list of nationally authorised medicinal products · de/h/0873/001 1-27003 chiesi pharmaceuticals...
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
09 March 2017 EMA/171073/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): beclometasone / formoterol (inhalative application)
Procedure No.: PSUSA/00010068/201607
List of nationally authorised medicinal products EMA/171073/2017 Page 2/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
ALABASTER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0874/002 037776034 MASTER PHARMA S.R.L. IT
ALABASTER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0874/002 037776046 MASTER PHARMA S.R.L. IT
ALABASTER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0874/002 037776059 MASTER PHARMA S.R.L. IT
Alabaster 100/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0874/001 037776010 MASTER PHARMA S.R.L. IT
Alabaster 100/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0874/001 037776022 MASTER PHARMA S.R.L. IT
ALABASTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0874/004 037776109 MASTER PHARMA S.R.L. IT
ALABASTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0874/004 037776111 MASTER PHARMA S.R.L. IT
ALABASTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0874/004 037776123 MASTER PHARMA S.R.L. IT
ALABASTER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0874/003 037776073 MASTER PHARMA S.R.L. IT
List of nationally authorised medicinal products EMA/171073/2017 Page 3/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
ALABASTER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0874/003 037776085 MASTER PHARMA S.R.L. IT
ALABASTER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0874/003 037776097 MASTER PHARMA S.R.L. IT
COMBAIR 100/6 mikrogramů v jednotlivé dávce roztok k inhalaci v tlakovém obalu
DE/H/0871/001 14/302/07-C CHIESI PHARMACEUTICALS GMBH
CZ
Combair 200 mikrogramů/6 mikrogramů/dávka roztok k inhalaci v tlakovém obalu
DE/H/0871/003 14/001/16-C CHIESI PHARMACEUTICALS GMBH
CZ
FORMODUAL 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0872/002 037778038 PROMEDICA S.R.L. IT
FORMODUAL 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0872/002 037778040 PROMEDICA S.R.L. IT
FORMODUAL 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0872/002 037778053 PROMEDICA S.R.L. IT
Formodual 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
DE/H/0873/001 OGYI-T-20362/01 CHIESI PHARMACEUTICALS GMBH
HU
Formodual 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
DE/H/0873/001 OGYI-T-20362/02 CHIESI PHARMACEUTICALS GMBH
HU
Formodual 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
DE/H/0873/001 OGYI-T-20362/03 CHIESI PHARMACEUTICALS GMBH
HU
List of nationally authorised medicinal products EMA/171073/2017 Page 4/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Formodual 100/6 microgram/dosis, aërosol, oplossing
DE/H/0873/001 RVG 34615 CHIESI PHARMACEUTICALS B.V.
NL
FORMODUAL 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
DE/H/0873/001 34009 381 211 2 4 CHIESI S.A. FR
FORMODUAL 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
DE/H/0873/001 34009 381 212 9 2 CHIESI S.A. FR
Formodual 100/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0872/001 037778014 PROMEDICA S.R.L. IT
Formodual 100/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0872/001 037778026 PROMEDICA S.R.L. IT
Formodual 100/6 microgramos/pulsación Solución para inhalación en envase a presión
DE/H/0873/001 68.809 CHIESI ESPAÑA, S.A. ES
Formodual 100/6 micrograms per actuation pressurised inhalation solution
DE/H/0873/001 PL 08829/0157 CHIESI LIMITED UK
Formodual 100/6 Mikrogramm/Sprühstoß, Druckgasinhalation, Lösung
DE/H/0873/001 1-27003 CHIESI PHARMACEUTICALS GMBH
AT
Formodual 100/6 mikrogramov na sprožitev inhalacijska raztopina pod tlakom
DE/H/0873/001 H/08/00648/001 CHIESI PHARMACEUTICALS GMBH
SI
List of nationally authorised medicinal products EMA/171073/2017 Page 5/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Formodual 100/6 mikrogramov na sprožitev inhalacijska raztopina pod tlakom
DE/H/0873/001 H/08/00648/002 CHIESI PHARMACEUTICALS GMBH
SI
Formodual 100/6 mikrogramov na sprožitev inhalacijska raztopina pod tlakom
DE/H/0873/001 H/08/00648/003 CHIESI PHARMACEUTICALS GMBH
SI
FORMODUAL 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0872/004 037778103 PROMEDICA S.R.L. IT
FORMODUAL 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0872/004 037778115 PROMEDICA S.R.L. IT
FORMODUAL 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0872/004 037778127 PROMEDICA S.R.L. IT
Formodual 200 microgramos/6 microgramos por pulsación solución para inhalación en envase a presión
DE/H/0873/003 80600 CHIESI ESPAÑA, S.A. ES
Formodual 200/6 microgrammes par dose, solution pour inhalation en flacon pressurisé
DE/H/0873/003 34009 300 400 2 7 CHIESI S.A. FR
Formodual 200/6 microgrammes par dose, solution pour inhalation en flacon pressurisé
DE/H/0873/003 34009 550 143 2 4 CHIESI S.A. FR
