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

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© 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

beclometasone List of nationally authorised medicinal products ...

Sep 1, 2017 - E MA /594294/2017. P age 2 /22. Product Name (in authorisation country). MRP/DCP. Authorisation number. National Authorisation Number.

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