Sep 1, 2017 - E MA /594294/2017. P age 2 /22. Product Name (in authorisation country). MRP/DCP. Authorisation number. Na
01 September 2017 EMA/594294/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: beclometasone
Procedure no.: PSUSA/00000306/201612
3 0 Churchill P lace ● C anary Wharf ● L ondon E14 5EU ● U nited Kingdom Telephone +4 4 (0 )20 3660 6 000 Facsimile +4 4 (0 )20 3660 5 525 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© E uropean M edic ines A genc y, 2 0 1 7 . Reproduc tion is authoris ed provided the s ourc e is ac knowledged.
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Sanasthmax® 250 Mikrogramm Druckgasinhalation, Lösung BIDIC LIN 5 mg C omprimidos gastrorresistentes de liberación prolongada BIDIC LIN 5 mg compresse gastroresistenti a rilascio prolungato BIDIC LIN 5 mg compresse gastroresistenti a rilascio prolungato C lipper 5 mg gastroresistant prolongedrelease tablets Beclo-Asma 250 microgramos/pulsación suspensión para inhalación en envase a presión BEC LO-RINO 50 microgramos suspensión para pulverización nasal MIFLASONE 100 µg, poudre pour inhalation en gélule MIFLASONE 100 µg, poudre pour inhalation en gélule
not available
45368.00.00
C HIESI GMBH
DE
IT/H/0100/001
66.707
PROMEDIC A S.R.L.
ES
IT/H/0100/001
029139021
PROMEDIC A S.R.L.
IT
IT/H/0100/001
029139033
PROMEDIC A S.R.L.
IT
IT/H/0100/001
PL 08829/0153
C HIESI LIMITED
UK
not available
59661
LABORATORIO ALDOUNIÓN, S.A.
ES
not available
54529
LABORATORIO ALDOUNIÓN, S.A.
ES
not available
3400933631055
NOVARTIS PHARMA S.A.S.
FR
not available
3400934845536
NOVARTIS PHARMA S.A.S.
FR
L is t of nationally authorised medicinal products E MA/594294/2017
P age 2 /22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number MIFLASONE 100 µg, poudre pour inhalation en gélule MIFLASONE 200 µg, poudre pour inhalation en gélule MIFLASONE 200 µg, poudre pour inhalation en gélule MIFLASONE 200 µg, poudre pour inhalation en gélule MIFLASONE 400 microgrammes, poudre pour inhalation en gélule MIFLASONE 400 microgrammes, poudre pour inhalation en gélule MIFLASONE 400 microgrammes, poudre pour inhalation en gélule MENADERM SIMPLEX 0,025% C REMA
not available
3400934845765
NOVARTIS PHARMA S.A.S.
FR
not available
3400933631116
NOVARTIS PHARMA S.A.S.
FR
not available
3400934845826
NOVARTIS PHARMA S.A.S.
FR
not available
3400934845994
NOVARTIS PHARMA S.A.S.
FR
not available
3400935659491
NOVARTIS PHARMA S.A.S.
FR
not available
3400935659552
NOVARTIS PHARMA S.A.S.
FR
not available
3400935659613
NOVARTIS PHARMA S.A.S.
FR
not available
041406012
IT
Neo-Sinefrina Alergo, 50 microgramas/dose, suspensão para pulverização nasal QVAR AUTOHALER 100 microgrammes/dose, solution pour inhalation en flacon pressurisé RINOC LENIL 100 microgrammi spray nasale, sospensione
not available
8437004
A. MENARINI - INDUSTRIE FARMAC EUTIC HE RIUNITE S.R.L. OMEGA PHARMA PORTUGUESA LDA
not available
NL23005
TEVA SANTÉ
FR
not available
035799028
C HIESI FARMAC EUTIC I S.P.A.
