25.9.2015

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

ANNEX III

List of the names, pharmaceutical form, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States

Member State

(EU/EEA)

Marketing authorisation holder

Product name

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Belgium

Ceva Santé Animale S.A/N.V.

Metrologielaan 6

1130 Brussel

Belgium

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Bulgaria

Ceva Animal Health Bulgaria

ul. Elemag 26, vh.b, Et.1, Apt.1

Sofia - 1113

Bulgaria

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Croatia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Cyprus

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Czech Republic

Ceva Animal Health Slovakia, s.r.o.

Račianska 153

831 53 Bratislava

Slovakia

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Estonia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

FRANCE

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Finland

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Germany

Ceva Tiergesundheit GmbH

Kanzlerstr. 4

40472 Düsseldorf

Germany

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Greece

Ceva Hellas LLC

15, Agiou Nikolaou str.

17455 ALIMOS

Greece

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Hungary

CEVA-Phylaxia Veterinary Biologicals Co. Ltd

Szállás u. 5.

1107 Budapest

Hungary

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Iceland

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Ireland

Ceva Santé Animale

10, av. de La Ballastière, 33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Italy

Ceva Salute Animale S.p.A.

Viale Colleoni 15, 20864 Agrate Brianza (MB)

Italy

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Latvia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Lituania

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

The Netherlands

Ceva Sante Animale B.V.

Tiendweg 8 c, 2670 AB Naaldwijk

The Netherlands

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Poland

Ceva Animal Health Polska Sp. z o.o.

ul. Okrzei 1A,

03-715 Warszawa

Poland

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Portugal

Ceva Saúde Animal

Produtos Farmacéuticos e Imunológicos, Lda.

Rua Doutor António Loureiro Borges

9/9A — 9oA, Miraflores, 1495 — 131 Algès

Portugal

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Romania

Ceva Santé Animale Romania

Str. Chindiei nr. 5

Sector 4

040185 Bucharest

Romania

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Slovakia

Ceva Animal Health Slovakia, s.r.o.

Račianska 153

831 53 Bratislava

Slovakia

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Slovenia

Ceva Santé Animale

10, av. de La Ballastière

33500 Libourne

France

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

Sweden

Ceva Animal Health A.B.

Annedalsvägen 9

227 64 Lund

Sweden

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

United Kingdom

Ceva Animal Health Ltd

Unit 3, Anglo Office Park, White Lion Road

Amersham, Bucks HP7 9FB

United Kingdom

Coglapix suspension for injection for pigs

Actinobacillus pleuropneumoniae serotype 1 (strain NT3) and Actinobacillus pleuropneumoniae serotype 2 (strains PO, U3, B4, SZ II)

expressing ApxI toxoid min. 28,9 ELISA unit/ml*

ApxII toxoid min. 16,7 ELISA unit/ml

ApxIII toxoid min. 6,8 ELISA unit/ml

*	Elisa unit/ml calculated serological titre in sera of immunised rabbits

Suspension for injection

Pigs

Intramuscular injection

		ISSN 1977-091X
Official Journal of the European Union		C 318

English edition	Information and Notices	Volume 58 25 September 2015

Notice No	Contents	page
	IV Notices
	NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
	European Commission
2015/C 318/01	Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)	1
2015/C 318/02	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 or Article 38 of Directive 2001/82/EC)	8

Date of the decision	Name of the medicinal product	INN (International Non-Proprietary Name)	Holder of the marketing authorisation	Number of the entry in the Community Register	Pharmaceutical form	ATC code (Anatomical Therapeutic Chemical Code)	Date of notification
14.8.2015	Odomzo	sonidegib	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/15/1030	Capsule, hard	L01XX48	18.8.2015
14.8.2015	Unituxin	dinutuximab	United Therapeutics Europe Ltd Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom	EU/1/15/1022	Concentrate for solution for infusion	L01XC16	18.8.2015
20.8.2015	Aripiprazole Sandoz	Aripiprazole	Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich	EU/1/15/1029	Tablet	N05AX12	24.8.2015
20.8.2015	Duloxetine Zentiva	duloxetine	Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika	EU/1/15/1028	Gastro-resistant capsule, hard	N06AX21	25.8.2015
20.8.2015	Respreeza	human alpha1-proteinase inhibitor	CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland	EU/1/15/1006	Powder and solvent for solution for infusion	B02AB02	25.8.2015
28.8.2015	Docetaxel Hospira UK Limited	docetaxel	Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom	EU/1/15/1017	Concentrate for solution for infusion	L01CD02	1.9.2015
28.8.2015	Farydak	panobinostat	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/15/1023	Capsule, hard	L01XX42	1.9.2015
28.8.2015	Kanuma	sebelipase alfa	Synageva BioPharma Ltd 1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom	EU/1/15/1033	Concentrate and solvent for solution for infusion	Pending	1.9.2015
28.8.2015	Pregabalin Accord	pregabalin	Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom	EU/1/15/1027	Capsule, hard	N03AX16	1.9.2015
28.8.2015	Strensiq	asfotase alfa	Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France	EU/1/15/1015	Solution for injection	Pending	1.9.2015

