6 April 2017 EMA/208664/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: Timolol (eye preparations)
Procedure no.: PSUSA/00010439/201607
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 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.
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
Timolol-POS 0,5%, Oční
not available
64/069/97-C
URSAPHARM SPOL. S.R.O.
CZ
not available
354 698-1
LABORATOIRES URSAPHARM
FR
kapky, roztok TIMOCOMOD 0,25 POUR CENT, collyre en solution TIMOCOMOD 0,50 POUR
S.A.S. not available
354 699-8
CENT, collyre en solution Timo-COMOD 0,25%,
LABORATOIRES URSAPHARM
FR
S.A.S. not available
RVG 21644
URSAPHARM BENELUX B.V.
NL
not available
64/538/00-C
URSAPHARM SPOL. S.R.O.
CZ
not available
64/068/97-C
URSAPHARM SPOL. S.R.O.
CZ
not available
RVG 21645
URSAPHARM BENELUX B.V.
NL
not available
64/811/93-C
PHARMASWISS ČESKÁ
CZ
oogdruppels 2,5 mg/ml Timo-COMOD 0,5%, Oční kapky, roztok Timolol-POS 0,25%, Oční kapky, roztok Timo-COMOD 0,5%, oogdruppels 5 mg/ml Arutimol 0,50 % Oční kapky, roztok Tim®-Ophtal® 0,1 %
REPUBLIKA S.R.O. not available
3003348.01.00
DR. WINZER PHARMA GMBH
DE
not available
3003348.02.00
DR. WINZER PHARMA GMBH
DE
sine Tim®-Ophtal® 0,25 % sine
List of nationally authorised medicinal products EMA/208664/2017
Page 2/30
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
Tim®-Ophtal® 0,5 %
not available
3003348.00.00
DR. WINZER PHARMA GMBH
DE
not available
11712.01.00
DR. GERHARD MANN CHEM.-
DE
sine Timomann® 0,25 %
PHARM. FABRIK GMBH Timomann® 0,5 %
not available
11712.02.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH IALUTIM 0,5% collirio,
not available
035893015
BAUSCH & LOMB IOM S.P.A
IT
not available
OGYI-T- 1904/01
PHARMASWISS ČESKÁ
HU
soluzione Arutimol 5 mg/ml oldatos szemcsepp Arutimol 5 mg/ml oldatos
REPUBLIKA S.R.O. not available
OGYI-T- 1904/02
szemcsepp
PHARMASWISS ČESKÁ
HU
REPUBLIKA S.R.O.
Tim®-Ophtal® 0,25%
not available
28699.01.00
DR. WINZER PHARMA GMBH
DE
Tim®-Ophtal® 0,5%
not available
28699.02.00
DR. WINZER PHARMA GMBH
DE
TimoEDO® 0,25 %
not available
23857.00.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH
List of nationally authorised medicinal products EMA/208664/2017
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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
TimoEDO® 0,5 %
not available
23857.01.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH Arutimol® uno
not available
3000482.00.00
Augentropfen 0,25 % Arutimol® uno
not available
3000482.01.00
not available
10409.01.00
not available
10409.00.00
not available
00-0007
DK/H/2468/002
HR-H-980830974
DR. GERHARD MANN CHEM.-
DE
CHAUVIN ANKERPHARM
LV
PHARMASWISS ČESKÁ
HR
REPUBLIKA S.R.O. DK/H/2468/001
PL 33616/0020
Drops, Solution Arutimol 0,50 % Oční
DE
GMBH
oko, otopina Vizioblok 2.5 mg/ml Eye
DR. GERHARD MANN CHEM.-
PHARM. FABRIK GMBH
pilieni, šķīdums Vizioblok 5 mg/ml kapi za
DE
PHARM. FABRIK GMBH
0,5 % Arutimol® 5 mg/ml acu
DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH
0,25 % Arutimol ® Augentropfen
DE
PHARM. FABRIK GMBH
Augentropfen 0,5 % Arutimol ® Augentropfen
DR. GERHARD MANN CHEM.-
PHARMASWISS ČESKÁ
UK
REPUBLIKA S.R.O. not available
kapky, roztok
List of nationally authorised medicinal products EMA/208664/2017
64/811/93-C
PHARMASWISS ČESKÁ
CZ
REPUBLIKA S.R.O.