List of nationally authorised medicinal products EMA/171073/2017 Page 6/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FORMODUAL 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0872/003 037778077 PROMEDICA S.R.L. IT
FORMODUAL 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0872/003 037778089 PROMEDICA S.R.L. IT
FORMODUAL 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0872/003 037778091 PROMEDICA S.R.L. IT
Formodual 200/6 micrograms per actuation pressurised inhalation solution
DE/H/0873/003 PL 08829/0176 CHIESI LIMITED UK
Formodual Nexthaler 100 microgramos/6 microgramos / inhalación polvo para inhalación
DE/H/0873/002 76.740 CHIESI ESPAÑA, S.A. ES
FORMODUAL NEXThaler 100/6 microgrammes/dose, poudre pour inhalation
DE/H/0873/002 34009 266 328 8 5 CHIESI S.A.S. FR
FORMODUAL NEXThaler 100/6 microgrammes/dose, poudre pour inhalation
DE/H/0873/002 34009 583 402 3 9 CHIESI S.A.S. FR
FORMODUAL NEXThaler 100/6 microgrammes/dose, poudre pour inhalation
DE/H/0873/002 34009 583 404 6 8 CHIESI S.A.S. FR
Formodual NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation
DE/H/0873/004 3400930039939 CHIESI S.A. FR
List of nationally authorised medicinal products EMA/171073/2017 Page 7/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Formodual NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation
DE/H/0873/004 3400955014270 CHIESI S.A. FR
Formodual NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation
DE/H/0873/004 3400955014287 CHIESI S.A. FR
Formodual NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation
DE/H/0873/004 3400930039939 CHIESI S.A. FR
Formodual NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation
DE/H/0873/004 3400955014270 CHIESI S.A. FR
Formodual NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation
DE/H/0873/004 3400955014287 CHIESI S.A. FR
Formodual Nexthaler 200 microgramos/6 microgramos por inhalación polvo para inhalación
DE/H/0873/004 80708 CHIESI ESPAÑA, S.A. ES
Formodual Nexthaler 200 microgramos/6 microgramos por inhalación polvo para inhalación
DE/H/0873/004 80708 CHIESI ESPAÑA, S.A. ES
Formodual, (100 mikrogramów + 6 mikrogramów)/dawkę, aerozol inhalacyjny, roztwór
DE/H/0873/001 14025 CHIESI PHARMACEUTICALS GMBH
PL
Fostair 100/6 micrograms per actuation pressurised inhalation solution
not available AA729/09701 CHERUBINO LIMITED (PARTNER CHIESI)
MT
List of nationally authorised medicinal products EMA/171073/2017 Page 8/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fostair 100/6 micrograms per actuation pressurised inhalation solution
DE/H/0871/001 PL 08829/0156 CHIESI LIMITED UK
Fostair 200/6 micrograms per actuation pressurised inhalation solution
DE/H/0871/003 PL 08829/0175 CHIESI LIMITED UK
Fostair NEXThaler 100 micrograms/6 micrograms per actuation inhalation powder
DE/H/0871/002 PL 08829/0173 CHIESI LIMITED UK
Fostair NEXThaler 200 micrograms/6 micrograms per actuation inhalation powder
DE/H/0871/004 PL 08829/0174 CHIESI LIMITED UK
Fostair NEXThaler 200 micrograms/6 micrograms per actuation inhalation powder
DE/H/0871/004 PL 08829/0174 CHIESI LIMITED UK
FOSTER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0871/002 037789031 CHIESI FARMACEUTICI S.P.A.
IT
FOSTER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0871/002 037789043 CHIESI FARMACEUTICI S.P.A.
IT
FOSTER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0871/002 037789056 CHIESI FARMACEUTICI S.P.A.
IT
Foster 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
DE/H/0871/001 OGYI-T-20363/01 CHIESI PHARMACEUTICALS GMBH
HU
Foster 100 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
DE/H/0871/001 OGYI-T-20363/02 CHIESI PHARMACEUTICALS GMBH
HU
Foster 100 mikrogramu/6 mikrogramai/dozeje ikvepiamieji milteliai
DE/H/0873/002 LT/1/14/3491/001 CHIESI PHARMACEUTICALS GMBH
LT
List of nationally authorised medicinal products EMA/171073/2017 Page 9/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster 100 mikrogramu/6 mikrogramai/dozeje ikvepiamieji milteliai
DE/H/0873/002 LT/1/14/3491/002 CHIESI PHARMACEUTICALS GMBH
LT
Foster 100 mikrogramu/6 mikrogramai/dozeje ikvepiamieji milteliai
DE/H/0873/002 LT/1/14/3491/003 CHIESI PHARMACEUTICALS GMBH
LT
Foster 100/6 microgram /dosis, aërosol, oplossing
DE/H/0871/001 RVG 34610 CHIESI PHARMACEUTICALS B.V.
NL
Foster 100/6 microgramas por aplicação solução pressurizada para inalação
DE/H/0871/001 5047428 CHIESI FARMACEUTICI S.P.A.
PT
Foster 100/6 microgramas por aplicação solução pressurizada para inalação
DE/H/0871/001 5047436 CHIESI FARMACEUTICI S.P.A.
PT
FOSTER 100/6 micrograme pe doza solutie de inhalat presurizata
DE/H/0873/001 4092/2011/02 CHIESI PHARMACEUTICALS GMBH
RO
FOSTER 100/6 micrograme pe doză soluţie de inhalat presurizată
DE/H/0873/001 4092/2011/01 CHIESI PHARMACEUTICALS GMBH
RO
Foster 100/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/001 037789017 CHIESI FARMACEUTICI S.P.A.
IT
Foster 100/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/001 037789029 CHIESI FARMACEUTICI S.P.A.
