theophylline: list of nationally authorised medicinal ... · list of nationally authorised...
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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
8 March 2018 EMA/135395/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: theophylline
Procedure No.: PSUSA/00002921/201706
List of nationally authorised medicinal products EMA/135395/2018 Page 2/22
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
DILATRANE 1 POUR CENT, sirop
not available V07675-3400930317808 SOCIETE D'ETUDES ET DE RECHERCHES PHARMACEUTIQUES (SERP)
FR
DILATRANE 100 mg, gélule à libération prolongée
not available V07674-3400930317747 SOCIETE D'ETUDES ET DE RECHERCHES PHARMACEUTIQUES (SERP)
FR
Theophyllin STADA® 400 mg Hartkapseln, retardiert
not available 31200.00.00 STADAPHARM GMBH DE
Slo-Phyllin 125 mg Capsules
not available PL 11648/0080 MERCK SERONO LTD. UK
Slo-Phyllin 250 mg Capsules
not available PL 11648/0081 MERCK SERONO LTD. UK
Slo-Phyllin 60 mg Capsules
not available PL 11648/0079 MERCK SERONO LTD. UK
SOLOSIN RETARD not available 2707.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN RETARD not available 2707.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN INFUSIONSLÖSUNGSKONZENTRAT
not available 2707.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN INFUSIONSLÖSUNGSKONZENTRAT
not available 2707.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
List of nationally authorised medicinal products EMA/135395/2018 Page 3/22
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
SOLOSIN RETARD MITE not available 2707.01.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN RETARD not available 2707.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN RETARD not available 2707.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN RETARD not available 2707.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN INFUSIONSLÖSUNGSKONZENTRAT
not available 2707.00.01 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN RETARD MITE not available 2707.01.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN RETARD MITE not available 2707.01.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN RETARD MITE not available 2707.01.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
SOLOSIN RETARD MITE not available 2707.01.00 SANOFI-AVENTIS DEUTSCHLAND GMBH
DE
List of nationally authorised medicinal products EMA/135395/2018 Page 4/22
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
Theo-Dur 200mg depottablett
not available 6607 BIOPHAUSIA AB NO
Theo-Dur 300mg depottablett
not available 6608 BIOPHAUSIA AB NO
Eufilina Venosa 200 mg solución inyectable
not available 1.891 TAKEDA GMBH (KONSTANZ) ES
Theo-dur 300 mg compresse a rilascio prolungato
not available 025267016 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
IT
Theo-dur 200 mg compresse a rilascio prolungato
not available 025267028 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
IT
Nuelin Depot 175 mg depottabletter
not available 8131 MEDA OY FI
Nuelin Depot 350 mg depottabletter
not available 8792 MEDA OY FI
Nuelin Depot 250 mg depottabletter
not available 8132 MEDA OY FI
Theolair 175 mg, comprimidos de liberación prolongada
not available 56160 MEDA PHARMA S.A.U. ES
List of nationally authorised medicinal products EMA/135395/2018 Page 5/22
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
Theolair 250 mg, comprimidos de liberación prolongada
not available 56161 MEDA PHARMA S.A.U. ES
THEOLAIR compresse a rilascio prolungato
not available 025730019 MEDA PHARMA S.P.A. IT
THEOLAIR compresse a rilascio prolungato
not available 025730021 MEDA PHARMA S.P.A. IT
Nuelin Depot 250 mg depottablett
not available 6590 MEDA AS NO
Nuelin Depot 350 mg depottablett
not available 6600 MEDA AS NO
Nuelin Depot 175 mg depottabletit
not available 8131 MEDA OY FI
Nuelin Depot 250 mg depottabletti
not available 8132 MEDA OY FI
Nuelin Depot 350 mg depottabletti
not available 8792 MEDA OY FI
Theolair Retard 175, tabletten met gereguleerde afgifte 175 mg
not available RVG 09107 MEDA PHARMA B.V. NL
List of nationally authorised medicinal products EMA/135395/2018 Page 6/22
