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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

11 January 2018 EMA/10900/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): diltiazem

Procedure No.: PSUSA/00001084/201705

List of nationally authorised medicinal products EMA/10900/2018 Page 2/21

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

ADIZEM® XL Capsules 120mg not available 19866 MUNDIPHARMA PHARMACEUTICALS LTD

CY

ADIZEM® XL Capsules 180mg not available 19812 MUNDIPHARMA PHARMACEUTICALS LTD

CY

ADIZEM® XL Capsules 240mg not available 19863 MUNDIPHARMA PHARMACEUTICALS LTD

CY

ADIZEM®-SR 120 mg prolonged release capsules

not available PA 1688/1/1-3 MUNDIPHARMA PHARMACEUTICALS LIMITED

IE

ADIZEM®-SR 180 mg prolonged release capsules

not available PA 1688/1/1-3 MUNDIPHARMA PHARMACEUTICALS LIMITED

IE

ADIZEM®-SR 90 mg prolonged release capsules

not available PA 1688/1/1 MUNDIPHARMA PHARMACEUTICALS LIMITED

IE

ADIZEM-SR capsules 120 mg not available PL 16950/0007 NAPP PHARMACEUTICALS LTD UK ADIZEM-SR capsules 180 mg not available PL 16950/0008 NAPP PHARMACEUTICALS LTD UK ADIZEM-SR capsules 90 mg not available PL 16950/0006 NAPP PHARMACEUTICALS LTD UK ADIZEM-XL 120 mg prolonged release capsules.

not available PA 1688/1/4 MUNDIPHARMA PHARMACEUTICALS LIMITED

IE

ADIZEM-XL 180 mg prolonged release capsules.

not available PA 1688/1/5 MUNDIPHARMA PHARMACEUTICALS LIMITED

IE

ADIZEM-XL capsules 240 mg_001 not available PA 1688/001/006 MUNDIPHARMA PHARMACEUTICALS LIMITED

IE

ADIZEM-XL capsules 300 mg_001 not available PA 1688/001/007 MUNDIPHARMA PHARMACEUTICALS LIMITED

IE

ALTIAZEM 120 mg compresse a rilascio prolungato

not available 025271038 ISTITUTO LUSO FARMACO D'ITALIA S.P.A.

IT

ALTIAZEM 300 mg capsule rigide a rilascio prolungato

not available 025271040 ISTITUTO LUSO FARMACO D'ITALIA S.P.A.

IT

ALTIAZEM 50 mg/5 ml polvere e solvente per soluzione iniettabile per uso endovenoso

not available 025271026 ISTITUTO LUSO FARMACO D'ITALIA S.P.A.

IT

ALTIAZEM 60 mg compresse not available 025271014 ISTITUTO LUSO FARMACO D'ITALIA S.P.A.

IT

Angiodrox 120 mg cápsulas duras de liberación prolongada

not available 60.217 BGP PRODUCTS OPERATIONS SL

ES

Angiodrox 180 mg cápsulas duras de liberación prolongada

not available 60.216 BGP PRODUCTS OPERATIONS SL

ES

List of nationally authorised medicinal products EMA/10900/2018 Page 3/21

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

Angiodrox 300 mg cápsulas duras de liberación prolongada

not available 60.214 BGP PRODUCTS OPERATIONS SL

ES

Angiodrox 90 mg cápsulas duras de liberación prolongada

not available 60.215 BGP PRODUCTS OPERATIONS SL

ES

ANGITIL SR 120 not available PL 06934/0196 ETHYPHARM UK ANGITIL SR 180 not available PL 06934/0197 ETHYPHARM UK ANGITIL SR 90 not available PL 06934/0195 ETHYPHARM UK ANGITIL XL 240 not available PL 06934/0198 ETHYPHARM UK ANGITIL XL 300 not available PL 06934/0199 ETHYPHARM UK ANGIZEM 120 mg compresse a rilascio prolungato

not available 025280049 SANOFI SPA IT

ANGIZEM 200 mg capsule rigide a rilascio prolungato

not available 025280064 SANOFI SPA IT

ANGIZEM 300 mg capsule rigide a rilascio prolungato

not available 025280052 SANOFI SPA IT

ANGIZEM 60 MG not available 025280025 SANOFI SPA IT BI-TILDIEM LP 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 565 316-1 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 333 479-9 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 565 315-5 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 363 443-2 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 363 442-6 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 565 317-8 SANOFI-AVENTIS FRANCE FR

