Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2015-01-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015032EN.01000901.xml










30.1.2015   


EN


Official Journal of the European Union


C 32/9





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2014 to 31 December 2014
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2015/C 032/02)
—   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




16.12.2014


Plendil


See Annex I


See Annex I


See Annex I


17.12.2014




11.12.2014


Suanovil 20 Captalin


See Annex II


See Annex II


See Annex II


12.12.2014




22.12.2014


Oxynal-Targin


See Annex III


See Annex III


See Annex III


23.12.2014




5.12.2014


Resflor


See Annex IV


See Annex IV


See Annex IV


9.12.2014




16.12.2014


Polymyxin


See Annex V


See Annex V


See Annex V


17.12.2014




22.12.2014


Docetaxel


Docetaxel and alcohol in their formulation


Not applicable


Not applicable


23.12.2014






(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, strength of the medicinal product, route of administration, marketing authorisation holders in the Member States










Member State
EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria


AstraZeneca Österreich GmbH
Schwarzenbergplatz 7
1037 Wien
Austria


Plendil retard 2,5 mg — Filmtabletten


2,5 mg


Prolonged-release tablet


Oral use




Austria


AstraZeneca Österreich GmbH
Schwarzenbergplatz 7
1037 Wien
Austria


Plendil retard 5 mg — Filmtabletten


5 mg


Prolonged-release tablet


Oral use




Belgium


NV AstraZeneca SA
Rue Egide van Ophemstraat
110, B-1180 Brussel
Belgium


Plendil 5 mg Retard


5 mg


Prolonged-release tablet


Oral use




Belgium


NV AstraZeneca SA
Rue Egide van Ophemstraat
110, B-1180 Brussel
Belgium


Plendil 10 mg Retard


10 mg


Prolonged-release tablet


Oral use




Bulgaria


AstraZeneca AB
S-151 85 Södertälje
Sweden


Плендил
(Plendil)