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
Theolair Retard 250, tabletten met gereguleerde afgifte 250 mg
not available RVG 08391 MEDA PHARMA B.V. NL
Theolair Retard 350, tabletten met gereguleerde afgifte 350 mg
not available RVG 08816 MEDA PHARMA B.V. NL
Nuelin Retard, depottabletter
not available 10557 MEDA AS DK
Nuelin Retard, depottabletter
not available 10262 MEDA AS DK
PEDIAPHYLLIN 200 mg Comprimé à libération prolongée
not available BE128502 LABORATOIRES SMB S.A. BE
PEDIAPHYLLIN 200 mg, tablet met verlengde afgifte
not available BE 128502 LABORATOIRES SMB S.A. BE
PEDIAPHYLLIN 200 mg Retardtablette
not available BE 128502 LABORATOIRES SMB S.A. BE
PEDIAPHYLLIN 200 mg Comprimé à libération prolongée
not available 0160/99/01/4904 LABORATOIRES SMB S.A. LU
PEDIAPHYLLIN 200 mg Retardtablette
not available 0160/99/01/4904 LABORATOIRES SMB S.A. LU
List of nationally authorised medicinal products EMA/135395/2018 Page 7/22
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
Xanthium 200 mg Gélules à libération prolongée
not available BE138573 LABORATOIRES SMB S.A. BE
Xanthium 300 mg Gélules à libération prolongée
not available BE158365 LABORATOIRES SMB S.A. BE
Xanthium 300 mg Capsule met verlengde afgifte, hard
not available BE158365 LABORATOIRES SMB S.A. BE
Xanthium 200 mg Hartkapseln, retardiert
not available BE138573 LABORATOIRES SMB S.A. BE
Xanthium 400 mg Gélules à libération prolongée
not available BE138564 LABORATOIRES SMB S.A. BE
Xanthium 400 mg Hartkapseln, retardiert
not available BE138564 LABORATOIRES SMB S.A. BE
Xanthium 300 mg Hartkapseln, retardiert
not available BE158365 LABORATOIRES SMB S.A. BE
Xanthium 200 mg Capsule met verlengde afgifte, hard
not available BE138573 LABORATOIRES SMB S.A. BE
Xanthium 400 mg Capsule met verlengde afgifte, hard
not available BE138564 LABORATOIRES SMB S.A. BE
List of nationally authorised medicinal products EMA/135395/2018 Page 8/22
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
Xanthium 200 mg Gélules à libération prolongée
not available 2002116791 LABORATOIRES SMB S.A. LU
Xanthium 200 mg Hartkapseln, retardiert
not available 2002116791 LABORATOIRES SMB S.A. LU
Xanthium 300 mg Gélules à libération prolongée
not available 2002116792 LABORATOIRES SMB S.A. LU
Xanthium 300 mg Hartkapseln, retardiert
not available 2002116792 LABORATOIRES SMB S.A. LU
Xanthium 400 mg Gélules à libération prolongée
not available 2002116793 LABORATOIRES SMB S.A. LU
Xanthium 400 mg Hartkapseln, retardiert
not available 2002116793 LABORATOIRES SMB S.A. LU
DILATRANE 50 mg, gélule à libération prolongée
not available NL13804-3400932787821 SOCIETE D'ETUDES ET DE RECHERCHES PHARMACEUTIQUES (SERP)
FR
Theo-Dur 300 mg depottabletter
not available 9446 BIOPHAUSIA AB SE
Theo-Dur 200 mg depottabletter
not available 9445 BIOPHAUSIA AB SE
List of nationally authorised medicinal products EMA/135395/2018 Page 9/22
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
UNIPHYLLIN® Ελιξίριο 50mg/5ml
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
UNIPHYLLIN® Σιρόπι 50mg/5ml
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
UNIPHYLLIN® Δισκία βραδείας αποδέσμευσης 100mg/tab
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
UNIPHYLLIN® Δισκία βραδείας αποδέσμευσης 200mg/tab
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
UNIPHYLLIN® Δισκία βραδείας αποδέσμευσης 300mg/tab
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
UNIPHYLLIN® Κάψουλες βραδείας αποδέσμευσης 100mg/cap
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
UNIPHYLLIN Κάψουλες βραδείας αποδέσμευσης 350mg/cap
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
UNIPHYLLIN® Υπόθετα 100mg/supp
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
UNIPHYLLIN® Υπόθετα 350mg/supp
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
List of nationally authorised medicinal products EMA/135395/2018 Page 10/22
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
UNIPHYLLIN, Eνέσιμο διάλυμα 240(218)mg/4ml Amp
not available 8570/06.02.2007 UNI-PHARMA KLEON TSETIS PHARMACEUTICAL LABORATORIES S.A.
