loperamide: List of nationally authorised medicinal ... · List of nationally authorised medicinal...
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30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 12 January 2017 EMA/36361/2017 Human Medicines Evaluation Division List of nationally authorised medicinal products Active substance: loperamide Procedure no.: PSUSA/00001903/201605
Transcript of loperamide: List of nationally authorised medicinal ... · List of nationally authorised medicinal...
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
An agency of the European Union
Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
12 January 2017 EMA/36361/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: loperamide
Procedure no.: PSUSA/00001903/201605
List of nationally authorised medicinal products EMA/382258/2015 Page 2/29
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
Boots Diarrhoea Relief 2 mg Capsules
not available 00014/0611 THE BOOTS COMPANY PLC UK
Value Health Diarrhoea Relief 2mg Capsules
not available 00014/0611 THE BOOTS COMPANY PLC UK
Imodium Instant, 2 mg, tabletki (liofilizat doustny)
not available 9091 MCNEIL PRODUCTS LIMITED PL
Imodium Instants 2 mg Orodispersible Tablets
not available PA 823/56/2 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
Imodium 2 mg Soft Capsules
not available PL 15513/0369 MCNEIL PRODUCTS LIMITED UK
Imodium 2 mg Capsules not available PA 823/56/3 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
Imodium 2 mg kemény kapszula
not available OGYI-T-2221/01 JOHNSON & JOHNSON KFT. HU
ИМОДИУМ 2 mg капсули, твърди
not available 20140030 MCNEIL PRODUCTS LIMITED BG
Imodium Classic 2 mg Capsules
not available PL: 15513/0309 MCNEIL PRODUCTS LIMITED UK
IMODIUM® ORIGINAL not available 22408/29-3-2011 JOHNSON & JOHNSON HELLAS CONSUMER AE
GR
List of nationally authorised medicinal products EMA/382258/2015 Page 3/29
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
ИМОДИУМ 2 mg капсули, твърди
not available 20140030 MCNEIL PRODUCTS LIMITED BG
Imodium IBS Relief 2mg Capsules, soft
not available PL 15513/0369 MCNEIL PRODUCTS LIMITED UK
ИМОДИУМ 2 mg капсули, твърди
not available 20140030 MCNEIL PRODUCTS LIMITED BG
Imodium Instants 2 mg Orodispersible Tablets
not available PA 823/56/2 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
ИМОДИУМ 2 mg капсули, твърди
not available 20140030 MCNEIL PRODUCTS LIMITED BG
Imodium Classic 2 mg Capsules
not available PL 15513/0309 MCNEIL PRODUCTS LIMITED UK
ИМОДИУМ 2 mg капсули, твърди
not available 20140030 MCNEIL PRODUCTS LIMITED BG
Imodium Classic 2 mg Capsules
not available PL 15513/0309 MCNEIL PRODUCTS LIMITED UK
ИМОДИУМ 2 mg капсули, твърди
not available 20140030 MCNEIL PRODUCTS LIMITED BG
List of nationally authorised medicinal products EMA/382258/2015 Page 4/29
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 Instants 2 mg Orodispersible Tablets
not available PA 823/56/2 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
Imodium Classic 2 mg Capsules
not available PL 15513/0309 MCNEIL PRODUCTS LIMITED UK
ИМОДИУМ 2 mg капсули, твърди
not available 20140030 MCNEIL PRODUCTS LIMITED BG
Imodium 2 mg kapslar, mjuka
not available 45655 MCNEIL SWEDEN AB SE
Imodium Classic 2 mg Capsules
not available PL 15513/0309 MCNEIL PRODUCTS LIMITED UK
Imodium 2 mg kemény kapszula
not available OGYI-T-2221/02 JOHNSON & JOHNSON KFT. HU
Imodium Instants 2 mg Orodispersible Tablets
not available PA 823/56/2 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
Imodium Classic 2 mg Capsules
not available PL 15513/0309 MCNEIL PRODUCTS LIMITED UK
Imodium 2 mg munsönderfallande tablett
not available 23069 MCNEIL SWEDEN AB SE
List of nationally authorised medicinal products EMA/382258/2015 Page 5/29
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 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 szájban diszpergálódó tabletta
not available OGYI-T-02221/03 JOHNSON & JOHNSON KFT. HU
Arret 2mg Hard Capsules not available PA 823/53/1 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
Arret 2mg Hard Capsules not available PA 823/53/1 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
Arret 2mg Hard Capsules not available PA 823/53/1 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
Imodium 2 mg töflur not available 900168 (IS) MCNEIL SWEDEN AB IS
Imodium 2 mg kapslar, mjuka
not available 45655 MCNEIL SWEDEN AB SE
Arret 2mg Hard Capsules not available PA 823/53/1 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
List of nationally authorised medicinal products EMA/382258/2015 Page 6/29
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 kapslar, mjuka
not available 45655 MCNEIL SWEDEN AB SE