5 mg


Prolonged-release tablet


Oral use




Croatia


AstraZeneca d.o.o.
Radnička cesta 80
10 000 Zagreb
Croatia


Plendil 5 mg
tablete s produljenim oslobađanjem


5 mg


Prolonged-release tablet


Oral use




Croatia


AstraZeneca d.o.o.
Radnička cesta 80
10 000 Zagreb
Croatia


Plendil 10 mg
tablete s produljenim oslobađanjem


10 mg


Prolonged-release tablet


Oral use




Cyprus


AstraZeneca AB
S-151 85 Södertälje
Sweden


Plendil


2,5 mg


Prolonged-release tablets


Oral use




Cyprus


AstraZeneca AB
S-151 85 Södertälje
Sweden


Plendil


5 mg


Prolonged-release tablet


Oral use




Cyprus


AstraZeneca AB
S-151 85 Södertälje
Sweden


Plendil


10 mg


Prolonged-release tablet


Oral use




Czech Republic


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


PLENDIL ER 5 mg


5 mg


Prolonged-release tablet


Oral use




Czech Republic


AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
United Kingdom


PLENDIL ER 10 mg


10 mg


Prolonged-release tablet


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Köbenhavn S.
Denmark


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Köbenhavn S.
Denmark


Plendil


5 mg


Prolonged-release tablet


Oral use




Denmark


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Köbenhavn S.
Denmark


Plendil


10 mg


Prolonged-release tablet


Oral use




Estonia


AstraZeneca AB
S-151 85 Södertälje
Sweden


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Estonia


AstraZeneca AB
S-151 85 Södertälje
Sweden


Plendil


5 mg


Prolonged-release tablet


Oral use




Estonia


AstraZeneca AB
S-151 85 Södertälje
Sweden


Plendil


10 mg


Prolonged-release tablet


Oral use




Finland


AstraZeneca Oy
Itsehallintokuja 4
02600 Espoo
Finland


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Finland


AstraZeneca Oy
Itsehallintokuja 4
02600 Espoo
Finland


Plendil


5 mg


Prolonged-release tablet


Oral use




Finland


AstraZeneca Oy
Itsehallintokuja 4
02600 Espoo
Finland


Plendil


10 mg


Prolonged-release tablet


Oral use




France


AstraZeneca
1 place Renault
92844 Rueil-Malmaison Cedex
France


FLODIL


5 mg


Prolonged-release tablet


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


Modip 2,5 mg


2,5 mg


Prolonged-release tablet


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


Modip 5 mg


5 mg


Prolonged-release tablet


Oral use




Germany


AstraZeneca GmbH
22876 Wedel
Germany


Modip 10 mg


10 mg


Prolonged-release tablet


Oral use




Greece


AstraZeneca S.A.
Theotokopoulou & Astronafton str
151 25 Maroussi
Greece


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Greece


AstraZeneca S.A.
Theotokopoulou & Astronafton str
151 25 Maroussi
Greece


Plendil


5 mg


Prolonged-release tablet


Oral use




Greece


AstraZeneca S.A.
Theotokopoulou & Astronafton str
151 25 Maroussi
Greece


Plendil


10 mg


Prolonged-release tablet


Oral use




Hungary


AstraZeneca Kft.
H-1113 Budapest
Bocskai út 134-146
Hungary


Plendil 2,5 mg retard filmtabletta


2,5 mg


Prolonged-release tablet


Oral use




Hungary


AstraZeneca Kft.
H-1113 Budapest
Bocskai út 134-146
Hungary


Plendil 5 mg retard filmtabletta


5 mg


Prolonged-release tablet


Oral use




Iceland


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Köbenhavn S.
Denmark


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Iceland


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Köbenhavn S.
Denmark


Plendil


5 mg


Prolonged-release tablet


Oral use




Iceland


AstraZeneca A/S
Arne Jacobsens Allé 13
2300 Köbenhavn S.
Denmark


Plendil


10 mg


Prolonged-release tablet


Oral use




Ireland


AstraZeneca UK Ltd.
600 Capability Green
Luton LU1 3LU
United Kingdom


Plendil 2,5 mg Prolonged-release, Film-coated Tablets


2,5 mg


Prolonged-release tablet


Oral use




Ireland


AstraZeneca UK Ltd.
600 Capability Green
Luton LU1 3LU
United Kingdom


Plendil 5 mg Prolonged-release, Film-coated Tablets


5 mg


Prolonged-release tablet


Oral use




Ireland


AstraZeneca UK Ltd.
600 Capability Green
Luton LU1 3LU
United Kingdom


Plendil 10 mg Prolonged-release, Film-coated Tablets


10 mg


Prolonged-release tablet


Oral use




Italy


AstraZeneca S.p.A
Palazzo Volta
Via F. Sforza
20080 Basiglio (MI)
Italy


Plendil 5 mg
compresse a rilascio prolungato


5 mg


Prolonged-release tablet


Oral use




Italy


AstraZeneca S.p.A
Palazzo Volta
Via F. Sforza
20080 Basiglio (MI)
Italy


Plendil 10 mg compresse a rilascio prolungato


10 mg


Prolonged-release tablet


Oral use




Italy


AstraZeneca S.p.A
Palazzo Volta
Via F. Sforza
20080 Basiglio (MI)
Italy


Feloday 5 mg
compresse a rilascio prolungato


5 mg


Prolonged-release tablet


Oral use




Italy


AstraZeneca S.p.A
Palazzo Volta
Via F. Sforza
20080 Basiglio (MI)
Italy


Feloday 10 mg
compresse a rilascio prolungato


10 mg


Prolonged-release tablet


Oral use




Italy


SIMESA S.p.A
Palazzo Galileo
Via F. Sforza
20080 Basiglio (MI)
Italy


Prevex 5 mg
compresse a rilascio prolungato


5 mg


Prolonged-release tablet


Oral use




Italy


SIMESA S.p.A
Palazzo Galileo
Via F. Sforza
20080 Basiglio (MI)
Italy


Prevex 10 mg
compresse a rilascio prolungato


10 mg


Prolonged-release tablet


Oral use




Latvia


AstraZeneca AB
S-151 85, Södertälje
Sweden


Plendil 5 mg ilgstošās darbības tabletes


5 mg


Prolonged-release tablet


Oral use




Latvia


AstraZeneca AB
S-151 85, Södertälje
Sweden


Plendil 10 mg ilgstošās darbības tabletes


10 mg


Prolonged-release tablet


Oral use




Lithuania


AstraZeneca AB
S-151 85, Södertälje
Sweden


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Lithuania


AstraZeneca AB
S-151 85, Södertälje
Sweden


Plendil


5 mg


Prolonged-release tablet


Oral use




Lithuania


AstraZeneca AB
S-151 85, Södertälje
Sweden


Plendil


10 mg


Prolonged-release tablet


Oral use




Luxembourg


NV AstraZeneca SA
Rue Egide van Ophemstraat
B-1180 Brussel
Belgium


PLENDIL 5 mg Retard


5 mg


Prolonged-release tablet


Oral use




Luxembourg


NV AstraZeneca SA
Rue Egide van Ophemstraat
B-1180 Brussel
Belgium


PLENDIL 10 mg Retard


10 mg


Prolonged-release tablet


Oral use




Malta


Astra Zeneca AB
Gartunavagen, S-151 85 Sodertalje, Sweden


Plendil 5 mg Prolonged-release, Film-coated Tablets


5 mg


Prolonged-release tablet


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


Plendil 2,5


2,5 mg


Prolonged-release tablet


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


Plendil 5


5 mg


Prolonged-release tablet


Oral use




Netherlands


AstraZeneca BV
Louis Pasteurlaan 5
2719 EE Zoetermeer
The Netherlands


Plendil 10


10 mg


Prolonged-release tablet


Oral use




Norway


AstraZeneca AS
Postboks 6050, Etterstad
0601 Oslo
Norway


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Norway


AstraZeneca AS
Postboks 6050, Etterstad
0601 Oslo
Norway


Plendil


5 mg


Prolonged-release tablet


Oral use




Norway


AstraZeneca AS
Postboks 6050, Etterstad
0601 Oslo
Norway


Plendil


10 mg


Prolonged-release tablet


Oral use




Poland


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil


5 mg


Prolonged-release tablet


Oral use




Poland


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil


10 mg


Prolonged-release tablet


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, 7
Queluz de baixo
2730-097 Barcarena
Portugal


Preslow


5 mg


Prolonged-release tablet


Oral use




Portugal


AstraZeneca Produtos Farmacêuticos, Lda.
Rua Humberto Madeira, 7
Queluz de baixo
2730-097 Barcarena
Portugal


Preslow


10 mg


Prolonged-release tablet


Oral use




Romania


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Romania


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil


5 mg


Prolonged-release tablet


Oral use




Romania


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil


10 mg


Prolonged-release tablet


Oral use




Slovak Republic


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil 2,5 mg


2,5 mg


Prolonged-release tablet


Oral use




Slovak Republic


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil 5 mg


5 mg


Prolonged-release tablet


Oral use




Slovak Republic


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil 10 mg


10 mg


Prolonged-release tablet


Oral use




Spain


AstraZeneca Farmacéutica Spain, S.A.
C/Serrano Galvache 56
Edificio Roble
28033 Madrid
Spain