GR
DILATRANE 200 mg, gélule à libération prolongée
not available V07672-3400930317686 SOCIETE D'ETUDES ET DE RECHERCHES PHARMACEUTIQUES (SERP)
FR
TEDRALAN 200 mg, gélule à libération prolongée
not available VNL6671-3400931035398 SOCIETE D'ETUDES ET DE RECHERCHES PHARMACEUTIQUES (SERP)
FR
Theo-Dur, depottabletter not available 10044 BIOPHAUSIA AB DK
Theo-Dur, depottabletter not available 10045 BIOPHAUSIA AB DK
Euphyllin long, 300 mg, kapsulki o zmodyfikowanym uwalnianiu, twarde
not available 4502 ASTRAZENECA AB PL
EUPHYLLIN CR N 200 kapsuly s predĺženým uvoľňovaním
not available 14/0135/94-S ASTRAZENECA AB SK
Euphyllin long, 200 mg, kapsułki o zmodyfikowanym uwalnianiu, twarde
not available 4501 ASTRAZENECA AB PL
EUPHYLLIN CR N 300 kapsuly s predĺženým uvoľňovaním
not available 14/0003/13-S ASTRAZENECA AB SK
List of nationally authorised medicinal products EMA/135395/2018 Page 11/22
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
EUPHYLLIN CR N 400 kapsuly s predĺženým uvoľňovaním
not available 14/0004/13-S ASTRAZENECA AB SK
Euphyllin CR N 100 Tvrdá tobolka s prodlouženým uvolňováním
not available 14/078/99-C ASTRAZENECA AB CZ
Euphyllin CR N 200 Tvrdá tobolka s prodlouženým uvolňováním
not available 14/079/99-C ASTRAZENECA AB CZ
Euphyllin CR N 300 Tvrdá tobolka s prodlouženým uvolňováním
not available 14/080/99-C ASTRAZENECA AB CZ
Euphyllin CR N 400 Tvrdá tobolka s prodlouženým uvolňováním
not available 14/081/99-C ASTRAZENECA AB CZ
Theo-dur 300 mg compresse a rilascio prolungato
not available 025267016 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
IT
Theo-dur 200 mg compresse a rilascio prolungato
not available 025267028 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.P.A.
IT
THEO-DUR® not available 42686/09/12-2-2010 LAVIPHARM S.A GR
THEO-DUR® not available 42687/09/12-2-2010 LAVIPHARM S.A GR
List of nationally authorised medicinal products EMA/135395/2018 Page 12/22
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
THEO-DUR® not available 20100 LAVIPHARM LIMITED CY
THEO-DUR® not available 20099 LAVIPHARM LIMITED CY
DILATRANE 300 mg, gélule à libération prolongée
not available NL13805-3400932787999 SOCIETE D'ETUDES ET DE RECHERCHES PHARMACEUTIQUES (SERP)
FR
DIFFUMAL not available 025740085 MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A.
IT
DIFFUMAL not available 025740097 MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A.
IT
AMINOMAL 0,67% soluzione orale (67 mg/10 ml)
not available 011226091 MALESCI ISTITUTO FARMACOBIOLOGICO - S.P.A.
