1 September 2017 EMA/593212/2017 Human Medicines Evaluation Division

List of nationally authorised medicinal products Active substance(s): flurbiprofen

Procedure No.: PSUSA/00001450/201611

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

ANTADYS 100 mg, comprimé pelliculé BENACTIV GOLA 0,25% Collutorio

not available not available

NL13424 033262015

BENACTIV GOLA 8,75 mg Pastiglie gusto Limone e Miele

not available

033262027

BENACTIV GOLA 8,75 mg Pastiglie gusto Limone e Miele

not available

033262039

BENACTIV GOLA 8,75 mg Pastiglie gusto Limone e Miele

not available

033262027

Benactiv Gola 8,75 mg Pastiglie gusto Limone e Miele

not available

033262039

BENACTIV GOLA 8,75 mg Pastiglie Senza Zucchero gusto Arancia

not available

033262078

BENACTIV GOLA 8,75 mg Pastiglie Senza Zucchero gusto Arancia

not available

033262080

Benactivdol Gola 8,75 mg/dose Spray per mucosa orale, soluzione

UK/H/5072/001

043050018

CEBUTID CEBUTID CEBUTID CEBUTID CORYFIN

not not not not not

available available available available available

322 267-5: 322 268-1 319 710-9 331 990-8 041827015

not available

041827027

not available

20040223

Product Name (in authorisation country)

100, comprimé enrobé 100, comprimé enrobé 50 mg, comprimé enrobé LP 200 mg, gélule à libération prolongée GOLA DOLORE 2,5 mg/ml collutorio

CORYFIN GOLA DOLORE 2,5 mg/ml spray per mucosa orale Cтрепсилс Интензив 8,75 mg таблетки за

EMA/593212/2017

is authorised TEVA SANTÉ RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED ALMIRALL, S.A. ALMIRALL, S.A. ALMIRALL, S.A. ALMIRALL, S.A. LABORATORIO FARMACEUTICO S.I.T. S.R.L. LABORATORIO FARMACEUTICO S.I.T. S.R.L. RECKITT BENCKISER

FR IT IT IT IT IT IT IT IT FR FR FR FR IT IT BG

Page 2/12

Product Name (in authorisation country)

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

смучене, Strepsils Intensive 8, 75 mg Lozenge

is authorised

Dobendan Direkt Flurbiprofen 8,75 mg Lutschtabletten Dobendan Direkt Flurbiprofen Spray 8,75 mg/Dosis Spray zur Anwendung in der Mundhöhle, Lösung Dobendan Direkt Zuckerfrei Flurbiprofen 8,75 mg Lutschtabletten Flubilarin 8,75 mg zuigtabletten Flubilarin 8,75 mg zuigtabletten Flugalin 100 mg bevont tabletta Flugalin 50 mg Flugalin 50 mg bevont tabletta FLUIBRON GOLA 0,25% Collutorio FLUIBRON GOLA 0,25% Spray per mucosa orale FLURACTIVE 0,25% Collutorio FLURACTIVE 0,25% Spray per mucosa orale Flurbiprofen 100 mg coated tablets Flurbiprofen 100 mg Tablets

UK/H/0388/001

51312.00.00

UK/H/5072/001

90453.00.00

UK/H/4701/001

84029.00.00

NL/H/3513/001 NL/H/3513/001 not available not available not available not available not available not available not available not available not available

BE501715 BE501724 OGYI-T-1641/02 29/0391/92-S OGYI-T-1641/01 042000012 042000024 041514011 041514023 PL 46302/0012 PL 17907/0325

Flurbiprofen 50 mg coated tablets Flurbiprofen 50mg Tablets

not available not available

PL 46302/0013 PL 17907/0324

Flurbiprofen 8.75mg Lozenges

UK/H/4701/001

PL 00063/0644

Flurbiprofen Conventia Medical 2,5 mg/ml oralno pršilo, raztopina FLURBIPROFENE EG 0,25% Collutorio FLURBIPROFENE EG 0,25% Spray per mucosa orale FLURBIPROFENE EUROGENERICI 8,75 mg Pastiglie gusto Limone e Miele FLURBIPROFENE EUROGENERICI 8,75 mg Pastiglie gusto Limone e Miele

