12 January 2017 EMA/36361/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: loperamide
Procedure no.: PSUSA/00001903/201605
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
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© 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
Boots Diarrhoea Relief 2
not available
00014/0611
THE BOOTS COMPANY PLC
UK
not available
00014/0611
THE BOOTS COMPANY PLC
UK
not available
9091
MCNEIL PRODUCTS LIMITED
PL
not available
PA 823/56/2
MCNEIL HEALTHCARE
IE
mg Capsules Value Health Diarrhoea Relief 2mg Capsules Imodium Instant, 2 mg, tabletki (liofilizat doustny) Imodium Instants 2 mg Orodispersible Tablets Imodium 2 mg Soft
(IRELAND) LIMITED not available
PL 15513/0369
MCNEIL PRODUCTS LIMITED
UK
not available
PA 823/56/3
MCNEIL HEALTHCARE
IE
Capsules Imodium 2 mg Capsules
(IRELAND) LIMITED Imodium 2 mg kemény
not available
OGYI-T-2221/01
JOHNSON & JOHNSON KFT.
HU
not available
20140030
MCNEIL PRODUCTS LIMITED
BG
not available
PL: 15513/0309
MCNEIL PRODUCTS LIMITED
UK
not available
22408/29-3-2011
JOHNSON & JOHNSON
GR
kapszula ИМОДИУМ 2 mg капсули, твърди Imodium Classic 2 mg Capsules IMODIUM® ORIGINAL
HELLAS CONSUMER AE
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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
ИМОДИУМ 2 mg
not available
20140030
MCNEIL PRODUCTS LIMITED
BG
not available
PL 15513/0369
MCNEIL PRODUCTS LIMITED
UK
not available
20140030
MCNEIL PRODUCTS LIMITED
BG
not available
PA 823/56/2
MCNEIL HEALTHCARE
IE
капсули, твърди Imodium IBS Relief 2mg Capsules, soft ИМОДИУМ 2 mg капсули, твърди Imodium Instants 2 mg Orodispersible Tablets ИМОДИУМ 2 mg
(IRELAND) LIMITED not available
20140030
MCNEIL PRODUCTS LIMITED
BG
not available
PL 15513/0309
MCNEIL PRODUCTS LIMITED
UK
not available
20140030
MCNEIL PRODUCTS LIMITED
BG
not available
PL 15513/0309
MCNEIL PRODUCTS LIMITED
UK
not available
20140030
MCNEIL PRODUCTS LIMITED
BG
капсули, твърди Imodium Classic 2 mg Capsules ИМОДИУМ 2 mg капсули, твърди Imodium Classic 2 mg Capsules ИМОДИУМ 2 mg капсули, твърди
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium Instants 2 mg
not available
PA 823/56/2
MCNEIL HEALTHCARE
IE
Orodispersible Tablets Imodium Classic 2 mg
(IRELAND) LIMITED not available
PL 15513/0309
MCNEIL PRODUCTS LIMITED
UK
not available
20140030
MCNEIL PRODUCTS LIMITED
BG
not available
45655
MCNEIL SWEDEN AB
SE
not available
PL 15513/0309
MCNEIL PRODUCTS LIMITED
UK
not available
OGYI-T-2221/02
JOHNSON & JOHNSON KFT.
HU
not available
PA 823/56/2
MCNEIL HEALTHCARE
IE
Capsules ИМОДИУМ 2 mg капсули, твърди Imodium 2 mg kapslar, mjuka Imodium Classic 2 mg Capsules Imodium 2 mg kemény kapszula Imodium Instants 2 mg Orodispersible Tablets Imodium Classic 2 mg
(IRELAND) LIMITED not available
PL 15513/0309
MCNEIL PRODUCTS LIMITED
UK
not available
23069
MCNEIL SWEDEN AB
SE
Capsules Imodium 2 mg munsönderfallande tablett
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium Instants
not available
PL 15513/0345
MCNEIL PRODUCTS LIMITED
UK
Imodium Instant
not available
49/0401/12-S
MCNEIL PRODUCTS LIMITED
SK
Imodium Instant 2 mg
not available
OGYI-T-02221/03
JOHNSON & JOHNSON KFT.