IT
L is t of nationally authorised medicinal products E MA/594294/2017
PT
P age 3 /22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number RINOC LENIL 50 microgrammi spray nasale, sospensione C LENILÒ 100 MIC ROGRAMMI POLVERE PER INALAZIONE C LENILÒ 200 MIC ROGRAMMI POLVERE PER INALAZIONE C LENILÒ 400 MIC ROGRAMMI POLVERE PER INALAZIONE BEC LOSPRAY 50 microgrammes/dose, solution pour inhalation en flacon pressurisé RINOC LENIL 100 microgrammes/dose, suspension pour pulvérisation nasale RINOC LENIL 100 microgrammes/dose, suspension pour pulvérisation nasale C LIPPER 5 mg compresse gastroresistenti a rilascio modificato C LIPPER 5 mg compresse gastroresistenti a rilascio modificato BEC LONEB 0,8 mg/2 ml sospensione per nebulizzatore
not available
035799016
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
023103106
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
023103118
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
023103120
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
3400936985674
C HIESI S.A.S.
FR
not available
34009 370 710 2 4
C HIESI S.A.S.
FR
not available
34009 370 711 9 2
C HIESI S.A.S.
FR
not available
029136037
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
029136025
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
034082014
MASTER PHARMA S.R.L.
IT
L is t of nationally authorised medicinal products E MA/594294/2017
P age 4 /22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number BEC LONEB 0,8 mg/2 ml sospensione per nebulizzatore Beclorhinol® aquosum 50 Mikrogramm Nasenspray, Suspension C LENIL 250 microgrammi soluzione pressurizzata per inalazione C LENIL 50 microgrammi soluzione pressurizzata per inalazione C LENILÒ JET 250 mcg soluzione pressurizzata per inalazione C LENILÒ JET 50 mcg soluzione pressurizzata per inalazione C LIPPER 3 mg/60 ml sospensione rettale C LENILEXX 100 mcg soluzione pressurizzata per inalazione C LENILEXX 100 mcg soluzione pressurizzata per inalazione con erogatore Autohaler C LENILEXX 50 mcg soluzione pressurizzata per inalazione C LENILEXX 50 mcg soluzione pressurizzata per inalazione con erogatore Autohaler
not available
034082026
MASTER PHARMA S.R.L.
IT
not available
5796.00.00
C HIESI GMBH
DE
not available
023103068
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
023103017
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
028825014
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
028825026
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
029136013
IT
not available
034179046
C HIESI FARMAC EUTIC I S.P.A. PROMEDIC A S.R.L.
not available
034179085
PROMEDIC A S.R.L.
IT
not available
034179022
PROMEDIC A S.R.L.
IT
not available
034179061
PROMEDIC A S.R.L.
IT
L is t of nationally authorised medicinal products E MA/594294/2017
IT
P age 5 /22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number C LENIL 100 microgrammi soluzione pressurizzata per inalazione C LENIL® FORTE SPRAY 250mcg pressurised inhalation solution Beclometason Sandoz Nevel 50, neusspray suspensie 50 microgram/dosis QVARSPRAY 100 microgrammes/dose, solution pour inhalation en flacon pressurisé BEC LOSPIN® 400 micrograms nebuliser suspension BEC LOSPIN® 800 micrograms nebuliser suspension BEC LOSPIN 400 microgrammes/1 ml, suspension pour inhalation par nébuliseur en récipient unidose BEC LOSPIN 800 microgrammes/2 ml, suspension pour inhalation par nébuliseur en récipient unidose C LENIL 0,8 mg/2 ml sospensione da nebulizzare
not available
23103171
C HIESI FARMAC EUTIC I S.P.A.
IT
not available
12678
VARNAVAS HADJIPANAYIS LTD. (LATSIA)
CY
not available
RVG 10957
SANDOZ B.V.
NL
not available
NL23004
TEVA SANTÉ
FR
IE/H/0160/001
PA 584/4/1
C HIESI FARMAC EUTIC I S.P.A.
IE
IE/H/0160/002
PA 584/4/2
C HIESI FARMAC EUTIC I S.P.A.
IE
not available
3400936963443
C HIESI S.A.S.
FR
not available
3400936963504
C HIESI S.A.S.
FR
not available
023103132
C HIESI FARMAC EUTIC I S.P.A.
