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© European Medicines Agency, 2020. Reproduction is authorised
provided the source is acknowledged.
17 April 2020 EMA/211991/2020 Human Medicines Evaluation
Division
List of nationally authorised medicinal products
Active substance: lercanidipine
Procedure no.: PSUSA/00001841/201908
-
List of nationally authorised medicinal products EMA/211991/2020
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
Реновиа 10 mg филмирани таблетки
not available 20010727 BERLIN-CHEMIE AG BG
LERCANIDIPINE ZENTIVA 20 mg, comprimé pelliculé
not available 34009 392 414 7 0 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 20 mg, comprimé pelliculé
not available 34009 391 605 3 5 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 20 mg, comprimé pelliculé
not available 34009 392 412 4 1 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 20 mg, comprimé pelliculé
not available 34009 391 604 7 4 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 20 mg, comprimé pelliculé
not available 34009 391 603 0 6 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 20 mg, comprimé pelliculé
not available 34009 392 413 0 2 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 20 mg, comprimé pelliculé
not available 34009 574 379 2 3 ZENTIVA FRANCE FR
Lercaton 20 mg filmtabletta not available OGYI-T-8077/04
BERLIN-CHEMIE AG HU Lercaton 20 mg filmtabletta not available
OGYI-T-8077/08 BERLIN-CHEMIE AG HU Lercaton 20 mg filmtabletta not
available OGYI-T-8077/07 BERLIN-CHEMIE AG HU ZANIDIP 10mg
Film-coated Tablets
not available PA 812/001/001 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IE
ZANIDIP 20mg Film-coated tablets
not available PA 812/001/002 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IE
LERCANIDIPINE BIOGARAN 20 not available 3400939241180 BIOGARAN
FR
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List of nationally authorised medicinal products EMA/211991/2020
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
mg, comprimé pelliculé LERCANIDIPINE BIOGARAN 20 mg, comprimé
pelliculé
not available 3400939241012 BIOGARAN FR
LERCANIDIPINE BIOGARAN 20 mg, comprimé pelliculé
not available 3400939170589 BIOGARAN FR
LERCANIDIPINE BIOGARAN 20 mg, comprimé pelliculé
not available 3400939170640 BIOGARAN FR
LERCANIDIPINE BIOGARAN 20 mg, comprimé pelliculé
not available 3400957441364 BIOGARAN FR
LERCANIDIPINE BIOGARAN 20 mg, comprimé pelliculé
not available 3400939240930 BIOGARAN FR
LERCANIDIPINE BIOGARAN 20 mg, comprimé pelliculé
not available 3400930050545 BIOGARAN FR
LERCANIDIPINE BIOGARAN 20 mg, comprimé pelliculé
not available 3400939170701 BIOGARAN FR
LERCANIDIPINE ZENTIVA 10 mg, comprimé pelliculé sécable
not available 34009 391 590 6 5 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 10 mg, comprimé pelliculé sécable
not available 34009 391 588 1 5 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 10 mg, comprimé pelliculé sécable
not available 34009 391 586 9 3 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 10 mg, comprimé pelliculé sécable
not available 34009 391 591 2 6 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 10 mg, comprimé pelliculé sécable
not available 34009 391 589 8 3 ZENTIVA FRANCE FR
LERCANIDIPINE ZENTIVA 10 mg, comprimé pelliculé sécable
not available 34009 391 587 5 4 ZENTIVA FRANCE FR
-
List of nationally authorised medicinal products EMA/211991/2020
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
LERCANIDIPINE ZENTIVA 10 mg, comprimé pelliculé sécable
not available 34009 391 592 9 4 ZENTIVA FRANCE FR
Lercan, 10 mg, tabletki powlekane
not available 21338 RECORDATI IRELAND LTD. PL
Lercan, 20 mg, tabletki powlekane
not available 21339 RECORDATI IRELAND LTD. PL
Lerpin 10 10 mg Potahované tablety
not available 83/217/02-C HERBACOS RECORDATI S.R.O.