HU
not available
PA 823/53/1
MCNEIL HEALTHCARE
IE
szájban diszpergálódó tabletta Arret 2mg Hard Capsules
(IRELAND) LIMITED Arret 2mg Hard Capsules
not available
PA 823/53/1
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED Arret 2mg Hard Capsules
not available
PA 823/53/1
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED Imodium 2 mg töflur
not available
900168 (IS)
MCNEIL SWEDEN AB
IS
Imodium 2 mg kapslar,
not available
45655
MCNEIL SWEDEN AB
SE
not available
PA 823/53/1
MCNEIL HEALTHCARE
IE
mjuka Arret 2mg Hard Capsules
(IRELAND) LIMITED
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium 2 mg kapslar,
not available
45655
MCNEIL SWEDEN AB
SE
Imodium 2 mg töflur
not available
900168 (IS)
MCNEIL SWEDEN AB
IS
Imodium 2 mg kapslar,
not available
45655
MCNEIL SWEDEN AB
SE
not available
45655
MCNEIL SWEDEN AB
SE
not available
120195
MCNEIL PRODUCTS LIMITED
EE
not available
880020 (IS)
MCNEIL SWEDEN AB
IS
not available
OGYI-T-02221/04
JOHNSON & JOHNSON KFT.
HU
not available
23069
MCNEIL SWEDEN AB
SE
not available
PL 15513/0345
MCNEIL PRODUCTS LIMITED
UK
mjuka
mjuka Imodium 2 mg kapslar, mjuka IMODIUM, 2 mg kõvakapslid Imodium 0,2 mg/ml mixtúra, lausn Imodium Instant 2 mg szájban diszpergálódó tabletta Imodium 2 mg munsönderfallande tablett Imodium Instants
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium Instant 2 mg
not available
OGYI-T-02221/05
JOHNSON & JOHNSON KFT.
HU
Imodium Instants
not available
PL 15513/0345
MCNEIL PRODUCTS LIMITED
UK
Imodium 2 mg
not available
23069
MCNEIL SWEDEN AB
SE
not available
OGYI-T-02221/06
JOHNSON & JOHNSON KFT.
HU
not available
23069
MCNEIL SWEDEN AB
SE
not available
23069
MCNEIL SWEDEN AB
SE
Imodium Instant
not available
49/0401/12-S
MCNEIL PRODUCTS LIMITED
SK
Imodium Instant
not available
49/0401/12-S
MCNEIL PRODUCTS LIMITED
SK
Imodium Instants
not available
PL 15513/0345
MCNEIL PRODUCTS LIMITED
UK
szájban diszpergálódó tabletta
munsönderfallande tablett Imodium Instant 2 mg szájban diszpergálódó tabletta Imodium 2 mg munsönderfallande tablett Imodium 2 mg munsönderfallande tablett
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium 2 mg
not available
23069
MCNEIL SWEDEN AB
SE
Imodium Instant
not available
49/0401/12-S
MCNEIL PRODUCTS LIMITED
SK
Imodium 2 mg
not available
23069
MCNEIL SWEDEN AB
SE
Imodium Instants
not available
PL 15513/0345
MCNEIL PRODUCTS LIMITED
UK
Imodium 2 mg töflur
not available
900168 (IS)
MCNEIL SWEDEN AB
IS
Imodium Instant, 2 mg,
not available
9091
MCNEIL PRODUCTS LIMITED
PL
not available
880020 (IS)
MCNEIL SWEDEN AB
IS
Imodium 2 mg töflur
not available
900168 (IS)
MCNEIL SWEDEN AB
IS
Imodium LiquiCaps 2 mg
not available
PL 15513/0367
MCNEIL PRODUCTS LIMITED
UK
munsönderfallande tablett
munsönderfallande tablett
tabletki (liofilizat doustny) Imodium 0,2 mg/ml mixtúra, lausn
Soft Capsules
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium 2 mg kietosios
not available
LT/1/93/0292/001
MCNEIL PRODUCTS LIMITED
LT
not available
BE 001215
JOHNSON & JOHNSON
BE
kapsules Imodium 2 mg harde capsules
CONSUMER N.V./S.A.