IT
L is t of nationally authorised medicinal products E MA/594294/2017
P age 6 /22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number BEC LONEB® 400 μικρογραμμάρια/1 ml, εναιώρημα για εισπνοή με εκνεφωτή BEC LOSPIN® 800 μικρογραμμάρια/2 ml, εναιώρημα για εισπνοή με εκνεφωτή Qvar Extrafijne Aërosol 50 Inhalator, 50 microgram/dosis, aërosol, oplossing Otri-Allergie Heuschnupfenspray 50 μg Beclometasondipropionat / Sprühstoß Nasenspray, Suspension Für Erwachsene Easyhaler® Beclometasone 200 micrograms/dose inhalation powder Inalone 50 microgrammi Spray nasale, sospensione Beconase Allergy Beconase Hayfever Beconase Hayfever Relief for Adults 0.05% Nasal Spray BEC LOMETASONE TEVA 50 microgrammes/dose, solution pour inhalation en flacon pressurisé
IE/H/0160/001
79810/06/04.05.2007
C HIESI HELLAS A.E.B.E.
GR
IE/H/0160/002
79812/06/4-5-2007
C HIESI HELLAS A.E.B.E.
GR
not available
RVG 21939
TEVA NEDERLAND B.V.
NL
not available
4179.00.00
NOVARTIS C ONSUMER HEALTH GMBH
DE
not available
PL 27925/0001
ORION C ORPORATION
UK
not available
024211056
VERELIBRON S.R.L.
IT
not available
PL 02855/0064
OMEGA PHARMA LTD
UK
not available
PL 02855/0065
OMEGA PHARMA LTD
UK
not available
NL22595
TEVA SANTÉ
FR
L is t of nationally authorised medicinal products E MA/594294/2017
P age 7 /22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number BEC LOMETASONE TEVA 250 microgrammes/dose, solution pour inhalation en flacon pressurisé C LIPPER 5 mg comprimés gastrorésistants à libération prolongée C LIPPER 5 mg comprimés gastrorésistants à libération prolongée C LIPPER 5 mg magensaftresistente Retardtabletten Beclometasondipropionat C LIPPER 5 mg C omprimidos gastrorresistentes de liberación prolongada BEC OLEX 5 mg compresse gastroresistenti a rilascio prolungato BEC OLEX 5 mg compresse gastroresistenti a rilascio prolungato BEC LO-RHINO 50 microgrammes/dose, suspension pour pulvérisation nasale en flacon
not available
NL22598
TEVA SANTÉ
FR
IT/H/0116/001
BE277602
C HIESI SA/NV
BE
IT/H/0116/001
1539/09020001
C HIESI SA/NV
LU
IT/H/0116/001
BE277602
C HIESI SA/NV
BE
IT/H/0116/001
66.706
C HIESI ESPAÑA S.A.U.
ES
IT/H/0116/001
029137039
MASTER PHARMA S.R.L.
IT
IT/H/0116/001
029137027
MASTER PHARMA S.R.L.
IT
not available
3400934178122
MEDA PHARMA SAS
FR
L is t of nationally authorised medicinal products E MA/594294/2017
P age 8 /22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number BEC LO-RHINO 50 microgrammes/dose, suspension pour pulvérisation nasale en flacon BEC LO-RHINO 50 microgrammes/dose, suspension pour pulvérisation nasale en flacon BEC LO-RHINO 50 microgrammes/dose, suspension pour pulvérisation nasale en flacon Qvar Autohaler 50 mikrograma stlačeni inhalat, otopina Qvar Autohaler 100 mikrograma stlačeni inhalat, otopina Qvar 50 Extrafijne Aërosol Redihaler voor volwassenen 50 microgram/dosis, aërosol, oplossing Qvar 100 Extrafijne Aërosol Redihaler voor volwassenen 100 microgram/dosis, aërosol, oplossing Ventolair® 100 μg Autohaler® Druckgasinhalation, Lösung
not available
3400934602221
MEDA PHARMA SAS
FR
not available
3400934602160
MEDA PHARMA SAS
FR
not available
3400934178290
MEDA PHARMA SAS
FR
not available
UP/I-530-09/10-01/96
PLIVA HRVATSKA D.O.O.
HR
not available
UP/I-530-09/10-01/97
PLIVA HRVATSKA D.O.O.
HR
not available
RVG 110252
TEVA NEDERLAND B.V.