List of nationally authorised medicinal products EMA/10900/2018 Page 4/21

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

BI-TILDIEM LP 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 565 318-4 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 mg, comprimé enrobé à libération prolongée

not available 556 958-4 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 mg, comprimé enrobé à libération prolongée

not available 556 565-2 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 mg, comprimé enrobé à libération prolongée

not available 563 128-3 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 mg, comprimé enrobé à libération prolongée

not available 333 478-2 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 120 mg, comprimé enrobé à libération prolongée

not available 556 959-0 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 565 319-0 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 565 320-9 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 363 445-5 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 565 321-5 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 565 322-1 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 363 444-9 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 mg, comprimé enrobé à libération prolongée

not available 333 477-6 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 mg, comprimé enrobé à libération prolongée

not available 556 566-9 SANOFI-AVENTIS FRANCE FR

List of nationally authorised medicinal products EMA/10900/2018 Page 5/21

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

BI-TILDIEM LP 90 mg, comprimé enrobé à libération prolongée

not available 556 984-5 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 mg, comprimé enrobé à libération prolongée

not available 556 983-9 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 mg, comprimé enrobé à libération prolongée

not available 563 130-8 SANOFI-AVENTIS FRANCE FR

BI-TILDIEM LP 90 mg, comprimé enrobé à libération prolongée

not available 333 475-3 SANOFI-AVENTIS FRANCE FR

Cardizem 60 mg filmdragerade tabletter

not available 10250 PFIZER AB SE

Cardizem 60 mg tabletti, kalvopäällysteinen

not available 9179 PFIZER OY FI

Cardizem Retard 120 mg depottabletter

not available 7612 PFIZER AS NO

Cardizem Retard 120 mg depottabletter

not available 10877 PFIZER AB SE

Cardizem Retard 120 mg depottabletti

not available 9510 PFIZER OY FI

Cardizem Retard 180 mg depottabletter

not available 7685 PFIZER AS NO

Cardizem Retard 180 mg depottabletter

not available 10962 PFIZER AB SE

Cardizem Retard 180 mg depottabletti

not available 10433 PFIZER OY FI

Cardizem Retard 90 mg depottabletter

not available 7611 PFIZER AS NO

Cardizem Retard 90 mg depottabletter

not available 10876 PFIZER AB SE

Cardizem Retard 90 mg depottabletti

not available 9509 PFIZER OY FI

Cardizem Uno 180 mg depottabletter

not available 94-1154 PFIZER AS NO

Cardizem Uno 240 mg depottabletter

not available 94-1156 PFIZER AS NO

List of nationally authorised medicinal products EMA/10900/2018 Page 6/21

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

Cardizem Uno 300 mg depottabletter

not available 94-1157 PFIZER AS NO

Cardizem Unotard 180 mg depottabletter

not available 13310 PFIZER AB SE

Cardizem Unotard 240 mg depottabletter

not available 13311 PFIZER AB SE

Cardizem Unotard 300 mg depottabletter

not available 13312 PFIZER AB SE

CARDIZEM® 60 mg filmdragerade tablett

not available 9179 PFIZER OY FI

CARDIZEM® RETARD 120 mg depottabletter

not available 9510 PFIZER OY FI

CARDIZEM® RETARD 180 mg depottabletter

not available 10433 PFIZER OY FI

CARDIZEM® RETARD 90 mg depottabletter

not available 9509 PFIZER OY FI

CARRELDON RETARD 240 mg comprimidos de liberación prolongada

not available 60742 ALFASIGMA ESPAÑA, S.L. ES

DIAZEM L.P. 120 mg, gélule à libération prolongée

not available 342 610-7 OU 34009 342 610 7 7

ETHYPHARM FR

DIAZEM L.P. 120 mg, gélule à libération prolongée

not available 342 611-3 OU 34009 342 611 3 8

ETHYPHARM FR

DIAZEM L.P. 120 mg, gélule à libération prolongée

not available 342 613-6 OU 34009 342 613 6 7

ETHYPHARM FR

DIAZEM L.P. 120 mg, gélule à libération prolongée

not available 342 614-2 OU 34009 342 614 2 8

ETHYPHARM FR

DIAZEM L.P. 180 mg, gélule à libération prolongée

not available 342 615-9 OU 34009 342 615 9 6

ETHYPHARM FR

DIAZEM L.P. 180 mg, gélule à libération prolongée

not available 342 616-5 OU 34009 342 616 5 7

ETHYPHARM FR

DIAZEM L.P. 180 mg, gélule à libération prolongée

not available 342 617-1 OU 34009 342 617 1 8

ETHYPHARM FR

DIAZEM L.P. 180 mg, gélule à libération prolongée

not available 342 618-8 OU 34009 342 618 8 6

ETHYPHARM FR

List of nationally authorised medicinal products EMA/10900/2018 Page 7/21

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

DIAZEM L.P. 90 mg, gélule à libération prolongée

not available 342 605-3 OU 34009 342 605 3 7

ETHYPHARM FR

DIAZEM L.P. 90 mg, gélule à libération prolongée

not available 342 607-6 OU 34009 342 607 6 6

ETHYPHARM FR

DIAZEM L.P. 90 mg, gélule à libération prolongée

not available 342 608-2 OU 34009 342 608 2 7

ETHYPHARM FR

DIAZEM L.P. 90 mg, gélule à libération prolongée

not available 342 609-9 OU 34009 342 609 9 5

ETHYPHARM FR

DILADEL not available 025275013 ZENTIVA ITALIA SRL IT DILADEL 120 mg compresse a rilascio prolungato

