EN Official Journal of the European Union C 318/8

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2015/C 318/02)

— Issuing, maintenance or modification of a national marketing authorisation

Date of the decision Name(s) of the medicinal product INN (International Non-Proprietary Name) Holder(s) of the marketing authorisation Member State concerned Date of notification 14.8.2015 Adrenaline auto injectors See Annex I See Annex I See Annex I 17.8.2015 20.8.2015 Amoxil and associated names See Annex II See Annex II See Annex II 21.8.2015 28.8.2015 Coglapix suspension for injection for pigs See Annex III See Annex III See Annex III 31.8.2015 28.8.2015 Bosentan Bonentan Not applicable Not applicable 1.9.2015 28.8.2015 Sodium oxybate Sodium oxybate Not applicable Not applicable 31.8.2015

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the Member States Member State (in EEA) Marketing authorisation holder INN Invented name Strength Pharmaceutical form Route of administration Austria Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen Junior 150 Mikrogramm in 0,3 ml — Injektionslösung (Fertigspritze) 150 Mikrogramm/0,3 ml Solution for injection Intramuscular use Austria Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen 300 Mikrogramm in 0,3 ml — Injektionslösung (Fertigspritze) 300 Mikrogramm/0,3 ml Solution for injection Intramuscular use Austria Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen 500 Mikrogramm/0,3 ml Injektionslösung in einer Fertigspritze 500 Mikrogramm/0,3 ml Solution for injection Intramuscular use Austria Meda Pharma GmbH Guglgasse 15 1110 Wien Austria Epinephrine EpiPen Junior 150 Mikrogramm Injektionslösung in einem Fertigpen 150 Mikrogramm Solution for injection Intramuscular use Austria Meda Pharma GmbH Guglgasse 15 1110 Wien Austria Epinephrine EpiPen 300 Mikrogramm Injektionslösung in einem FertigPen 300 Mikrogramm Solution for injection Intramuscular use Austria Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark Epinephrine hydrotartrat Jext 150 Mikrogramm Injektionslösung in einem Fertigpen 150 Mikrogramm Solution for injection Intramuscular use Austria Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark Epinephrine hydrotartrat Jext 300 Mikrogramm Injektionslösung in einem Fertigpen 300 Mikrogramm Solution for injection Intramuscular use Belgium Meda Pharma sa-nv Chaussée de la Hulpe 166 1170 Brussels Belgium Epinephrine Epipen 300 μg Solution for injection Intramuscular use Belgium Meda Pharma sa-nv Chaussée de la Hulpe 166 1170 Brussels Belgium Epinephrine Epipen junior 150 μg Solution for injection Intramuscular use Belgium ALK-Abello Boge Alle 6-8 2970 Horsholm Denmark Epinephrine Bitartrate Jext 150 μg Solution for injection Intramuscular use Belgium ALK-Abello Boge Alle 6-8 2970 Horsholm Denmark Epinephrine Bitartrate Jext 300 μg Solution for injection Intramuscular use Bulgaria Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen Junior 150 mcg/0,3 ml Solution for injection Intramuscular use Bulgaria Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen 300 mcg/0,3 ml Solution for injection Intramuscular use Bulgaria MEDA Pharma GmbH & Co. KG Benzstr. 1 + Bad Homburg 61352 Germany Adrenaline EpiPen Jr. 150 mcg/0,3 ml Solution for injection Intramuscular use Bulgaria MEDA Pharma GmbH & Co. KG Benzstr. 1 + Bad Homburg 61352 Germany Adrenaline EpiPen 300 mcg/0,3 ml Solution for injection Intramuscular use Croatia Medical Intertrade d.o.o. Dr Franje Tuđmana 3 Sveta Nedjelja 10431 Croatia Epinephrine EpiPen 0,3 mg otopina za injekciju 0,3 mg Solution for injection Intramuscular use Croatia Medical Intertrade d.o.o. Dr Franje Tuđmana 3 Sveta Nedjelja 10431 Croatia Epinephrine EpiPen Jr 0,15 mg otopina za injekciju 0,15 mg Solution for injection Intramuscular use Cyprus Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen 300 mcg/0,3 ml Solution for injection Intramuscular use Cyprus Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen Junior 150 mcg/0,3 ml Solution for injection Intramuscular use Czech Republic MEDA Pharma s.r.o. Kodaňská 1441/46 110 00 Prague 10 Czech Republic Epinephrine Epipen 300 mikrogramů 0,3 mg per dose (0,3 mg/0,3 ml) Solution for injection in pre-filled pen Intramuscular use Czech Republic MEDA Pharma s.r.o. Kodaňská 1441/46 110 00 Prague 10 Czech Republic Epinephrine Epipen JR. 150 mikrogramů 0,15 mg per dose (0,15 mg/0,3 ml) Solution for injection in pre-filled pen Intramuscular use Czech Republic Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen injekční roztok 300 mikrogramů/0,3 ml (předplněná injekční stříkačka) 0,3 mg per dose (0,3 mg/0,3 ml) Solution for injection Intramuscular use Czech