EE/H/2017/002

H/16/02175/001

HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER (DEUTSCHLAND) GMBH RECKITT BENCKISER (DEUTSCHLAND) GMBH RECKITT BENCKISER (DEUTSCHLAND) GMBH SANDOZ N.V. SANDOZ N.V. MYLAN EPD KFT. BGP PRODUCTS S.R.O. MYLAN EPD KFT. CHIESI FARMACEUTICI S.P.A. CHIESI FARMACEUTICI S.P.A. FG S.R.L. FG S.R.L. MYLAN PRODUCTS LIMITED BRISTOL LABORATORIES LTD (BERKHAMSTED) MYLAN PRODUCTS LIMITED BRISTOL LABORATORIES LTD (BERKHAMSTED) RECKITT BENCKISER (UK) LIMITED CONVENTIA MEDICAL LLP

not available not available not available

041815010 041815022 042814018

EPIFARMA S.R.L. EPIFARMA S.R.L. FG S.R.L.

IT IT IT

not available

042814020

FG S.R.L.

IT

EMA/593212/2017

DE DE DE BE BE HU SK HU IT IT IT IT UK UK UK UK UK SI

Page 3/12

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

FLURBIPROFENE IPSO PHARMA 0,25% Collutorio FLURBIPROFENE IPSO PHARMA 0,25% Spray per mucosa orale FLURBIPROFENE PENSA 0,25% Collutorio FLURBIPROFENE PENSA 0,25% Spray per mucosa orale FLURBIPROFENE TEVA 0,25% Collutorio FLURBIPROFENE TEVA 0,25% Spray per mucosa orale FLURENT 0,25% Collutorio FLURENT 0,25% Spray per mucosa orale Flurent 8,75 mg Pastiglie gusto Limone e Miele Flurent 8,75 mg Pastiglie gusto Limone e Miele FROBEN 100 mg compresse rivestite Froben 100 mg comprimidos revestidos

not available not available

043508011 043508023

IPSO PHARMA S.R.L. IPSO PHARMA S.R.L.

IT IT

not available not available

043510015 043510027

FG S.R.L. FG S.R.L.

IT IT

not available not available

043509013 043509025

TEVA ITALIA S.R.L. TEVA ITALIA S.R.L.

IT IT

not not not not not not

041513019 041513021 041513033 041513045 024284034 5550884

IT IT IT IT IT PT

FROBEN 100 mg granulato effervescente Froben 2,5mg/ml Στοματικό εκνέφωμα, διάλυμα Froben 2,5mg/ml Διάλυμα για στοματικές πλύσεις Froben 2,5 mg/ml aerosols izsmidzināšanai mutes dobumā, šķīdums Froben 2,5 mg/ml burnos gleivinės purškalas (tirpalas) Froben 2,5 mg/ml mondspoeling Froben 2,5 mg/ml Mundwasser Froben 2,5 mg/ml Mundwasser Froben 2,5 mg/ml solution pour bain de bouche Froben 2,5 mg/ml solution pour bain de bouche Froben 2,5 mg/ml solution pour pulvérisation buccale Froben 2,5 mg/ml solution pour pulvérisation buccale Froben 2,5 mg/ml spray voor oromucosaal gebruik,

not available EE/H/0217/002 EE/H/0217/001 EE/H/0217/002

024284150 12113/14-02-2017 12112/14-02-2017 16-0074

PHARMEG S.R.L. PHARMEG S.R.L. PHARMEG S.R.L. PHARMEG S.R.L. BGP PRODUCTS S.R.L. BGP PRODUCTS UNIPESSOAL, LDA. BGP PRODUCTS S.R.L. BGP PRODUCTS LTD BGP PRODUCTS LTD BGP PRODUCTS SIA