IMODIUM
not available
49/0071/92-S
MCNEIL PRODUCTS LIMITED
SK
Imodium Softcaps 2 mg,
not available
RVG 106802
JOHNSON & JOHNSON
NL
zachte capsules Imodium 2 mg gélules
CONSUMER B.V. not available
BE 001215
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A. Imodium 2 mg kapseli,
not available
28359
pehmeä Imodium LiquiRelief 2mg
FI
JANSSEN-CILAG OY not available
PA 823/56/5
Soft Capsules Imodium akut Softkapsel
MCNEIL, A DIVISION OF
MCNEIL HEALTHCARE
IE
(IRELAND) LIMITED not available
80523.00.00
JOHNSON & JOHNSON GMBH
DE
not available
34564.00.00
JOHNSON & JOHNSON GMBH
DE
2 mg Weichkapseln Imodium akut lingual 2 mg Schmelztabletten
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium IBS Relief 2 mg
not available
PL 15513/0367
MCNEIL PRODUCTS LIMITED
UK
not available
BE001215
JOHNSON & JOHNSON
BE
Capsules, soft Imodium 2 mg harde capsules Imodium Softcaps 2 mg,
CONSUMER N.V./S.A. not available
RVG 106802
zachte capsules Imodium Softcaps 2 mg,
NL
CONSUMER B.V. not available
RVG 106802
zachte capsules Imodium 2 mg gélules
JOHNSON & JOHNSON
JOHNSON & JOHNSON
NL
CONSUMER B.V. not available
BE 001215
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A. Imodium Softcaps 2 mg,
not available
RVG 106802
zachte capsules Imodium Softcaps 2 mg,
not available
RVG 106802
JOHNSON & JOHNSON
NL
CONSUMER B.V. not available
BE001215
capsules Imodium 2 mg gélules
NL
CONSUMER B.V.
zachte capsules Imodium 2 mg harde
JOHNSON & JOHNSON
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A. not available
BE 001215
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium 2 mg kietosios
not available
LT/1/93/0292/002
MCNEIL PRODUCTS LIMITED
LT
IMODIUM
not available
49/0071/92-S
MCNEIL PRODUCTS LIMITED
SK
Imodium 2 mg kapseli,
not available
28359
MCNEIL, A DIVISION OF
FI
kapsules
pehmeä Imodium 2 mg kapseli,
JANSSEN-CILAG OY not available
28359
pehmeä Imodium akut lingual 2
MCNEIL, A DIVISION OF
FI
JANSSEN-CILAG OY not available
34564.00.00
JOHNSON & JOHNSON GMBH
DE
not available
34564.00.00
JOHNSON & JOHNSON GMBH
DE
not available
80523.00.00
JOHNSON & JOHNSON GMBH
DE
not available
BE 181422
JOHNSON & JOHNSON
BE
mg Schmelztabletten Imodium akut lingual 2 mg Schmelztabletten Imodium akut Softkapsel 2 mg Weichkapseln Imodium Instant 2 mg comprimés
CONSUMER N.V./S.A.
orodispersibles Imodium Instant 2 mg
not available
comprimés
BE 181422
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
orodispersibles
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium Instant 2 mg
not available
BE181422
JOHNSON & JOHNSON
BE
orodispergeerbare
CONSUMER N.V./S.A.
tabletten Imodium Instant 2 mg
not available
BE181422
orodispergeerbare
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
tabletten Imodium Softgels 2 mg
not available
5448659
JOHNSON & JOHNSON LDA
PT
Imodium Instant Melts
not available
PL 15513/0346
MCNEIL PRODUCTS LIMITED
UK
IMODIUM 2 mg capsule
not available
023673104
JOHNSON & JOHNSON S.P.A.