Imodium 2 mg töflur not available 900168 (IS) MCNEIL SWEDEN AB IS
Imodium 2 mg kapslar, mjuka
not available 45655 MCNEIL SWEDEN AB SE
Imodium 2 mg kapslar, mjuka
not available 45655 MCNEIL SWEDEN AB SE
IMODIUM, 2 mg kõvakapslid
not available 120195 MCNEIL PRODUCTS LIMITED EE
Imodium 0,2 mg/ml mixtúra, lausn
not available 880020 (IS) MCNEIL SWEDEN AB IS
Imodium Instant 2 mg szájban diszpergálódó tabletta
not available OGYI-T-02221/04 JOHNSON & JOHNSON KFT. HU
Imodium 2 mg munsönderfallande tablett
not available 23069 MCNEIL SWEDEN AB SE
Imodium Instants not available PL 15513/0345 MCNEIL PRODUCTS LIMITED UK
List of nationally authorised medicinal products EMA/382258/2015 Page 7/29
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 Instant 2 mg szájban diszpergálódó tabletta
not available OGYI-T-02221/05 JOHNSON & JOHNSON KFT. HU
Imodium Instants not available PL 15513/0345 MCNEIL PRODUCTS LIMITED UK
Imodium 2 mg munsönderfallande tablett
not available 23069 MCNEIL SWEDEN AB SE
Imodium Instant 2 mg szájban diszpergálódó tabletta
not available OGYI-T-02221/06 JOHNSON & JOHNSON KFT. HU
Imodium 2 mg munsönderfallande tablett
not available 23069 MCNEIL SWEDEN AB SE
Imodium 2 mg munsönderfallande tablett
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
List of nationally authorised medicinal products EMA/382258/2015 Page 8/29
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 munsönderfallande tablett
not available 23069 MCNEIL SWEDEN AB SE
Imodium Instant not available 49/0401/12-S MCNEIL PRODUCTS LIMITED SK
Imodium 2 mg munsönderfallande tablett
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, tabletki (liofilizat doustny)
not available 9091 MCNEIL PRODUCTS LIMITED PL
Imodium 0,2 mg/ml mixtúra, lausn
not available 880020 (IS) MCNEIL SWEDEN AB IS
Imodium 2 mg töflur not available 900168 (IS) MCNEIL SWEDEN AB IS
Imodium LiquiCaps 2 mg Soft Capsules
not available PL 15513/0367 MCNEIL PRODUCTS LIMITED UK
List of nationally authorised medicinal products EMA/382258/2015 Page 9/29
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 kietosios kapsules
not available LT/1/93/0292/001 MCNEIL PRODUCTS LIMITED LT
Imodium 2 mg harde capsules
not available BE 001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
IMODIUM not available 49/0071/92-S MCNEIL PRODUCTS LIMITED SK
Imodium Softcaps 2 mg, zachte capsules
not available RVG 106802 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 2 mg gélules not available BE 001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 2 mg kapseli, pehmeä
not available 28359 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
Imodium LiquiRelief 2mg Soft Capsules
not available PA 823/56/5 MCNEIL HEALTHCARE (IRELAND) LIMITED
IE
Imodium akut Softkapsel 2 mg Weichkapseln
not available 80523.00.00 JOHNSON & JOHNSON GMBH DE
Imodium akut lingual 2 mg Schmelztabletten
not available 34564.00.00 JOHNSON & JOHNSON GMBH DE
List of nationally authorised medicinal products EMA/382258/2015 Page 10/29
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 IBS Relief 2 mg Capsules, soft
not available PL 15513/0367 MCNEIL PRODUCTS LIMITED UK
Imodium 2 mg harde capsules
not available BE001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Softcaps 2 mg, zachte capsules
not available RVG 106802 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium Softcaps 2 mg, zachte capsules
not available RVG 106802 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 2 mg gélules not available BE 001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Softcaps 2 mg, zachte capsules
not available RVG 106802 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium Softcaps 2 mg, zachte capsules
not available RVG 106802 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 2 mg harde capsules
not available BE001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 2 mg gélules not available BE 001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
List of nationally authorised medicinal products EMA/382258/2015 Page 11/29
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 kietosios kapsules
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, pehmeä
not available 28359 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
Imodium 2 mg kapseli, pehmeä
not available 28359 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
Imodium akut lingual 2 mg Schmelztabletten
not available 34564.00.00 JOHNSON & JOHNSON GMBH DE
Imodium akut lingual 2 mg Schmelztabletten
not available 34564.00.00 JOHNSON & JOHNSON GMBH DE
Imodium akut Softkapsel 2 mg Weichkapseln
not available 80523.00.00 JOHNSON & JOHNSON GMBH DE
Imodium Instant 2 mg comprimés orodispersibles