IT
AFONILUM SR 125 125 mg, kapsuly s predlženým uvolnovaním
not available 14/0595/94-S BGP PRODUCTS S.R.O. SK
AFONILUM SR 250 250 mg, kapsuly s predlženým uvolnovaním
not available 14/0595/94-S BGP PRODUCTS S.R.O. SK
AFONILUM SR 375 375mg|kapsuly s predlženým uvolnovaním
not available 14/0595/94-S BGP PRODUCTS S.R.O. SK
List of nationally authorised medicinal products EMA/135395/2018 Page 13/22
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
THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable
not available 326 913-9 PIERRE FABRE MEDICAMENT FR
THEOSTAT LP 200 mg, comprimé sécable à libération prolongée
not available 327 873.0 SAS PIERRE FABRE MEDICAMENT
FR
THEOSTAT 300 mg A LIBERATION PROLONGEE, comprimé sécable
not available 34009 326 021 0 0 PIERRE FABRE MEDICAMENT FR
THEOSTAT LP 200 mg, comprimé sécable à libération prolongée
not available 327 874.7 PIERRE FABRE MEDICAMENT FR
THEOSTAT LP 200 mg, comprimé sécable à libération prolongée
not available 327 875.3 PIERRE FABRE MEDICAMENT FR
THEOSTAT LP 200 mg, comprimé sécable à libération prolongée
not available 327 877.6 PIERRE FABRE MEDICAMENT FR
THEOSTAT LP 200 mg, comprimé sécable à libération prolongée
not available 554 929.7 PIERRE FABRE MEDICAMENT FR
THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable
not available 326 914-5 PIERRE FABRE MEDICAMENT FR
List of nationally authorised medicinal products EMA/135395/2018 Page 14/22
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
THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable
not available 326 915-1 PIERRE FABRE MEDICAMENT FR
THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable
not available 327 138-9 PIERRE FABRE MEDICAMENT FR
THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable
not available 554 701-6 PIERRE FABRE MEDICAMENT FR
THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable
not available 556 814-2 PIERRE FABRE MEDICAMENT FR
THEOSTAT 300 mg A LIBERATION PROLONGEE, comprimé sécable
not available 34009 327 314 1 1 PIERRE FABRE MEDICAMENT FR
THEOSTAT 300 mg A LIBERATION PROLONGEE, comprimé sécable
not available 34009 554 187 0 2 PIERRE FABRE MEDICAMENT FR
THEOPLUS 100 Tableta s prodlouženým uvolňováním
not available 14/900//92-C PIERRE FABRE MEDICAMENT CZ
List of nationally authorised medicinal products EMA/135395/2018 Page 15/22
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
THEOPLUS 100 not available 14/0900/92-S SAS PIERRE FABRE MEDICAMENT
SK
THEOPLUS 300 Tableta s prodlouženým uvolňováním
not available 14/900/92- A/C PIERRE FABRE MEDICAMENT CZ
THEOPLUS 300 not available 14/900/92-S PIERRE FABRE MEDICAMENT SK
Theophyllin STADA® 200 mg Hartkapseln, retardiert
not available 33294.01.00 STADAPHARM GMBH DE
Theophyllin STADA® 300 mg Hartkapseln, retardiert
not available 33294.02.00 STADAPHARM GMBH DE
PEDIAPHYLLIN 200 mg Comprimé à libération prolongée
not available BE128502 LABORATOIRES SMB S.A. BE
PEDIAPHYLLIN 200 mg, tablet met verlengde afgifte
not available BE 128502 LABORATOIRES SMB S.A. BE
PEDIAPHYLLIN 200 mg Retardtablette
not available BE 128502 LABORATOIRES SMB S.A. BE
PEDIAPHYLLIN 200 mg Comprimé à libération prolongée
not available 0160/99/01/4904 LABORATOIRES SMB S.A. LU
List of nationally authorised medicinal products EMA/135395/2018 Page 16/22
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
PEDIAPHYLLIN 200 mg Retardtablette
not available 0160/99/01/4904 LABORATOIRES SMB S.A. LU