Republic Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen Junior injekční roztok 150 mikrogramů/0,3 ml (předplněná injekční stříkačka) 0,15 mg per dose (0,15 mg/0,3 ml) Solution for injection Intramuscular use Denmark Lincoln Medical Limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom Adrenaline Anapen 300 mcg/0,3 ml Solution for injection Intramuscular use Denmark Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen Junior 150 mcg/0,3 ml Solution for injection Intramuscular use Denmark Meda AS Solvang 8 DK-3450 Allerød Denmark Adrenaline EpiPen 0,3 mg/dose Solution for injection Intramuscular use Denmark Meda AS Solvang 8 DK-3450 Allerød Denmark Adrenaline EpiPen Jr. 0,15 mg/dose Solution for injection Intramuscular use Denmark ALK-Abello A/S Bøge Alle 6-8 DK-2970 Hørsholm Denmark Adrenaline Jext 150 mcg Solution for injection, pre-filled pen Intramuscular use Denmark ALK-Abello A/S Bøge Alle 6-8 DK-2970 Hørsholm Denmark Adrenaline Jext 300 mcg Solution for injection, pre-filled pen Intramuscular use Estonia Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine ANAPEN 150 mcg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Estonia Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine ANAPEN 300 mcg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Estonia SIA Meda Pharma Vienibas gatve 109, Riga LV-1058 Latvia Epinephrine EPIPEN 150 mcg/0,3 ml Solution for injection in pre-filled pen Intramuscular use Estonia SIA Meda Pharma Vienibas gatve 109, Riga LV-1058 Latvia Epinephrine EPIPEN 300 mcg/0,3 ml Solution for injection in pre-filled pen Intramuscular use Finland Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline ANAPEN 0,3 mg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Finland Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline ANAPEN JUNIOR 0,15 mg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Finland Meda Oy Vaisalantie 4 02130 Espoo Finland Adrenaline EPIPEN 300 mikrog Solution for injection in pre-filled pen Intramuscular use Finland Meda Oy Vaisalantie 4 02130 Espoo Finland Adrenaline EPIPEN JR. 150 mikrog Solution for injection in pre-filled pen Intramuscular use Finland ALK-Abello A/S Bøge Alle 6-8 B.O. BOX 408 2970 Horsholm Denmark Adrenaline tartrate JEXT 150 mikrog Solution for injection in pre-filled pen Intramuscular use Finland ALK-Abello A/S Bøge Alle 6-8 B.O. BOX 408 2970 Horsholm Denmark Adrenaline tartrate JEXT 300 mikrog Solution for injection in pre-filled pen Intramuscular use France BIOPROJET PHARMA 9 Rue Rameau 75002 Paris France Adrenaline ANAPEN 150 microgrammes/0,3 ml, solution for injection in pre-filled syringe 150 μg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use France BIOPROJET PHARMA 9 Rue Rameau 75002 Paris France Adrenaline ANAPEN 300 microgrammes/0,3 ml, solution for injection in pre-filled syringe 300 μg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use France Meda Pharma 25 boulevard de l’Amiral Bruix 75016 Paris France Adrenaline EPIPEN 0,15 mg/0,3 ml, solution for injection in pre-filled pen 0,15 mg/0,3 ml Solution for injection in pre-filled pen Intramuscular use France Meda Pharma 25 boulevard de l’Amiral Bruix 75016 Paris France Adrenaline EPIPEN 0,30 mg/0,3 ml, solution for injection in pre-filled pen 0,30 mg/0,3 ml Solution for injection in pre-filled pen Intramuscular use France ALK-Abelló A/S Boge Allé 6-8. 2970 Horsholm Denmark Adrenaline JEXT 150 microgrammes, solution for injection in pre-filled pen 150 μg Solution for injection in pre-filled pen Intramuscular use France ALK-Abelló A/S Boge Allé 6-8. 2970 Horsholm Denmark Adrenaline JEXT 300 microgrammes, solution for injection in pre-filled pen 300 μg Solution for injection in pre-filled pen Intramuscular use Germany ALK-ABELLO A/S Boge Alle 6-8 2970 Horsholm Denmark Epinephrine JEXT 300 Mikrogramm Injektionslösung in einem Fertigpen 0,3 mg/0,3 ml Solution for injection Intramuscular use Germany ALK-ABELLO A/S Boge Alle 6-8 2970 Horsholm Denmark Epinephrine JEXT 150 Mikrogramm Injektionslösung in einem Fertigpen 0,15 mg/0,15 ml Solution for injection Intramuscular use Germany Lincoln Medical Ltd Unit 8 Wilton Buisiness Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen 300 Mikrogramm Injektionslösung 300 μg/0,3 ml Solution for injection Intramuscular use Germany Lincoln Medical Ltd Unit 8 Wilton Buisiness Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen Junior 150 Mikrogramm Injektionslösung 150 μg/0,3 ml Solution for injection Intramuscular use Germany MEDA Pharma GmbH & Co. KG Benzstr. 1 61352 Bad Homburg Germany Epinephrine Fastjekt 2 mg/2 ml Solution for injection Intramuscular use Germany MEDA Pharma GmbH & Co. KG Benzstr. 