not available BE 181422 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Instant 2 mg comprimés orodispersibles
not available BE 181422 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
List of nationally authorised medicinal products EMA/382258/2015 Page 12/29
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 Instant 2 mg orodispergeerbare tabletten
not available BE181422 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Instant 2 mg orodispergeerbare tabletten
not available BE181422 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Softgels 2 mg capsula mole
not available 5448659 JOHNSON & JOHNSON LDA PT
Imodium Instant Melts not available PL 15513/0346 MCNEIL PRODUCTS LIMITED UK
IMODIUM 2 mg capsule molli
not available 023673104 JOHNSON & JOHNSON S.P.A. IT
Imodium Smelt, frysetørrede tabletter
not available 48356 MCNEIL DENMARK APS DK
Imodium akut 2 mg Schmelztabletten
not available 1-22679 JOHNSON & JOHNSON GMBH AT
IMODIUM 2 mg capsule rigide
not available 023673066 JOHNSON & JOHNSON S.P.A. IT
Imodium, oral opløsning not available 09832 MCNEIL DENMARK APS DK
List of nationally authorised medicinal products EMA/382258/2015 Page 13/29
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
Имодиум 2 mg твърди капсули
not available 20010160 MCNEIL PRODUCTS LIMITED BG
Imodium akut 2 mg Schmelztabletten
not available 1-22679 JOHNSON & JOHNSON GMBH AT
Imodium Softgels 2 mg capsula mole
not available 5448717 JOHNSON & JOHNSON LDA PT
Imodium Smelt, frysetørrede tabletter
not available 48356 MCNEIL DENMARK APS DK
Imodium Softgels 2 mg capsula mole
not available 5448667 JOHNSON & JOHNSON LDA PT
Imodium Smelt, frysetørrede tabletter
not available 48356 MCNEIL DENMARK APS DK
Imodium Softgels 2 mg capsula mole
not available 5448675 JOHNSON & JOHNSON LDA PT
Imodium Softgels 2 mg capsula mole
not available 5448709 JOHNSON & JOHNSON LDA PT
Imodium Instant Melts not available PL 15513/0346 MCNEIL PRODUCTS LIMITED UK
List of nationally authorised medicinal products EMA/382258/2015 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 Smelt, frysetørrede tabletter
not available 48356 MCNEIL DENMARK APS DK
Imodium Smelt, frysetørrede tabletter
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 kapsulas N20
not available 00-1274 MCNEIL PRODUCTS LIMITED LV
Imodium® akut 2 mg Hartkapseln
not available 14373.00.00 JOHNSON & JOHNSON GMBH DE
Imodium® akut 2 mg Hartkapseln
not available 14373.00.00 JOHNSON & JOHNSON GMBH DE
Imodium 2 mg harde capsules
not available RVG 06945 JOHNSON & JOHNSON CONSUMER B.V.
NL
List of nationally authorised medicinal products EMA/382258/2015 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 Rapid 2 mg comprimido orodispersível
not available 2438489 JOHNSON & JOHNSON LDA PT
Imodium 0,2 mg/ml drank
not available RVG 08423 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 0,2 mg/ml drank
not available RVG 08423 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium Instant smelttablet 2 mg orodispergeerbare tabletten
not available RVG 33724 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium Instant smelttablet 2 mg orodispergeerbare tabletten
not available RVG 33724 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 2 mg harde capsules
not available RVG 06945 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 2 mg harde capsules
not available RVG 06945 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 2 mg harde capsules
not available RVG 06945 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 2 mg tabletti, kalvopäällysteinen
not available 11114 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
List of nationally authorised medicinal products EMA/382258/2015 Page 16/29
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, kalvopäällysteinen
not available 11114 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
IMODIUM RAPID 2 MG tablety dispergovatelné v ústech
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 tablety dispergovatelné v ústech
not available 49/112/14-C MCNEIL PRODUCTS LIMITED CZ
IMODIUM RAPID 2 MG tablety dispergovatelné v ústech
not available 49/112/14-C MCNEIL PRODUCTS LIMITED CZ
IMODIUM RAPID 2 MG tablety dispergovatelné v ústech
not available 49/112/14-C MCNEIL PRODUCTS LIMITED CZ
List of nationally authorised medicinal products EMA/382258/2015 Page 17/29
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 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 lösning
not available 10606 MCNEIL SWEDEN AB SE
List of nationally authorised medicinal products EMA/382258/2015 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 0,2 mg/ml oral lösning
not available 10606 MCNEIL SWEDEN AB SE
Diacure 2 mg omhulde tabletten
not available RVG 10864 JOHNSON & JOHNSON CONSUMER B.V.