NL
not available
RVG 110255
TEVA NEDERLAND B.V.
NL
not available
41249.00.00
TEVA GMBH
DE
L is t of nationally authorised medicinal products E MA/594294/2017
P age 9 /22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Ventolair® 100 μg Dosieraerosol Druckgasinhalation, Lösung Ventolair® mite 50 μg Autohaler® Druckgasinhalation, Lösung AeroBec® N 50 μg Dosieraerosol Druckgasinhalation, Lösung AeroBec® N 100 μg Dosieraerosol Druckgasinhalation, Lösung Ventolair® mite 50 μg Dosieraerosol Druckgasinhalation, Lösung AeroBec® N 100 μg Autohaler® Druckgasinhalation, Lösung Menaderm Simple 0,25 mg/g crema Qvar Extrafijne Aërosol 100 Inhalator, 100 microgram/dosis, aërosol, oplossing Qvar 50 microgram/dosis, aërosol, oplossing
not available
41238.00.00
TEVA GMBH
DE
not available
41249.01.00
TEVA GMBH
DE
not available
41242.01.00
TEVA GMBH
DE
not available
41242.00.00
TEVA GMBH
DE
not available
41238.01.00
TEVA GMBH
DE
not available
41253.00.00
TEVA GMBH
DE
not available
46.410
ES
not available
RVG 21938
LABORATORIOS MENARINI, S.A. TEVA NEDERLAND B.V.
not available
BE 214882
UC B PHARMA S.A. (ANDERL BE)
BE
L is t of nationally authorised medicinal products E MA/594294/2017
NL
P age 10/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Qvar 100 microgram/dosis, aërosol, oplossing Qvar Autohaler 50 microgram/dosis, aërosol, oplossing Qvar Autohaler 100 microgram/dosis, aërosol, oplossing Qvar 100 microgrammes/dose, solution pour inhalation en flacon pressurisé Qvar 50 microgrammes/dose, solution pour inhalation en flacon pressurisé Qvar Autohaler 100 microgrammes/dose, solution pour inhalation en flacon pressurisé Qvar 100 microgrammes/dose, solution pour inhalation en flacon pressurisé Qvar 50 microgrammes/dose, solution pour inhalation en flacon pressurisé Qvar Autohaler 100 microgrammes/dose, solution pour inhalation en flacon pressurisé
not available
BE 214907
UC B PHARMA S.A. (ANDERL BE)
BE
not available
BE 214916
UC B PHARMA S.A. (ANDERL BE)
BE
not available
BE 214925
UC B PHARMA S.A. (ANDERL BE)
BE
not available
BE 214907
UC B PHARMA S.A. (ANDERL BE)
BE
not available
0072/11071191
UC B PHARMA S.A. (ANDERL BE)
LU
not available
0072/11071194
UC B PHARMA S.A. (ANDERL BE)
LU
not available
0072/11071192
UC B PHARMA S.A. (ANDERL BE)
LU
not available
BE 214882
UC B PHARMA S.A. (ANDERL BE)
BE
not available
BE 214925
UC B PHARMA S.A. (ANDERL BE)
BE
L is t of nationally authorised medicinal products E MA/594294/2017
P age 11/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Qvar Autohaler 50 microgrammes/dose, solution pour inhalation en flacon pressurisé Qvar Autohaler 50 microgrammes/dose, solution pour inhalation en flacon pressurisé TOPSTER “3mg sospensione rettale” 10 flaconi con cannula TOPSTER “42mg schiuma rettale” contenitore sotto pressione + 14 cannule TOPSTER “3mg supposte“ 10 supposte Becotide 50 microgramos/inhalación, solución para inhalación en envase a presión Beconase 50 mikrog/annos nenäsumute, suspensio Beconase 50 mikrog/annos nenäsumute, suspensio Otri-Allergie Heuschnupfenspray 50 μg Beclometasondipropionat / Sprühstoß Nasenspray, Suspension Für Erwachsene
not available
BE 214916
UC B PHARMA S.A. (ANDERL BE)
BE
not available
0072/11071193
UC B PHARMA S.A. (ANDERL BE)
LU
not available
031115049
SOFAR S.P.A.