Plendil 5 mg comprimidos de liberación prolongada


5 mg


Prolonged-release tablet


Oral use




Sweden


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil


2,5 mg


Prolonged-release tablet


Oral use




Sweden


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil


5 mg


Prolonged-release tablet


Oral use




Sweden


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Plendil


10 mg


Prolonged-release tablet


Oral use




Sweden


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Felodipin AstraZeneca


2,5 mg


Prolonged-release tablet


Oral use




Sweden


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Felodipin AstraZeneca


5 mg


Prolonged-release tablet


Oral use




Sweden


AstraZeneca AB
S-151 85 Sodertalje
Sweden


Felodipin AstraZeneca


10 mg


Prolonged-release tablet


Oral use




United Kingdom


AstraZeneca UK Ltd.
600 Capability Green
Luton LU1 3LU
United Kingdom


Plendil


2,5 mg


Prolonged-release tablet


Oral use




United Kingdom


AstraZeneca UK Ltd.
600 Capability Green
Luton LU1 3LU
United Kingdom


Plendil


5 mg


Prolonged-release tablet


Oral use




United Kingdom


AstraZeneca UK Ltd.
600 Capability Green
Luton LU1 3LU
United Kingdom


Plendil


10 mg


Prolonged-release tablet


Oral use







ANNEX II
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States











Member State EU/EEA


Applicant/Marketing Authorisation Holder


Product name


INN


Strength


Pharmaceutical form


Animal species




Belgium


Merial Belgium SA
Culliganlaan 1c
1831 Diegem
Belgium


Captalin


Spiramycin


1 0 00  000 IU/ml


Solution for injection


Cattle




Bulgaria


Ceva Animal Health Bulgaria Ltd
26 Elemag Str., ent.B, app.1
Sofia 1113
Bulgaria


Spirovet 6 00  000 IU/ml инжекционен разрвор за говеда и свине/Spirovet 6 00  000 IU/ml solution for injection for cattle and pigs


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Czech Republic


Merial
29 avenue Tony Garnier
69007 Lyon
France


SUANOVIL 20 injekční roztok


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Czech Republic


Ceva Sante Animale
Z.I. La Ballastière
Libourne
France


SPIROVET 6 00  000 IU/ml solution for injection for cattle and pigs


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Estonia


Merial
29 avenue Tony Garnier
69007 Lyon
France


Suanovil 20


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Estonia


Ceva Sante Animale
10 avenue de la Ballastière
33500 Libourne
France


Spirovet


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




France


Merial
29 avenue Tony Garnier
69007 Lyon
France


Suanovil 20


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




France


Merial
29 avenue Tony Garnier
69007 Lyon
France


Captalin


Spiramycin


1 0 00  000 IU/ml


Solution for injection


Cattle




France


Ceva Sante Animale
10 avenue de la Ballastière
33500 Libourne
France


Spirovet


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




France


Ceva Sante Animale
10 avenue de la Ballastière
33500 Libourne
France


Spiramycine CEVA 6 00  000 UI/ML solution injectable pour bovins et porcins


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Greece


Merial
29 avenue Tony Garnier
69007 Lyon
France


Suanovil 20


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Hungary


Merial
29 avenue Tony Garnier
69007 Lyon
France


Suanovil 20 % injekció


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Hungary


Ceva-Phylaxia Zrt.
Szállás u. 5
1107 Budapest
Hungary


Spirovet 6 00  000 NE/ml, injekció szarvasmarha és sertés részére


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Ireland


Ceva Sante Animale
10 avenue de la Ballastière
33500 Libourne
France


SPIROVET 6 00  000 IU/ml solution for injection for cattle and pigs


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Italy


Merial Italia S.p.A.
Via Vittor Pisani 16
20124 Milano
Italy


Captalin


Spiramycin


1 0 00  000 IU/ml


Solution for injection


Cattle




Italy


Merial Italia S.p.A.
Via Vittor Pisani 16
20124 Milano
Italy


Spiramin


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Italy


Ceva Salute Animale S.p.A.
Viale Colleoni, 15
20864 Agrate Brianza (MB)
Italy


Spiravet 20


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Latvia


Merial
29 avenue Tony Garnier
69007 Lyon
France


Suanovil 20


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Lithuania


Ceva Sante Animale
Z.I. La Ballastière
33500 Libourne
France


SPIROVET 6 00  000 TV/ml, injekcinis tirpalas galvijams ir kiaulėms


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Portugal


Merial Portuguesa — Saúde Animal, LDA
Av. Maria Lamas, lote 19 — BL. A Piso 2
Parque Industrial e Comercial Serra das Minas
2635-432 Rio de Mouro
Portugal


Suanovil 20


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Portugal


Ceva Saúde Animal — Produtos Farmacêuticos e Imunológicos, Lda.
Rua Doutor António Loureiro Borges,
9/9A, 9oA Miraflores
1495-131 Algés
Portugal


SPIROVET 6 00  000 UI/ml solução injetável para bovinos e suínos


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Romania


Ceva Sante Animale
Z.I. de la Ballastière, BP 126
33500 Libourne Cedex
FRANCE


Spirovet


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Romania


Merial
Rue de Bourgelat 17
69002 Lyon
France


Suanovil 20


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Slovakia


Merial
29 avenue Tony Garnier
69007 Lyon
France


Suanovil 20 injekčný roztok


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Slovenia


Ceva Sante Animale
10 avenue de la Ballastière
33500 Libourne
France


SPIROVET 6 00  000 IU/ml raztopina za injiciranje za govedo in prašiče


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




Spain


Merial Laboratorios S.A.
Tarragona, No 161 — Locales D/E 08820 Barcelona
Spain


Suanovil 20


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs




United Kingdom


Ceva Animal Health Ltd
Unit 3
Anglo Office Park
White Lion Road
Amersham
Buckinghamshire
HP7 9FB
United Kingdom