EE/H/0217/002

LT/1/16/3925/001

BGP PRODUCTS SIA

LT

EE/H/0217/001 EE/H/0217/001 EE/H/0217/001 EE/H/0217/001 EE/H/0217/001 EE/H/0217/002

BE494595 BE494595 2016110297 BE494595 2016110297 BE494604

MYLAN MYLAN MYLAN MYLAN MYLAN MYLAN

SPRL SPRL SPRL SPRL SPRL SPRL

BE BE LU BE LU BE

EE/H/0217/002

2016110298

MYLAN EPD SPRL

LU

EE/H/0217/002

BE494604

MYLAN EPD SPRL

BE

Product Name (in authorisation country)

EMA/593212/2017

available available available available available available

is authorised

EPD EPD EPD EPD EPD EPD

IT GR GR LV

Page 4/12

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

EE/H/0217/002

BE494604

MYLAN EPD SPRL

BE

EE/H/0217/002

2016110298

MYLAN EPD SPRL

LU

not available EE/H/0217/002

024284073 5707443

IT PT

Froben 2,5 mg/ml solução para lavagem da boca

EE/H/0217/001

5707435

FROBEN GOLA 0,25% Collutorio FROBEN GOLA 0,25% Spray per mucosa orale Froben Tablets 100 mg Froben Tablets 50 mg Froben, 2,5 mg/ml suuloputuslahus Froben, 2,5 mg/ml suuõõnesprei, lahus KAVOFLOG 0,25% Collutorio KAVOFLOG 0,25% Collutorio KAVOFLOG 0,25% Spray per mucosa orale KAVOFLOG 0,25% Spray per mucosa orale Lilidol Gola 8,75 mg Pastiglie gusto Limone e Miele Lilidol Gola 8,75 mg Pastiglie gusto Limone e Miele NEO BOROCILLINA GOLA DOLORE “8,75 mg pastiglie senza zucchero gusto menta” NEO BOROCILLINA GOLA DOLORE “8,75 mg pastiglie senza zucchero gusto menta” NEO BOROCILLINA GOLA DOLORE “8,75 mg pastiglie senza zucchero gusto menta” Ocufen OCUFEN 0,12 mg / 0,4 ml, collyre en récipient unidose OCUFEN 0,12 mg / 0,4 ml, collyre en récipient unidose

not available not available not available not available EE/H/0217/001 EE/H/0217/002 not available not available not available not available not available not available not available

042822015 042822027 PL 46302/0012 PL 46302/0013 913716 913616 041794013 041794013 041794025 041794025 042807014 042807026 035760065

BGP PRODUCTS S.R.L. BGP PRODUCTS UNIPESSOAL, LDA. BGP PRODUCTS UNIPESSOAL, LDA. BGP PRODUCTS S.R.L. BGP PRODUCTS S.R.L. MYLAN PRODUCTS LIMITED MYLAN PRODUCTS LIMITED BGP PRODUCTS SIA BGP PRODUCTS SIA POOL-PHARMA S.R.L. POOL-PHARMA S.R.L. POOL-PHARMA S.R.L. POOL-PHARMA S.R.L. PHARMEG S.R.L. PHARMEG S.R.L. ALFA WASSERMANN SPA

not available

035760077

ALFA WASSERMANN SPA

IT

not available

035760040

ALFA WASSERMANN SPA

IT

not available not available

PL 00426/0069 334 434-9

ALLERGAN LTD HORUS PHARMA

UK FR

not available

334 026-1

HORUS PHARMA

FR

Product Name (in authorisation country)

oplossing Froben 2,5 mg/ml Spray, Lösung zur Anwendung in der Mundhöhle Froben 2,5 mg/ml Spray, Lösung zur Anwendung in der Mundhöhle FROBEN 5mg/ml sciroppo Froben 2,5 mg/ml solução para pulverização bucal

EMA/593212/2017

is authorised

PT IT IT UK UK EE EE IT IT IT IT IT IT IT

Page 5/12

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

OCUFEN 0,3 mg/ml collirio, soluzione

not available

027245024

OCUFLUR O.K. 0,3 mg/ml Augentropfen OROFLUX 0,25% Collutorio OROFLUX 0,25% Spray per mucosa orale Oroflux 8,75 mg Pastiglie gusto Limone e Miele Oroflux 8,75 mg Pastiglie gusto Limone e Miele Strefen 8,75 mg munnsogstöflur

not available not available not available not available not available UK/H/0388/001

27168.00.00 041512017 041512029 041512031 041512043 IS/1/08/019/01

STREFEN 8,75 mg ORANGE SANS SUCRE, pastille édulcorée à l’acésulfame potassique STREFEN 8,75 mg ORANGE SANS SUCRE, pastille édulcorée à l’acésulfame potassique Strefen 8,75 mg pastillas para chupar sabor miel y limón Strefen 8,75 mg pastillas para chupar sabor naranja Strefen 8,75 mg sugetabletter

not available

34009 300 024 0 7

not available

34009 300 024 1 4

UK/H/0388/001

72.938

UK/H/4701/001

76902

not available

13-9573

Strefen 8,75 mg sugtabletter

UK/H/0388/001

26284

Strefen Apelsin 8,75 mg sugtabletter

UK/H/4701/001

45657

Strefen brez sladkorja z okusom pomeranče 8,75 mg pastile

UK/H/4701/001

H/12/01463/001

Strefen brez sladkorja z okusom pomeranče 8,75 mg pastile

UK/H/4701/001

H/12/01463/002

Strefen Direct 8.75mg Oromucosal Spray

UK/H/5072/001

PL 00063/0715

Product Name (in authorisation country)

EMA/593212/2017

is authorised ALLERGAN PHARMACEUTICALS IRELAND OMNIVISION GMBH EPIFARMA S.R.L. EPIFARMA S.R.L. EPIFARMA S.R.L. EPIFARMA S.R.L. RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE FRANCE RECKITT BENCKISER HEALTHCARE FRANCE RECKITT BENCKISER HEALTHCARE S.A. RECKITT BENCKISER HEALTHCARE S.A. RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER

IT DE IT IT IT IT IS FR FR ES ES NO SE SE SI SI UK

Page 6/12

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

Strefen Honey and Lemon

not available

PL 00063/0714

Strefen Orange

UK/H/4701/001

48206

Strefen Orange 8,75 mg imeskelytabletti

UK/H/4701/001

29493

Strefen Orange 8,75 mg Sukkerfri, munnsogstöflur

UK/H/4701/001

IS/1/12/078/01

Strefen Spray 8,75 mg/dosis solución para pulverización bucal Strefen, sugetabletter

UK/H/5072/001

79428

UK/H/0388/001

42422

STREFENSPRAY 8,75 mg, solution pour pulvérisation buccale Streflam 8.75mg lozenges

UK/H/5072/001

34009 300 468 7 6

UK/H/0388/001

PL 00063/0631

STREPFEN ®

UK/H/0388/001

021310

STREPFEN ®

UK/H/0388/001

2802401

Strepfen 8,75 mg keelspray

UK/H/5072/001

RVG 114130

Strepfen 8,75 mg Lutschtabletten

UK/H/0388/001

BE356614

Strepfen 8,75 mg pastile

not available

HR-H-084514166

Strepfen 8,75 mg pastile

UK/H/0388/001

H/10/01462/003

Product Name (in authorisation country)

EMA/593212/2017

is authorised HEALTHCARE (UK) LIMITED RECKITT BENCKISER HEALTHCARE (UK) LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE S.A. RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE FRANCE RECKITT BENCKISER HEALTHCARE (UK) LIMITED RECKITT BENCKISER HELLAS CHEMICALS ABEE RECKITT BENCKISER HELLAS CHEMICALS ABEE RECKITT BENCKISER HEALTHCARE B.V. RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER (CROATIA) D.O.O. RECKITT BENCKISER HEALTHCARE INTERNATIONAL

UK DK FI IS ES DK FR UK CY GR NL BE HR SI

Page 7/12

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

Strepfen 8,75 mg pastile

UK/H/0388/001

H/10/01462/001

Strepfen 8,75 mg pastile

UK/H/0388/001

H/10/01462/002

Strepfen 8,75 mg pastile

UK/H/0388/001

H/10/01462/001

Strepfen 8,75 mg pastilles

UK/H/0388/001

BE356614

Strepfen 8,75 mg pastilles

UK/H/388/001

2010040068

Strepfen 8,75 mg szopogató tabletta

not available

OGYI-T-8900/13

Strepfen 8,75 mg szopogató tabletta

not available

OGYI-T-8900/01

Strepfen 8,75 mg zuigtabletten

UK/H/0388/001

BE356614

Strepfen brez sladkorja z okusom pomaranče 8,75 mg pastile

UK/H/4701/001

H/12/01463/003

Strepfen Citroen & Honing 8,75 mg zuigtabletten

UK/H/0388/001

RVG 101477

Strepfen cukormentes 8,75 mg szopogató tabletta

not available

OGYI-T-8900/10

Strepfen cukormentes 8,75 mg szopogató tabletta

not available

OGYI-T-8900/11

Product Name (in authorisation country)

EMA/593212/2017

is authorised LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE B.V. RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER

SI SI SI BE LU HU HU BE SI NL HU HU

Page 8/12

Product Name (in authorisation country)

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

Strepfen cukormentes 8,75 mg szopogató tabletta

not available

OGYI-T-8900/12

Strepfen DIREKT 16,2 mg/ml szájnyálkahártyán alkalmazott oldatos spray

UK/H/5072/001

OGYI-T-8900/14

Strepfen Laranja sem açúcar 8,75 mg pastilhas

UK/H/4701/001

5478052

Strepfen Laranja sem Açúcar 8.75 mg pastilhas

UK/H/4701/001

5478045

Strepfen Mel e Limão 8,75 mg Pastilhas

UK/H/0388/001

5154810

Strepfen Mel e Limão 8,75 mg Pastilhas

UK/H/0388/001

3700481

Strepfen Mel e Limão 8,75 mg Pastilhas

UK/H/0388/001

5154828

Strepfen naranča bez šećera 8,75 mg pastile

not available

Strepfen Sans Sucre 8,75 mg pastilles

UK/H/4701/001

UP/I-530-09/1201/604 BE428644

Strepfen Sans Sucre 8,75 mg pastilles

UK/H/4701/001

2013010042

Strepfen Sinaasappel Suikervrij 8,75 mg, zuigtabletten Strepfen Spray 16,2 mg/ml solução para pulverização bucal Strepfen Spray 8,75 mg/Dose Spray zur Anwendung in der Mundhöhle, Lösung

UK/H/4701/001

RVG 109114

UK/H/5072/001

5631031

UK/H/5072/001

BE466746

Strepfen Spray 8,75mg/dose spray voor

UK/H/5072/001

BE466746

EMA/593212/2017

is authorised HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE, LDA. RECKITT BENCKISER HEALTHCARE, LDA. RECKITT BENCKISER HEALTHCARE, LDA. RECKITT BENCKISER HEALTHCARE, LDA. RECKITT BENCKISER HEALTHCARE, LDA. RECKITT BENCKISER (CROATIA) D.O.O. RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER HEALTHCARE B.V. RECKITT BENCKISER HEALTHCARE, LDA. RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER

HU HU PT PT PT PT PT HR BE LU NL PT BE BE

Page 9/12

Product Name (in authorisation country)

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

oromucosaal gebruik, oplossing Strepfen Spray 8,75mg/dose, solution pour pulvérisation buccale

UK/H/5072/001

BE466746

Strepfen Sprej 8,75 mg orálna roztoková aerodisperzia

UK/H/5072/001

69/0341/14-S

Strepfen Sprej 8,75 mg orální sprej, roztok

UK/H/5072/001

69/044/15-C

Strepfen Sugar Free 8.75 mg Lozenges

UK/H/4701/001

021793

Strepfen Suikervrij 8,75 mg zuigtabletten

UK/H/4701/001

BE428644

Strepfen Zuckerfrei 8,75 mg Lutschtabletten

UK/H/4701/001

BE428644

Strepflam 8,75 mg kietosios pastilės

UK/H/4701/001

LT/1/12/3080/001

Strepflam 8,75 mg kietosios pastilės

UK/H/4701/001

LT/1/12/3080/002

Strepflam 8,75 mg kietosios pastilės

UK/H/4701/001

LT/1/12/3080/003

Strepflam 8.75 mg Lozenges

UK/H/4701/001

021793

Strepsils 8,75 mg Lutschtabletten

UK/H/0388/001

1-24413

Strepsils 8,75 mg/Dosis Spray zur Anwendung in der Mundhöhle, Lösung Strepsils Intensiv 8,75 mg / doză spray bucofaringian, soluție

UK/H/5072/001

135920

UK/H/5072/001

7174/2014/01

EMA/593212/2017

is authorised HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HELLAS CHEMICALS ABEE RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER HEALTHCARE (BELGIUM) SA/NV RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER HELLAS CHEMICALS ABEE RECKITT BENCKISER (DEUTSCHLAND) GMBH RECKITT BENCKISER (DEUTSCHLAND) GMBH RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED

BE SK CZ GR BE BE LT LT LT CY AT AT RO

Page 10/12

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

Strepsils Intensiv Miere Şi Lămâie 8,75 mg, pastile

not available

1957/2009/02

Strepsils Intensiv Miere Şi Lămâie 8,75 mg, pastile

not available

1957/2009/01

Strepsils Intensive 8,75 mg sūkājamās tabletes

not available

04 - 0416

Strepsils Intensive 8,75 mg kietosios pastilės

UK/H/0388/001

LT/1/09/1455/001

Strepsils Intensive 8,75 mg kietosios pastilės

UK/H/0388/001

LT/1/09/1455/002

Strepsils Intensive 8,75 mg kietosios pastilės

UK/H/0388/001

LT/1/09/1455/003

Strepsils Intensive 8.75mg/dose Oromucosal Spray

UK/H/5072/001

PA 979/41/5

Strepsils Intensive Direct, 8,75 mg/dawkę, aerozol do stosowania w jamie ustnej, roztwór Strepsils Intensive Orange 8,75 mg losengid (suhkruvaba) Strepsils Intensive, 8,75 mg losengid

UK/H/5072/001

22348

UK/H/4701/001

794512

UK/H/0388/001

615108

Strepsils Intensive, 8,75mg, tabletki do ssania

not available

8304

Strepsils Orange Zuckerfrei 8,75 mg Lutschtabletten TRANSACT Lat 40 mg cerotti medicati TRANSACT Lat 40 mg cerotti medicati Transact Lat, 40 mg, penso impregnado Transact Lat, 40 mg, penso impregnado Transact Lat, 40 mg, penso impregnado Transact Lat, 40 mg, penso impregnado Стрепсилс Интензив Спрей 8,75 mg/доза спрей за устна лигавица, разтвор Strepsils Intensive

UK/H/4701/001

1-31557

not available not available not available not available not available not available UK/H/5072/001

028741015 28741039 5109582 2338283 5109582 2338283 20150012

Product Name (in authorisation country)

EMA/593212/2017

is authorised RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL LIMITED RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER IRELAND LTD. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (POLAND) S.A. RECKITT BENCKISER (DEUTSCHLAND) GMBH AMDIPHARM LIMITED AMDIPHARM LIMITED AMDIPHARM LIMITED AMDIPHARM LIMITED AMDIPHARM LIMITED AMDIPHARM LIMITED RECKITT BENCKISER HEALTHCARE INTERNATIONAL

RO RO LV LT LT LT IE PL EE EE PL AT IT IT PT PT PT PT BG

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Product Name (in authorisation country)

Spray 8,75 mg/dose oromucosal spray, solution

EMA/593212/2017

MRP/DCP

National

MAH of product in the

Member State

Authorisation

Authorisation

member state

where product

number

Number

is authorised LIMITED

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