Xanthium 200 mg Gélules à libération prolongée
not available BE138573 LABORATOIRES SMB S.A. BE
Xanthium 300 mg Gélules à libération prolongée
not available BE158365 LABORATOIRES SMB S.A. BE
Xanthium 300 mg Capsule met verlengde afgifte, hard
not available BE158365 LABORATOIRES SMB S.A. BE
Xanthium 200 mg Hartkapseln, retardiert
not available BE138573 LABORATOIRES SMB S.A. BE
Xanthium 400 mg Gélules à libération prolongée
not available BE138564 LABORATOIRES SMB S.A. BE
Xanthium 400 mg Hartkapseln, retardiert
not available BE138564 LABORATOIRES SMB S.A. BE
Xanthium 300 mg Hartkapseln, retardiert
not available BE158365 LABORATOIRES SMB S.A. BE
Xanthium 200 mg Capsule met verlengde afgifte, hard
not available BE138573 LABORATOIRES SMB S.A. BE
List of nationally authorised medicinal products EMA/135395/2018 Page 17/22
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
Xanthium 400 mg Capsule met verlengde afgifte, hard
not available BE138564 LABORATOIRES SMB S.A. BE
Xanthium 200 mg Gélules à libération prolongée
not available 2002116791 LABORATOIRES SMB S.A. LU
Xanthium 200 mg Hartkapseln, retardiert
not available 2002116791 LABORATOIRES SMB S.A. LU
Xanthium 300 mg Gélules à libération prolongée
not available 2002116792 LABORATOIRES SMB S.A. LU
Xanthium 300 mg Hartkapseln, retardiert
not available 2002116792 LABORATOIRES SMB S.A. LU
Xanthium 400 mg Gélules à libération prolongée
not available 2002116793 LABORATOIRES SMB S.A. LU
Xanthium 400 mg Hartkapseln, retardiert
not available 2002116793 LABORATOIRES SMB S.A. LU
Euphylong® i.v. 200, 200 mg, Injektionslösung
not available 21810.00.01 TAKEDA GMBH (KONSTANZ) DE
Euphylong® 200 mg, Hartkapsel, retardiert
not available 3003022.01.00 TAKEDA GMBH (KONSTANZ) DE
List of nationally authorised medicinal products EMA/135395/2018 Page 18/22
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
Euphylong® 250 mg, Hartkapsel, retardiert
not available 9689.00.00 TAKEDA GMBH (KONSTANZ) DE
Respicur 400 mg capsule rigide a rilascio prolungato
not available 027435078 TAKEDA ITALIA S.P.A. IT
Euphylong® 125 mg, Hartkapsel, retardiert
not available 24676.02.00 TAKEDA GMBH (KONSTANZ) DE
Respicur 200 mg capsule rigide a rilascio prolungato
not available 027435080 TAKEDA ITALIA S.P.A. IT
Euphylong® 300 mg, Hartkapsel, retardiert
not available 3003022.00.00 TAKEDA GMBH (KONSTANZ) DE
EUPHYLLINE L.A. 400 mg, gélule à libération prolongée
not available 34009 338 494 6 7 TAKEDA FRANCE S.A.S. FR
Euphyllin CR retard, 250 mg, tabletki o przedłużonym uwalnianiu
not available R/6654 TAKEDA PHARMA SP.Z.O.O. PL
Respicur 300 mg capsule rigide a rilascio prolungato
not available 027435155 TAKEDA ITALIA S.P.A. IT
EUPHYLLINE L.A. 100 mg, gélule à libération prolongée
not available 34009 333 752 7 0 TAKEDA FRANCE S.A.S. FR
List of nationally authorised medicinal products EMA/135395/2018 Page 19/22
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
EUPHYLLINE L.A. 300 mg, gélule à libération prolongée
not available 34009 333 753 3 1 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 200 mg, gélule à libération prolongée
not available 34009 555 162 1 7 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 100 mg, gélule à libération prolongée
not available 34009 553 061 3 9 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 100 mg, gélule à libération prolongée