IT
not available
48356
MCNEIL DENMARK APS
DK
not available
1-22679
JOHNSON & JOHNSON GMBH
AT
not available
023673066
JOHNSON & JOHNSON S.P.A.
IT
not available
09832
MCNEIL DENMARK APS
DK
capsula mole
molli Imodium Smelt, frysetørrede tabletter Imodium akut 2 mg Schmelztabletten IMODIUM 2 mg capsule rigide Imodium, oral opløsning
List of nationally authorised medicinal products EMA/382258/2015
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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
Имодиум 2 mg твърди
not available
20010160
MCNEIL PRODUCTS LIMITED
BG
not available
1-22679
JOHNSON & JOHNSON GMBH
AT
not available
5448717
JOHNSON & JOHNSON LDA
PT
not available
48356
MCNEIL DENMARK APS
DK
not available
5448667
JOHNSON & JOHNSON LDA
PT
not available
48356
MCNEIL DENMARK APS
DK
not available
5448675
JOHNSON & JOHNSON LDA
PT
not available
5448709
JOHNSON & JOHNSON LDA
PT
not available
PL 15513/0346
MCNEIL PRODUCTS LIMITED
UK
капсули Imodium akut 2 mg Schmelztabletten Imodium Softgels 2 mg capsula mole Imodium Smelt, frysetørrede tabletter Imodium Softgels 2 mg capsula mole Imodium Smelt, frysetørrede tabletter Imodium Softgels 2 mg capsula mole Imodium Softgels 2 mg capsula mole Imodium Instant Melts
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium Smelt,
not available
48356
MCNEIL DENMARK APS
DK
not available
48356
MCNEIL DENMARK APS
DK
Imodium Instant Melts
not available
PL 15513/0346
MCNEIL PRODUCTS LIMITED
UK
Imodium Instant Melts
not available
PL 15513/0346
MCNEIL PRODUCTS LIMITED
UK
Imodium
not available
7253
MCNEIL SWEDEN AB
NO
IMODIUM 2 mg cietas
not available
00-1274
MCNEIL PRODUCTS LIMITED
LV
not available
14373.00.00
JOHNSON & JOHNSON GMBH
DE
not available
14373.00.00
JOHNSON & JOHNSON GMBH
DE
not available
RVG 06945
JOHNSON & JOHNSON
NL
frysetørrede tabletter Imodium Smelt, frysetørrede tabletter
kapsulas N20 Imodium® akut 2 mg Hartkapseln Imodium® akut 2 mg Hartkapseln Imodium 2 mg harde capsules
List of nationally authorised medicinal products EMA/382258/2015
CONSUMER B.V.
Page 14/29
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
Imodium Rapid 2 mg
not available
2438489
JOHNSON & JOHNSON LDA
PT
not available
RVG 08423
JOHNSON & JOHNSON
NL
comprimido orodispersível Imodium 0,2 mg/ml drank Imodium 0,2 mg/ml
CONSUMER B.V. not available
RVG 08423
drank Imodium Instant
JOHNSON & JOHNSON
NL
CONSUMER B.V. not available
RVG 33724
smelttablet 2 mg
JOHNSON & JOHNSON
NL
CONSUMER B.V.
orodispergeerbare tabletten Imodium Instant
not available
RVG 33724
smelttablet 2 mg
JOHNSON & JOHNSON
NL
CONSUMER B.V.
orodispergeerbare tabletten Imodium 2 mg harde
not available
RVG 06945
capsules Imodium 2 mg harde
not available
RVG 06945
JOHNSON & JOHNSON
NL
CONSUMER B.V. not available
RVG 06945
capsules Imodium 2 mg tabletti,
NL
CONSUMER B.V.