not available 025275025 ZENTIVA ITALIA SRL IT

DILADEL 200 not available 025275049 ZENTIVA ITALIA SRL IT DILADEL 300 not available 025275037 ZENTIVA ITALIA SRL IT Dilfar 120 mg cápsulas de libertação prolongada

not available 2328888 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

Dilfar 120 mg cápsulas de libertação prolongada

not available 2328987 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

Dilfar 120 mg cápsulas de libertação prolongada

not available 4694386 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

Dilfar 180 180 mg comprimidos de libertação prolongada

not available 4694485 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

Dilfar 180 180 mg comprimidos de libertação prolongada

not available 3644085 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

Dilfar 60 mg comprimidos de libertação prolongada

not available 8613224 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

Dilfar 60 mg comprimidos de libertação prolongada

not available 8613232 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

Dilfar 60 mg comprimidos de libertação prolongada

not available 4694287 TEVA PHARMA – PRODUTOS FARMACÊUTICOS LDA

PT

DILTIAZEM BIOGARAN 60 mg, comprimé

not available 3400934892141 BIOGARAN FR

DILTIAZEM BIOGARAN 60 mg, comprimé

not available 3400956126477 BIOGARAN FR

DILTIAZEM GECONTROLEERDE AFGIFTE 120

not available RVG 18594 SANOFI-AVENTIS NETHERLANDS B.V.

NL

List of nationally authorised medicinal products EMA/10900/2018 Page 8/21

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

DILTIAZEM GECONTROLEERDE AFGIFTE 120

not available RVG 18594 SANOFI-AVENTIS NETHERLANDS B.V.

NL

DILTIAZEM GECONTROLEERDE AFGIFTE 90

not available RVG 18593 SANOFI-AVENTIS NETHERLANDS B.V.

NL

DILTIAZEM GECONTROLEERDE AFGIFTE 90

not available RVG 18593 SANOFI-AVENTIS NETHERLANDS B.V.

NL

Diltiazem modified release tablets 60mg

not available PL 20416/0066 CRESCENT PHARMA LIMITED UK

Diltiazem Mundipharma 300 mg cápsulas duras de liberación prolongada

not available 62.272 MUNDIPHARMA PHARMACEUTICALS SL

ES

DILTIAZEM TEVA L.P. 120 mg, gélule à libération prolongée

not available NL21170 TEVA SANTÉ FR

DILTIAZEM TEVA L.P. 90 mg, gélule à libération prolongée

not available NL21169 TEVA SANTÉ FR

DILTIAZEM TEVA LP 300 mg, gélule à libération prolongée

not available NL24975 TEVA SANTÉ FR

DILTIAZEM WINTHROP L.P. 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 377 307-9 SANOFI-AVENTIS FRANCE FR

DILTIAZEM WINTHROP L.P. 120 MG, COMPRIME ENROBE A LIBERATION PROLONGEE

not available 570 208-9 SANOFI-AVENTIS FRANCE FR

DILTIAZEM WINTHROP L.P. 90 MG, COMPRIME A LIBERATION PROLONGEE

not available 377 302-7 SANOFI-AVENTIS FRANCE FR

DILTIAZEM WINTHROP L.P. 90 MG, COMPRIME A LIBERATION PROLONGEE

not available 570 207-2 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 269 439 5 0 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 269 438 9 9 SANOFI-AVENTIS FRANCE FR

List of nationally authorised medicinal products EMA/10900/2018 Page 9/21

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

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 584 448 7 6 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 269 436 6 0 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 269 440 3 2 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 584 449 3 7 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 584 448 7 6 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 584 447 0 8 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 200 MG GELULE A LIBERATION PROLONGEE

not available 34009 269 437 2 1 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 269 442 6 1 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 584 450 1 9 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 584 452 4 8 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 584 453 0 9 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 584 451 8 7 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 269 444 9 0 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 269 443 2 2 SANOFI-AVENTIS FRANCE FR

List of nationally authorised medicinal products EMA/10900/2018 Page 10/21

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

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 269 445 5 1 SANOFI-AVENTIS FRANCE FR

DILTIAZEM ZENTIVA LAB LP 300 mg, gélule à libération prolongée

not available 34009 269 446 1 2 SANOFI-AVENTIS FRANCE FR

DILTIWAS RETARD 120 mg cápsulas

not available 60091 ALFASIGMA ESPAÑA, S.L. ES

Dilzem ® 60 mg δισκία not available 9383 PFIZER HELLAS, A.E. CY Dilzem ®90 mg retard δισκία παρατεταμένης αποδέσμευσης

not available 12017 PFIZER HELLAS, A.E. CY

Dilzem 120 mg retard filmtabletta not available OGYI-T- 1294/02 PFIZER KFT. HU Dilzem 120 mg retard filmtabletta not available OGYI-T- 1294/04 PFIZER KFT. HU Dilzem 120 mg retard filmtabletta not available OGYI-T- 1294/03 PFIZER KFT. HU Dilzem 120 retard, 120 mg, tabletki o przedłużonym uwalnianiu