Page 4/30
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
Tim®-Ophtal® 0,1 %
not available
3003348.01.00
DR. WINZER PHARMA GMBH
DE
not available
3003348.02.00
DR. WINZER PHARMA GMBH
DE
not available
3003348.00.00
DR. WINZER PHARMA GMBH
DE
not available
11712.01.00
DR. GERHARD MANN CHEM.-
DE
sine Tim®-Ophtal® 0,25 % sine Tim®-Ophtal® 0,5 % sine Timomann® 0,25 %
PHARM. FABRIK GMBH Timomann® 0,5 %
not available
11712.02.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH IALUTIM 0,5% collirio,
not available
035893015
BAUSCH & LOMB IOM S.P.A
IT
not available
OGYI-T- 1904/01
PHARMASWISS ČESKÁ
HU
soluzione Arutimol 5 mg/ml oldatos szemcsepp Arutimol 5 mg/ml oldatos
REPUBLIKA S.R.O. not available
OGYI-T- 1904/02
szemcsepp Tim®-Ophtal® 0,25%
PHARMASWISS ČESKÁ
HU
REPUBLIKA S.R.O. not available
List of nationally authorised medicinal products EMA/208664/2017
28699.01.00
DR. WINZER PHARMA GMBH
DE
Page 5/30
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
Tim®-Ophtal® 0,5%
not available
28699.02.00
DR. WINZER PHARMA GMBH
DE
TimoEDO® 0,25 %
not available
23857.00.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH TimoEDO® 0,5 %
not available
23857.01.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH Arutimol® uno
not available
3000482.00.00
Augentropfen 0,25 % Arutimol® uno
not available
3000482.01.00
not available
10409.01.00
not available
10409.00.00
DR. GERHARD MANN CHEM.-
DE
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH not available
00-0007
pilieni, šķīdums TIMOPTOL-XE 2,5 mg/ml,
DE
PHARM. FABRIK GMBH
0,5 % Arutimol® 5 mg/ml acu
DR. GERHARD MANN CHEM.PHARM. FABRIK GMBH
0,25 % Arutimol ® Augentropfen
DE
PHARM. FABRIK GMBH
Augentropfen 0,5 % Arutimol ® Augentropfen
DR. GERHARD MANN CHEM.-
CHAUVIN ANKERPHARM
LV
GMBH not available
RVG 17017
MERCK SHARP & DOHME BV
NL
oogdruppels, oplossing
List of nationally authorised medicinal products EMA/208664/2017
Page 6/30
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
TIMOPTOL-XE 5 mg/ml,
not available
RVG 17018
MERCK SHARP & DOHME BV
NL
not available
024278107
SANTEN ITALY S.R.L.
IT
not available
024278121
SANTEN ITALY S.R.L.
IT
not available
024278133
SANTEN ITALY S.R.L.
IT
not available
024278145
SANTEN ITALY S.R.L.
IT
not available
34009 335 463 2 8
LABORATOIRES THEA
FR
not available
34009 335 464 9 6
LABORATOIRES THEA
FR
not available
340 429-3
LABORATOIRES THEA
FR
not available
361 989-8
LABORATOIRES THEA
FR
oogdruppels, oplossing TIMOPTOL 0,25% collirio, soluzione TIMOPTOL 0,50% collirio, soluzione TIMOPTOL XE 0,25% collirio a rilascio prolungato TIMOPTOL XE 0,50% collirio a rilascio prolungato OPHTIM 0,25 POUR CENT (0,625 mg/0,25 ml), collyre en récipient unidose OPHTIM 0,50 POUR CENT (1,25 mg/0,25 ml), collyre en récipient unidose TIMABAK 0,10 %, collyre en solution TIMABAK 0,10 %, collyre en solution
List of nationally authorised medicinal products EMA/208664/2017
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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
TIMABAK 0,50 %, collyre
not available
34009 340 431 8 5
LABORATOIRES THEA
FR
not available
34009 361 991 2 5
LABORATOIRES THEA
FR
not available
340430-1
LABORATOIRES THEA
FR
not available
361 990-6
LABORATOIRES THEA
FR
not available
65.150
LABORATORIOS THEA S.A.
ES
not available
65.151
LABORATORIOS THEA S.A.