IT
not available
031115013
SOFAR S.P.A.
IT
not available
031115025
SOFAR S.P.A.
IT
not available
52.810
GLAXOSMITHKLINE, S.A.
ES
not available
8949
GLAXOSMITHKLINE OY
FI
not available
8949
GLAXOSMITHKLINE OY
FI
not available
4179.00.00
NOVARTIS C ONSUMER HEALTH GMBH
DE
L is t of nationally authorised medicinal products E MA/594294/2017
P age 12/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Becloforte 250 microgramos/inhalación, solución para inhalación en envase a presión Beconase 50 mikrogrami deguna aerosols, suspensija Beclotaide, 50 microgramas/dose, solução pressurizada para inalação Beclotaide Forte, 250 microgramas/dose, solução pressurizada para inalação Becotide Nasal 50 mikrogram/dos nässpray, suspension BEC ONASE 50 microgrammes, suspension pour pulvérisation nasale en flacon pulvérisateur BEC OTIDE 250 microgrammes/dose, solution pour inhalation en flacon pressurisé Beconase, næsespray, suspension Beconase Aqueous Nasal Spray Becotide Evohaler 50 micrograms, Pressurised Inhalation Solution
not available
59.377
GLAXOSMITHKLINE S.A.
ES
not available
99-0392
GLAXOSMITHKLINE LATVIA SIA
LV
not available
8395905
ALENFARMA ESPEC IALIDADES FARMAC EUTIC AS, LIMITADA
PT
not available
8395913
ALENFARMA ESPEC IALIDADES FARMAC EUTIC AS, LIMITADA
PT
not available
10066
GLAXOSMITHKLINE AB
SE
not available
NL14488-1
LABORATOIRE GLAXOSMITHKLINE S.A.S.
FR
not available
NL14228
LABORATOIRE GLAXOSMITHKLINE
FR
not available
11375
DK
not available
PL 10949/0104
GLAXOSMITHKLINE PHARMA A/S GLAXO WELLC OME LTD
not available
PA 1077/042/006
GLAXOSMITHKLINE (IRELAND) LIMITED
IE
L is t of nationally authorised medicinal products E MA/594294/2017
UK
P age 13/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution Becotide Evohaler 100 micrograms, Pressurised Inhalation Solution Beconase Aqueous Nasal Spray
not available
PA 1077/042/009
GLAXOSMITHKLINE (IRELAND) LIMITED
IE
not available
PA 1077/042/007
GLAXOSMITHKLINE (IRELAND) LIMITED
IE
not available
MA167/00201
MT
Beclomet Easyhaler 200 mikrogram/dos inhalationspulver Qvar Extrafijne Aërosol 50 AeroC hamber Plus met mondstuk, 50 microgram/dosis, aërosol, oplossing EC OBEC 250 microgrammes/dose, solution pour inhalation en flacon pressurisé Menaderm Simple 0,25 mg/ml emulsión cutánea REC TO MENADERM pomada rectal Qvar Extrafijne Aërosol 50 Inhalator, 50 microgram/dosis, aërosol, oplossing Beclonasal Aqua 50 mikrogramm/dózis szuszpenziós orrspray Beclonasal Aqua 50 mikrogramm/dózis szuszpenziós orrspray
not available
14714
GLAXO WELLC OME UK LTD TRADING AS GLAXOSMITHKLINE UK ORION C ORPORATION
not available
RVG 29141
TEVA NEDERLAND B.V.
NL
not available
NL22602
TEVA SANTÉ
FR
not available
49.968
ES
not available
53.508
not available
RVG 21937
LABORATORIOS MENARINI, S.A. LABORATORIOS MENARINI, S.A. TEVA NEDERLAND B.V.