not available 4829 PFIZER EUROPE MA EEIG PL

Dilzem 180 mg retard filmtabletta not available OGYI-T- 1294/06 PFIZER KFT. HU Dilzem 180 mg retard filmtabletta not available OGYI-T- 1294/07 PFIZER KFT. HU Dilzem 180 mg retard filmtabletta not available OGYI-T- 1294/05 PFIZER KFT. HU Dilzem 180 retard, 180 mg, tabletki o przedłużonym uwalnianiu

not available 4833 PFIZER EUROPE MA EEIG PL

Dilzem 60 mg comprimate not available 5926/2005/01 PFIZER EUROPE MA EEIG RO Dilzem 90 mg retard comprimate cu eliberare prelungită

not available 5927/2005/01 PFIZER EUROPE MA EEIG RO

Dilzem 90 mg retard filmtabletta not available OGYI-T- 1294/01 PFIZER KFT. HU Dilzem Retard, 90 mg, tabletki o przedłużonym uwalnianiu

not available R/2132 PFIZER EUROPE MA EEIG PL

Dilzem® 120 mg retard, Retardtabletten

not available 1488.01.01 PFIZER PHARMA PFE GMBH DE

Dilzem® 180 mg retard, Retardtabletten

not available 1488.02.01 PFIZER PHARMA PFE GMBH DE

Dilzem® 90 mg retard, Retardtabletten

not available 22571.00.01 PFIZER PHARMA PFE GMBH DE

DILZENE 120 mg compresse a rilascio prolungato

not available 025277068 ALFASIGMA S.P.A. IT

List of nationally authorised medicinal products EMA/10900/2018 Page 11/21

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

DILZENE 300 mg capsule rigide a rilascio prolungato

not available 025277070 ALFASIGMA S.P.A. IT

DILZENE 50 mg/3 ml polvere e solvente per soluzione iniettabile per uso endovenoso

not available 025277031 ALFASIGMA S.P.A. IT

DILZENE 60 mg compresse a rilascio modificato

not available 025277017 ALFASIGMA S.P.A. IT

DINISOR RETARD 120 mg comprimidos de liberación modificada

not available 58.590 PARKE-DAVIS, S.L. ES

DINISOR RETARD 180 mg comprimidos de liberación modificada

not available 59.776 PARKE-DAVIS, S.L. ES

Doclis Retard 120 cápsulas not available 60089 LABORATORIOS BIAL, S.A. ES Doclis Retard 240 cápsulas not available 60090 LABORATORIOS BIAL, S.A. ES Etizem 120mg cápsula dura de libertação prolongada

not available 2218493 NEO-FARMACÊUTICA, S.A. PT

Etizem 120mg cápsula dura de libertação prolongada

not available 2218592 NEO-FARMACÊUTICA, S.A. PT

Etizem 180 mg cápsula dura de libertação prolongada

not available 2218790 NEO-FARMACÊUTICA, S.A. PT

Etizem 180mg cápsula dura de libertação prolongada

not available 2218691 NEO-FARMACÊUTICA, S.A. PT

Etizem 180mg cápsula dura de libertação prolongada

not available 4659793 NEO-FARMACÊUTICA, S.A. PT

Etizem 240mg cápsula dura de libertação prolongada

not available 2123495 NEO-FARMACÊUTICA, S.A. PT

Etizem 240mg cápsula dura de libertação prolongada

not available 4659892 NEO-FARMACÊUTICA, S.A. PT

Etizem 240mg cápsula dura de libertação prolongada

not available 2123594 NEO-FARMACÊUTICA, S.A. PT

Etizem 300 mg cápsula dura de libertação prolongada

not available 2218998 NEO-FARMACÊUTICA, S.A. PT

Etizem 300 mg cápsula dura de libertação prolongada

not available 4659991 NEO-FARMACÊUTICA, S.A. PT

List of nationally authorised medicinal products EMA/10900/2018 Page 12/21

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

Etizem 300mg cápsula dura de libertação prolongada

not available 2218899 NEO-FARMACÊUTICA, S.A. PT

Etizem 90 mg cápsula dura de libertação prolongada

not available 2218295 NEO-FARMACÊUTICA, S.A. PT

Etizem 90 mg cápsula dura de libertação prolongada

not available 2218394 NEO-FARMACÊUTICA, S.A. PT

Herbesser 60mg comprimidos de liberta ﾃｧﾃ｣o prolongada

not available 9505149 LABORATÓRIOS DELTA, S.A. PT

Herbesser 60mg comprimidos de liberta ﾃｧﾃ｣o prolongada

not available 9505123 LABORATÓRIOS DELTA, S.A. PT

Herbesser 60mg comprimidos de liberta ﾃｧﾃ｣o prolongada

not available 4661997 LABORATÓRIOS DELTA, S.A. PT

Herbesser 60mg comprimidos de liberta ﾃｧﾃ｣o prolongada

not available 9505172 LABORATÓRIOS DELTA, S.A. PT

Herbesser 90mg comprimidos de liberta ﾃｧﾃ｣o prolongada

not available 9505164 LABORATÓRIOS DELTA, S.A. PT

Herbesser 90mg comprimidos de liberta ﾃｧﾃ｣o prolongada

not available 4662094 LABORATÓRIOS DELTA, S.A. PT

Herbesser 90mg comprimidos de liberta ﾃｧﾃ｣o prolongada

not available 9505180 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 120 mg cápsulas de libertação prolongada