ES
not available
2999985
LABORATOIRES THEA
PT
not available
5879788
LABORATOIRES THEA
PT
not available
3000080
LABORATOIRES THEA
PT
en solution TIMABAK 0,50 %, collyre en solution TIMABAK 0,25 %, collyre en solution TIMABAK 0,25 %, collyre en solution TIMABAK 0,25% colirio en solución TIMABAK 0,50% colirio en solución TIMABAK 2,5 mg/ml, colírio, solução TIMABAK 2,5 mg/ml, colírio, solução TIMABAK 5 mg/ml, colírio, solução
List of nationally authorised medicinal products EMA/208664/2017
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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
TIMABAK 5 mg/ml,
not available
5879689
LABORATOIRES THEA
PT
not available
BE207864
THEA PHARMA
BE
not available
BE207864
THEA PHARMA
BE
not available
1409/11071183
THEA PHARMA
LU
not available
1409/11071185
THEA PHARMA
LU
not available
033951017
THEA FARMA
IT
not available
033951029
THEA FARMA
IT
not available
BE207855
THEA PHARMA
BE
not available
BE207855
THEA PHARMA
BE
colírio, solução Timabak 0,50% collyre en solution Timabak 0,50 %, oogdruppels, oplossing Timabak 0,25% collyre en solution Timabak 0,50% collyre en solution TIMOLABAK 2,5 mg/ml collirio, soluzione TIMOLABAK 5 mg/ml collirio, soluzione Timabak 0,25% collyre en solution Timabak 0,25 %, oogdruppels, oplossing
List of nationally authorised medicinal products EMA/208664/2017
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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
TIMOPTIC 0,5%, 5
not available
R/1807
SANTEN OY
PL
not available
H/97/01531/001
SANTEN OY
SI
not available
H/97/01531/002
SANTEN OY
SI
not available
OGYI-T- 1904/01
PHARMASWISS ČESKÁ
HU
mg/ml, krople do oczu, roztwór TIMOPTIC -XE 2,5 mg/ml kapljice za oko, raztopina TIMOPTIC -XE 5 mg/ml kapljice za oko, raztopina Arutimol 5 mg/ml oldatos szemcsepp Arutimol 5 mg/ml oldatos
REPUBLIKA S.R.O. not available
OGYI-T- 1904/02
szemcsepp Eyopto 5 mg/ml Eye
PHARMASWISS ČESKÁ
HU
REPUBLIKA S.R.O. DK/H/2456/002
PL 17277/0344
PHARMATHEN S.A.
UK
DK/H/2456/001
PL 17277/0343
PHARMATHEN S.A.
UK
DK/H/2456/001
137038
PHARMATHEN S.A.
AT
DK/H/2456/002
1370387
PHARMATHEN S.A.
AT
Drops, Solution Eyopto 2.5 mg/ml Eye Drops, Solution Eyopto 2,5 mg/ml Augentropfen, Lösung Eyopto 5 mg/ml Augentropfen, Lösung
List of nationally authorised medicinal products EMA/208664/2017
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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
Blutim 0. 5% w/v Eye
not available
PL 31103/0023
BLUMONT PHARMA LTD
UK
not available
PL 31103/0022
BLUMONT PHARMA LTD
UK
UK/H/4232/001
PL 31103/0007
BLUMONT PHARMA LTD
UK
UK/H/4232/002
PL31103/0008
BLUMONT PHARMA LTD
UK
UK/H/4103/001
PL 25298/0054
BROWN & BURK UK LIMITED
UK
UK/H/4103/002
PL 25298/0055
BROWN & BURK UK LIMITED
UK
UK/H/4103/002
PL 25298/0055
BROWN & BURK UK LIMITED
UK
UK/H/4103/001
PA1648/002/001
BROWN & BURK UK LIMITED
IE
UK/H/4103/002
P A 1648/002/002
BROWN & BURK UK LIMITED
IE
Drops Solution Blutim 0.25% w/v Eye Drops Solution Timolol 0.25% w/v Eye Drops Solution Timolol 0. 5% w/v Eye Drops Solution Timolol 0.25% w/v Eye Drops Solution Timolol 0.5% w/v Eye Drops Solution Timolol 0.5% w/v Eye Drops Solution Timolol 0.25% w/v Eye Drops, Solution Timolol 0.5% w/v Eye Drops, Solution
List of nationally authorised medicinal products EMA/208664/2017
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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
Timolol 0.5% w/v Eye
UK/H/4103/002
PA1648/002/002
BROWN & BURK UK LIMITED
IE
Timolol 0,1% PCH
not available
RVG 15045
PHARMACHEMIE B.V
NL
BLOCANOL DEPOT 5
not available
11431
SANTEN OY
FI
not available
11431
SANTEN OY
FI
not available
8048
SANTEN OY
NO
not available
BE230352
SANTEN OY
BE
not available
BE230352
SANTEN OY
BE
not available
BE230352
SANTEN OY
BE
not available
BE230361
SANTEN OY
BE
Drops, Solution
mg/ml depotsilmätipat BLOCANOL DEPOT 5 mg/ml depotögondroppar Blocadren Depot 5 mg/ml depotøyedråper TIMOPTOL 2,50 mg/ml (0,25%), oogdruppels, oplossing Timoptol® 2,50 mg/ml (0,25%), collyre en solution Timoptol ® 2,50 mg/ml (0,25 %), Augentropfen TIMOPTOL 5,0 mg/ml (0,5%), oogdruppels, oplossing
List of nationally authorised medicinal products EMA/208664/2017
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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
Timoptol® 5,0 mg/ml
not available
BE230361
SANTEN OY
BE
not available
BE230361
SANTEN OY
BE
not available
2002127029
SANTEN OY
LU
not available
2002127028
SANTEN OY
LU
not available
64/069/97-C
URSAPHARM SPOL. S.R.O.