NL
Imodium 2 mg gélules not available 2008069795 JOHNSON & JOHNSON CONSUMER N.V./S.A.
LU
Imodium 2 mg gélules not available 2008069795 JOHNSON & JOHNSON CONSUMER N.V./S.A.
LU
Imodium 2 mg gélules not available 2008069795 JOHNSON & JOHNSON CONSUMER N.V./S.A.
LU
Imodium Instant 2 mg comprimés orodispersibles
not available 2008069796 JOHNSON & JOHNSON CONSUMER N.V./S.A.
LU
Imodium 0,2 mg/ml solution buvable
not available 2008069794 JOHNSON & JOHNSON CONSUMER N.V./S.A.
LU
Imodium 0,2 mg/ml solution buvable
not available 2008069794 JOHNSON & JOHNSON CONSUMER N.V./S.A.
LU
Imodium Instant 2 mg comprimés orodispersibles
not available 2008069796 JOHNSON & JOHNSON CONSUMER N.V./S.A.
LU
List of nationally authorised medicinal products EMA/382258/2015 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 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 Capsules
not available PL 15513/0310 MCNEIL PRODUCTS LIMITED UK
Imodium Original 2 mg Capsules
not available PL 15513/0310 MCNEIL PRODUCTS LIMITED UK
Imodium Original 2 mg Capsules
not available PL 15513/0310 MCNEIL PRODUCTS LIMITED UK
Imodium 0,2 mg/ml drank
not available BE099005 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 0,2 mg/ml solution buvable
not available BE099005 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
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 solution buvable
not available BE099005 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 0,2 mg/ml drank
not available BE099005 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
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 solução oral
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
List of nationally authorised medicinal products EMA/382258/2015 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 0,2 mg/ml solução oral
not available 9385211 JOHNSON & JOHNSON LDA PT
Imodium, tabletter not available 13970 MCNEIL DENMARK APS DK
Imodium akut N 2 mg Tabletten
not available 30274.00.00 JOHNSON & JOHNSON GMBH DE
Imodium akut N 2 mg Tabletten
not available 30274.00.00 JOHNSON & JOHNSON GMBH DE
Imodium akut N 2 mg Tabletten
not available 30274.00.00 JOHNSON & JOHNSON GMBH DE
Imodium akut N 2 mg Tabletten
not available 30274.00.00 JOHNSON & JOHNSON GMBH DE
IMODIUMCAPS 2mg, gélule
not available 34009 385 718 4 4 JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE
FR
IMODIUM 2 mg cietās kapsulas N6
not available 98-0799 MCNEIL PRODUCTS LIMITED LV
IMODIUMCAPS 2mg, gélule
not available 34009 385 719 05 JOHNSON & JOHNSON SANTÉ BEAUTÉ FRANCE
FR
List of nationally authorised medicinal products EMA/382258/2015 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 not available 7633 MCNEIL SWEDEN AB NO
Imodium Liquicaps 2 mg zachte capsules
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg capsules, molles
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg zachte capsules
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg zachte capsules
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg capsules, molles
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg zachte capsules
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg capsules, molles
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg capsules, molles
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
List of nationally authorised medicinal products EMA/382258/2015 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 zachte capsules
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg capsules, molles
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 0,2 mg/ml drank
not available BE099005 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 2 mg harde capsules
not available BE001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 0,2 mg/ml drank
not available BE099005 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 2 mg harde capsules
not available BE001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 2 mg harde capsules
not available BE001215 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Instant 2 mg Schmelztabletten
not available BE181422 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Instant 2 mg Schmelztabletten
not available BE181422 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
List of nationally authorised medicinal products EMA/382258/2015 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 Liquicaps 2 mg Weichkapseln
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg Weichkapseln
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg Weichkapseln
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg Weichkapseln
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium Liquicaps 2 mg Weichkapseln
not available BE470640 JOHNSON & JOHNSON CONSUMER N.V./S.A.