capsules Imodium 2 mg harde
JOHNSON & JOHNSON
JOHNSON & JOHNSON
NL
CONSUMER B.V. not available
kalvopäällysteinen
List of nationally authorised medicinal products EMA/382258/2015
11114
MCNEIL, A DIVISION OF
FI
JANSSEN-CILAG OY
Page 15/29
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
Imodium 2 mg tabletti,
not available
11114
MCNEIL, A DIVISION OF
FI
kalvopäällysteinen IMODIUM RAPID 2 MG
JANSSEN-CILAG OY not available
49/112/14-C
MCNEIL PRODUCTS LIMITED
CZ
Imodium
not available
7633
MCNEIL SWEDEN AB
NO
Imodium
not available
7633
MCNEIL SWEDEN AB
NO
Imodium 2 mg töflur
not available
900168 (IS)
MCNEIL SWEDEN AB
IS
IMODIUM
not available
49/071/92-S/C
MCNEIL PRODUCTS LIMITED
CZ
IMODIUM RAPID 2 MG
not available
49/112/14-C
MCNEIL PRODUCTS LIMITED
CZ
not available
49/112/14-C
MCNEIL PRODUCTS LIMITED
CZ
not available
49/112/14-C
MCNEIL PRODUCTS LIMITED
CZ
tablety dispergovatelné v ústech
tablety dispergovatelné v ústech IMODIUM RAPID 2 MG tablety dispergovatelné v ústech IMODIUM RAPID 2 MG tablety dispergovatelné v ústech
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium 2 mg tablett
not available
11165
MCNEIL SWEDEN AB
SE
Imodium 2 mg töflur
not available
900168 (IS)
MCNEIL SWEDEN AB
IS
Imodium 2 mg töflur
not available
900168 (IS)
MCNEIL SWEDEN AB
IS
Imodium 2 mg töflur
not available
900168 (IS)
MCNEIL SWEDEN AB
IS
IMODIUM
not available
49/071/92-S/C
MCNEIL PRODUCTS LIMITED
CZ
Imodium 2 mg tablett
not available
11165
MCNEIL SWEDEN AB
SE
Imodium 2 mg tablett
not available
11165
MCNEIL SWEDEN AB
SE
Imodium 2 mg tablett
not available
11165
MCNEIL SWEDEN AB
SE
Imodium 0,2 mg/ml oral
not available
10606
MCNEIL SWEDEN AB
SE
lösning
List of nationally authorised medicinal products EMA/382258/2015
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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
Imodium 0,2 mg/ml oral
not available
10606
MCNEIL SWEDEN AB
SE
not available
RVG 10864
JOHNSON & JOHNSON
NL
lösning Diacure 2 mg omhulde tabletten Imodium 2 mg gélules
CONSUMER B.V. not available
2008069795
JOHNSON & JOHNSON
LU
CONSUMER N.V./S.A. Imodium 2 mg gélules
not available
2008069795
JOHNSON & JOHNSON
LU
CONSUMER N.V./S.A. Imodium 2 mg gélules
not available
2008069795
JOHNSON & JOHNSON
LU
CONSUMER N.V./S.A. Imodium Instant 2 mg
not available
2008069796
comprimés
JOHNSON & JOHNSON
LU
CONSUMER N.V./S.A.
orodispersibles Imodium 0,2 mg/ml
not available
2008069794
solution buvable Imodium 0,2 mg/ml
LU
CONSUMER N.V./S.A. not available
2008069794
solution buvable Imodium Instant 2 mg
JOHNSON & JOHNSON
JOHNSON & JOHNSON
LU
CONSUMER N.V./S.A. not available
comprimés
2008069796
JOHNSON & JOHNSON
LU
CONSUMER N.V./S.A.