IT
Foster 100/6 microgramos/pulsación Solución para inhalación en envase a presión
DE/H/0871/001 68.802 CHIESI ESPAÑA, S.A. ES
FOSTER 100/6 mikrograma po potisku, stlaceni inhalat, otopina
not available UP/I-530-09/13-02/261 CHIESI PHARMACEUTICALS GMBH
HR
FOSTER 100/6 mikrograma po potisku, stlačeni inhalat, otopina
not available UP/I-530-09/13-02/261 CHIESI PHARMACEUTICALS GMBH
HR
List of nationally authorised medicinal products EMA/171073/2017 Page 10/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster 100/6 mikrogramai/išpurškime suslegtas inhaliacinis tirpalas
DE/H/0873/001 LT/1/08/1211/002 CHIESI PHARMACEUTICALS GMBH
LT
Foster 100/6 mikrogramai/išpurškime suslegtas inhaliacinis tirpalas
DE/H/0873/001 LT/1/08/1211/003 CHIESI PHARMACEUTICALS GMBH
LT
Foster 100/6 mikrogramai/išpurškime suslėgtas inhaliacinis tirpalas
DE/H/0873/001 LT/1/08/1211/001 CHIESI PHARMACEUTICALS GMBH
LT
FOSTER 100/6 mikrogrami/izsmidzinājumā aerosols inhalācijām, zem spiediena, šķīdums
DE/H/0873/001 08-0224 CHIESI PHARMACEUTICALS GMBH
LV
Foster 100/6 Mikrogramm Druckgasinhalation
DE/H/0872/001 64261.00.00 CHIESI GMBH DE
Foster 100/6 Mikrogramm/Sprühstoß, Druckgasinhalation, Lösung
DE/H/0871/001 1-27002 CHIESI PHARMACEUTICALS GMBH
AT
Foster 100/6 mikrogramov na inhaláciu inhalacný roztok v tlakovom obale
DE/H/0871/001 14/0110/07-S CHIESI PHARMACEUTICALS GMBH
SK
Foster 100/6 mikrogramov na sprožitev inhalacijska raztopina pod tlakom
DE/H/0871/001 H/07/00656/001 CHIESI PHARMACEUTICALS GMBH
SI
Foster 100/6 mikrogramov na sprožitev inhalacijska raztopina pod tlakom
DE/H/0871/001 H/07/00656/002 CHIESI PHARMACEUTICALS GMBH
SI
Foster 100/6 mikrogramov na sprožitev inhalacijska raztopina pod tlakom
DE/H/0871/001 H/07/00656/003 CHIESI PHARMACEUTICALS GMBH
SI
List of nationally authorised medicinal products EMA/171073/2017 Page 11/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster 100/6 μικρογραμμάρια ανά ψεκασμό. Διάλυμα για εισπνοή υπό πίεση.
DE/H/0873/001 20440 CHIESI FARMACEUTICI S.P.A.
CY
Foster 100/6 μικρογραμμάρια ανά ψεκασμό. Διάλυμα για εισπνοή υπό πίεση.
DE/H/0871/001 79619/6-12-2007 CHIESI HELLAS A.E.B.E. GR
Foster 200 microgramas/dose + 6 microgramas/dose solução pressurizada para inalação
DE/H/0871/003 5667225 CHIESI FARMACEUTICI S.P.A.
PT
Foster 200 micrograme/6 micrograme soluție de inhalat presurizată
DE/H/0873/003 8611/2016/01 CHIESI PHARMACEUTICALS GMBH
RO
Foster 200 micrograme/6 micrograme soluție de inhalat presurizată
DE/H/0873/003 8611/2016/02 CHIESI PHARMACEUTICALS GMBH
RO
Foster 200 micrograme/6 micrograme soluție de inhalat presurizată
DE/H/0873/003 8611/2016/03 CHIESI PHARMACEUTICALS GMBH
RO
FOSTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0871/004 037789106 CHIESI FARMACEUTICI S.P.A.
IT
FOSTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0871/004 037789118 CHIESI FARMACEUTICI S.P.A.
IT
FOSTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0871/004 037789120 CHIESI FARMACEUTICI S.P.A.
IT
FOSTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0871/004 037789106 CHIESI FARMACEUTICI S.P.A.
IT
FOSTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0871/004 037789118 CHIESI FARMACEUTICI S.P.A.
IT
List of nationally authorised medicinal products EMA/171073/2017 Page 12/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FOSTER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0871/004 037789120 CHIESI FARMACEUTICI S.P.A.
IT
Foster 200 microgramos/6 microgramos por pulsación solución para inhalación en envase a presión
DE/H/0871/003 80599 CHIESI ESPAÑA, S.A. ES
Foster 200 mikrogrami/6 mikrogrami/izsmidzinājumā aerosols inhalācijām, zem spiediena, šķīdums
DE/H/0873/003 15-0197 CHIESI PHARMACEUTICALS GMBH
LV
Foster 200 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
DE/H/0871/003 OGYI-T-20363/06 CHIESI PHARMACEUTICALS GMBH
HU
Foster 200 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
DE/H/0871/003 OGYI-T-20363/07 CHIESI PHARMACEUTICALS GMBH
HU
Foster 200 mikrogramm/6 mikrogramm túlnyomásos inhalációs oldat
DE/H/0871/003 OGYI-T-20363/08 CHIESI PHARMACEUTICALS GMBH
HU
Foster 200 mikrogramov/6 mikrogramov na sprožitev inhalacijska raztopina pod tlakom
DE/H/0871/003 H/07/00656/010-012 CHIESI PHARMACEUTICALS GMBH
SI
Foster 200 mikrogramų/6 mikrogramai/išpurškime įkvepiamieji milteliai
DE/H/0873/004 LT/1/14/3491/004 CHIESI PHARMACEUTICALS GMBH
LT
Foster 200 mikrogramų/6 mikrogramai/išpurškime įkvepiamieji milteliai
DE/H/0873/004 LT/1/14/3491/005 CHIESI PHARMACEUTICALS GMBH
LT
Foster 200 mikrogramų/6 mikrogramai/išpurškime įkvepiamieji milteliai
DE/H/0873/004 LT/1/14/3491/006 CHIESI PHARMACEUTICALS GMBH
LT
Foster 200 mikrogramų/6 mikrogramai/išpurškime įkvepiamieji milteliai
DE/H/0873/004 LT/1/14/3491/004 CHIESI PHARMACEUTICALS GMBH
LT
List of nationally authorised medicinal products EMA/171073/2017 Page 13/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster 200 mikrogramų/6 mikrogramai/išpurškime įkvepiamieji milteliai
DE/H/0873/004 LT/1/14/3491/005 CHIESI PHARMACEUTICALS GMBH
LT
Foster 200 mikrogramų/6 mikrogramai/išpurškime įkvepiamieji milteliai
DE/H/0873/004 LT/1/14/3491/006 CHIESI PHARMACEUTICALS GMBH
LT
Foster 200/6 microgram/dosis, aërosol, oplossing
DE/H/0871/003 RVG 115693 CHIESI PHARMACEUTICALS B.V.