CZ
not available
PL 16058/0020
SANTEN OY
UK
not available
PL 16058/0019
SANTEN OY
UK
not available
PL 16058/0021
SANTEN OY
UK
not available
PL 16058/0018
SANTEN OY
UK
(0,5%), collyre en solution Timoptol ® 5,0 mg/ml (0,5 %), Augentropfen Timoptol® 5,0 mg/ml (0,5%), collyre en solution Timoptol® 2,50 mg/ml (0,25%), collyre en solution Timolol-POS 0,5%, Oční kapky, roztok Timoptol® 0.25% w/v Eye Drops Solution Timoptol® 0.5% w/v Eye Drops Solution Timoptol® Unit Dose 0.25% w/v Eye Drops Solution Timoptol® Unit Dose 0.5% w/v Eye Drops Solution
List of nationally authorised medicinal products EMA/208664/2017
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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
Timoptol® LA 0.25% w/v
not available
PL 16058/0023
SANTEN OY
UK
not available
PL 16058/0022
SANTEN OY
UK
not available
64/811/93-C
PHARMASWISS ČESKÁ
CZ
Gel-Forming Eye Drops Solution Timoptol® LA 0.5% w/v Gel-Forming Eye Drops Solution Arutimol 0,50 % Oční kapky, roztok Tim®-Ophtal® 0,1 %
REPUBLIKA S.R.O. not available
3003348.01.00
DR. WINZER PHARMA GMBH
DE
not available
3003348.02.00
DR. WINZER PHARMA GMBH
DE
not available
3003348.00.00
DR. WINZER PHARMA GMBH
DE
not available
11712.01.00
DR. GERHARD MANN CHEM.-
DE
sine Tim®-Ophtal® 0,25 % sine Tim®-Ophtal® 0,5 % sine Timomann® 0,25 %
PHARM. FABRIK GMBH Timomann® 0,5 %
not available
11712.02.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH IALUTIM 0,5% collirio,
not available
035893015
BAUSCH & LOMB IOM S.P.A
IT
soluzione
List of nationally authorised medicinal products EMA/208664/2017
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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
Tim®-Ophtal® 0,25%
not available
28699.01.00
DR. WINZER PHARMA GMBH
DE
Tim®-Ophtal® 0,5%
not available
28699.02.00
DR. WINZER PHARMA GMBH
DE
TimoEDO® 0,25 %
not available
23857.00.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH TimoEDO® 0,5 %
not available
23857.01.00
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH Arutimol® uno
not available
3000482.00.00
Augentropfen 0,25 % Arutimol® uno
DE
PHARM. FABRIK GMBH not available
3000482.01.00
Augentropfen 0,5 % BLOCANOL 5 mg/ml
DR. GERHARD MANN CHEM.-
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH not available
7753
SANTEN OY
FI
not available
7753
SANTEN OY
FI
not available
RVG 21644
URSAPHARM BENELUX B.V.
NL
silmätipat, liuos BLOCANOL 5 mg/ml ögondroppar, lösning Timo-COMOD 0,25%, oogdruppels 2,5 mg/ml
List of nationally authorised medicinal products EMA/208664/2017
Page 15/30
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
Timo-COMOD 0,5%, Oční
not available
64/538/00-C
URSAPHARM SPOL. S.R.O.