not available 8769505 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 120 mg cápsulas de libertação prolongada

not available 8769513 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 120 mg cápsulas de libertação prolongada

not available 4662284 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 180 mg cápsulas de libertação prolongada

not available 8769547 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 180 mg cápsulas de libertação prolongada

not available 4662391 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 180 mg cápsulas de libertação prolongada

not available 8769554 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 180 mg cápsulas de libertação prolongada

not available 4662490 LABORATÓRIOS DELTA, S.A. PT

List of nationally authorised medicinal products EMA/10900/2018 Page 13/21

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

Herbesser SR 240 mg cápsulas de libertação prolongada

not available 8769562 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 240 mg cápsulas de libertação prolongada

not available 4662599 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 240 mg cápsulas de libertação prolongada

not available 8769570 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 240 mg cápsulas de libertação prolongada

not available 4662698 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 300 mg cápsulas de libertação prolongada

not available 4662797 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 300 mg cápsulas de libertação prolongada

not available 4662896 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 90 mg cápsulas de libertação prolongada

not available 9769521 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 90 mg cápsulas de libertação prolongada

not available 9769539 LABORATÓRIOS DELTA, S.A. PT

Herbesser SR 90 mg cápsulas de libertação prolongada

not available 4662193 LABORATÓRIOS DELTA, S.A. PT

Kenzem 120mg SR Capsules not available PL 30464/0145 ATHLONE PHARMACEUTICALS LIMITED

UK

Kenzem 120mg SR Capsules not available PL 30464/0145 ATHLONE PHARMACEUTICALS LIMITED

UK

Kenzem 60mg SR Capsules not available PL 30464/0143 ATHLONE PHARMACEUTICALS LIMITED

UK

Kenzem 60mg SR Capsules not available PL 30464/0143 ATHLONE PHARMACEUTICALS LIMITED

UK

Kenzem 90mg SR Capsules not available PL 30464/0144 ATHLONE PHARMACEUTICALS LIMITED

UK

Kenzem 90mg SR Capsules not available PL 30464/0144 ATHLONE PHARMACEUTICALS LIMITED

UK

LACEROL 60 mg not available 60.231 LACER S.A. ES LACEROL COR RETARD 240 mg comprimidos de liberación prolongada

not available 60.740 LACER S.A. ES

List of nationally authorised medicinal products EMA/10900/2018 Page 14/21

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

Lacerol HTA Retard 240 mg cápsulas duras de liberación prolongada

not available 60.200 LACER S.A. ES

Lacerol retard 120 mg cápsulas duras de liberación prolongada

not available 60.006 LACER S.A. ES

Lacerol retard 180 mg cápsulas duras de liberación prolongada

not available 60.007 LACER S.A. ES

LACEROL RETARD 300 mg cápsulas duras de liberación prolongada

not available 61.652 LACER S.A. ES

Lacerol Retard 90 mg cápsulas duras de liberación prolongada

not available 60.005 LACER S.A. ES

MASDIL 300 mg cápsulas de liberación prolongada

not available 59.911 LABORATORIOS DR. ESTEVE S.A.

ES

Masdil 60 mg comprimidos not available 55285 LABORATORIOS DR. ESTEVE S.A.

ES

Masdil Retard 120 mg comprimidos de liberación prolongada

not available 58.483 LABORATORIOS DR. ESTEVE S.A.

ES

MONO-TILDIEM LP 200 MG, GELULE A LIBERATION PROLONGEE

not available 335 722-8 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 200 MG, GELULE A LIBERATION PROLONGEE

not available 557 861-4 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 200 MG, GELULE A LIBERATION PROLONGEE

not available 372 298-1 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 200 MG, GELULE A LIBERATION PROLONGEE

not available 557 860-8 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 200 MG, GELULE A LIBERATION PROLONGEE

not available 557 863-7 SANOFI-AVENTIS FRANCE FR

List of nationally authorised medicinal products EMA/10900/2018 Page 15/21

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

MONO-TILDIEM LP 200 MG, GELULE A LIBERATION PROLONGEE

not available 557 862-0 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 200 MG, GELULE A LIBERATION PROLONGEE

not available 372 228-3 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 200 MG, GELULE A LIBERATION PROLONGEE

not available 557 864-3 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 300 MG, GELULE A LIBERATION PROLONGEE

not available 557 856-0 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 300 MG, GELULE A LIBERATION PROLONGEE