1 61352 Bad Homburg Germany Epinephrine FASTJEKT Junior 0,5 mg/1 ml Solution for injection Intramuscular use Germany PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Epinephrine Emerade 150 Mikrogramm Injektionslösung in einem Fertigpen 0,5 mg/0,5 ml Solution for injection Intramuscular use Germany PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Epinephrine Emerade 300 Mikrogramm Injektionslösung in einem Fertigpen 0,5 mg/0,5 ml Solution for injection Intramuscular use Germany PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Epinephrine Emerade 500 Mikrogramm Injektionslösung in einem Fertigpen 0,5 mg/0,5 ml Solution for injection Intramuscular use Greece Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine ANAPEN 300 mcg/0,3 ml Solution for injection Intramuscular use Greece Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine ANAPEN 150 mcg/0,3 ml Solution for injection Intramuscular use Greece DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E., 1st Km Leof. Paianias-Markopoulou, 19002 Paiania, Greece Epinephrine FASTPEN 0,15 mg/3 ml Solution for injection Intramuscular use Greece DOCTUM FARMAKEYTIKI K. GIOKARIS & SIA A.E., 1st Km Leof. Paianias-Markopoulou, 19002 Paiania, Greece Epinephrine FASTPEN 0,30 mg/0,3 ml Solution for injection Intramuscular use Hungary Lincoln Medical Ltd Unit 8, Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline ANAPEN 300 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben 300 microgramm/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Hungary Lincoln Medical Ltd Unit 8, Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline ANAPEN JUNIOR 150 mikrogramm/0,3 ml oldatos injekció előretöltött fecskendőben 150 microgramm/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Hungary Meda Pharma Hungary Kft. Váci út 91. Budapest H-1139 Hungary Adrenaline EPIPEN 300 mikrogramm oldatos injekció előre töltött tollban 300 microgramm/0,3 ml Solution for injection in pre-filled pen Intramuscular use Hungary Meda Pharma Hungary Kft. Váci út 91. Budapest H-1139 Hungary Adrenaline EPIPEN JUNIOR 150 mikrogramm oldatos injekció előre töltött tollban 150 microgramm/0,3 ml Solution for injection in pre-filled pen Intramuscular use Iceland Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenalinum (Epinephrinum) Anapen 300 microg/0,3 ml Solution for injection Intramuscular use Iceland Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenalinum (Epinephrinum) Anapen Junior 150 microg/0,3 ml Solution for injection Intramuscular use Iceland Meda AB Pipers väg 2A, Box 906 SE-170 09, Solna Sweden Adrenalinum (Epinephrinum) EpiPen 300 microg Solution for injection Intramuscular use Iceland Meda AB Pipers väg 2A, Box 906 SE-170 09, Solna Sweden Adrenalinum (Epinephrinum) EpiPen Junior 150 microg Solution for injection Intramuscular use Iceland ALK-Abelló A/S Böge Alle 6-8, 2970 Horsholm Denmark Adrenalinum bítartrat (Epinephrinum bítartrat) Jext 150 microg Solution for injection Intramuscular use Iceland ALK-Abelló A/S, Böge Alle 6-8, 2970 Horsholm Denmark Adrenalinum bítartrat (Epinephrinum bítartrat) Jext 300 microg Solution for injection Intramuscular use Ireland Lincoln Medical Ltd Unit 8 Wilton Business Centre, Wilton, Salisbury SP2 0AH United Kingdom Adrenaline (epinephrine) BP Anapen 300 micrograms in 0,3 ml solution for injection in a pre-filled syringe 300 micrograms in 0,3 ml solution Solution for injection in a pre-filled syringe Intramuscular use Ireland Lincoln Medical Ltd Unit 8 Wilton Business Centre, Wilton, Salisbury SP2 0AH United Kingdom Adrenaline (epinephrine) BP Adrenaline (epinephrine) BP 150 micrograms in 0,3 ml solution Solution for injection in a pre- filled syringe Intramuscular use Ireland Meda Health Sales Ireland Limited Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland Adrenaline Ph. Eur. Epipen 300 micrograms solution for injection in pre-filled pen 300 micrograms in 0,3 ml solution Solution for injection in a pre-filled pen Intramuscular use Ireland Meda Health Sales Ireland Limited Unit 34/35, Block A Dunboyne Business Park Dunboyne, Co. Meath Ireland Adrenaline Ph. Eur. Epipen Junior 150 micrograms solution for injection in pre-filled pen 150 micrograms Solution for injection in a pre-filled pen Intramuscular use Ireland ALK-Abello A/S Boge Alle 6-8 DK-2970 Horsholm Denmark Adrenaline (as adrenaline tartrate) Jext 300 micrograms solution for injection in pre-filled pen 300 micrograms Solution for injection in pre-filled pen Intramuscular use Ireland ALK-Abello A/S Boge Alle 6-8 DK-2970 Horsholm Denmark Adrenaline (as adrenaline tartrate) Jext 150 micrograms solution for injection in pre-filled pen 150 micrograms Solution for injection in pre-filled pen