CZ
not available
64/068/97-C
URSAPHARM SPOL. S.R.O.
CZ
not available
RVG 21645
URSAPHARM BENELUX B.V.
NL
RVG 57607
RVG 57607
SANDOZ B.V.
NL
RVG 57609
RVG 57609
SANDOZ B.V.
NL
RVG 57608
RVG 57608
SANDOZ B.V.
NL
TIMOHEXAL 0,5%
16832/95
64/287/98-C
HEXAL AG
CZ
GELTIM LP 1 mg/g, gel
FR/H/0288/001
370 682-9
LABORATOIRES THEA
FR
FR/H/0288/001
381 822-1
LABORATOIRES THEA
FR
kapky, roztok Timolol-POS 0,25%, Oční kapky, roztok Timo-COMOD 0,5%, oogdruppels 5 mg/ml Timolol Sandoz 1 mg/ml, oogdruppels Timolol Sandoz 5 mg/ml oogdruppels Timolol Sandoz 2,5 mg/ml oogdruppels
ophtalmique en récipient unidose GELTIM LP 1 mg/g, gel ophtalmique en récipient unidose
List of nationally authorised medicinal products EMA/208664/2017
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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
TIOPEX 1 mg/g, eye gel
FR/H/0288/001
PL 20162/0010
LABORATOIRES THEA
UK
FR/H/0288/001
PA 1107/3/1
LABORATOIRES THEA
IE
FR/H/288/01
5932082
LABORATOIRES THEA
PT
FR/H/0288/001
037700010
LABORATOIRES THEA
IT
FR/H/0288/001
3622/2011/01-02
LABORATOIRES THEA
RO
FR/H/0288/001
RVG 33801
LABORATOIRES THEA
NL
FR/H/0288/001
1-26709
LABORATOIRES THEA
AT
FR/H/0288/001
BE302732
LABORATOIRES THEA
BE
FR/H/0288/001
BE302732
LABORATOIRES THEA
BE
in single-dose container Timofluid 1 mg/g eye gel in single-dose container TIMOGEL 1 mg/g, gel oftálmico em recipiente unidose TIMOGEL 1 mg/g gel oftalmico in contenitore monodose GELTIM 1mg/g gel oftalmic în recipient unidoză TIMOGEL 1mg/g, oogel in verpakking voor éénmalig gebruik Timogel 1 mg/g Augengel im Einzeldosisbehältnis Geltim 1 mg/g, gel ophtalmique en récipient unidose Geltim 1 mg/g, ooggel in verpakking voor éénmalig gebruik
List of nationally authorised medicinal products EMA/208664/2017
Page 17/30
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
GELTIM 1 mg/g,
FR/H/0288/001
56194/25-8-2015
LABORATOIRES THEA
GR
FR/H/0288/001
BE302732
LABORATOIRES THEA
LU
FR/H/0288/001
20100276
LABORATOIRES THEA
BG
FR/H/0288/001
5117973
LABORATOIRES THEA
PT
not available
BE243013
SANTEN OY
BE
not available
BE243013
SANTEN OY
BE
not available
BE243013
SANTEN OY
BE
not available
BE243004
SANTEN OY
BE
οφθαλμική γέλη σε περιέκτη μιας δόσης Geltim 1 mg/g, gel ophtalmique en récipient unidose ГЕЛТИМ 1 mg/g гел за очи в еднодозова опаковка TIMOGEL 1 mg/g, gel oftálmico em recipiente unidose TIMOPTOLGEL 2,50 mg/ml (0,25%), oogdruppels met verlengde afgifte Timoptolgel® 2,50 mg/ml (0,25%), collyre à libération prolongée Timoptolgel ® 2,50 mg/ml (0,25 %), Augentropfen mit verlängerter Wirkungsdauer TIMOPTOLGEL 5,0 mg/ml (0,5%), oogdruppels met verlengde afgifte
List of nationally authorised medicinal products EMA/208664/2017
Page 18/30
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
Timoptolgel® 5,0 mg/ml
not available
BE243004
SANTEN OY
BE
not available
BE243004
SANTEN OY
BE
not available
1995090382
SANTEN OY
LU
not available
1995090381
SANTEN OY
LU
not available
8719310
ALCON PORTUGAL -
PT
(0,5%), collyre à libération prolongée Timoptolgel ® 5,0 mg/ml (0,5 %), Augentropfen mit verlängerter Wirkungsdauer Timoptolgel® 5,0 mg/ml (0,5%), collyre à libération prolongée Timoptolgel® 2,50 mg/ml (0,25%), collyre à libération prolongée Nyolol 0,50 % 5 mg/ml Colírio, solução
PRODUTOS E EQUIPAMENTOS OFTALMOLÓGICOS, LDA.