C Z/H/0493/001
OGYI-T-20209/01
ORION C ORPORATION
HU
C Z/H/0493/001
OGYI-T-20209/02
ORION C ORPORATION
HU
L is t of nationally authorised medicinal products E MA/594294/2017
SE
ES NL
P age 14/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Beclonasal Aqua, 50 mikrogramów/dawkę, aerozol do nosa, zawiesina Beclonasal, 50 mikrogrammi/annuses ninasprei, suspensioon Beclomet Nasal Aqua 50 µg, nosní sprej, suspenze Beclomet Nasal Aqua 50 μg nosová suspenzná aerodisperzia BEC LOMETASONE DOC 0,025% C rema BEC LONEB® 400 micrograms nebuliser suspension BEC LONEB® 800 micrograms nebuliser suspension Sanasthmax® 400 Mikrogramm/1 ml Suspension für einen Vernebler BEC LONEB® 400 μικρογραμμάρια/1 ml, εναιώρημα για εισπνοή με εκνεφωτή BEC LOSPIN® 800 μικρογραμμάρια/2 ml, εναιώρημα για εισπνοή με εκνεφωτή
C Z/H/0493/001
12396
ORION C ORPORATION
PL
C Z/H/0493/001
521306
ORION C ORPORATION
EE
C Z/H/0493/001
69/245/06-C
ORION C ORPORATION
CZ
C Z/H/0493/001
14/0309/06-S
ORION C ORPORATION
SK
not available
022975039
DOC GENERIC I S.R.L.
IT
IE/H/0159/001
PA 584/3/1
C HIESI FARMAC EUTIC I S.P.A.
IE
IE/H/0159/002
PA 584/3/2
C HIESI FARMAC EUTIC I S.P.A.
IE
IE/H/0159/001
62894.00.00
C HIESI GMBH
DE
IE/H/0159/001
79806/06/04.05.2007
C HIESI HELLAS A.E.B.E.
GR
IE/H/0159/002
79808/06/4-5-2007
C HIESI HELLAS A.E.B.E.
GR
L is t of nationally authorised medicinal products E MA/594294/2017
P age 15/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number JML Hayfever Relief for Adults 50 micrograms / dose Nasal Spray Beclometasone Dipropionate 50 micrograms per spray Aqueous Nasal Spray Pollenase Hayfever Relief for Adults 50 micrograms / dose Nasal Spray Tesco Hayfever Relief Nasal Spray for Adults 50 micrograms / dose Nasal Spray Superdrug Hayfever Relief For Adults 50 micrograms / dose Nasal Spray Boots Hayfever Relief For Adults 50 micrograms / dose Nasal Spray Numark Hayfever Relief for Adults 50 micrograms/dose Nasal Spray Essential Waitrose Hayfever Relief For Adults 50 micrograms/dose Nasal Spray Lloyds Pharmacy Hayfever Relief for Adults 50 micrograms/dose Nasal Spray
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0178
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
L is t of nationally authorised medicinal products E MA/594294/2017
P age 16/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Wilko Hayfever Relief for Adults 50 micrograms/dose Nasal Spray Asda Hayfever Relief for Adults 50 micrograms/dose Nasal Spray C areway Hayfever Relief for Adults 50micrograms/dose Nasal Spray Qvar Extrafijne Aërosol 100 AeroC hamber Plus met mondstuk, 100 microgram/dosis, aërosol, oplossing Qvar Extrafijne Aërosol 50 AeroC hamber Plus met masker, 50 microgram/dosis, aërosol, oplossing RHINOMAXIL 100 microgrammes/dose, suspension pour pulvérisation nasale RHINOMAXIL 100 microgrammes/dose, suspension pour pulvérisation nasale Beclometason-C T 0,10 mg Nasenspray Beclometason-C T 0,05 mg Nasenspray
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
PL 16431/0176
AYRTON SAUNDERS LTD.
UK
not available
RVG 29142
TEVA NEDERLAND B.V.
NL
not available
RVG 29143
TEVA NEDERLAND B.V.
NL
not available
3400937071253
ZAMBON FRANC E S.A.
FR
not available
3400937071314
ZAMBON FRANC E S.A.