orodispersibles
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Page 18/29
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
Imodium 2 mg tablett
not available
11165
MCNEIL SWEDEN AB
SE
Imodium 2 mg tablett
not available
11165
MCNEIL SWEDEN AB
SE
Imodium 2 mg tablett
not available
11165
MCNEIL SWEDEN AB
SE
Imodium 2 mg tablett
not available
11165
MCNEIL SWEDEN AB
SE
Imodium Original 2 mg
not available
PL 15513/0310
MCNEIL PRODUCTS LIMITED
UK
not available
PL 15513/0310
MCNEIL PRODUCTS LIMITED
UK
not available
PL 15513/0310
MCNEIL PRODUCTS LIMITED
UK
not available
BE099005
JOHNSON & JOHNSON
BE
Capsules Imodium Original 2 mg Capsules Imodium Original 2 mg Capsules Imodium 0,2 mg/ml drank Imodium 0,2 mg/ml
CONSUMER N.V./S.A. not available
solution buvable
List of nationally authorised medicinal products EMA/382258/2015
BE099005
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Page 19/29
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
Imodium 0,2 mg/ml
not available
BE099005
JOHNSON & JOHNSON
BE
solution buvable Imodium 0,2 mg/ml
CONSUMER N.V./S.A. not available
BE099005
drank
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Imodium 2mg Kapseln
not available
16.789
JOHNSON & JOHNSON GMBH
AT
Imodium, tabletter
not available
13970
MCNEIL DENMARK APS
DK
IMODIUM 0,2 mg/ml
not available
5337357
JOHNSON & JOHNSON LDA
PT
IMODIUM, 2 mg, capsulas
not available
9385104
JOHNSON & JOHNSON LDA
PT
IMODIUM, 2 mg, capsulas
not available
9385112
JOHNSON & JOHNSON LDA
PT
Imodium, tabletter
not available
13970
MCNEIL DENMARK APS
DK
Imodium 2mg Kapseln
not available
16.789
JOHNSON & JOHNSON GMBH
AT
solução oral
List of nationally authorised medicinal products EMA/382258/2015
Page 20/29
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
IMODIUM 0,2 mg/ml
not available
9385211
JOHNSON & JOHNSON LDA
PT
Imodium, tabletter
not available
13970
MCNEIL DENMARK APS
DK
Imodium akut N 2 mg
not available
30274.00.00
JOHNSON & JOHNSON GMBH
DE
not available
30274.00.00
JOHNSON & JOHNSON GMBH
DE
not available
30274.00.00
JOHNSON & JOHNSON GMBH
DE
not available
30274.00.00
JOHNSON & JOHNSON GMBH
DE
not available
34009 385 718 4 4
JOHNSON & JOHNSON
FR
solução oral
Tabletten Imodium akut N 2 mg Tabletten Imodium akut N 2 mg Tabletten Imodium akut N 2 mg Tabletten IMODIUMCAPS 2mg, gélule IMODIUM 2 mg cietās
SANTÉ BEAUTÉ FRANCE not available
98-0799
MCNEIL PRODUCTS LIMITED
LV
not available
34009 385 719 05
JOHNSON & JOHNSON
FR
kapsulas N6 IMODIUMCAPS 2mg, gélule
List of nationally authorised medicinal products EMA/382258/2015
SANTÉ BEAUTÉ FRANCE
Page 21/29
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
Imodium
not available
7633
MCNEIL SWEDEN AB
NO
Imodium Liquicaps 2 mg
not available
BE470640
JOHNSON & JOHNSON
BE
zachte capsules Imodium Liquicaps 2 mg
CONSUMER N.V./S.A. not available
BE470640
capsules, molles Imodium Liquicaps 2 mg
not available
BE470640
not available
BE470640
not available
BE470640
not available
BE470640
BE
JOHNSON & JOHNSON
BE
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A. not available
BE470640
capsules, molles Imodium Liquicaps 2 mg
JOHNSON & JOHNSON
CONSUMER N.V./S.A.
zachte capsules Imodium Liquicaps 2 mg
BE
CONSUMER N.V./S.A.
capsules, molles Imodium Liquicaps 2 mg
JOHNSON & JOHNSON CONSUMER N.V./S.A.
zachte capsules Imodium Liquicaps 2 mg
BE
CONSUMER N.V./S.A.