Spirovet


Spiramycin


6 00  000 IU/ml


Solution for injection


Cattle
Pigs







ANNEX III
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


Product name


Strength


Pharmaceutical form


Route of administration




Austria


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Austria


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Austria


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Austria


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Belgium


Mundipharma Comm. VA
Blarenberglaan 3C, Mechelen
2800
Belgium


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




Belgium


Mundipharma Comm. VA
Blarenberglaan 3C, Mechelen
2800
Belgium


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




Belgium


Mundipharma Comm. VA
Blarenberglaan 3C, Mechelen
2800
Belgium


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




Belgium


Mundipharma Comm. VA
Blarenberglaan 3C, Mechelen
2800
Belgium


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral




Bulgaria


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Bulgaria


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Bulgaria


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Bulgaria


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Cyprus


Mundipharma Pharmaceuticals Ltd.
13, Othellos Street, Dhali Industrial Zone, Nicosia
Cyprus


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




Cyprus


Mundipharma Pharmaceuticals Ltd.
13, Othellos Street, Dhali Industrial Zone, Nicosia
Cyprus


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




Cyprus


Mundipharma Pharmaceuticals Ltd.
13, Othellos Street, Dhali Industrial Zone, Nicosia
Cyprus


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




Cyprus


Mundipharma Pharmaceuticals Ltd.
13, Othellos Street, Dhali Industrial Zone, Nicosia
Cyprus


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral




Czech Republic


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride)


Targin 5 mg/2,5 mg tablety s prodlouženým uvolňováním


5 mg/2,5 mg


prolonged-release tablets


oral




Czech Republic


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride)


Targin 10 mg/5 mg tablety s prodlouženým uvolňováním


10 mg/5 mg


prolonged-release tablets


oral




Czech Republic


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride)


Targin 20 mg/10 mg tablety s prodlouženým uvolňováním


20 mg/10 mg


prolonged-release tablets


oral




Czech Republic


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate (Naloxone hydrochloride)


Targin 40 mg/20 mg tablety s prodlouženým uvolňováním


40 mg/20 mg


prolonged-release tablets


oral




Denmark


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Denmark


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Denmark


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Denmark


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Estonia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




Estonia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




Estonia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




Estonia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral




Finland


Mundipharma Oy
Rajatorpantie 41 B
01640 Vantaa
Finland


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


10 mg/5 mg


prolonged-release tablets


oral




Finland


Mundipharma Oy
Rajatorpantie 41 B
01640 Vantaa
Finland


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


20 mg/10 mg


prolonged-release tablets


oral




Finland


Mundipharma Oy
Rajatorpantie 41 B
01640 Vantaa
Finland


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


5 mg/2,5 mg


prolonged-release tablets


oral




Finland


Mundipharma Oy
Rajatorpantie 41 B
01640 Vantaa
Finland


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


40 mg/20 mg


prolonged-release tablets


oral




France


Mundipharma SAS
100, avenue de Suffren, Paris
75015
France


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




France


Mundipharma SAS
100, avenue de Suffren Paris
75015
France


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




France


Mundipharma SAS
100, avenue de Suffren
Paris
75015
France


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




France


Mundipharma SAS
100, avenue de Suffren
Paris
75015
France


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral




Germany


Mundipharma GmbH
Mundipharma Str. 2
Limburg
65549
Germany


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Oxynal


10 mg/5 mg


prolonged-release tablets


oral




Germany


Mundipharma GmbH
Mundipharma Str. 2, Limburg
65549
Germany


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Oxynal


20 mg/10 mg


prolonged-release tablets


oral




Germany


Mundipharma GmbH
Mundipharma Str. 2, Limburg
65549
Germany


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Germany


Mundipharma GmbH
Mundipharma Str. 2
Limburg
65549
Germany


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Germany


Mundipharma GmbH
Mundipharma Str. 2 Limburg
65549
Germany


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Germany


Mundipharma GmbH
Mundipharma Str. 2 Limburg
65549
Germany


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Hungary


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




Hungary


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




Hungary


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




Hungary


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral




Iceland


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Iceland


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Iceland


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Iceland


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Ireland


Mundipharma Pharmaceuticals Ltd.
Millbank House, Arkle Road
Sandyford, Dublin 18
Ireland


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Ireland


Mundipharma Pharmaceuticals Ltd.
Millbank House, Arkle Road
Sandyford, Dublin 18
Ireland


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Ireland


Mundipharma Pharmaceuticals Ltd.
Millbank House, Arkle Road
Sandyford, Dublin 18
Ireland


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Ireland


Mundipharma Pharmaceuticals Ltd.
Millbank House, Arkle Road
Sandyford, Dublin 18
Ireland


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Italy


Mundipharma Pharmaceuticals Srl
Via G. Serbelloni 4, Milano
20122
Italy


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Italy


Mundipharma Pharmaceuticals Srl
Via G. Serbelloni 4, Milano
20122
Italy


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Italy


Mundipharma Pharmaceuticals Srl
Via G. Serbelloni 4, Milano
20122
Italy


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Italy


Mundipharma Pharmaceuticals Srl
Via G. Serbelloni 4, Milano
20122
Italy


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Latvia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Latvia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride


Targin


10 mg/5 mg


prolonged-release tablets


oral




Latvia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride


Targin


20 mg/10 mg


prolonged-release tablets


oral




Latvia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride


Targin


40 mg/20 mg


prolonged-release tablets


oral




Luxembourg


Mundipharma Comm. VA
Blarenberglaan 3C, Mechelen
2800
Belgium


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




Luxembourg


Mundipharma Comm. VA
Blarenberglaan 3C Mechelen
2800
Belgium


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




Luxembourg


Mundipharma Comm. VA
Blarenberglaan 3C Mechelen
2800
Belgium


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




Luxembourg


Mundipharma Comm. VA
Blarenberglaan 3C Mechelen
2800
Belgium


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral




Norway


Mundipharma AS
Dicks vei 10B, 1366
Lysaker
Norway


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


10 mg/5 mg


prolonged-release tablets


oral




Norway


Mundipharma AS
Dicks vei 10B, 1366
Lysaker
Norway


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


20 mg/10 mg


prolonged-release tablets


oral




Norway


Mundipharma AS
Dicks vei 10B, 1366
Lysaker
Norway


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


5 mg/2,5 mg


prolonged-release tablets


oral




Norway


Mundipharma AS
Dicks vei 10B, 1366
Lysaker
Norway


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


40 mg/20 mg


prolonged-release tablets


oral




Poland


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Poland


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Poland


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Poland


Norpharma A/S
Slotsmarken 15, Horsholm
2970
Denmark


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Portugal


Mundipharma Farmaceutica Lda
Rua Duque de Palmela, no 23, Lisboa
1250-097
Portugal


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Portugal


Mundipharma Farmaceutica Lda
Rua Duque de Palmela, no 23, Lisboa
1250-097
Portugal


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Portugal


Mundipharma Farmaceutica Lda
Rua Duque de Palmela, no 23, Lisboa
1250-097
Portugal


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Portugal


Mundipharma Farmaceutica Lda
Rua Duque de Palmela, no 23, Lisboa
1250-097
Portugal


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Romania


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Romania


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Romania


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Romania


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Slovak Republic


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Slovak Republic


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Slovak Republic


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Slovak Republic


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Slovenia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




Slovenia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




Slovenia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




Slovenia


Mundipharma Gesellschaft m.b.H
Apollogasse 16-18, Wien
1070
Austria


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral




Spain


Mundipharma Pharmaceuticals, S.L.
C/Bahía de Pollensa, 11 Madrid
28042
Spain


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


5 mg/2,5 mg


prolonged-release tablets


oral




Spain


Mundipharma Pharmaceuticals, S.L.
C/Bahía de Pollensa, 11
Madrid
28042
Spain


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


10 mg/5 mg


prolonged-release tablets


oral




Spain


Mundipharma Pharmaceuticals, S.L.
C/Bahía de Pollensa, 11, Madrid
28042
Spain


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


20 mg/10 mg


prolonged-release tablets


oral




Spain


Mundipharma Pharmaceuticals, S.L.
C/Bahía de Pollensa, 11
Madrid
28042
Spain


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targin


40 mg/20 mg


prolonged-release tablets


oral




Sweden


Mundipharma AB
Mölndalsvägen 30B
Göteborg
412 63
Sweden


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


10 mg/5 mg


prolonged-release tablets


oral




Sweden


Mundipharma AB
Mölndalsvägen 30B Göteborg
412 63
Sweden


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


20 mg/10 mg


prolonged-release tablets


oral




Sweden


Mundipharma AB
Mölndalsvägen 30B Göteborg
412 63
Sweden


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


5 mg/2,5 mg


prolonged-release tablets


oral




Sweden


Mundipharma AB
Mölndalsvägen 30B Göteborg
412 63
Sweden


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targiniq


40 mg/20 mg


prolonged-release tablets


oral




The Netherlands


Mundipharma Pharmaceuticals B.V.
De Wel 20, MV Hoevelaken
3871
The Netherlands


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




The Netherlands


Mundipharma Pharmaceuticals B.V.
De Wel 20, MV Hoevelaken
3871
The Netherlands


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




The Netherlands


Mundipharma Pharmaceuticals B.V.
De Wel 20, MV Hoevelaken
3871
The Netherlands


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




The Netherlands


Mundipharma Pharmaceuticals B.V.
De Wel 20, MV Hoevelaken
3871
The Netherlands


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral




United Kingdom


Napp Pharmaceuticals Ltd.
Cambridge Science Park Milton Road
CB4 0GW
United Kingdom


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


10 mg/5 mg


prolonged-release tablets


oral




United Kingdom


Napp Pharmaceuticals Ltd.
Cambridge Science Park Milton Road
CB4 0GW
United Kingdom


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


20 mg/10 mg


prolonged-release tablets


oral




United Kingdom


Napp Pharmaceuticals Ltd.
Cambridge Science Park Milton Road
CB4 0GW
United Kingdom


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


5 mg/2,5 mg


prolonged-release tablets


oral




United Kingdom


Napp Pharmaceuticals Ltd.
Cambridge Science Park Milton Road
CB4 0GW
United Kingdom


Oxycodone hydrochloride/Naloxone hydrochloride dihydrate


Targinact


40 mg/20 mg


prolonged-release tablets


oral







ANNEX IV
List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States












Member State EU/EEA


Marketing authorisation holder


Name


INN


Pharmaceutical form


Strength


Animal species


Route of administration




Austria


Intervet GesmbH
Siemensstrasse 107
1210 Wien
Austria


RESFLOR 300/16,5 mg/mL Lösung zur Injektion für Rinder


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Belgium


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor 300, 16,5 mg/mL solution injectable pour bovines


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Bulgaria


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


РЕСФЛОР 300/16,5 мг/мл Разтвор за инжективно приложение при eдри преживни животни


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Cyprus


Schering-Plough S.A.
63, Agiou Dimitriou street
17456 Alimos
Greece


RESFLOR 300/16,5 mg/mL Ενέσιμο Διάλυμα για βοοειδή


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Czech Republic


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor injekční roztok pro skot


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Denmark


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor vet. injection, solution for Injection for Cattle


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Estonia


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor vet. injection, solution for Injection for Cattle