Intramuscular use Italy MEDA PHARMA S.P.A. Viale Brenta 18 20139 Milano Italy Adrenaline FASTJEKT 330 mcg Solution for injection in a pre-filled injector Intramuscular use Italy MEDA PHARMA S.P.A. Viale Brenta 18 20139 Milano Italy Adrenaline FASTJEKT 165 mcg Solution for injection in a pre-filled injector Intramuscular use Italy ALK-ABELLÓ A/S Boge Alle 6-8 DK-2970 Horsholm Denmark Adrenaline tartrate JEXT 300 mcg Solution for injection in a pre-filled pen Intramuscular use Italy ALK-ABELLÓ A/S Boge Alle 6-8 DK-2970 Horsholm Denmark Adrenaline tartrate JEXT 150 mcg Solution for injection in a pre-filled pen Intramuscular use Italy Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline CHENPEN 300 mcg Solution for injection in a pre-filled syringe Parenteral use Italy Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline CHENPEN 150 mcg Solution for injection in a pre-filled syringe Parenteral use Latvia Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen 150 micrograms/0,3 ml solution for injection in pre-filled syringe 150 micrograms/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Latvia Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Epinephrine Anapen 300 micrograms/0,3 ml solution for injection in pre-filled syringe 300 micrograms/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Latvia Meda Pharma SIA Vienibas gatve 109 Riga, LV-1058 Latvia Epinephrine Epipen 150 micrograms solution for injection in pre-filled pen 150 micrograms Solution for injection in pre-filled pen Intramuscular use Latvia Meda Pharma SIA Vienibas gatve 109 Riga, LV-1058 Latvia Epinephrine Epipen 300 micrograms solution for injection in pre-filled pen 300 micrograms Solution for injection in pre-filled pen Intramuscular use Lithuania Lincoln Medical Ltd Unit 8, Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom Epinephrine Anapen 300 microgram/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Lithuania Lincoln Medical Ltd Unit 8, Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom Epinephrine Anapen 150 microgram/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Lithuania SIA Meda Pharma Vienibas gatve 109 Riga LV-1058 Latvia Epinephrine Epipen 300 microgram/0,3 ml Solution for injection in pre-filled pen Intramuscular use Lithuania SIA Meda Pharma Vienibas gatve 109 Riga LV-1058 Latvia Epinephrine Epipen 150 microgram/0,3 ml Solution for injection in pre-filled pen Intramuscular use Luxembourg Lincoln Medical Ltd Unit 8, Wilton Business Centre, Wilton Salisbury SP2 OAH United kingdom Adrenalin Anapen 150 μg Solution for injection in pre-filled pen Intramuscular use Luxembourg Lincoln Medical Ltd Unit 8, Wilton Business Centre, Wilton Salisbury SP2 OAH United kingdom Adrenalin Anapen 300 μg Solution for injection in pre-filled pen Intramuscular use Luxembourg Meda Pharma GmbH&Co.KG Benzstrasse 1 61352 Bad Homburg Germany Adrenalin (hydrochloride) Fastjekt 300 μg Solution for injection in pre-filled pen Intramuscular use Luxembourg Meda Pharma GmbH&Co.KG Benzstrasse 1 61352 Bad Homburg Germany Adrenalin (hydrochloride) Fastjekt junior 150 μg Solution for injection in pre-filled pen Intramuscular use Luxembourg Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark Adrenalin (tartrate) Jext 150 μg Solution for injection in pre-filled pen Intramuscular use Luxembourg Alk Abello A/S Boge Alle 6-8 2970 Horsholm Denmark Adrenalin (tartrate) Jext 300 μg Solution for injection in pre-filled pen Intramuscular use Malta Lincoln Medical Limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom Adrenalin Anapen 300 micrograms in 0,3 ml solution for injection in a pre-filled syringe 300 micrograms/0,3 ml Solution for injection Intramuscular use Malta Lincoln Medical Limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH United Kingdom Adrenalin Anapen Junior 150 micrograms in 0,3 ml solution for injection in a pre-filled syringe 150 micrograms/0,3 ml Solution for injection Intramuscular use Norway Lincoln Medical limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH Great Britain Adrenaline Anapen 300 microg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Norway Lincoln Medical limited Unit 8 Wilton Business Centre Wilton Salisbury SP2 0AH Great Britain Adrenaline Anapen Junior 150 microg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Norway Meda AS Askerveien 61 Postboks 194 1371 Asker Norway Adrenaline EpiPen 300 microg Solution for injection in pre-filled syringe Intramuscular use Norway Meda AS Askerveien 61 Postboks 194 1371 Asker Norway Adrenaline EpiPen Jr 150 microg Solution for injection in pre-filled syringe Intramuscular use Norway ALK-Abelló AS Bøge Alle 6-8 DK-2970 Hørsholm Denmark