Nyolol 0,25 % 2,5 mg/ml
not available
8719302
colírio, solução
ALCON PORTUGAL -
PT
PRODUTOS E EQUIPAMENTOS OFTALMOLÓGICOS, LDA.
NYOLOL 0,25%
not available
BE178105
ALCON NV
BE
not available
BE178096
ALCON NV
BE
Augentropfen NYOLOL 0,5% Augentropfen
List of nationally authorised medicinal products EMA/208664/2017
Page 19/30
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
NYOLOL 0.5% eye drops,
not available
16908
ALCON LABORATORIES
CY
solution NYOLOL 0,25 % collyre
HELLAS S.A. not available
BE178105
ALCON NV
BE
not available
BE178096
ALCON NV
BE
not available
BE178096
ALCON NV
BE
not available
BE178105
ALCON NV
BE
not available
OGYI-T-1919/01
ALCON CUSI, S.A
HU
not available
16 514
SANTEN OY
AT
not available
16 515
SANTEN OY
AT
not available
RVG 15700
PHARMACHEMIE BV
NL
en solution NYOLOL 0,5% oogdruppels, oplossing NYOLOL 0,5 % collyre en solution NYOLOL 0,25% oogdruppels, oplossing CUSIMOLOL 5 mg/ml oldatos szemcsepp Timoptic 0,25% Augentropfen Timoptic 0,5% Augentropfen Timolol 0,5% PCH
List of nationally authorised medicinal products EMA/208664/2017
Page 20/30
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
Timolol 0.25 % w/v Eye
UK/H/1602/01/DC
29831/0353
WOCKHARDT UK LTD
UK
UK/H/1602/01/DC
PA 1339/017/001
WOCKHARDT UK LTD
IE
UK/H/1602/01/DC
MA154/04001
WOCKHARDT UK LTD
MT
UK/H/1602/02/DC
29831/0354
WOCKHARDT UK LTD
UK
UK/H/1602/02/DC
PA 1339/017/002
WOCKHARDT UK LTD
IE
UK/H/1602/02/DC
MA154/04002
WOCKHARDT UK LTD
MT
UK/H/1602/01/DC
2143-01
WOCKHARDT UK LTD
CY
UK/H/1602/02/DC
2143-02
WOCKHARDT UK LTD
CY
not available
8895
SANTEN OY
FI
Drops, Solution Timolol 0.25 % w/v Eye Drops, Solution Timolol 0.25 % w/v Eye Drops, Solution Timolol 0.5% w/v eye drops, solution Timolol 0.5% w/v Eye Drops, Solution Timolol 0.5% w/v Eye Drops, Solution Timolol Wockhardt 0.25 % w/v Eye Drops, Solution Timolol Wockhardt 0.5 % w/v Eye Drops, Solution OFTAN TIMOLOL 2,5 mg/ml silmätipat, liuos
List of nationally authorised medicinal products EMA/208664/2017
Page 21/30
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
OFTAN® TIMOLOL 2,5
not available
8895
SANTEN OY
FI
not available
96-0282
SANTEN OY
LV
not available
8896
SANTEN OY
FI
not available
8896
SANTEN OY
FI
not available
10247
SANTEN OY
SE
not available
853721
SANTEN OY
IS
not available
11928
SANTEN OY
DK
not available
188097
SANTEN OY
EE
not available
96-0283
SANTEN OY
LV
mg/ml ögondroppar, lösning OFTAN TIMOLOL 2,5 mg/ml, acu pilieni, šķīdums OFTAN TIMOLOL 5 mg/ml silmätipat, liuos OFTAN® TIMOLOL 5 mg/ml ögondroppar, lösning Optimol 5 mg/ml ögondroppar, lösning OPTIMOL 5 mg/ml, augndropar, lausn Optimol, øjendråber, opløsning OFTAN TIMOLOL 5 mg/ml silmatilgad, lahus OFTAN TIMOLOL 5 mg/ml, acu pilieni, šķīdums
List of nationally authorised medicinal products EMA/208664/2017
Page 22/30
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
Oftan Timolol 0,50% Oční
not available
64/825/99-C
SANTEN OY
CZ
not available
11350
SANTEN OY
FI
not available
11350
SANTEN OY
FI
not available
940092
SANTEN OY
IS
Optimol ukonserveret
not available
14072
SANTEN OY
DK
Optimol 5 mg/ml
not available
11194
SANTEN OY
SE
not available
20020959
SANTEN OY
BG