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Finland


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor vet. injection, solution for Injection for Cattle


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




France


Intervet MSD Santé Animale
7 Rue Olivier de Serres
Angers Technopole
CS 17144
49071 Beaucouzé
France


RESFLOR SOLUTION INJECTABLE


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Germany


Intervet Deutschland GmbH
Feldstraße 1a
D-85716 Unterschleißheim
Germany


RESFLOR 300/16,5 mg/mL Lösung zur Injektion für Rinder


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Greece


Intervet Hellas S.A.
63, Agiou Dimitriou street
17456 Alimos
Greece


RESFLOR 300/16,5 mg/mL Ενέσιμο Διάλυμα για βοοειδή


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Hungary


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


RESFLOR INJEKCIÓS OLDAT


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Ireland


Intervet Ireland Ltd.
Magna Drive
Magna Business Park
Citywest Rd.
Dublin 24
Ireland


RESFLOR 300/16,5 mg/mL Solution for Injection for Cattle


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Italy


Intervet MSD Santé Animale
7 Rue Olivier de Serres
Angers Technopole
CS 17144
49071 Beaucouzé
France


RESFLOR 300/16,5 mg/mL SOLUZIONE INIETTABILE per bovini


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Latvia


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor vet. injection, solution for Injection for Cattle


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Lithuania


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor vet. injection, solution for Injection for Cattle


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Luxembourg


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor 300, 16,5 mg/mL solution injectable pour bovines


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




The Netherlands


Intervet Nederland B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor 300, 16,5 mg/mL oplossing voor injectie voor runderen


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Norway


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor vet. injection, solution for Injection for Cattle


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Poland


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor 300/16,5 mg/mL roztwór do wstrzykiwań dla bydła


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Portugal


MSD Animal Health, Lda.
Quinta da Fonte
Edifício Vasco da Gama 19
2770-192 Paço de Arcos
Portugal


RESFLOR 300/16,5 mg/mL Solução Injectável para Bovinos


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Romania


Intervet Romania s.r.l.
Soseua de Centura no. 13A
Comuna Chiajna
Judet Ilfov
Romania


RESFLOR 300/16,5 mg/mL solutie injectabila pentru bovine


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Slovakia


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor injekčný roztok pre hovädzí dobytok


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Slovenia


Intervet International B.V.
Wim de Koerverstraat 35
5831 AN Boxmeer
The Netherlands


Resflor 300/16,5 mg/mL raztopina za injiciranje za govedo


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




Spain


Merck Sharp & Dohme Animal Health S.L.
Polígono Industrial El Montalvo I
c/Zeppelín no 6, parcela 38
37008 Carbajosa de la Sagrada — Salamanca
Spain


RESFLOR SOLUCIÓN INYECTABLE


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous




United Kingdom


Intervet UK Ltd.
Walton Manor, Walton
Milton Keynes MK7 7AJ
United Kingdom


RESFLOR 300/16,5 mg/mL Solution for Injection for Cattle


Florfenicol, flunixin


Solution for injection


300 mg/ml 16,5 mg/ml


Cattle


Subcutaneous







ANNEX V
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration and marketing authorisation holders in the Member States










Member State
(in EEA)


Marketing authorisation holder


Product name


Strength


Pharmaceutical form


Route of administration




Austria


Forest Pharma B.V.
Newtonlaan 115
3584 BH Utrecht
The Netherlands


Colistin Forest — Trockenstechampullen mit Lösungsmittel


1 0 00  000 I.U.


powder and solvent for suspension for injection, nebuliser solution


intramuscular use,
intravenous use,
inhalation use




Austria


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Tadim 1 Million I.E. Pulver zur Herstellung einer Infusionslösung


1 0 00  000 I.U.


powder for solution for infusion


intravenous use




Austria


Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300 Copenhagen S
Denmark


Colistin Xellia 1 Million I.E. Pulver zur Herstellung einer Injektions-/Infusionslösung


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




Austria


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Tadim 1 Million I.E. Pulver zur Herstellung einer Lösung für einen Vernebler


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Austria


PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany


ColiFin 1 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Austria


PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany


ColiFin 2 Mio. I.E. Pulver zur Herstellung einer Lösung für einen Vernebler


2 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Belgium


Forest Laboratories UK Ltd.
Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent DA2 6SL
United Kingdom


Colistineb 1 0 00  000 IE


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use,
inhalation use




Belgium


Forest Laboratories UK Ltd. Riverbridge House
Anchor Boulevard
Crossways Business Park Dartford
Kent DA2 6SL
United Kingdom


Colistineb 2 0 00  000 IE


2 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use,
inhalation use




Bulgaria


Alvogen IPCo.S.ar. I.
5 Rue Heienhaff
Senningerberg
L-1736
Luxembourg


Colistin Alvogen


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




Bulgaria


Alvogen IPCo.S.ar. I.
5 Rue Heienhaff
Senningerberg
L-1736
Luxembourg


Colistin Alvogen


2 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




Croatia


Altamedics d.o.o.
Karlovačka cesta 24a, Zagreb
10020
Croatia


Colixin 1 milijun IU prašak za otopinu za injekciju


1 0 00  000 I.U.


powder for solution for injection


intravenous use




Czech Republic


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford
Kent DA2 6SL
United Kingdom


Colomycin injekce 1 0 00  000 IU


1 0 00  000 I.U.


powder for solution for injection/infusion or nebuliser solution


intravenous use,
inhalation use




Denmark


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin


1 0 00  000 I.U.


nebuliser solution


inhalation use




Denmark


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin


1 0 0 00  000I.U.


powder for solution for infusion


intravenous use




Denmark


Xellia Pharmaceuticals ApS Dalslandsgade 11
DK-2300
Copenhagen S
Denmark


Colistimethatnatrium ‘Xellia’


