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)
Date: 2015-09-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2015318EN.01000801.xml










25.9.2015   


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







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