not available
7096
SANTEN OY
NO
not available
03-2108
SANTEN OY
NO
kapky, roztok OFTAN TIMOLOL 5 mg/ml silmätipat, liuos kertaannospipetissä OFTAN® TIMOLOL 5 mg/ml ögondroppar, lösning i endosbehållare OPTIMOL 5 mg/ml, augndropar, lausn í stakskammtaíláti
ögondroppar, lösning, endosbehållare ОФТАН ТИМОЛОЛ 5 mg/ml капки за очи, разтвор OFTAN TIMOLOL 5 mg/ml eye drops, solution Oftan 5 mg/ml, øyedråper, oppløsning Oftan 5 mg/ml, øyedråper, oppløsning i endosebeholdere List of nationally authorised medicinal products EMA/208664/2017
Page 23/30
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
OFTAN TIMOLOL 5 mg/ml
not available
LT/1/95/2520/002
SANTEN OY
LT
FI/H/0114/001
63347
LABORATORIOS THEA S.A.
ES
FI/H/0114/001
63.347
LABORATORIOS THEA S.A.
ES
Timolol 0,25% PCH.
not available
RVG 15699
PHARMACHEMIE B.V
NL
Blocadren Depot 2,5
not available
11901
SANTEN OY
SE
not available
11902
SANTEN OY
SE
not available
6123
VIANEX S.A.
GR
not available
6122
VIANEX S.A.
GR
not available
033901048
VISUFARMA SPA
IT
akių lašai (tirpalas) Timogel1mg/ggel oftálmico Timogel1mg/ggel oftálmico
mg/ml, depotögondroppar Blocadren Depot 5 mg/ml, depotögondroppar Οφθαλμικές σταγόνες, διάλυμα TEMSERIN 0.25% Oφθαλμικές σταγόνες, διάλυμα TEMSERIN 0.5% TIMOD
5mg/ml collirio,
soluzione
List of nationally authorised medicinal products EMA/208664/2017
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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
DROPTIMOL 0.25% eye
not available
MA10600301
FARMIGEA SPA
MT
not available
MA10600302
FARMIGEA SPA
MT
not available
027626062
FARMIGEA SPA
IT
not available
027626023
FARMIGEA SPA
IT
not available
027626086
FARMIGEA SPA
IT
not available
027626047
FARMIGEA SPA
IT
not available
29208.02.00
URSAPHARM ARZNEIMITTEL
DE
drops, solution DROPTIMOL 0.50% eye drops, solution D R O P T I M O L 0,25% collirio, soluzione D R O P T I M O L 0,25% collirio, soluzione D R O P T I M O L 0,50% collirio, soluzione D R O P T I M O L 0,50% collirio, soluzione Timo-COMOD 0,1 % Augentropfen Timo-COMOD 0,25 %
GMBH not available
29208.00.00
Augentropfen Timo-COMOD 0,5 %
URSAPHARM ARZNEIMITTEL
DE
GMBH not available
Augentropfen
List of nationally authorised medicinal products EMA/208664/2017
29208.01.00
URSAPHARM ARZNEIMITTEL
DE
GMBH
Page 25/30
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
TIMOD 2,5mg/ml collirio,
not available
033901036
VISUFARMA SPA
IT
not available
PA0879/007/001
SANTEN OY
IE
not available
PA0879/007 /002
SANTEN OY
IE
not available
34009 337 339 7 1
MSD FRANCE
FR
not available
34009 322 432 6 6
MSD FRANCE
FR
not available
34009 322 429 5 5
MSD FRANCE
FR
not available
34009 337 340 5 3
MSD FRANCE
FR
not available
20120196
ANTIBIOTIC-RAZGRAD AD
BG
not available
25829.02.00
OMNIVISION GMBH
DE
soluzione Timoptol 0.25% w/v Eye Drops Solution Timoptol 0.5% w/v Eye Drops Solution TIMOPTOL LP 0,25 %, collyre en solution TIMOPTOL 0,25 %, collyre en solution TIMOPTOL 0,50 %, collyre en solution TIMOPTOL LP 0,50 %, collyre en solution ТИМОЛОЛ ВИЖЪН, 5 mg/ml, капки за очи, разтвор dispatim 0,5% sine
List of nationally authorised medicinal products EMA/208664/2017
Page 26/30
