in a prefilled syringe Parenteral use Italy CHENPEN 150 mcg in a prefilled syringe Parenteral use 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 Lithuania Lithuania Lithuania 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 Lithuania 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 Adrenalin Anapen 150 µg Adrenalin Anapen 300 µg Adrenalin (hydrochloride) Fastjekt 300 µg Luxembourg Meda Pharma GmbH&Co.KG Benzstrasse Bad Homburg 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 Norway 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 Norway Lincoln Medical limited Unit 8 Wilton Business Wilton Salisbury Great Britain Anapen Junior 150 microg/0,3 Norway Meda AS Askerveien 61 Postboks Asker Norway EpiPen 300 microg 18

19 Norway Meda AS Askerveien 61 Postboks Asker Norway EpiPen Jr 150 microg Norway ALK-Abelló AS Bøge Alle 6-8 DK-2970 Hørsholm tartrate Jext 150 microg Norway Poland Poland Poland ALK-Abelló AS Bøge Alle 6-8 DK-2970 Hørsholm Warszawskie Zakłady Farmaceutyczne POLFA S.A. ul. Karolkowa 22/ Warszawa Lincoln Medical Limited Unit 8, Wilton Business, Lincoln Medical Limited Unit 8, Wilton Business, tartrate Jext 300 microg Adrenalina WZF 300 mcg/0,3 Solution for infusion in prefilled syringe/pen Anapen 300 mcg Solution for infusion Anapen Junior 150 mcg Solution for infusion 19

20 Poland Meda Pharma GmbH & Co. KG Benzstrasse Bad Homburg EpiPen Jr. 150 mcg / dose Solution for infusion Poland Meda Pharma GmbH & Co. KG Benzstrasse Bad Homburg EpiPen Senior 300 mcg / dose Solution for infusion 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 Adrenalină (epinefrină) EpiPen 150 micrograme 150 micrograms/ dose in a pre-filled pen Romania MEDA Pharma GmbH & Co. KG Benzstr. 1, Bad Homburg v.d. Höhe Adrenalină (epinefrină) EpiPen 300 micrograme 300 micrograms/ dose in a pre-filled pen Slovak Republic Meda Pharma spol. s r. o. Trnavská cesta Bratislava Slovak Republic Epinephrine EpiPen 300 µg/dose Slovak Republic Meda Pharma spol. s r. o. Trnavská cesta Bratislava Slovak Republic Epinephrine EpiPen Jr. 150 µg/dose Slovak Republic ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm Epinephrine Jext 150 mikrogramov 150 µg/dose Slovak Republic 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 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 Epipen za otroke 150 mikrogramov/0,3 raztopina za injiciranje v napolnjenem injekcijskem peresniku 150 mcg/0,3 Spain 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 Spain Spain Spain Spain 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 Spain 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 Meda AB Box Solna EpiPen 300 mikrogram Parenteral use Meda AB Box Solna EpiPen jr 150 mikrogram Parenteral use Wilton Salisbury SP20AH Anapen 0,3 mg/dose Parenteral use Wilton Salisbury SP20AH Anapen Junior 0,15 mg/dose Parenteral use ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm tartrate Jext 300 mikrogram Parenteral use ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm tartrate Jext 150 mikrogram Parenteral use 24

25 PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic tartrate Emerade 500 mikrogram Parenteral use PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic tartrate Emerade 300 mikrogram Parenteral use PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c Prague Czech Republic tartrate Emerade 150 mikrogram Parenteral use Meda AB Box Solna Nepipe 300 mikrogram Parenteral use Meda AB Box Solna Nepipe Junior 150 mikrogram Parenteral use 25

26 The Netherlands The Netherlands The Netherlands.. Meda Pharma B.V. Krijgsman DM Amstelveen The Netherlands Anapen, oplossing voor injectie Anapen junior, oplossing voor injectie EpiPen Junior 150 microgram/dosis 0,3 microgram/ dosis 0,15 microgram/ dosis 0,15 microgram/ dosis in a pre-filled syringe The Netherlands Meda Pharma B.V. Krijgsman DM Amstelveen The Netherlands EpiPen 300 microgram/dosis 0,3 microgram/ dosis in a pre-filled syringe The Netherlands ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horshlom Jext 150 microgram, oplossing voor injectie 0,15 microgram/ dosis The Netherlands ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horshlom Jext 300 microgram, oplossing voor injectie 0,3 microgram/ dosis 26

27 United Kingdom Alk Abello A-S Boge Alle 6-8 Hersholm 2970 tartrate Jext 150 micrograms pre-filled pen 150 micrograms United Kingdom Alk Abello A-S Boge Alle 6-8. Hersholm 2970 tartrate Jext 300 micrograms pre-filled pen 300 micrograms United Kingdom United Kingdom United Kingdom United Kingdom 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-injector 0.3mg Epipen auto-injector 0.15mg tartrate Emerade 150 micrograms solution for injection in pre-filled pen 1 in 1000 Intramuscular/subcu taneous use 0.3 mg 0.15 mg 150 micrograms 27

28 United Kingdom 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 United Kingdom 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