FR
not available
52466.01.00
TEVA GMBH
DE
not available
52466.00.00
TEVA GMBH
DE
L is t of nationally authorised medicinal products E MA/594294/2017
P age 17/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
TEVA C ZEC H INDUSTRIES S.R.O TEVA C ZEC H INDUSTRIES S.R.O
CZ
number Ecobec 100 mikrogramů
not available
14-090-01-C
Ecobec 250 mikrogramů Roztok k inhalaci v tlakovém obalu Beclazone 50 micrograms Easi-Breathe C FC -Free Inhaler Pressurised Inhalation Solution Beclazone 250 micrograms Easi-Breathe C FC -Free Inhaler Pressurised Inhalation Solution Beclazone 100 micrograms Easi-Breathe C FC -Free Inhaler Pressurised Inhalation Solution Sanasthmax® Junior 50Mikrogramm Druckgasinhalation, Lösung BEC OTIDE 50 mcg spray nasale, sospensione
not available
14/091/01-C
IE/H/126/001
PA 436/21/13
NORTON WATERFORD T/A IVAX PHARMAC EUTIC ALS IRELAND
IE
IE-H-126-001-003
PA 436/21/16
NORTON WATERFORD T/A IVAX PHARMAC EUTIC ALS IRELAND
IE
IE/H/126/002
PA 436/21/14
NORTON WATERFORD T/A IVAX PHARMAC EUTIC ALS IRELAND
IE
not available
5794.00.00
C HIESI GMBH
DE
not available
023378058
IT
BEC OTIDE 250 microgrammi/erogazione soluzione pressurizzata per inalazione BEC OTIDE 50 microgrammi/erogazione soluzione pressurizzata per inalazione
not available
023378072
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
not available
023378019
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
IT
L is t of nationally authorised medicinal products E MA/594294/2017
CZ
IT
P age 18/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Beclometasonratiopharm® 50 μg Nasenspray MENADERM SIMPLEX 0,025% SOLUZIONE C UTANEA Qvar Extrafijne Aërosol 100 Autohaler, 100 microgram/dosis, aërosol, oplossing Menaderm Simple 0,25 mg/g ungüento Ecobec 50 mikrogramů Roztok k inhalaci v tlakovém obalu Ventolair® Steri-Neb® 800 Mikrogramm Suspension für einen Vernebler Ventolair 400 Mikrogramm Suspension für einen Vernebler BEC LOMETASONE TEVA 400 microgrammes/1 ml, suspension pour inhalation par nébuliseur en récipient unidose BEC LOMETASONE TEVA 800 microgrammes/2 ml, suspension pour inhalation par nébuliseur en récipient unidose Beclonasal Aqua 50 mikrogram/dos nässpray, suspension
not available
44826.00.00
RATIOPHARM GMBH
DE
not available
041406036
IT
not available
RVG 21940
A. MENARINI - INDUSTRIE FARMAC EUTIC HE RIUNITE S.R.L. TEVA NEDERLAND B.V.
not available
49.969
ES
not available
14/014/03-C
LABORATORIOS MENARINI, S.A. TEVA C ZEC H INDUSTRIES S.R.O
DE/H/3694/002
90122.00.00
TEVA GMBH
DE
DE/H/3694/001
88500.00.00
TEVA GMBH
DE
DE/H/3694/001
NL43907
TEVA SANTÉ
FR
DE/H/3694/002
NL43908
TEVA SANTÉ
FR
not available
12066
ORION OYJ
FI
L is t of nationally authorised medicinal products E MA/594294/2017
NL
CZ
P age 19/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Beclonasal Forte Aqua 100 mikrog/dos nässpray, suspension Beclonasal Aqua 50 mikrog/annos nenäsumute, suspensio Beclonasal Forte Aqua 100 mikrog/annos nenäsumute, suspensio BEMEDREX EASYHALER 200 microgrammes/dose, poudre pour inhalation BEMEDREX EASYHALER 200 microgrammes/dose, poudre pour inhalation BEMEDREX EASYHALER 200 microgrammes/dose, poudre pour inhalation Bemedrex Easyhaler 100 microgrammi/dose polvere per inalazione Bemedrex Easyhaler 100 microgrammi/dose polvere per inalazione Bemedrex Easyhaler 100 microgrammi/dose polvere per inalazione BEMEDREX EASYHALER 200 microgrammi /dose polvere per inalazione