zachte capsules Imodium Liquicaps 2 mg
JOHNSON & JOHNSON
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A. not available
capsules, molles
List of nationally authorised medicinal products EMA/382258/2015
BE470640
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Page 22/29
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
Imodium Liquicaps 2 mg
not available
BE470640
JOHNSON & JOHNSON
BE
zachte capsules Imodium Liquicaps 2 mg
CONSUMER N.V./S.A. not available
BE470640
capsules, molles Imodium 0,2 mg/ml
not available
BE099005
not available
BE001215
not available
BE099005
not available
BE001215
not available
BE001215
JOHNSON & JOHNSON
BE
JOHNSON & JOHNSON
BE
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A. not available
BE181422
Schmelztabletten Imodium Instant 2 mg
BE
CONSUMER N.V./S.A.
capsules Imodium Instant 2 mg
JOHNSON & JOHNSON
CONSUMER N.V./S.A.
capsules Imodium 2 mg harde
BE
CONSUMER N.V./S.A.
drank Imodium 2 mg harde
JOHNSON & JOHNSON CONSUMER N.V./S.A.
capsules Imodium 0,2 mg/ml
BE
CONSUMER N.V./S.A.
drank Imodium 2 mg harde
JOHNSON & JOHNSON
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A. not available
Schmelztabletten
List of nationally authorised medicinal products EMA/382258/2015
BE181422
JOHNSON & JOHNSON
BE
CONSUMER N.V./S.A.
Page 23/29
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
Imodium Liquicaps 2 mg
not available
BE470640
JOHNSON & JOHNSON
BE
Weichkapseln Imodium Liquicaps 2 mg
CONSUMER N.V./S.A. not available
BE470640
Weichkapseln Imodium Liquicaps 2 mg
not available
BE470640
not available
BE470640
not available
BE470640
not available
11114
BE
JOHNSON & JOHNSON
BE
MCNEIL, A DIVISION OF
FI
JANSSEN-CILAG OY not available
11114
filmdragerad Imodium 2 mg kemény
JOHNSON & JOHNSON
CONSUMER N.V./S.A.
filmdragerad Imodium 2 mg tablett,
BE
CONSUMER N.V./S.A.
Weichkapseln Imodium 2 mg tablett,
JOHNSON & JOHNSON CONSUMER N.V./S.A.
Weichkapseln Imodium Liquicaps 2 mg
BE
CONSUMER N.V./S.A.
Weichkapseln Imodium Liquicaps 2 mg
JOHNSON & JOHNSON
MCNEIL, A DIVISION OF
FI
JANSSEN-CILAG OY not available
OGYI-T-2221/01
JOHNSON & JOHNSON KFT.
HU
not available
28359
MCNEIL, A DIVISION OF
FI
kapszula Imodium 2 mg kapsel, mjuk
List of nationally authorised medicinal products EMA/382258/2015
JANSSEN-CILAG OY
Page 24/29
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
Imodium 2 mg kapsel,
not available
28359
MCNEIL, A DIVISION OF
FI
mjuk Imodium 2 mg kapsel,
JANSSEN-CILAG OY not available
28359
mjuk Imodium 2 mg
MCNEIL, A DIVISION OF
FI
JANSSEN-CILAG OY not available
7810/2015/02
MCNEIL PRODUCTS LIMITED
RO
not available
7810/2015/04
MCNEIL PRODUCTS LIMITED
RO
not available
7810/2015/03
MCNEIL PRODUCTS LIMITED
RO
not available
7810/2015/01
MCNEIL PRODUCTS LIMITED
RO
Imodium Instants
not available
PL 15513/0345
MCNEIL PRODUCTS LIMITED
UK
Lopitum, 2mg, cápsulas
not available
5164074
MEDIREX PHARMA, LDA.
PT
“Lopemid 2mg capsule
not available
023691013
VISUFARMA SPA
IT
comprimate orodispersabile Imodium 2 mg comprimate orodispersabile Imodium 2 mg comprimate orodispersabile Imodium 2 mg comprimate orodispersabile
rigide”
List of nationally authorised medicinal products EMA/382258/2015
Page 25/29
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
PERACEL, gélule
not available
349 663-9
MERCK MÉDICATION
FR
FAMILIALE S.A.S. PERACEL, gélule
not available
339 672-5
MERCK MÉDICATION
FR
FAMILIALE S.A.S. Loperamid Sandoz 2 mg -
942.772
1-24708
SANDOZ GMBH
AT
not available
5792/2013/01
TERAPIA S.A.