CZ
Lerpin 20 20 mg Potahované tablety
not available 83/ 404/05-C HERBACOS RECORDATI S.R.O.
CZ
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225071 INNOVA PHARMA S.P.A. IT
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225083 INNOVA PHARMA S.P.A. IT
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225095 INNOVA PHARMA S.P.A. IT
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225107 INNOVA PHARMA S.P.A. IT
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225119 INNOVA PHARMA S.P.A. IT
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225121 INNOVA PHARMA S.P.A. IT
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225133 INNOVA PHARMA S.P.A. IT
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225145 INNOVA PHARMA S.P.A. IT
Lercanidipine HCl 10 mg film-coated tablets
UK/H/0354/001 PL 04595/0009 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA
UK
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List of nationally authorised medicinal products EMA/211991/2020
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
S.P.A. LERCARNIDIPINE HCl 20 mg film-coated tablets
UK/H/0354/002 PL04595/0010 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
UK
LERCADIP 20 mg compresse rivestite con film
UK/H/0354/002 033225069 INNOVA PHARMA S.P.A. IT
Carmen 20 mg Filmtabletten DE/H/6286/002 48836.01.00
BERLIN-CHEMIE AG DE Carmen 10 mg Filmtabletten DE/H/6286/001
48836.00.00 BERLIN-CHEMIE AG DE ZANIDIP 10 mg, comprimé pelliculé
sécable
not available 34009 347 637 0 0 BOUCHARA RECORDATI FR
ZANIDIP 10 mg, comprimé pelliculé sécable
not available 34009 347 638 7 8 BOUCHARA RECORDATI FR
ZANIDIP 10 mg, comprimé pelliculé sécable
not available 34009 372 259 6 0 BOUCHARA RECORDATI FR
ZANIDIP 10 mg, comprimé pelliculé sécable
not available 34009 347 639 3 9 BOUCHARA RECORDATI FR
ZANIDIP 10 mg, comprimé pelliculé sécable
not available 34009 347 640 1 1 BOUCHARA RECORDATI FR
ZANIDIP 10 mg, comprimé pelliculé sécable
not available 34009 372 260 4 2 BOUCHARA RECORDATI FR
ZANIDIP 10 mg, comprimé pelliculé sécable
not available 34009 347 641 8 9 BOUCHARA RECORDATI FR
ZANIDIP 20 mg, comprimé pelliculé
not available 34009 359 967 0 1 BOUCHARA RECORDATI FR
ZANIDIP 20 mg, comprimé pelliculé
not available 34009 359 968 7 9 BOUCHARA RECORDATI FR
ZANIDIP 20 mg, comprimé not available 34009 372 286 3 3 BOUCHARA
RECORDATI FR
-
List of nationally authorised medicinal products EMA/211991/2020
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
pelliculé ZANIDIP 20 mg, comprimé pelliculé
not available 34009 563 716 2 4 BOUCHARA RECORDATI FR
ZANIDIP 20 mg, comprimé pelliculé
not available 34009 563 717 9 2 BOUCHARA RECORDATI FR
ZANIDIP 20 mg, comprimé pelliculé
not available 34009 372 288 6 2 BOUCHARA RECORDATI FR
ZANIDIP 20 mg, comprimé pelliculé
not available 34009 563 718 5 3 BOUCHARA RECORDATI FR
LERCADIP 10 mg compresse rivestite con film
not available 033225020 INNOVA PHARMA S.P.A. IT
LERCADIP 10 mg compresse rivestite con film
not available 033225032 INNOVA PHARMA S.P.A. IT
LERCADIP 10 mg compresse rivestite con film
not available 033225044 INNOVA PHARMA S.P.A. IT
LERCADIP 10 mg compresse rivestite con film
not available 033225057 INNOVA PHARMA S.P.A. IT
LERCADIP 10 mg compresse rivestite con film
not available 033225018 INNOVA PHARMA S.P.A. IT
LERCAN 10 mg, comprimé pelliculé sécable
not available 34009 349 490 7 4 BOUCHARA RECORDATI FR
LERCAN 10 mg, comprimé pelliculé sécable
not available 34009 349 491 3 5 BOUCHARA RECORDATI FR
LERCAN 10 mg, comprimé pelliculé sécable
not available 34009 371 241 6 4 BOUCHARA RECORDATI FR
LERCAN 10 mg, comprimé pelliculé sécable
not available 34009 349 493 6 4 BOUCHARA RECORDATI FR
-
List of nationally authorised medicinal products EMA/211991/2020
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
LERCAN 10 mg, comprimé pelliculé sécable
