Sep 1, 2017 - Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 ... List of nationally authorised medicinal pr
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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