NL
FOSTER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/003 037789070 CHIESI FARMACEUTICI S.P.A.
IT
FOSTER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/003 037789082 CHIESI FARMACEUTICI S.P.A.
IT
FOSTER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/003 037789094 CHIESI FARMACEUTICI S.P.A.
IT
Foster 200/6 mikrogramai/išpurškime suslėgtasis įkvepiamasis tirpalas
DE/H/0873/003 LT/1/08/1211/004 CHIESI PHARMACEUTICALS GMBH
LT
Foster 200/6 mikrogramai/išpurškime suslėgtasis įkvepiamasis tirpalas
DE/H/0873/003 LT/1/08/1211/005 CHIESI PHARMACEUTICALS GMBH
LT
Foster 200/6 mikrogramai/išpurškime suslėgtasis įkvepiamasis tirpalas
DE/H/0873/003 LT/1/08/1211/006 CHIESI PHARMACEUTICALS GMBH
LT
Foster 200/6 Mikrogramm pro Sprühstoß, Druckgasinhalation, Lösung
DE/H/0871/003 136513 CHIESI PHARMACEUTICALS GMBH
AT
List of nationally authorised medicinal products EMA/171073/2017 Page 14/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster 200/6 mikrogramov/dávka inhalacný roztok v tlakovom obale
DE/H/0871/003 14/0439/15-S CHIESI PHARMACEUTICALS GMBH
SK
FOSTER NEXThaler 100 micrograme/6 micrograme pe doză pulbere de inhalat
DE/H/0873/002 6161/2014/01 CHIESI PHARMACEUTICALS GMBH
RO
FOSTER NEXThaler 100 micrograme/6 micrograme pe doză pulbere de inhalat
DE/H/0873/002 6161/2014/02 CHIESI PHARMACEUTICALS GMBH
RO
FOSTER NEXThaler 100 micrograme/6 micrograme pe doză pulbere de inhalat
DE/H/0873/002 6161/2014/03 CHIESI PHARMACEUTICALS GMBH
RO
Foster Nexthaler 100 microgramos/6 microgramos / inhalación polvo para inhalación
DE/H/0871/002 76.713 CHIESI ESPAÑA, S.A. ES
Foster NEXThaler 100 mikrogrami/6 mikrogrami devā inhalācijas pulveris
DE/H/0873/002 14-0135 CHIESI PHARMACEUTICALS GMBH
LV
FOSTER NEXThaler 100 Mikrogramm/6 Mikrogramm pro Dosis Pulver zur Inhalation
DE/H/0871/002 1-31744 CHIESI PHARMACEUTICALS GMBH
AT
Foster Nexthaler 100 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/002 OGYI-T-20363/03 CHIESI PHARMACEUTICALS GMBH
HU
Foster Nexthaler 100 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/002 OGYI-T-20363/05 CHIESI PHARMACEUTICALS GMBH
HU
Foster Nexthaler 100 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/002 OGYI-T-20363/04 CHIESI PHARMACEUTICALS GMBH
HU
List of nationally authorised medicinal products EMA/171073/2017 Page 15/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster Nexthaler 100 mikrogramov /6 mikrogramov v davke inhalacneho prasku
DE/H/0871/002 14/0506/12-S CHIESI PHARMACEUTICALS GMBH
SK
Foster NEXThaler 100 mikrogramov/6 mikrogramov na vdih, prašek za inhaliranj
DE/H/0871/002 5363-I-560/13 CHIESI PHARMACEUTICALS GMBH
SI
Foster NEXThaler 100 μικρογραμμάρια/6 μικρογραμμάρια ανά δόση κόνις για εισπνοή
DE/H/0871/002 51871 CHIESI HELLAS AEBE GR
Foster NEXThaler 100/6 microgram/dosis, inhalatiepoeder
DE/H/0871/002 RVG 110104 CHIESI PHARMACEUTICALS B.V.
NL
Foster Nexthaler 200 microgramas/dose + 6 microgramas/dose pó para inalação
DE/H/0871/004 5666557 CHIESI FARMACEUTICI S.P.A.
PT
Foster Nexthaler 200 microgramas/dose + 6 microgramas/dose pó para inalação
DE/H/0871/004 5666557 CHIESI FARMACEUTICI S.P.A.
PT
Foster NEXTHaler 200 micrograme/6 micrograme pulbere de inhalat
DE/H/0873/004 8612/2016/01 CHIESI PHARMACEUTICALS GMBH
RO
Foster NEXTHaler 200 micrograme/6 micrograme pulbere de inhalat
DE/H/0873/004 8612/2016/02 CHIESI PHARMACEUTICALS GMBH
RO
Foster NEXTHaler 200 micrograme/6 micrograme pulbere de inhalat
DE/H/0873/004 8612/2016/03 CHIESI PHARMACEUTICALS GMBH
RO
Foster NEXTHaler 200 micrograme/6 micrograme pulbere de inhalat
DE/H/0873/004 8612/2016/01 CHIESI PHARMACEUTICALS GMBH
RO
List of nationally authorised medicinal products EMA/171073/2017 Page 16/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster NEXTHaler 200 micrograme/6 micrograme pulbere de inhalat
DE/H/0873/004 8612/2016/02 CHIESI PHARMACEUTICALS GMBH
RO
Foster NEXTHaler 200 micrograme/6 micrograme pulbere de inhalat
DE/H/0873/004 8612/2016/03 CHIESI PHARMACEUTICALS GMBH
RO
Foster Nexthaler 200 microgramos/6 microgramos por inhalación polvo para inhalación
DE/H/0871/004 80707 CHIESI ESPAÑA S.A. ES
Foster Nexthaler 200 microgramos/6 microgramos por inhalación polvo para inhalación
DE/H/0871/004 80707 CHIESI ESPAÑA S.A. ES
Foster NEXThaler 200 mikrogrami/6 mikrogrami devā inhalācijas pulveris
DE/H/0873/002 15-0198 CHIESI PHARMACEUTICALS GMBH
LV
FOSTER NEXThaler 200 Mikrogramm/6 Mikrogramm pro Inhalation, Pulver zur Inhalation
DE/H/0871/004 136512 CHIESI PHARMACEUTICALS GMBH
AT
FOSTER NEXThaler 200 Mikrogramm/6 Mikrogramm pro Inhalation, Pulver zur Inhalation
DE/H/0871/004 136512 CHIESI PHARMACEUTICALS GMBH
AT
Foster Nexthaler 200 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/004 OGYI-T-20363/09 CHIESI PHARMACEUTICALS GMBH
HU
Foster Nexthaler 200 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/004 OGYI-T-20363/10 CHIESI PHARMACEUTICALS GMBH
HU
List of nationally authorised medicinal products EMA/171073/2017 Page 17/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster Nexthaler 200 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/004 OGYI-T-20363/11 CHIESI PHARMACEUTICALS GMBH
HU
Foster Nexthaler 200 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/004 OGYI-T-20363/09 CHIESI PHARMACEUTICALS GMBH
HU
Foster Nexthaler 200 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/004 OGYI-T-20363/10 CHIESI PHARMACEUTICALS GMBH
HU
Foster Nexthaler 200 mikrogramm/6 mikrogramm/adag inhalációs por
DE/H/0871/004 OGYI-T-20363/11 CHIESI PHARMACEUTICALS GMBH
HU
Foster NEXThaler 200 mikrogramov/6 mikrogramov na vdih prašek za inhaliranje
DE/H/0871/004 H/07/00656/013-018 CHIESI PHARMACEUTICALS GMBH
SI
Foster NEXThaler 200 mikrogramov/6 mikrogramov na vdih prašek za inhaliranje
DE/H/0871/004 H/07/00656/013-018 CHIESI PHARMACEUTICALS GMBH
SI
Foster NEXThaler 200/6 microgram/dosis, inhalatiepoeder
DE/H/0871/004 RVG 115695 CHIESI PHARMACEUTICALS B.V.
NL
Foster NEXThaler 200/6 microgram/dosis, inhalatiepoeder
DE/H/0871/004 RVG 115695 CHIESI PHARMACEUTICALS B.V.
NL
Foster Nexthaler 200/6 mikrogramov/dávka inhalačný prášok
DE/H/0871/004 14/0440/15-S CHIESI PHARMACEUTICALS GMBH
SK
Foster Nexthaler 200/6 mikrogramov/dávka inhalačný prášok
DE/H/0871/004 14/0440/15-S CHIESI PHARMACEUTICALS GMBH
SK
List of nationally authorised medicinal products EMA/171073/2017 Page 18/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Foster NextHaler, 100/6 mikrogrammi/annuses inhalatsioonipulber
DE/H/0871/002 834314 CHIESI PHARMACEUTICALS GMBH
EE
Foster NextHaler, 200/6 mikrogrammi/annuses inhalatsioonipulber
DE/H/0873/004 885815 CHIESI PHARMACEUTICALS GMBH
EE
Foster NextHaler, 200/6 mikrogrammi/annuses inhalatsioonipulber
DE/H/0873/004 885815 CHIESI PHARMACEUTICALS GMBH
EE
FOSTER, 100/6 mikrogrammi/annuses inhalatsiooniaerosool, lahus
DE/H/0873/001 585108 CHIESI PHARMACEUTICALS GMBH
EE
FOSTER, 200/6 mikrogrammi/annuses inhalatsiooniaerosool, lahus
DE/H/0873/003 885715 CHIESI PHARMACEUTICALS GMBH
EE
FOSTER® 200 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
DE/H/0872/003 92265.00.00 CHIESI GMBH DE
FOSTER® NEXThaler® 100 Mikrogramm/6 Mikrogramm pro Dosis Pulver zur Inhalation
DE/H/0872/002 85305.00.00 CHIESI GMBH DE
FOSTER® NEXThaler® 200 Mikrogramm/6 Mikrogramm pro Inhalation Pulver zur Inhalation
DE/H/0872/004 92269.00.00 CHIESI GMBH DE
Fostex NEXThaler, (100 mikrogramów + 6 mikrogramów)/dawke inhalacyjna, proszek do inhalacji
DE/H/0871/002 20878 CHIESI PHARMACEUTICALS GMBH
PL
List of nationally authorised medicinal products EMA/171073/2017 Page 19/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Fostex NEXThaler, (200 mikrogramów + 6 mikrogramów)/dawkę inhalacyjną, proszek do inhalacji
DE/H/0871/004 22765 CHIESI PHARMACEUTICALS GMBH
PL
Fostex NEXThaler, (200 mikrogramów + 6 mikrogramów)/dawkę inhalacyjną, proszek do inhalacji
DE/H/0871/004 22765 CHIESI PHARMACEUTICALS GMBH
PL
Fostex, (100 mikrogramów + 6 mikrogramów)/dawke, aerozol inhalacyjny, roztwór
DE/H/0871/001 12954 CHIESI PHARMACEUTICALS GMBH
PL
Fostex, (200 mikrogramów + 6 mikrogramów)/dawke inhalacyjna, aerozol inhalacyjny, roztwór
DE/H/0871/003 22764 CHIESI PHARMACEUTICALS GMBH
PL
INNOVAIR 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
DE/H/0871/001 34009 381 412 8 3 CHIESI S.A.S. FR
INNOVAIR 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
DE/H/0871/001 34009 381 413 4 4 CHIESI S.A.S. FR
Innovair 100/6 mikrogram per dos inhalationsspray, lösning
DE/H/0873/001 26231 CHIESI FARMACEUTICI S.P.A.
SE
Innovair 100/6 mikrogram/dos inhalationsspray, lösning
DE/H/0873/001 24254 CHIESI FARMACEUTICI S.P.A.
FI
Innovair 100/6 mikrogrammaa/annos, inhalaatiosumute, liuos
DE/H/0873/001 24254 CHIESI FARMACEUTICI S.P.A.
FI
List of nationally authorised medicinal products EMA/171073/2017 Page 20/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Innovair 200/6 microgrammes par dose, solution pour inhalation en flacon pressurisé
DE/H/0873/003 34009 300 400 3 4 CHIESI S.A. FR
Innovair 200/6 microgrammes par dose, solution pour inhalation en flacon pressurisé
DE/H/0873/003 34009 550 143 3 1 CHIESI S.A. FR
Innovair 200/6 mikrogram/dos inhalationsspray, lösning
DE/H/0873/003 32422 CHIESI FARMACEUTICI S.P.A.
FI
Innovair 200/6 mikrogrammaa/annos, inhalaatiosumute, liuos
DE/H/0873/003 32422 CHIESI FARMACEUTICI S.P.A.
FI
INNOVAIR NEXTHALER 100 microgrammes/6 microgrammes par dose, poudre pour Inhalation
DE/H/0871/002 34009 266 362 1 0 CHIESI S.A.S. FR
INNOVAIR NEXTHALER 100 microgrammes/6 microgrammes par dose, poudre pour Inhalation
DE/H/0871/002 34009 583 405 2 9 CHIESI S.A.S. FR
INNOVAIR NEXTHALER 100 microgrammes/6 microgrammes par dose, poudre pour Inhalation
DE/H/0871/002 34009 583 406 9 7 CHIESI S.A.S. FR
Innovair nexthaler 100 mikrog/6 mikrog/annos, inhalaatiojauhe
DE/H/0873/002 31698 CHIESI FARMACEUTICI S.P.A.
FI
Innovair nexthaler 100 mikrog/6 mikrog/dos inhalationspulver
DE/H/0873/002 31698 CHIESI FARMACEUTICI S.P.A.
FI
Innovair NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation.
DE/H/0871/004 3400930039946 CHIESI S.A.S. FR
List of nationally authorised medicinal products EMA/171073/2017 Page 21/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Innovair NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation.
DE/H/0871/004 3400955014294 CHIESI S.A.S. FR
Innovair NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation.
DE/H/0871/004 3400955014300 CHIESI S.A.S. FR
Innovair NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation.
DE/H/0871/004 3400930039946 CHIESI S.A.S. FR
Innovair NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation.
DE/H/0871/004 3400955014294 CHIESI S.A.S. FR
Innovair NEXThaler 200 microgrammes/6 microgrammes par dose, poudre pour inhalation.
DE/H/0871/004 3400955014300 CHIESI S.A.S. FR
Innovair nexthaler 200 mikrog/6 mikrog/annos, inhalaatiojauhe
DE/H/0873/004 32423 CHIESI FARMACEUTICI S.P.A.
FI
Innovair nexthaler 200 mikrog/6 mikrog/annos, inhalaatiojauhe
DE/H/0873/004 32423 CHIESI FARMACEUTICI S.P.A.
FI
Innovair nexthaler 200 mikrog/6 mikrog/dos inhalationspulver
DE/H/0873/004 32423 CHIESI FARMACEUTICI S.P.A.
FI
Innovair nexthaler 200 mikrog/6 mikrog/dos inhalationspulver
DE/H/0873/004 32423 CHIESI FARMACEUTICI S.P.A.
FI
Innovair, inhalationsspray, opløsning 100+6 mikrogram/dosis
DE/H/0873/001 42331 CHIESI FARMACEUTICI S.P.A.
DK
List of nationally authorised medicinal products EMA/171073/2017 Page 22/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Innovair, inhalationsspray, opløsning, i trykbeholder
DE/H/0873/003 54356 CHIESI FARMACEUTICI S.P.A.
DK
Inuvair 100/6 microgram /dosis, aërosol, oplossing
DE/H/0873/001 BE300176 CHIESI SA/NV BE
INUVAIR 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
DE/H/0873/001 BE300176 CHIESI SA/NV BE
INUVAIR 100/6 microgrammes/dose, solution pour inhalation en flacon pressurisé
DE/H/0873/001 1276/08010001 CHIESI SA/NV LU
Inuvair 100/6 Mikrogramm Druckgasinhalation
DE/H/0873/001 BE 300176 CHIESI SA/NV BE
INUVAIR 100/6 Mikrogramm Druckgasinhalation, Lösung
DE/H/0874/001 64263.00.00 JANSSEN-CILAG GMBH DE
Inuvair 100/6 μικρογραμμάρια ανά ψεκασμό. Διάλυμα για εισπνοή υπό πίεση
DE/H/0873/001 81411/21-12-2012 CHIESI HELLAS A.E.B.E. GR
INUVAIR 200 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
DE/H/0874/003 92268.00.00 JANSSEN-CILAG GMBH DE
Inuvair 200/6 microgram per dosis, aërosol, oplossing
DE/H/0873/004 BE483031 CHIESI SA/NV BE
Inuvair 200/6 microgram per dosis, aërosol, oplossing
DE/H/0873/004 BE483031 CHIESI SA/NV BE
Inuvair 200/6 microgrammes par dose, solution pour inhalation en flacon pressurisé
DE/H/0873/004 BE483031 CHIESI SA/NV BE
Inuvair 200/6 microgrammes par dose, solution pour inhalation en flacon pressurisé
DE/H/0873/004 BE483031 CHIESI SA/NV BE
List of nationally authorised medicinal products EMA/171073/2017 Page 23/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Inuvair 200/6 microgrammes par dose, solution pour inhalation en flacon pressurisé
DE/H/0873/003 BE483031 CHIESI SA/NV LU
Inuvair 200/6 Mikrogramm pro Sprühstoß, Druckgasinhalation, Lösung
DE/H/0873/004 BE483031 CHIESI SA/NV BE
Inuvair 200/6 Mikrogramm pro Sprühstoß, Druckgasinhalation, Lösung
DE/H/0873/004 BE483031 CHIESI SA/NV BE
Inuvair Nexthaler 100 microgram/6 microgram per dosis; inhalatiepoeder
DE/H/0873/002 BE432013 CHIESI SA/NV BE
Inuvair Nexthaler 100 microgrammes/6 microgrammes par dose, poudre pour inhalation
DE/H/0873/002 BE432013 CHIESI SA/NV BE
Inuvair Nexthaler 100 microgrammes/6 microgrammes par dose, poudre pour inhalation
DE/H/0873/002 BE432013 CHIESI SA/NV LU
Inuvair Nexthaler 100 Mikrogramm/6 Mikrogramm pro Dosis Pulver zur Inhalation
DE/H/0873/002 BE432013 CHIESI SA/NV BE
Inuvair Nexthaler 200 microgram/6 microgram per inhalatie, inhalatiepoeder
DE/H/0873/004 BE483040 CHIESI SA/NV BE
Inuvair Nexthaler 200 microgram/6 microgram per inhalatie, inhalatiepoeder
DE/H/0873/004 BE483040 CHIESI SA/NV BE
Inuvair Nexthaler 200 microgrammes/6 microgrammes par inhalation, poudre pour inhalation
DE/H/0873/004 BE483040 CHIESI SA/NV BE
List of nationally authorised medicinal products EMA/171073/2017 Page 24/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Inuvair Nexthaler 200 microgrammes/6 microgrammes par inhalation, poudre pour inhalation
DE/H/0873/004 BE483040 CHIESI SA/NV BE
Inuvair Nexthaler 200 microgrammes/6 microgrammes par inhalation, poudre pour inhalation
DE/H/0873/004 BE483040 CHIESI SA/NV LU
Inuvair Nexthaler 200 microgrammes/6 microgrammes par inhalation, poudre pour inhalation
DE/H/0873/004 BE483040 CHIESI SA/NV LU
Inuvair Nexthaler 200 Mikrogramm/6 Mikrogramm pro Inhalation, Pulver zur Inhalation
DE/H/0873/004 BE483040 CHIESI SA/NV BE
Inuvair Nexthaler 200 Mikrogramm/6 Mikrogramm pro Inhalation, Pulver zur Inhalation
DE/H/0873/004 BE483040 CHIESI SA/NV BE
Inuvair NEXThaler® 100 Mikrogramm/6 Mikrogramm pro Dosis, Pulver zur Inhalation
DE/H/0874/002 85308.00.00 CHIESI FARMACEUTICI S.P.A.
DE
INUVAIR® NEXThaler® 200 Mikrogramm/6 Mikrogramm pro Inhalation Pulver zur Inhalation
DE/H/0874/004 92272.00.00 CHIESI FARMACEUTICI S.P.A.
DE
INUVER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0873/002 037798030 CHIESI FARMACEUTICI S.P.A.
IT
List of nationally authorised medicinal products EMA/171073/2017 Page 25/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
INUVER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0873/002 037798042 CHIESI FARMACEUTICI S.P.A.
IT
INUVER 100 microgrammi/6 microgrammi polvere per inalazione
DE/H/0873/002 037798055 CHIESI FARMACEUTICI S.P.A.