Date of the decision	Name of the medicinal product	Holder of the marketing authorisation	Number of the entry in the Community Register	Date of notification
6.8.2015	Aerius	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/00/160	10.8.2015
6.8.2015	Azomyr	Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom	EU/1/00/157	10.8.2015
6.8.2015	IDflu	Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France	EU/1/08/507	10.8.2015
6.8.2015	Intanza	Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France	EU/1/08/505	10.8.2015
12.8.2015	Cyanokit	SERB S.A. Avenue Louise 480, 1050 Brussels, Belgique	EU/1/07/420	14.8.2015
12.8.2015	Retacrit	Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom	EU/1/07/431	14.8.2015
14.8.2015	Cialis	Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland	EU/1/02/237	18.8.2015
14.8.2015	Komboglyze	AstraZeneca AB SE-151 85 Södertälje, Sverige	EU/1/11/731	18.8.2015
14.8.2015	Norvir	AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom	EU/1/96/016	18.8.2015
20.8.2015	Adcirca	Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland	EU/1/08/476	24.8.2015
20.8.2015	BeneFIX	Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom	EU/1/97/047	24.8.2015
20.8.2015	Eliquis	Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom	EU/1/11/691	24.8.2015
20.8.2015	Entyvio	Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark	EU/1/14/923	24.8.2015
20.8.2015	Eporatio	ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland	EU/1/09/573	24.8.2015
20.8.2015	Fareston	Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi	EU/1/96/004	24.8.2015
20.8.2015	Infanrix hexa	GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique	EU/1/00/152	1.9.2015
20.8.2015	Invokana	Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België	EU/1/13/884	24.8.2015
20.8.2015	Kalydeco	Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom	EU/1/12/782	27.8.2015
20.8.2015	Keppra	UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België	EU/1/00/146	24.8.2015
20.8.2015	OLYSIO	Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België	EU/1/14/924	24.8.2015
20.8.2015	Qutenza	Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland	EU/1/09/524	24.8.2015
20.8.2015	Stayveer	Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland	EU/1/13/832	24.8.2015
20.8.2015	Tracleer	Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom	EU/1/02/220	24.8.2015
20.8.2015	Twynsta	Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland	EU/1/10/648	24.8.2015
20.8.2015	Vokanamet	Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België	EU/1/14/918	24.8.2015
25.8.2015	Adasuve	Ferrer Internacional S.A. Gran Via Carlos III, 94 08028 Barcelona Spain	EU/1/13/823	27.8.2015
25.8.2015	Biopoin	Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland	EU/1/09/565	27.8.2015
25.8.2015	IDflu	Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France	EU/1/08/507	27.8.2015
25.8.2015	Intanza	Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France	EU/1/08/505	27.8.2015
25.8.2015	Mekinist	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/14/931	27.8.2015
25.8.2015	Optaflu	Novartis Influenza Vaccines Marburg GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland	EU/1/07/394	27.8.2015
25.8.2015	Revolade	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/10/612	27.8.2015
25.8.2015	Tafinlar	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/13/865	27.8.2015
25.8.2015	Temozolomide Teva	Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland	EU/1/09/606	27.8.2015
25.8.2015	Zykadia	Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom	EU/1/15/999	27.8.2015
28.8.2015	Fluenz Tetra	MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland	EU/1/13/887	1.9.2015

Date of the decision	Name of the medicinal product	Holder of the marketing authorisation	Number of the entry in the Community Register	Date of notification
6.8.2015	Advocate	Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland	EU/2/03/039	10.8.2015
20.8.2015	Eurican Herpes 205	Merial 29 avenue Tony Garnier, F-69007 Lyon, France	EU/2/01/029	24.8.2015
28.8.2015	Equilis StrepE	Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland	EU/2/04/043	1.9.2015
28.8.2015	Fevaxyn Pentofel	Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique	EU/2/96/002	1.9.2015