not available 34009 349 494 2 5 BOUCHARA RECORDATI FR
LERCAN 10 mg, comprimé pelliculé sécable
not available 34009 371 242 2 5 BOUCHARA RECORDATI FR
LERCAN 10 mg, comprimé pelliculé sécable
not available 34009 349 495 9 3 BOUCHARA RECORDATI FR
LERCAN 20 mg, comprimé pelliculé
not available 34009 359 969 3 0 BOUCHARA RECORDATI FR
LERCAN 20 mg, comprimé pelliculé
not available 34009 359 970 1 2 BOUCHARA RECORDATI FR
LERCAN 20 mg, comprimé pelliculé
not available 34009 371 243 9 3 BOUCHARA RECORDATI FR
LERCAN 20 mg, comprimé pelliculé
not available 34009 563 719 1 4 BOUCHARA RECORDATI FR
LERCAN 20 mg, comprimé pelliculé
not available 34009 563 721 6 4 BOUCHARA RECORDATI FR
LERCAN 20 mg, comprimé pelliculé
not available 34009 371 244 5 4 BOUCHARA RECORDATI FR
LERCAN 20 mg, comprimé pelliculé
not available 34009 563 722 2 5 BOUCHARA RECORDATI FR
LERCADIP 10 mg comprimidos recubiertos con película
not available 61.928 CASEN RECORDATI, S.L. ES
LERCADIP 20 mg comprimidos recubiertos con película
not available 65.395 CASEN RECORDATI, S.L. ES
LERZAM 10 mg, comprimidos recubiertos con película
not available 61.929 CASEN RECORDATI, S.L. ES
LERZAM 20 mg, comprimidos recubiertos con película
not available 65.394 CASEN RECORDATI, S.L. ES
-
List of nationally authorised medicinal products EMA/211991/2020
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
Zanidip 10 mg filmdrasjerte tabletter
UK/H/0132/001 98-6653 MEDA AS NO
Zanidip 20 mg filmdrasjerte tabletter
UK/H/0132/002 02-1601 MEDA AS NO
LERCANIDIPINE BOUCHARA-RECORDATI 10 mg, comprimé pelliculé
sécable
not available 34009 391 570 5 4 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 10 mg, comprimé pelliculé
sécable
not available 34009 391 571 1 5 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 10 mg, comprimé pelliculé
sécable
not available 34009 391 572 8 3 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 10 mg, comprimé pelliculé
sécable
not available 34009 391 573 4 4 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 10 mg, comprimé pelliculé
sécable
not available 34009 391 574 0 5 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 10 mg, comprimé pelliculé
sécable
not available 34009 391 575 7 3 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 10 mg, comprimé pelliculé
sécable
not available 34009 391 576 3 4 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 20 mg, comprimé pelliculé
not available 34009 391 702 9 9 BOUCHARA RECORDATI FR
-
List of nationally authorised medicinal products EMA/211991/2020
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
LERCANIDIPINE BOUCHARA-RECORDATI 20 mg, comprimé pelliculé
not available 34009 391 703 5 0 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 20 mg, comprimé pelliculé
not available 34009 391 704 1 1 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 20 mg, comprimé pelliculé
not available 34009 392 406 4 0 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 20 mg, comprimé pelliculé
not available 34009 392 407 0 1 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 20 mg, comprimé pelliculé
not available 34009 392 408 7 9 BOUCHARA RECORDATI FR
LERCANIDIPINE BOUCHARA-RECORDATI 20 mg, comprimé pelliculé
not available 34009 574 408 2 4 BOUCHARA RECORDATI FR
CARDIOVASC 10 mg compresse rivestite con film
not available 033226010 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 20 mg compresse rivestite con film
not available 033226061 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 10 mg compresse rivestite con film
not available 033226022 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 10 mg compresse not available 033226034 RECORDATI
INDUSTRIA IT
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List of nationally authorised medicinal products EMA/211991/2020
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
rivestite con film CHIMICA E FARMACEUTICA S.P.A.