BE
Imodium 2 mg tablett, filmdragerad
not available 11114 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
Imodium 2 mg tablett, filmdragerad
not available 11114 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
Imodium 2 mg kemény kapszula
not available OGYI-T-2221/01 JOHNSON & JOHNSON KFT. HU
Imodium 2 mg kapsel, mjuk
not available 28359 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
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
Imodium 2 mg kapsel, mjuk
not available 28359 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
Imodium 2 mg kapsel, mjuk
not available 28359 MCNEIL, A DIVISION OF JANSSEN-CILAG OY
FI
Imodium 2 mg comprimate orodispersabile
not available 7810/2015/02 MCNEIL PRODUCTS LIMITED RO
Imodium 2 mg comprimate orodispersabile
not available 7810/2015/04 MCNEIL PRODUCTS LIMITED RO
Imodium 2 mg comprimate orodispersabile
not available 7810/2015/03 MCNEIL PRODUCTS LIMITED RO
Imodium 2 mg comprimate orodispersabile
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 rigide”
not available 023691013 VISUFARMA SPA IT
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
PERACEL, gélule not available 349 663-9 MERCK MÉDICATION FAMILIALE S.A.S.
FR
PERACEL, gélule not available 339 672-5 MERCK MÉDICATION FAMILIALE S.A.S.
FR
Loperamid Sandoz 2 mg - Kapseln
942.772 1-24708 SANDOZ GMBH AT
Loperamid Terapia 2 mg capsule
not available 5792/2013/01 TERAPIA S.A. RO
Loperamide HCl RXT 2 mg, capsules
not available RVG 56839 RXT NL
DYSPAGON 2 mg, gélule not available 339 673.1 PIERRE FABRE MEDICAMENT FR
ENTEROG ANTIDIARROICO
not available 026112033 SANOFI SPA IT
Loperamid-ratiopharm 2 mg plėvele dengtos tabletės
not available LT/1/95/1296/001 RATIOPHARM GMBH LT
LOPERAMIDA RIMAFAR 2 mg cápsulas
not available 57.915 LABORATORIOS RIMAFAR S.L ES
List of nationally authorised medicinal products EMA/382258/2015 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
DIARETYL 2 mg, gélule not available NL 21475-3400935842145 COOPERATION PHARMACEUTIQUE FRANCAISE
FR
DIARETYL 2 mg, gélule not available NL 21475-3400934115486 COOPERATION PHARMACEUTIQUE FRANCAISE
FR
Diocalm Ultra Capsules not available PL 17905/0049 SSL INTERNATIONAL PLC. UK
Loperan 2 mg cápsulas duras
not available 55.317 CHIESI ESPAÑA S.A. ES
DISSENTEN ANTIDIARREA 2 mg compresse
not available 043905013 SPA – SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A.
IT
Dissenten, 2 mg, tabletki not available R/0207 SPA – SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A.
PL
DISSENTEN 2 mg compresse
not available 023694021 SPA – SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A.
IT
DISSENTEN 2 mg compresse
not available 023694058 SPA – SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A.
IT
Fortasec 2 mg cápsulas duras
not available 51.101 LABORATORIOS DR. ESTEVE S.A.
ES
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
Loperamid-ratiopharm® 0,2 mg/ml Lösung zum Einnehmen
not available 6898018.00.00 RATIOPHARM GMBH DE
Boots Diarrhoea Relief 2 mg Capsules
not available 00014/0611 THE BOOTS COMPANY PLC UK
Value Health Diarrhoea Relief 2mg Capsules
not available 00014/0611 THE BOOTS COMPANY PLC UK
Salvacolina 2 mg comprimidos
not available 32.202 LABORATORIOS SALVAT, S.A.
ES
Loperamid-ratiopharm 2 mg, õhukese polümeerikattega tabletid
not available 063894 RATIOPHARM GMBH EE
Salvacolina 0,2 mg/ml solución oral
not available 36.747 LABORATORIOS SALVAT, S.A.
ES
DIASTROLIB 2 mg, lyophilisat oral
not available NL 31999 TEVA SANTÉ FR
Boots Pharmaceuticals Diarrhoea Relief 2 mg Hard Capsules
not available 4/59/1 THE BOOTS COMPANY PLC IE
Loperamide Hydrochloride 2mg Tablets
not available PL 11311/0025 TILLOMED LABORATORIES LTD
UK
List of nationally authorised medicinal products EMA/382258/2015 Page 29/29
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 LTD
UK
LOPERAMIDE LYOC 2 mg, lyophilisat oral
not available NL22126 TEVA SANTÉ FR