Adrenaline tartrate Jext 150 microg Solution for injection in pre-filled syringe Intramuscular use Norway ALK-Abelló AS Bøge Alle 6-8 DK-2970 Hørsholm Denmark Adrenaline tartrate Jext 300 microg Solution for injection in pre-filled syringe Intramuscular use Poland Warszawskie Zakłady Farmaceutyczne POLFA S.A. ul. Karolkowa 22/24 01-207 Warszawa Adrenaline Adrenalina WZF 300 mcg/0,3 ml Solution for infusion in pre-filled syringe/pen Intramuscular use Poland Lincoln Medical Limited Unit 8, Wilton Business Centre, Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen 300 mcg Solution for infusion Intramuscular use Poland Lincoln Medical Limited Unit 8, Wilton Business Centre, Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen Junior 150 mcg Solution for infusion Intramuscular use Poland Meda Pharma GmbH & Co. KG Benzstrasse 1 61352 Bad Homburg Germany Adrenaline EpiPen Jr. 150 mcg/dose Solution for infusion Intramuscular use Poland Meda Pharma GmbH & Co. KG Benzstrasse 1 61352 Bad Homburg Germany Adrenaline EpiPen Senior 300 mcg/dose Solution for infusion Intramuscular use Portugal Lincoln Medical Ltd Unit 8, Wilton Business Centre, Wilton SP2 0AH Salisbury United Kingdom Adrenaline Anapen 0,15 mg/0,3 ml 0,15 mg/0,3 ml Solution for injection Intramuscular use Portugal Lincoln Medical Ltd Unit 8, Wilton Business Centre, Wilton SP2 0AH Salisbury United Kingdom Adrenaline Anapen 0,3 mg/0,3 ml 0,3 mg/0,3 ml Solution for injection Intramuscular use Portugal Meda Pharma — Produtos Farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa Portugal Adrenaline Epipen 0,15 mg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Portugal Meda Pharma — Produtos Farmacêuticos, S.A. Rua do Centro Cultural, 13 1749-066 Lisboa Portugal Adrenaline Epipen 0,3 mg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Romania MEDA Pharma GmbH & Co. KG Benzstr. 1, 61352 Bad Homburg v.d. Höhe Germany Adrenalină (epinefrină) EpiPen 150 micrograme 150 micrograms/dose Solution for injection in a pre-filled pen Intramuscular use Romania MEDA Pharma GmbH & Co. KG Benzstr. 1, 61352 Bad Homburg v.d. Höhe Germany Adrenalină (epinefrină) EpiPen 300 micrograme 300 micrograms/dose Solution for injection in a pre-filled pen Intramuscular use Slovak Republic Meda Pharma spol. s r. o. Trnavská cesta 50 821 02 Bratislava Slovak Republic Epinephrine EpiPen 300 μg/dose Solution for injection in pre-filled pen Intramuscular use Slovak Republic Meda Pharma spol. s r. o. Trnavská cesta 50 821 02 Bratislava Slovak Republic Epinephrine EpiPen Jr. 150 μg/dose Solution for injection in pre-filled pen Intramuscular use Slovak Republic ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm Denmark Epinephrine Jext 150 mikrogramov 150 μg/dose Solution for injection in pre-filled pen Intramuscular use Slovak Republic ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm Denmark Epinephrine Jext 300 mikrogramov 300 μg/dose Solution for injection in pre-filled pen Intramuscular use Slovenia Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United kingdom Adrenaline Anapen 300 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 300 mcg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Slovenia Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United kingdom Adrenaline Anapen za otroke 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 150 mcg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Slovenia Meda Pharma GmbH & Co. KG, Benzstrasse 1 61352 Bad Homburg Germany Adrenaline Epipen 300 mikrogramov/0,3 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 300 mcg/0,3 ml Solution for injection in pre-filled pen Intramuscular use Slovenia Meda Pharma GmbH & Co. KG, Benzstrasse 1 61352 Bad Homburg Germany Adrenaline Epipen za otroke 150 mikrogramov/0,3 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 150 mcg/0,3 ml Solution for injection in pre-filled pen Intramuscular use Spain MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2a planta Parque Empresarial San Fernando 28830 San Fernando de Henares (Madrid) Spain Adrenaline Altellus 150 microgramos niños, solución inyectable en pluma precargada 0,15 mg/0,3 ml Solution for injection in pre-filled pen Intramuscular use Spain MEDA PHARMA, SAU Avda. de Castilla, 2 Edificio Berlín 2a planta Parque Empresarial San Fernando 28830 San Fernando de Henares (Madrid) Spain Adrenaline Altellus 300 microgramos adultos solución inyectable en pluma precargada 0,30 mg/0,3 ml Solution for injection in pre-filled pen Intramuscular use Spain Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen 0,15 mg/0,3 ml solución inyectable en jeringa precargada 0,15 mg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Spain Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen 0,30 mg/0,3 ml solución inyectable en jeringa precargada 0,30 mg/0,3 ml Solution for injection in pre-filled syringe Intramuscular use Spain ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark Adrenaline tartrate Jext 150 microgramos solución inyectable en pluma precargada 0,15 mg/0,3 ml Solution for injection in pre-filled pen Intramuscular use Spain ALK ABELLÓ, S/A Bloque Alle, 6-8 DK-2970 Horsholm Denmark Adrenaline tartrate Jext 300 microgramos solución inyectable en pluma precargada 0,30 mg/0,3 ml Solution for injection in pre-filled pen Intramuscular use Sweden Meda AB Box 906 170 09 Solna Sweden Adrenaline EpiPen 300 mikrogram Solution for injection in pre-filled pen Parenteral use Sweden Meda AB Box 906 170 09 Solna Sweden Adrenaline EpiPen jr 150 mikrogram Solution for injection in pre-filled pen Parenteral use Sweden Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton Salisbury SP20AH United Kingdom Adrenaline Anapen 0,3 mg/dose Solution for injection in pre-filled syringe Parenteral use Sweden Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton Salisbury SP20AH United Kingdom Adrenaline Anapen Junior 0,15 mg/dose Solution for injection in pre-filled syringe Parenteral use Sweden ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm Denmark Adrenaline tartrate Jext 300 mikrogram Solution for injection in pre-filled pen Parenteral use Sweden ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horsholm Denmark Adrenaline tartrate Jext 150 mikrogram Solution for injection in pre-filled pen Parenteral use Sweden PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Adrenaline tartrate Emerade 500 mikrogram Solution for injection in pre-filled pen Parenteral use Sweden PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Adrenaline tartrate Emerade 300 mikrogram Solution for injection in pre-filled pen Parenteral use Sweden PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Adrenaline tartrate Emerade 150 mikrogram Solution for injection in pre-filled pen Parenteral use Sweden Meda AB Box 906 170 09 Solna Sweden Adrenaline Nepipe 300 mikrogram Solution for injection in pre-filled pen Parenteral use Sweden Meda AB Box 906 170 09 Solna Sweden Adrenaline Nepipe Junior 150 mikrogram Solution for injection in pre-filled pen Parenteral use The Netherlands Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen, oplossing voor injectie 0,3 microgram/ dosis Solution for injection Intramuscular use The Netherlands Lincoln Medical Ltd Unit 8 Wilton Business Centre Wilton, Salisbury SP2 0AH United Kingdom Adrenaline Anapen junior, oplossing voor injectie 0,15 microgram/ dosis Solution for injection Intramuscular use The Netherlands Meda Pharma B.V. Krijgsman 20 1186 DM Amstelveen The Netherlands Adrenaline EpiPen Junior 150 microgram/dosis 0,15 microgram/ dosis Solution for injection in a pre-filled syringe Intramuscular use The Netherlands Meda Pharma B.V. Krijgsman 20 1186 DM Amstelveen The Netherlands Adrenaline EpiPen 300 microgram/dosis 0,3 microgram/ dosis Solution for injection in a pre-filled syringe Intramuscular use The Netherlands ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horshlom Denmark Adrenaline Jext 150 microgram, oplossing voor injectie 0,15 microgram/ dosis Solution for injection Intramuscular use The Netherlands ALK-Abelló A/S Boge Allé 6-8 DK-2970 Horshlom Denmark Adrenaline Jext 300 microgram, oplossing voor injectie 0,3 microgram/ dosis Solution for injection Intramuscular use United Kingdom Alk Abello A-S Boge Alle 6-8 Hersholm 2970 Denmark Adrenaline tartrate Jext 150 micrograms solution for injection in pre-filled pen 150 micrograms Solution for injection Intramuscular use United Kingdom Alk Abello A-S Boge Alle 6-8. Hersholm 2970 Denmark Adrenaline tartrate Jext 300 micrograms solution for injection in pre-filled pen 300 micrograms Solution for injection Intramuscular use United Kingdom Aurum Pharmaceuticals Limited, Bampton Road Harold Hill Romford Essex RM3 8UG United Kingdom Adrenaline acid tartrate Adrenaline (epinephrine) 1 in 1 000 solution for injection BP auto-injector 1 in 1 000 Solution for injection Intramuscular/subcutaneous use United Kingdom Meda Pharmaceuticals Limited, Skyway House Parsonage Road, Takeley Bishops Stortford CM22 6PU United Kingdom Adrenaline Epipen auto-injector 0,3 mg 0,3 mg Solution for injection Intramuscular use United Kingdom Meda Pharmaceuticals Limited Skyway House, Parsonage Road, Takeley Bishops Stortford CM22 6PU United Kingdom Adrenaline Epipen auto-injector 0,15 mg 0,15 mg Solution for injection Intramuscular use United Kingdom PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Adrenaline tartrate Emerade 150 micrograms solution for injection in pre-filled pen 150 micrograms Solution for injection Intramuscular use United Kingdom PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Adrenaline tartrate Emerade 300 micrograms solution for injection in pre-filled pen 300 micrograms Solution for injection Intramuscular use United Kingdom PharmaSwiss Ceska republika s.r.o. Jankovcova 1569/2c 170 00 Prague Czech Republic Adrenaline tartrate Emerade 500 micrograms solution for injection in pre-filled pen 500 micrograms Solution for injection Intramuscular use