CARDIOVASC 10 mg compresse rivestite con film
not available 033226046 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 10 mg compresse rivestite con film
not available 033226059 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 20 mg compresse rivestite con film
not available 033226073 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 20 mg compresse rivestite con film
not available 033226085 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 20 mg compresse rivestite con film
not available 033226097 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 20 mg compresse rivestite con film
not available 033226109 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 20 mg compresse rivestite con film
not available 033226111 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 20 mg compresse rivestite con film
not available 033226123 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
CARDIOVASC 20 mg compresse rivestite con film
not available 033226135 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA
IT
-
List of nationally authorised medicinal products EMA/211991/2020
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
S.P.A. CARDIOVASC 20 mg compresse rivestite con film
not available 033226147 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
Lecalpin, 20 mg, tabletki powlekane
EE/H/0280/002 16620 ACTAVIS GROUP PTC EHF. PL
Lercanil 10 mg filmom obložene tablete
not available HR-H-744433323-02 BERLIN-CHEMIE MENARINI HRVATSKA
D.O.O.
HR
Lercanil 10 mg filmom obložene tablete
not available HR-H-744433323-03 BERLIN-CHEMIE MENARINI HRVATSKA
D.O.O.
HR
Lercanil 20 mg filmom obložene tablete
not available HR-H-146144027-01 BERLIN-CHEMIE MENARINI HRVATSKA
D.O.O.
HR
Lercanil 20 mg filmom obložene tablete
not available HR-H-146144027-02 BERLIN-CHEMIE MENARINI HRVATSKA
D.O.O.
HR
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/011 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/010 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
LERCAPIN 10 mg, õhukese polümeerikattega tabletid
not available 371502 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
EE
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/006 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/012 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG
LT
-
List of nationally authorised medicinal products EMA/211991/2020
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
S.A. Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/009 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/005 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/007 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/014 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/004 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/008 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 20 mg plėvele dengtos tabletės
not available LT/1/01/0808/013 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
PRIMACOR, 10 mg, tabletki powlekane
not available 9285 BERLIN-CHEMIE AG PL
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/021 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 10 mg plėvele dengtos not available LT/1/01/0808/002
MENARINI INTERNATIONAL LT
-
List of nationally authorised medicinal products EMA/211991/2020
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
tabletės OPERATIONS LUXEMBOURG S.A.
PRIMACOR, 20 mg, tabletki powlekane
not available 17457 BERLIN-CHEMIE AG PL
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/015 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/016 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/019 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/018 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/001 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/017 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/020 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Lercapin 10 mg apvalkotās tabletes
not available 01-0392 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LV
-
List of nationally authorised medicinal products EMA/211991/2020
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
Lercapin 20 mg apvalkotās tabletes
not available 05-0296 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LV
LERCAPIN 20 mg, õhukese polümeerikattega tabletid
not available 510906 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
EE
Lercapin 10 mg plėvele dengtos tabletės
not available LT/1/01/0808/003 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
LT
Leridip 10 mg comprimate filmate
not available 12290/2019/02 BERLIN-CHEMIE AG RO
Leridip 10 mg comprimate filmate
not available 12290/2019/05 BERLIN-CHEMIE AG RO
Leridip 10 mg comprimate filmate
not available 12290/2019/04 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/06 BERLIN-CHEMIE AG RO
Leridip 10 mg comprimate filmate
not available 12290/2019/03 BERLIN-CHEMIE AG RO
Leridip 10 mg comprimate filmate
not available 12290/2019/01 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/04 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/01 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/07 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate not available 12291/2019/02
BERLIN-CHEMIE AG RO
-
List of nationally authorised medicinal products EMA/211991/2020
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
filmate Leridip 20 mg comprimate filmate
not available 12291/2019/03 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/09 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/05 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/08 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/11 BERLIN-CHEMIE AG RO
Leridip 20 mg comprimate filmate
not available 12291/2019/10 BERLIN-CHEMIE AG RO
Lercanil 10 mg filmom obložene tablete
not available HR-H-744433323-01 BERLIN-CHEMIE MENARINI HRVATSKA
D.O.O.