not available 557 858-3 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 300 MG, GELULE A LIBERATION PROLONGEE

not available 557 855-4 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 300 MG, GELULE A LIBERATION PROLONGEE

not available 557 854-8 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 300 MG, GELULE A LIBERATION PROLONGEE

not available 372 299-8 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 300 MG, GELULE A LIBERATION PROLONGEE

not available 372 230-8 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 300 MG, GELULE A LIBERATION PROLONGEE

not available 557 857-7 SANOFI-AVENTIS FRANCE FR

MONO-TILDIEM LP 300 MG, GELULE A LIBERATION PROLONGEE

not available 335 721-1 SANOFI-AVENTIS FRANCE FR

Slozem 120mg Capsules not available PL 11648/0045 MERCK SERONO LTD. UK Slozem 120mg Capsules not available PL 11648/0045 MERCK SERONO LTD. UK Slozem 180mg Capsules not available PL 11648/0046 MERCK SERONO LTD. UK

List of nationally authorised medicinal products EMA/10900/2018 Page 16/21

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

Slozem 180mg Capsules not available PL 11648/0046 MERCK SERONO LTD. UK Slozem 240mg Capsules not available PL 11648/0047 MERCK SERONO LTD. UK Slozem 240mg Capsules not available PL 11648/0047 MERCK SERONO LTD. UK Slozem 300mg Capsules not available PL 11648/0042 MERCK SERONO LTD. UK Slozem 300mg Capsules not available PL 11648/0042 MERCK SERONO LTD. UK TILDIEM not available 025278019 SANOFI SPA IT TILDIEM 100 mg, poudre pour solution injectable (I.V.)

not available 556 349-8 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 mg, poudre pour solution injectable (I.V.)

not available 556 350-6 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 mg, poudre pour solution injectable (I.V.)

not available 556 347-5 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 mg, poudre pour solution injectable (I.V.)

not available 556 348-1 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 mg, poudre pour solution injectable (I.V.)

not available 556 346-9 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 MG, POUDRE POUR SOLUTION INJECTABLE (IV)

not available 556 347-5 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 MG, POUDRE POUR SOLUTION INJECTABLE (IV)

not available 556 350-6 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 MG, POUDRE POUR SOLUTION INJECTABLE (IV)

not available 556 346-9 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 MG, POUDRE POUR SOLUTION INJECTABLE (IV)

not available 556 348-1 SANOFI-AVENTIS FRANCE FR

TILDIEM 100 MG, POUDRE POUR SOLUTION INJECTABLE (IV)

not available 556 349-8 SANOFI-AVENTIS FRANCE FR

TILDIEM 120 mg compresse a rilascio prolungato

not available 025278058 SANOFI SPA IT

TILDIEM 200 not available 025278072 SANOFI SPA IT TILDIEM 25 mg, poudre et solution pour préparation injectable I.V.

not available 554 872-5 SANOFI-AVENTIS FRANCE FR

TILDIEM 25 mg, poudre et solution pour préparation injectable I.V.

not available 327 305-2 SANOFI-AVENTIS FRANCE FR

List of nationally authorised medicinal products EMA/10900/2018 Page 17/21

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

TILDIEM 25 mg, poudre et solution pour préparation injectable I.V.

not available 554 906-7 SANOFI-AVENTIS FRANCE FR

TILDIEM 25 mg, poudre et solution pour préparation injectable I.V.

not available 327 305-2 SANOFI-AVENTIS FRANCE FR

TILDIEM 25 mg, poudre et solution pour préparation injectable I.V.

not available 554 872-5 SANOFI-AVENTIS FRANCE FR

TILDIEM 25 MG, POUDRE POUR SOLUTION INJECTABLE (IV)

not available 554 906-7 SANOFI-AVENTIS FRANCE FR

TILDIEM 300 not available 025278060 SANOFI SPA IT TILDIEM 300 RETARD not available 0006/11081246 SANOFI BELGIUM LU TILDIEM 300 RETARD not available 0006/11081246 SANOFI BELGIUM LU TILDIEM 300 RETARD not available 0006/11081246 SANOFI BELGIUM LU TILDIEM 60 mg comprimés not available BE120872 SANOFI BELGIUM BE TILDIEM 60 mg comprimés not available BE120872 SANOFI BELGIUM BE TILDIEM 60 mg comprimés not available BE120872 SANOFI BELGIUM BE TILDIEM 60 mg comprimés not available 0006/11081244 SANOFI BELGIUM LU TILDIEM 60 mg comprimés not available 0006/11081244 SANOFI BELGIUM LU TILDIEM 60 mg tabletten not available BE120872 SANOFI BELGIUM BE TILDIEM 60 mg tabletten not available BE120872 SANOFI BELGIUM BE TILDIEM 60 mg tabletten not available BE120872 SANOFI BELGIUM BE TILDIEM 60 mg, comprimé not available 563 131-4 SANOFI-AVENTIS FRANCE FR TILDIEM 60 mg, comprimé not available 324 855-1 SANOFI-AVENTIS FRANCE FR TILDIEM 60 mg, comprimé not available 556 819-4 SANOFI-AVENTIS FRANCE FR TILDIEM 60 mg, comprimé not available 323 817-9 SANOFI-AVENTIS FRANCE FR TILDIEM LA 200 not available PL 04425/0639 AVENTIS PHARMA LTD UK TILDIEM LA 200 not available PL 04425/0639 AVENTIS PHARMA LTD UK TILDIEM LA 200 not available PL 04425/0639 AVENTIS PHARMA LTD UK TILDIEM LA 300 not available PL 04425/0638 AVENTIS PHARMA LTD UK TILDIEM LA 300 not available PL 04425/0638 AVENTIS PHARMA LTD UK TILDIEM LA 300 not available PL 04425/0638 AVENTIS PHARMA LTD UK TILDIEM RETARD 120MG not available PL 04425/0642 AVENTIS PHARMA LTD UK TILDIEM RETARD 120MG not available PL 04425/0642 AVENTIS PHARMA LTD UK