not available 34009 325 016 3 2 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 100 mg, gélule à libération prolongée
not available 34009 560 449 3 1 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 200 mg, gélule à libération prolongée
not available 34009 333 751 0 2 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 200 mg, gélule à libération prolongée
not available 34009 560 452 4 2 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 200 mg, gélule à libération prolongée
not available 34009 328 014 1 1 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 300 mg, gélule à libération prolongée
not available 34009 325 018 6 1 TAKEDA FRANCE S.A.S. FR
List of nationally authorised medicinal products EMA/135395/2018 Page 20/22
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
EUPHYLLINE L.A. 300 mg, gélule à libération prolongée
not available 34009 560 450 1 3 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 300 mg, gélule à libération prolongée
not available 34009 553 063 6 8 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 400 mg, gélule à libération prolongée
not available 34009 560 451 8 1 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 400 mg, gélule à libération prolongée
not available 34009 555 168 8 5 TAKEDA FRANCE S.A.S. FR
EUPHYLLINE L.A. 400 mg, gélule à libération prolongée
not available 34009 328 218 6 0 TAKEDA FRANCE S.A.S. FR
Afonilum SR 125 mg Tvrdá tobolka s prodlouženým uvolňováním
not available 14/468/95-A/C BGP PRODUCTS CZECH REPUBLIC S.R.O.
CZ
Afonilum SR 250 mg Tvrdá tobolka s prodlouženým uvolňováním
not available 14/468/95-B/C BGP PRODUCTS CZECH REPUBLIC S.R.O.
CZ
Uniphyllin® 300 mg not available 25497.00.00 MUNDIPHARMA GMBH DE
Uniphyllin® 400 mg not available 02738.00.00 MUNDIPHARMA GMBH DE
List of nationally authorised medicinal products EMA/135395/2018 Page 21/22
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
Uniphyllin® 600 mg not available 02738.02.00 MUNDIPHARMA GMBH DE
Unifyl retard 300 mg Tabletten
not available 1-18815 MUNDIPHARMA GES.M.B.H AT
Unifyl retard 200 mg Tabletten
not available 1-18171 MUNDIPHARMA GES.M.B.H AT
Unifyl retard 400 mg Tabletten
not available 1-17835 MUNDIPHARMA GES.M.B.H AT
Unifyl retard 600 mg Tabletten
not available 1-18818 MUNDIPHARMA GES.M.B.H AT
UNIPHYLLIN CONTINUS tablets 400 mg
not available 19865 MUNDIPHARMA PHARMACEUTICALS LTD
CY
UNIPHYLLIN® CONTINUS® 200 mg prolonged release tablets
not available PA 1688/11/1 MUNDIPHARMA PHARMACEUTICALS LIMITED
IE
UNIPHYLLIN® CONTINUS® 300 mg prolonged release tablets
not available PA 1688/11/2 MUNDIPHARMA PHARMACEUTICALS LIMITED
IE
UNIPHYLLIN® CONTINUS® 400 mg prolonged release tablets
not available PA 1688/11/3 MUNDIPHARMA PHARMACEUTICALS LIMITED
IE
List of nationally authorised medicinal products EMA/135395/2018 Page 22/22
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
UNIPHYLLIN CONTINUS 200 mg prolonged release tablets
not available PL 16950/0066 NAPP PHARMACEUTICALS LTD
UK
UNIPHYLLIN CONTINUS 300 mg prolonged release tablets
not available PL 16950/0067 NAPP PHARMACEUTICALS LTD
UK
UNIPHYLLIN CONTINUS 400 mg prolonged release tablets
not available PL 16950/0068 NAPP PHARMACEUTICALS LTD
UK
Unicontin 400 mg comprimidos de libertação prolongada
not available 9628719 MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
Unicontin 400 mg comprimidos de libertação prolongada
not available 9628727 MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT