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