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




France


Sanofi-Aventis France
1-13 boulevard R. Rolland
75014 Paris
France


COLIMYCINE 1 MUI, poudre et solvant pour inhalation par nébuliseur


1 0 00  000 I.U.


powder and solvent for nebuliser solution


inhalation use




France


Sanofi-Aventis France
1-13 boulevard R. Rolland
75014 Paris
France


COLIMYCINE 1 0 00  000 U.I., poudre et solvant pour solution injectable


1 0 00  000 I.U.


powder and solvent for solution for injection


intravenous use




France


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


TADIM 1 million d'unités internationales (UI) poudre pour solution pour inhalation par nébuliseur


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Germany


Forest Laboratories Nederland B.V.
Newtonlaan 115
3584 BH Utrecht
The Netherlands


Colistin CF


1 0 00  000 I.U.


powder and solvent for nebuliser solution


inhalation use




Germany


InfectoPharm Arzneimittel und Consilium GmbH
Von-Humboldt-Straße 1
64646
Heppenheim
Germany


Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektions- oder Infusionslösung


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




Germany


InfectoPharm Arzneimittel und Consilium GmbH
Von-Humboldt-Straße 1
64646 Heppenheim
Germany


Colistimethat-Natrium Infectopharm I.E. Pulver zur Herstellung einer Injektions- oder Infusionslösung


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




Germany


Profile Pharma Limited Bicentennial Building
Southern Gate
Chichester
PO19 8EZ
United Kingdom


Promixin 1 MI.E. Pulver zur Herstellung einer Lösung für einen Vernebler


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Germany


Profile Pharma Limited
Bicentennial Building
Southern Gate
Chichester
PO19 8EZ
United Kingdom


Promixin 1 MI.E. Pulver zur Herstellung einer Lösung für einer Infusionslösung


1 0 00  000 I.U.


powder for solution for infusion


intravenous use




Greece


NORMA HELLAS AE
54 Menandrou str
10431 Athens
Greece


COLISTIN/NORMA


1 0 00  000 I.U.


powder for solution for injection


intramuscular use




Greece


NORMA HELLAS AE
54 Menandrou str
10431 Athens
Greece


COLISTIN/NORMA


1 0 00  000 I.U.


powder and solvent for nebuliser solution


inhalation use




Greece


NORMA HELLAS AE
54 Menandrou str
10431 Athens
Greece


COLISTIN/NORMA


1 0 00  000 I.U.


powder for solution for infusion


intravenous use




Greece


NORMA HELLAS AE
54 Menandrou str
10431 Athens
Greece


COLISTIN/NORMA


2 0 00  000 I.U.


powder for solution for infusion


intravenous use




Greece


ALLERTEC HELLAS AE
74 Karamanli str.
55134, Kalamaria, Thessaloniki
Greece


TADIM


1 0 00  000 I.U.


powder and solvent for nebuliser solution


inhalation use




Hungary


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park Dartford, Kent
DA2 6SL
United Kingdom


COLOMYCIN


1 0 00  000 I.U.


powder for solution for injection/infusion,
powder for nebuliser solution


intravenous use,
inhalation use




Hungary


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford, Kent
DA2 6SL
United Kingdom


COLOMYCIN


2 0 00  000 I.U.


powder for solution for injection/infusion,
powder for nebuliser solution


intravenous use,
inhalation use




Iceland


Alvogen IPCo S.à.r.l.,
5 Rue Heienhaff,
L-1736
Senningerberg
Luxembourg


Colistimethate Alvogen


1 0 00  000 I.U.


powder for solution for injection or infusion


intravenous use




Iceland


Alvogen IPCo S.à.r.l.,
5 Rue Heienhaff,
L-1736
Senningerberg
Luxembourg


Colistimethate Alvogen


2 0 00  000 I.U.


powder for solution for injection or infusion


intravenous use




Ireland


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford, Kent
DA2 6SL
United Kingdom


Colomycin Injection 1 million International Units.
Powder for solution for injection, infusion or inhalation


1 0 00  000 I.U.


powder for solution for injection, infusion or inhalation


intravenous use,
inhalation use




Ireland


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford, Kent
DA2 6SL
United Kingdom


Colomycin Injection 2 million International Units.
Powder for solution for injection, infusion or inhalation


2 0 00  000 I.U.


powder for solution for injection, infusion or inhalation


intravenous use,
inhalation use




Ireland


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin, 1 million International Units (IU), Powder for Nebuliser Solution


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Italy


UCB Pharma S.p.A. Via Gadames
5720151 —
Milano (MI)
Italy


COLIMICINA


1 0 00  000 I.U.


powder and solvent for solution for injection


intramuscular use




Italy


PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany


COLFINAIR


1 0 00  0000 I.U.


powder for nebuliser solution


inhalation use




Italy


PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany


COLFINAIR


2 0 00  000 I.U.


powder for nebuliser solution


Inhalation use




Italy


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


PROMIXIN


1 0 0 00  000 I.U.


powder for nebuliser solution


Inhalation use




Luxembourg


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Tadim


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Malta


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford, Kent
DA2 6SL
United Kingdom


Colomycin Injection 1million International Units powder for solution for injection, infusion or inhalation


1 0 00  000 I.U.


powder for solution for injection/infusion/inhalation


intravenous use,
inhalation use




Norway


Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300 Copenhagen S
Denmark


Colistimethate Xellia


1 0 00  000 I.U.


powder for solution for infusion


intravenous use




Norway


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin


1 0 00  000 I.U.


powder for nebuliser solution


nasal use




Norway


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin


1 0 00  000 I.U.