not available
9783
ORION OYJ
FI
not available
12066
ORION OYJ
FI
not available
9783
ORION OYJ
FI
FI/H/0101/001
346 096-6
ORION C ORPORATION
FR
FI/H/0101/001
346 097-2
ORION C ORPORATION
FR
FI/H/0101/001
346 098-9
ORION C ORPORATION
FR
FI/H/0101/002
034144028/M
ORION C ORPORATION
IT
FI/H/0101/002
034144030/M
ORION C ORPORATION
IT
FI/H/0101/002
034144042/M
ORION C ORPORATION
IT
FI/H/0101/001
034144016/M
ORION C ORPORATION
IT
L is t of nationally authorised medicinal products E MA/594294/2017
P age 20/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number BEMEDREX EASYHALER 200 microgrammi /dose polvere per inalazione BEMEDREX EASYHALER 200 microgrammi /dose polvere per inalazione Bemedrex Easyhaler 400 microgrammi/dose polvere per inalazione Bemedrex Easyhaler 400 microgrammi/dose polvere per inalazione Bemedrex Easyhaler 400 microgrammi/dose polvere per inalazione Beclomet Easyhaler Beclomet Easyhaler Beclomet Easyhaler Beclomet Easyhaler 200 Mikrogramm/DosisInhalationspulver Beclomet Easyhaler 400 Mikrogramm/DosisInhalationspulver Beclomet Easyhaler 0,4 mg/Dosis, Pulver zur Inhalation Beclomet Easyhaler 0,2 mg/Dosis, Pulver zur Inhalation Beclomet Easyhaler 0,1 mg/Dosis, Pulver zur Inhalation
FI/H/0101/001
034144093/M
ORION C ORPORATION
IT
FI/H/0101/001
034144081/M
ORION C ORPORATION
IT
FI/H/0101/003
034144055/M
ORION C ORPORATION
IT
FI/H/0101/003
034144067/M
ORION C ORPORATION
IT
FI/H/0101/003
034144079/M
ORION C ORPORATION
IT
FI/H/0101/002 FI/H/0101/001 FI/H/0101/003 FI/H/0101/001
30524 19213 30525 1-22446
ORION ORION ORION ORION
C ORPORATION C ORPORATION C ORPORATION C ORPORATION
DK DK DK AT
FI/H/0101/003
1-23764
ORION C ORPORATION
AT
DE/H/2035/003
49276.02.00
ORION C ORPORATION
DE
DE/H/2035/001
49276.00.00
ORION C ORPORATION
DE
DE/H/2035/002
49276.01.00
ORION C ORPORATION
DE
L is t of nationally authorised medicinal products E MA/594294/2017
P age 21/22
Product Name (in
MRP/DCP
authorisation country)
Authorisation
National Authorisation Number
MAH of product in the
Member State where
Member State
product is authorised
number Qvar Extrafijne Aërosol 100 AeroC hamber Plus met masker, 100 microgram/dosis, aërosol, oplossing Beclazone 100 micrograms C FC Free Inhaler Pressurised Inhalation Solution Beclazone 50 micrograms C FC -Free Inhaler Pressurised Inhalation Solution Beclazone 250 micrograms C FC -Free Inhaler Pressurised Inhalation Solution BecloHEXAL® 100 Mikrogramm Dosieraerosol, Druckgasinhalation, Lösung BEC LOPHAR 400 microgram inhalatiepoeder in harde capsules Beclometason Sandoz Nevel 50, neusspray suspensie 50 microgram/dosis
not available
RVG 29144
TEVA NEDERLAND B.V.
NL
IE/H/0118/002
PA 436/21/10
NORTON WATERFORD T/A IVAX PHARMAC EUTIC ALS IRELAND
IE
IE/H/0118/001
PA 436/21/9
NORTON WATERFORD T/A IVAX PHARMAC EUTIC ALS IRELAND
IE
IE/H/118/004
PA 436/21/12
NORTON WATERFORD T/A IVAX PHARMAC EUTIC ALS IRELAND
IE
IE/H/118/002
49722.01.00
NORTON WATERFORD T/A IVAX PHARMAC EUTIC ALS IRELAND
DE
not available
BE191055
SANDOZ N.V.
BE
not available
RVG 10957
SANDOZ B.V.
NL
L is t of nationally authorised medicinal products E MA/594294/2017
P age 22/22