IT
Inuver 100/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/001 037798016/M CHIESI FARMACEUTICI S.P.A.
IT
Inuver 100/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/001 037798028/M CHIESI FARMACEUTICI S.P.A.
IT
INUVER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0873/004 037798105 CHIESI FARMACEUTICI S.P.A.
IT
INUVER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0873/004 037798117 CHIESI FARMACEUTICI S.P.A.
IT
INUVER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0873/004 037798129 CHIESI FARMACEUTICI S.P.A.
IT
INUVER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0873/004 037798105 CHIESI FARMACEUTICI S.P.A.
IT
INUVER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0873/004 037798117 CHIESI FARMACEUTICI S.P.A.
IT
INUVER 200 microgrammi/6 microgrammi per inalazione polvere per inalazione
DE/H/0873/004 037798129 CHIESI FARMACEUTICI S.P.A.
IT
INUVER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/003 037798079 CHIESI FARMACEUTICI S.P.A.
IT
INUVER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/003 037798081 CHIESI FARMACEUTICI S.P.A.
IT
List of nationally authorised medicinal products EMA/171073/2017 Page 26/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
INUVER 200/6 microgrammi per erogazione soluzione pressurizzata per inalazione
DE/H/0871/003 037798093 CHIESI FARMACEUTICI S.P.A.
IT
Inuxair 100 mikrogram/6 mikrogram/dose inhalasjonspulver
DE/H/0873/002 13-9658 CHIESI FARMACEUTICI S.P.A.
NO
Inuxair 100/6 mikrogram/dose inhalasjonsaerosol, oppløsning
DE/H/0873/001 07 5330 CHIESI FARMACEUTICI S.P.A.
NO
Inuxair 200 mikrogram/6 mikrogram/inhalasjon inhalasjonspulver.
DE/H/0873/004 14-10185 CHIESI FARMACEUTICI S.P.A.
NO
Inuxair 200 mikrogram/6 mikrogram/inhalasjon inhalasjonspulver.
DE/H/0873/004 14-10185 CHIESI FARMACEUTICI S.P.A.
NO
Inuxair 200/6 mikrogram/dose inhalasjonsaerosol, oppløsning
DE/H/0873/003 14-10186 CHIESI FARMACEUTICI S.P.A.
NO
Inuνair NEXThaler 100 μικρογραμμάρια/6 μικρογραμμάρια ανά δόση κόνις για εισπνοή
DE/H/0874/002 31747 CHIESI HELLAS AEBE GR
Kantos 100/6 Mikrogramm Druckgasinhalation
DE/H/0871/001 64260.00.00 CHIESI GMBH DE
Kantos Master 100/6 Mikrogramm Druckgasinhalation
DE/H/0873/001 64262.00.00 CHIESI FARMACEUTICI S.P.A.
DE
Kantos Master NEXThaler® 100 Mikrogramm/6 Mikrogramm pro Dosis, Pulver zur Inhalation
DE/H/0873/002 85307.00.00 CHIESI FARMACEUTICI S.P.A.
DE
List of nationally authorised medicinal products EMA/171073/2017 Page 27/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
KANTOS MASTER® 200 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
DE/H/0873/003 92267.00.00 CHIESI FARMACEUTICI S.P.A.
DE
KANTOS MASTER® NEXThaler® 200 Mikrogramm/6 Mikrogramm pro Inhalation Pulver zur Inhalation
DE/H/0873/004 92271.00.00 CHIESI FARMACEUTICI S.P.A.
DE
KANTOS MASTER® NEXThaler® 200 Mikrogramm/6 Mikrogramm pro Inhalation Pulver zur Inhalation
DE/H/0873/004 92271.00.00 CHIESI FARMACEUTICI S.P.A.
DE
KANTOS® 200 Mikrogramm/6 Mikrogramm pro Inhalation Druckgasinhalation, Lösung
DE/H/0871/003 92266.00.00 CHIESI GMBH DE
KANTOS® NEXThaler® 100 Mikrogramm/6 Mikrogramm pro Dosis Pulver zur Inhalation
DE/H/0871/002 85306.00.00 CHIESI GMBH DE
KANTOS® NEXThaler® 200 Mikrogramm/6 Mikrogramm pro Inhalation Pulver zur Inhalation
DE/H/0871/004 92270.00.00 CHIESI GMBH DE
KANTOS® NEXThaler® 200 Mikrogramm/6 Mikrogramm pro Inhalation Pulver zur Inhalation
DE/H/0871/004 92270.00.00 CHIESI GMBH DE
ФОСТЕР 100/6 микрограма/ доза, разтвор под налягане за инхалация
DE/H/0873/001 II-2020 CHIESI PHARMACEUTICALS GMBH
BG
ФОСТЕР 200/6 микрограма на доза разтвор под налягане за инхалация
DE/H/0873/003 20150403 CHIESI PHARMACEUTICALS GMBH
BG
List of nationally authorised medicinal products EMA/171073/2017 Page 28/28
Product name (in authorisation country)
MRP/DCP or CP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Фостер Некстхалер 100 микрограма/6 микрограма/ доза прах за инхалация
DE/H/0873/002 II-21385 CHIESI PHARMACEUTICALS GMBH
BG
Фостер НЕКСТхалерхалер 200 микрограма/6 микрограма/ доза прах за инхалация
DE/H/0873/004 20150404 CHIESI PHARMACEUTICALS GMBH
BG
Фостер НЕКСТхалерхалер 200 микрограма/6 микрограма/ доза прах за инхалация
DE/H/0873/004 20150404 CHIESI PHARMACEUTICALS GMBH
BG