powder for solution for infusion


intravenous use




Poland


Tarchomińskie Zakłady Farmaceutyczne ‘Polfa’ S.A.
2, A. Fleminga Str.
03-176 Warsaw
Poland


Colistin TZF


1 0 00  000 I.U.


powder for solution for injection, injection or inhalation


intramuscular use,
intravenous use,
inhalation use




Poland


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Portugal


Generis Farmacêutica, S.A.
Rua João de Deus 19
2700-487 Amadora
Portugal


Colistina Generis


1 0 00  000 I.U.


powder for solution for injection or for nebuliser solution


intravenous use,
inhalation use




Portugal


Pharmis Biofarmacêutica, Lda.
Praceta do Farol, lote 101
Cascais 2750-341
Portugal


Colixin


2 0 00  000 I.U.


powder for solution for injection or for nebuliser solution


intravenous use,
inhalation use




Portugal


Pharmis Biofarmacêutica, Lda.
Praceta do Farol, lote 101
Cascais 2750-341
Portugal


Colixin


1 0 00  000 I.U.


powder for solution for injection or for nebuliser solution


intravenous use,
inhalation use




Portugal


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Romania


S.C. ANTIBIOTICE S.A.,
Str. Valea Lupului nr. 1
707410 Iaşi
România


COLISTINĂ ANTIBIOTICE
1 0 00  000 UI,


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




Romania


Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300 Copenhagen S
Denmark


Colistimetat sodic Xellia 1 milion unităţi internaţionale (U.I.)


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




Slovak Republic


Sanofi-Aventis Slovakia s.r.o.
Einsteinova 24
851 01 Bratislava
Slovak Republic


Colimycine


1 0 00  000 I.U.


powder for solution for injection


intravenous use,
intramuscular use




Slovak Republic


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford, Kent DA2 6SL
United Kingdom


KOLOMYCÍN INJEKCIA 1 milión IU


1 0 00  000 I.U.


powder for solution for injection/infusion/
inhalation


intravenous use,
inhalation use




Slovak Republic


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford, Kent DA2 6SL
United Kingdom


KOLOMYCÍN INJEKCIA 2 milión IU


2 0 00  000 I.U.


powder for solution for injection/infusion/
inhalation


intravenous use,
inhalation use




Spain


GES GENÉRICOS ESPAÑOLES LABORATORIO, S.A.
Cólquide, 6 — Portal 2,
1o-Oficina F
28230 Las Rozas (Madrid)
Spain


Colistimetato de sodio GES 1 MUI polvo para solución inyectable/para inhalación por nebulizador


1 0 00  000 I.U.


powder for solution for injection,
powder for nebuliser solution


intravenous use,
inhalation use




Spain


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin 1 millón de Unidades Internacionales (UI) polvo para solución para inhalación por nebulizador


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Spain


Pharmis Biofarmacêutica, Lda.
Praceta do Farol, lote 101
Cascais 2750-341
Portugal


Colixin 1 MUI polvo para solución inyectable o para solución para inhalación por nebulizador


1 0 00  000 I.U.


powder for solution for injection,
powder for nebuliser solution


intravenous use,
inhalation use




Sweden


Profile Pharma Limited
Bicentennial Building
Southern Gate
Chichester
West Sussex
PO19 8EZ
United Kingdom


Tadim


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




Sweden


Profile Pharma Limited
Bicentennial Building
Southern Gate
Chichester
West Sussex
PO19 8EZ
United Kingdom


Tadim


1 0 00  000 I.U.


powder for solution for infusion


intravenous use




Sweden


Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300 Copenhagen S
Denmark


Colistin Xellia


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




The Netherlands


Forest Pharma B.V.
Newtonlaan 115
3584 BH Utrecht
The Netherlands


Colistin, poeder voor verneveloplossing met oplosmiddel 1.000.000 IE


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




United Kingdom


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford, Kent DA2 6SL
United Kingdom


Colomycin Injection 2 million international units powder for solution for injection, infusion or inhalation


2 0 00  000 I.U.


powder for solution for injection


intravenous use




United Kingdom


Forest Laboratories UK Limited Riverbridge House
Anchor Boulevard
Crossways Business Park
Dartford, Kent DA2 6SL
United Kingdom


Colomycin Injection 1 million international units powder for solution for injection, infusion or inhalation


1 0 00  000 I.U.


powder for solution for injection, infusion or inhalation


intramuscular use, intravenous use,
inhalation use




United Kingdom


Xellia Pharmaceuticals ApS
Dalslandsgade 11
DK-2300 Copenhagen S
Denmark


Colistimethate sodium 1 million international units powder for solution for injection or infusion


1 0 00  000 I.U.


powder for solution for injection/infusion


intravenous use




United Kingdom


Beacon Pharmaceuticals Limited,
Tunbridge Wells, Kent
TN1 1YG
United Kingdom


Colistimethate sodium 1 million I.U. powder for solution for injection


1 0 00  000 I.U.


powder for solution for injection


intravenous use,
inhalation use




United Kingdom


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin 1 million international units (IU) powder for nebuliser solution


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




United Kingdom


Profile Pharma Limited
Chichester Business Park
City Fields Way
Tangmere, Chichester
West Sussex
PO20 2FT
United Kingdom


Promixin 1 million international units (IU) powder for solution for infusion


1 0 00  000 I.U.


powder for solution for injection


intramuscular use,
intravenous use




United Kingdom


PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany


Colifin 1 MIU powder for nebuliser solutions


1 0 00  000 I.U.


powder for nebuliser solution


inhalation use




United Kingdom


PARI Pharma GmbH
Moosstrasse 3
82319 Starnberg
Germany


Colifin 2 MIU powder for nebuliser solutions


2 0 00  000 I.U.


powder for nebuliser solution


inhalation use