List of nationally authorised medicinal products EMA/10900/2018 Page 18/21

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

TILDIEM RETARD 120MG not available PL 04425/0642 AVENTIS PHARMA LTD UK TILDIEM RETARD 120MG not available PL 04425/0642 AVENTIS PHARMA LTD UK TILDIEM RETARD 120MG not available PL 04425/0642 AVENTIS PHARMA LTD UK TILDIEM RETARD 120MG not available PL 04425/0642 AVENTIS PHARMA LTD UK TILDIEM RETARD 120MG not available PL 04425/0642 AVENTIS PHARMA LTD UK TILDIEM RETARD 120MG not available PL 04425/0642 AVENTIS PHARMA LTD UK TILDIEM RETARD 200 mg gélules à libération prolongée

not available BE177457 SANOFI BELGIUM BE

TILDIEM RETARD 200 mg gélules à libération prolongée

not available BE177457 SANOFI BELGIUM BE

TILDIEM RETARD 200 mg gélules à libération prolongée

not available BE177457 SANOFI BELGIUM BE

TILDIEM RETARD 200 mg gélules à libération prolongée

not available 0006/11081245 SANOFI BELGIUM LU

TILDIEM RETARD 200 mg gélules à libération prolongée

not available 0006/11081245 SANOFI BELGIUM LU

TILDIEM RETARD 200 mg harde capsules met verlengde afgifte

not available BE177457 SANOFI BELGIUM BE

TILDIEM RETARD 200 mg harde capsules met verlengde afgifte

not available BE177457 SANOFI BELGIUM BE

TILDIEM RETARD 200 mg harde capsules met verlengde afgifte

not available BE177457 SANOFI BELGIUM BE

TILDIEM RETARD 300 mg gélules à libération prolongée

not available BE156371 SANOFI BELGIUM BE

TILDIEM RETARD 300 mg gélules à libération prolongée

not available BE156371 SANOFI BELGIUM BE

TILDIEM RETARD 300 mg gélules à libération prolongée

not available BE156371 SANOFI BELGIUM BE

TILDIEM RETARD 300 mg harde capsules met verlengde afgifte

not available BE156371 SANOFI BELGIUM BE

TILDIEM RETARD 300 mg harde capsules met verlengde afgifte

not available BE156371 SANOFI BELGIUM BE

TILDIEM RETARD 300 mg harde capsules met verlengde afgifte

not available BE156371 SANOFI BELGIUM BE

TILDIEM RETARD 90MG not available PL 04425/0641 AVENTIS PHARMA LTD UK

List of nationally authorised medicinal products EMA/10900/2018 Page 19/21

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

TILDIEM RETARD 90MG not available PL 04425/0641 AVENTIS PHARMA LTD UK TILDIEM RETARD 90MG not available PL 04425/0641 AVENTIS PHARMA LTD UK TILDIEM RETARD 90MG not available PL 04425/0641 AVENTIS PHARMA LTD UK TILDIEM RETARD 90MG not available PL 04425/0641 AVENTIS PHARMA LTD UK TILDIEM RETARD 90MG not available PL 04425/0641 AVENTIS PHARMA LTD UK TILDIEM RETARD 90MG not available PL 04425/0641 AVENTIS PHARMA LTD UK TILDIEM RETARD 90MG not available PL 04425/0641 AVENTIS PHARMA LTD UK TILDIEM TABLETS 60MG / DILTIAZEM TABLETS 60MG

not available PL 04425/0640 AVENTIS PHARMA LTD UK

TILDIEM TABLETS 60MG / DILTIAZEM TABLETS 60MG

not available PL 04425/0640 AVENTIS PHARMA LTD UK

TILDIEM TABLETS 60MG / DILTIAZEM TABLETS 60MG

not available PL 04425/0640 AVENTIS PHARMA LTD UK

TILDIEM TABLETS 60MG / DILTIAZEM TABLETS 60MG

not available PL 04425/0640 AVENTIS PHARMA LTD UK

TILDIEM TABLETS 60MG / DILTIAZEM TABLETS 60MG

not available PL 04425/0640 AVENTIS PHARMA LTD UK

TILDIEM XR 200 not available RVG 16538 SANOFI-AVENTIS NETHERLANDS B.V.