ANNEX II List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States Member State (in EEA) Marketing Authorisation Holder Invented Name Strength Pharmaceutical form Route of administration Content (concentration) Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 1 g Dispersible tablet Oral Use N/A Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 500 mg Capsule, hard Oral Use N/A Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 125 mg Powder for oral suspension Oral Use 125 mg/5 ml Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 250 mg Powder for oral suspension Oral Use 250 mg/5 ml Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 500 mg Powder for oral suspension Oral Use 500 mg Belgium GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 1 g Powder and solvent for solution for injection Intravenous/ Intramuscular 1 g Cyprus SmithKline Beecham Limited, 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil 500 mg Capsule Oral Use N/A Cyprus SmithKline Beecham Limited, 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil Forte 250 mg Powder for oral suspension Oral Use 250 mg/5 ml France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 500 mg Capsule Oral Use N/A France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 1 g Dispersible tablet Oral Use N/A France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 250 mg Powder for oral suspension Oral Use 250 mg/5 ml France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 500 mg Powder for solution for injection Intravenous/ Intramuscular 500 mg France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 1 g Powder for solution for injection Intravenous/ Intramuscular 1 g France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 2 g Powder for solution for injection Intravenous 2 g France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 1 g Powder and solvent for solution for injection Intramuscular 1 g France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 1 g Powder for oral suspension (sachet) Oral Use N/A France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 125 mg Powder for oral suspension Oral Use 125 mg/5 ml France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Clamoxyl 500 mg Powder for oral suspension Oral Use 500 mg/5 ml France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Amoxicilline Biogaran 1 g Dispersible tablet Oral Use N/A France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Amoxicilline Biogaran 500 mg Capsule Oral Use N/A France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Amoxicilline Biogaran 125 mg Powder for oral suspension Oral Use 125 mg/5 ml France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Amoxicilline Biogaran 250 mg Powder for oral suspension Oral Use 250 mg/5 ml France Laboratoire GlaxoSmithKline 100, route de Versailles 78163 Marly-le-Roi Cedex France Amoxicilline Biogaran 500 mg Powder for oral suspension Oral Use 500 mg/5 ml Greece GlaxoSmithKline a.e.b.e. 266 Kifisias Avenue 152 32 Halandri Greece Amoxil 500 mg Capsule, hard Oral Use N/A Greece GlaxoSmithKline a.e.b.e. 266 Kifisias Avenue 152 32 Halandri Greece Amoxil 250 mg Powder for oral suspension Oral Use 250 mg/5 ml Greece GlaxoSmithKline a.e.b.e. 266 Kifisias Avenue 152 32 Halandri Greece Amoxil 500 mg Powder for oral suspension Oral Use 500 mg/5 ml Greece GlaxoSmithKline a.e.b.e. 266 Kifisias Avenue 152 32 Halandri Greece Amoxil 1 g Dispersible tablet Oral Use N/A Greece GlaxoSmithKline a.e.b.e. 266 Kifisias Avenue 152 32 Halandri Greece Amoxil 1 g Powder and solvent for solution for injection Intravenous/ Intramuscular 1 g/vial Ireland GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham Dublin 16 Ireland Amoxil Paediatric 125 mg/1,25 ml Powder for Oral Suspension 125 mg Powder for oral suspension Oral Use 125 mg/1,25 ml Ireland GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham Dublin 16 Ireland Amoxil 3 g Powder for Oral Suspension Sachets 3 g Powder for oral suspension (sachet) Oral Use 3 g Ireland GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham Dublin 16 Ireland Amoxil Vials 500 mg, powder for solution for injection or infusion 500 mg Powder for solution for injection or infusion Intravenous/ Intramuscular 500 mg Latvia GlaxoSmithKline Latvia SIA Duntes iela 11 Rīga LV-1013 Latvia Amoxil 500 mg kapsulas 500 mg Capsule Oral Use N/A Lithuania Beecham Group plc. Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil 1 g Dispersible tablet Oral Use N/A Lithuania Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil 250 mg Powder for oral suspension Oral Use 250 mg/5 ml Lithuania Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil 500 mg Capsule, hard Oral Use N/A Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 1 g Powder and solvent for solution for injection Intravenous/ Intramuscular 1 g Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 1 g Powder for solution for injection Intravenous/ Intramuscular 1 g Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 125 mg Powder for oral suspension Oral Use 125 mg/5 ml Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 1 g Dispersible tablet Oral Use N/A Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 250 mg Powder for oral suspension Oral Use 250 mg/5 ml Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 500 mg Capsule Oral Use N/A Luxembourg GlaxoSmithKline Pharmaceuticals s.a./n.v. Site Apollo Avenue Pascal, 2- 4- 6 B-1300 Wavre Belgium Clamoxyl 500 mg Powder for oral suspension Oral Use 500 mg/5 ml Malta Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil Syrup Sucrose-Free/Dye-Free 250 mg/5 ml 250 mg Powder for Oral Suspension Oral Use 250 mg/5 ml Malta Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil Capsules 500 mg 500 mg Capsule Oral Use N/A Portugal Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda. Rua Dr António Loureiro Borges, 3 Arquiparque-Miraflores 1495-131 Algés Portugal Clamoxyl 500 mg Capsule Oral Use N/A Portugal Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda. Rua Dr António Loureiro Borges, 3 Arquiparque-Miraflores 1495-131 Algés Portugal Clamoxyl 1 g Dispersible tablet Oral Use N/A Portugal Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda. Rua Dr António Loureiro Borges, 3 Arquiparque-Miraflores 1495-131 Algés Portugal Clamoxyl 250 mg/5 ml Powder for oral suspension Oral Use 250 mg/5 ml Portugal Beecham Portuguesa — Produtos Farmacêuticos e Químicos, Lda. Rua Dr António Loureiro Borges, 3 Arquiparque-Miraflores 1495-131 Algés Portugal Clamoxyl 500 mg/5 ml Powder for oral suspension Oral Use 500 mg/5 ml Spain GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain Clamoxyl 1 g comprimidos 1 g Tablet Oral Use N/A Spain GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain Clamoxyl 750 mg comprimidos 750 mg Tablet Oral Use N/A Spain GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain Clamoxyl 500 mg cápsulas 500 mg Capsule, hard Oral Use N/A Spain GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain Clamoxyl 1 g polvo para suspensión oral en sobre 1 g Powder for oral suspension Oral Use N/A Spain GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain Clamoxyl 500 mg polvo para suspensión oral en sobre 500 mg Powder for oral suspension Oral Use N/A Spain GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain Clamoxyl 250 mg polvo para suspensión oral en sobre 250 mg Powder for oral suspension Oral Use N/A Spain GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain Clamoxyl 250 mg/5 ml polvo para suspensión oral en frasco 250 mg Powder for oral suspension Oral Use 250 mg/5 ml Spain GlaxoSmithKline, S.A. PTM- Severo Ochoa, 2 28760-Tres Cantos (Madrid) Spain Clamoxyl 1 g intramuscular 1 g Powder and solvent for solution for injection Intramuscular Use 1 g/vial United Kingdom Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil 250 mg Capsule Oral Use N/A United Kingdom Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil 500 mg Capsule Oral Use N/A United Kingdom Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil paediatric suspension 125 mg Powder for oral suspension Oral Use 125 mg/1,25 ml United Kingdom Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil sachets 3 g sucrose free 3 g Powder for oral suspension Oral Use 3 g United Kingdom Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil Vials for Injection 250 mg Powder for solution for injection Intravenous/ Intramuscular 250 mg United Kingdom Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil Vials for Injection 500 mg Powder for solution for injection Intravenous/ Intramuscular 500 mg United Kingdom Beecham Group plc Great West Road Brentford Middlesex TW8 9GS United Kingdom Amoxil Vials for Injection 1 g Powder for solution for injection Intravenous/ Intramuscular 1 g