RO
not available
RVG 56839
RXT
NL
DYSPAGON 2 mg, gélule
not available
339 673.1
PIERRE FABRE MEDICAMENT
FR
ENTEROG
not available
026112033
SANOFI SPA
IT
not available
LT/1/95/1296/001
RATIOPHARM GMBH
LT
not available
57.915
LABORATORIOS RIMAFAR S.L
ES
Kapseln Loperamid Terapia 2 mg capsule Loperamide HCl RXT 2 mg, capsules
ANTIDIARROICO Loperamid-ratiopharm 2 mg plėvele dengtos tabletės LOPERAMIDA RIMAFAR 2 mg cápsulas
List of nationally authorised medicinal products EMA/382258/2015
Page 26/29
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
DIARETYL 2 mg, gélule
not available
NL 21475-3400935842145
COOPERATION
FR
PHARMACEUTIQUE FRANCAISE DIARETYL 2 mg, gélule
not available
NL 21475-3400934115486
COOPERATION
FR
PHARMACEUTIQUE FRANCAISE Diocalm Ultra Capsules
not available
PL 17905/0049
SSL INTERNATIONAL PLC.
UK
Loperan 2 mg cápsulas
not available
55.317
CHIESI ESPAÑA S.A.
ES
not available
043905013
SPA – SOCIETÀ PRODOTTI
IT
duras DISSENTEN ANTIDIARREA 2 mg
ANTIBIOTICI S.P.A.
compresse Dissenten, 2 mg, tabletki
not available
R/0207
SPA – SOCIETÀ PRODOTTI
PL
ANTIBIOTICI S.P.A. DISSENTEN 2 mg
not available
023694021
compresse DISSENTEN 2 mg
IT
ANTIBIOTICI S.P.A. not available
023694058
compresse Fortasec 2 mg cápsulas
SPA – SOCIETÀ PRODOTTI
SPA – SOCIETÀ PRODOTTI
IT
ANTIBIOTICI S.P.A. not available
duras
List of nationally authorised medicinal products EMA/382258/2015
51.101
LABORATORIOS DR. ESTEVE
ES
S.A.
Page 27/29
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
Loperamid-ratiopharm®
not available
6898018.00.00
RATIOPHARM GMBH
DE
not available
00014/0611
THE BOOTS COMPANY PLC
UK
not available
00014/0611
THE BOOTS COMPANY PLC
UK
not available
32.202
LABORATORIOS SALVAT,
ES
0,2 mg/ml Lösung zum Einnehmen Boots Diarrhoea Relief 2 mg Capsules Value Health Diarrhoea Relief 2mg Capsules Salvacolina 2 mg comprimidos Loperamid-ratiopharm 2
S.A. not available
063894
RATIOPHARM GMBH
EE
not available
36.747
LABORATORIOS SALVAT,
ES
mg, õhukese polümeerikattega tabletid Salvacolina 0,2 mg/ml solución oral DIASTROLIB 2 mg,
S.A. not available
NL 31999
TEVA SANTÉ
FR
not available
4/59/1
THE BOOTS COMPANY PLC
IE
not available
PL 11311/0025
TILLOMED LABORATORIES
UK
lyophilisat oral Boots Pharmaceuticals Diarrhoea Relief 2 mg Hard Capsules Loperamide Hydrochloride 2mg
LTD
Tablets
List of nationally authorised medicinal products EMA/382258/2015
Page 28/29
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
Normaloe 2mg Tablets
not available
PL 11311/0025
TILLOMED LABORATORIES
UK
LTD LOPERAMIDE LYOC 2 mg,
not available
NL22126
TEVA SANTÉ
FR
lyophilisat oral
List of nationally authorised medicinal products EMA/382258/2015
Page 29/29