NL

TILDIEM XR 200 not available RVG 16538 SANOFI-AVENTIS NETHERLANDS B.V.

NL

TILDIEM XR 200 not available RVG 16538 SANOFI-AVENTIS NETHERLANDS B.V.

NL

Tildiem XR 200 mg, capsules met gereguleerde afgifte

not available RVG 16538 SANOFI-AVENTIS NETHERLANDS B.V.

NL

TILDIEM XR 300 not available RVG 16539 SANOFI-AVENTIS NETHERLANDS B.V.

NL

TILDIEM XR 300 not available RVG 16539 SANOFI-AVENTIS NETHERLANDS B.V.

NL

TILDIEM XR 300 not available RVG 16539 SANOFI-AVENTIS NETHERLANDS B.V.

NL

Tildiem XR 300 mg, capsules met gereguleerde afgifte

not available RVG 16539 SANOFI-AVENTIS NETHERLANDS B.V.

NL

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 120 mg/TAB

not available 179110502 SANOFI-AVENTIS AEBE GR

List of nationally authorised medicinal products EMA/10900/2018 Page 20/21

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

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 120 mg/TAB

not available 179110501 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 120 mg/TAB

not available 179110505 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 120 mg/TAB

not available 179110504 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 120 mg/TAB

not available 179110503 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 120 mg/TAB

not available 179110506 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 90 mg/TAB

not available 179110402 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 90 mg/TAB

not available 179110401 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 90 mg/TAB

not available 179110404 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 90 mg/TAB

not available 179110403 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 90 mg/TAB

not available 179110406 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία παρατεταμένης αποδέσμευσης, 90 mg/TAB

not available 179110405 SANOFI-AVENTIS AEBE GR

TILDIEM δισκία, 60 mg/tab not available 179110101 SANOFI-AVENTIS AEBE GR TILDIEM δισκία, 60 mg/tab not available 179110103 SANOFI-AVENTIS AEBE GR TILDIEM δισκία, 60 mg/tab not available 179110102 SANOFI-AVENTIS AEBE GR TILDIEM, καψάκια ελεγχόμενης αποδέσμευσης, σκληρά 200 mg/CAP

not available 88150/10/14-06-11 SANOFI-AVENTIS AEBE GR

TILDIEM, καψάκια ελεγχόμενης αποδέσμευσης, σκληρά 200 mg/CAP

not available 179110701 SANOFI-AVENTIS AEBE GR

TILDIEM, καψάκια ελεγχόμενης αποδέσμευσης, σκληρά 200 mg/CAP

not available 179110703 SANOFI-AVENTIS AEBE GR

List of nationally authorised medicinal products EMA/10900/2018 Page 21/21

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

TILDIEM, καψάκια ελεγχόμενης αποδέσμευσης, σκληρά 300 mg/CAP

not available 179110601 SANOFI-AVENTIS AEBE GR

TILDIEM, καψάκια ελεγχόμενης αποδέσμευσης, σκληρά 300 mg/CAP

not available 179110602 SANOFI-AVENTIS AEBE GR

TILDIEM, καψάκια ελεγχόμενης αποδέσμευσης, σκληρά 300 mg/CAP

not available 43391/14-06-11 SANOFI-AVENTIS AEBE GR

TILKER 120 MG COMPRIMIDOS DE LIBERACION PROLONGADA

not available 60101 SANOFI-AVENTIS, S.A. ES

TILKER 120 MG COMPRIMIDOS DE LIBERACION PROLONGADA

not available 60101 SANOFI-AVENTIS, S.A. ES

TILKER 200 MG CAPSULAS DE LIBERACION PROLONGADA

not available 60819 SANOFI-AVENTIS, S.A. ES

TILKER 300 MG CAPSULAS DE LIBERACION PROLONGADA

not available 59950 SANOFI-AVENTIS, S.A. ES

TILKER 300 MG CAPSULAS DE LIBERACION PROLONGADA

not available 59950 SANOFI-AVENTIS, S.A. ES

UNI-MASDIL 200 mg cápsulas de liberación prolongada

not available 60.820 LABORATORIOS DR. ESTEVE S.A.

ES

Zatim XL 200 mg Prolonged-release Capsules

not available PL 33579/0004 NEOPHARMA LIMITED UK

Zatim XL 300 mg Prolonged-release Capsules

not available PL 33579/0005 NEOPHARMA LIMITED UK

Zemret 180 XL Capsules not available PL 11311/0449 TILLOMED LABORATORIES LTD

UK

Zemret 240 XL Capsules not available PL 11311/0450 TILLOMED LABORATORIES LTD

UK

Zemret 300 XL Capsules not available PL 11311/0451 TILLOMED LABORATORIES LTD

UK