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
dispatim 0,25% sine
not available
25829.01.00
OMNIVISION GMBH
DE
Timo-COMOD 0,1 %
not available
29208.02.00
URSAPHARM ARZNEIMITTEL
DE
Augentropfen Timo-COMOD 0,25 %
GMBH not available
29208.00.00
Augentropfen Timo-COMOD 0,5 %
not available
29208.01.00
not available
354 698-1
DE
LABORATOIRES URSAPHARM
FR
S.A.S. not available
354 699-8
CENT, collyre en solution Timacar Depot,
URSAPHARM ARZNEIMITTEL GMBH
CENT, collyre en solution TIMOCOMOD 0,50 POUR
DE
GMBH
Augentropfen TIMOCOMOD 0,25 POUR
URSAPHARM ARZNEIMITTEL
LABORATOIRES URSAPHARM
FR
S.A.S. not available
15344
SANTEN OY
DK
not available
15345
SANTEN OY
DK
not available
55.237
SANTEN OY
ES
depotøjendråber Timacar Depot, depotøjendråber TIMOFTOL 2,5 mg/ml colirio en solución
List of nationally authorised medicinal products EMA/208664/2017
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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
Timosan 1 mg/ml
not available
1997/05251
SANTEN OY
NO
not available
LT/1/2000/1673/001
SANTEN OY
LT
Timosan 1 mg/g acu gels
not available
01-0251
SANTEN OY
LV
Timosan 1 mg/g
not available
269199
SANTEN OY
EE
not available
14333
SANTEN OY
SE
FI/H/0114/001
IS/1/00/003/01
SANTEN OY
IS
FI/H/0114/001
31346
SANTEN OY
DK
FI/H/0114/001
13366
SANTEN OY
FI
FI/H/0114/001
13366
SANTEN OY
FI
depotøyedråper TIMOSAN 0,1 % akių gelis
silmageel Timosan 1 mg/ml depotögondroppar Timosan Depot 1 mg/g, augnhlaup Timosan Depot 1 mg/g øjengel Timosan 1 mg/g silmägeeli Timosan® 1 mg/g ögongel
List of nationally authorised medicinal products EMA/208664/2017
Page 28/30
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
Timosan 1 mg/ml
not available
05-3381
SANTEN OY
NO
not available
22395
SANTEN OY
SE
not available
8492801
SANTEN OY
PT
not available
8492819
SANTEN OY
PT
not available
8492827
SANTEN OY
PT
not available
5199419
SANTEN OY
PT
not available
8492835
SANTEN OY
PT
not available
5199427
SANTEN OY
PT
not available
55.236
SANTEN OY
ES
depotøyedråper, oppløsning i endosebeholder Timosan 1 mg/ml depotögondroppar, endosbehållare Timoptol 2,5 mg/ml colírio, solução Timoptol 5 mg/ml, colírio, solução Timoptol 0,5 mg/0,2 ml colírio, solução Timoptol 0,5 mg/0,2 ml colírio, solução Timoptol 1 mg/0,2 ml colírio, solução Timoptol 1 mg/0,2 ml colírio, solução TIMOFTOL 5 mg/ml colirio en solución
List of nationally authorised medicinal products EMA/208664/2017
Page 29/30
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
Arutimol® 5 mg/ml acu
not available
00-0007
CHAUVIN ANKERPHARM
LV
pilieni, šķīdums Arutimol ® Augentropfen
GMBH not available
10409.01.00
0,25 % Arutimol ® Augentropfen
DE
PHARM. FABRIK GMBH not available
10409.00.00
0,5 % Timo-Vision 0,1%
DR. GERHARD MANN CHEM.-
DR. GERHARD MANN CHEM.-
DE
PHARM. FABRIK GMBH not available
21915.00.00
OMNIVISION GMBH
DE
not available
21915.01.00
OMNIVISION GMBH
DE
not available
21915.02.00
OMNIVISION GMBH
DE
Augentropfen 1 mg Timolol / ml Timo-Vision 0,25% Augentropfen 2,5 mg Timolol / ml Timo-Vision 0,5% Augentropfen 5 mg Timolol / ml
List of nationally authorised medicinal products EMA/208664/2017
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