HR
Lercapress 10 mg filmsko obložene tablete
not available H/02/00895/004 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
SI
Lercapress 10 mg filmsko obložene tablete
not available H/02/00895/002 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
SI
Lercapress 10 mg filmsko obložene tablete
not available H/02/00895/001 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
SI
Lercapress 10 mg filmsko obložene tablete
not available H/02/00895/005 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
SI
Lercapress 10 mg filmsko not available H/02/00895/003 MENARINI
INTERNATIONAL SI
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List of nationally authorised medicinal products EMA/211991/2020
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
obložene tablete OPERATIONS LUXEMBOURG S.A.
Реновиа 20 mg филмирани таблетки
not available 20050450 BERLIN-CHEMIE AG BG
Lercadip 20 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0870/002 24690/4-4-2012 RECORDATI HELLAS PHARMACEUTICALS
AE
GR
Lercadip 10 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0870/001 24689/4-4-2012 RECORDATI HELLAS PHARMACEUTICALS
AE
GR
Zanidip 20 mg Comprimidos revestidos por película
UK/H/0870/002 5328554 JABA RECORDATI, S.A. PT
Zanidip 10 mg Comprimidos revestidos por película
UK/H/0870/001 5013628 JABA RECORDATI, S.A. PT
Zanedip 10 mg επικαλυμμένα με λεπτό υμένιο δισκία
DE/H/6287/001 022270 RECORDATI HELLAS PHARMACEUTICALS AE
CY
Zanedip 20 mg επικαλυμμένα με λεπτό υμένιο δισκία
DE/H/6287/002 022271 RECORDATI HELLAS PHARMACEUTICALS AE
CY
LERCADIP 10 mg film-coated tablets
UK/H/0870/001/MR PL 04595/0017 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
UK
LERCADIP 20 mg film-coated tablets
UK/H/0870/002/MR PL 04595/0016 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
UK
Zanidip 10 mg Comprimidos revestidos por película
UK/H/0870/001 5013610 JABA RECORDATI, S.A. PT
Zanidip 20 mg Comprimidos revestidos por película
UK/H/0870/002 5013636 JABA RECORDATI, S.A. PT
Lercanidipin-Omniapharm® 10 mg Filmtabletten
DE/H/6287/001 65405.00.00 RECORDATI PHARMA GMBH DE
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List of nationally authorised medicinal products EMA/211991/2020
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
Lercanidipin-Omniapharm® 20 mg Filmtabletten
DE/H/6287/002 65406.00.00 RECORDATI PHARMA GMBH DE
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 3400939158006 BIOGARAN FR
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 3400939158464 BIOGARAN FR
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 3400939157924 BIOGARAN FR
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 3400939157863 BIOGARAN FR
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 3400939158174 BIOGARAN FR
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 3400930050538 BIOGARAN FR
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 3400939158235 BIOGARAN FR
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 3400939158525 BIOGARAN FR
LERCANIDIPINE BIOGARAN 10 mg, comprimé pelliculé sécable
not available 34009 301 921 3 9 BIOGARAN FR
Lercapress 20 mg filmsko obložene tablete
not available H/02/00895/009 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
SI
Lercapress 20 mg filmsko obložene tablete
not available H/02/00895/007 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
SI
Lercapress 20 mg filmsko obložene tablete
not available H/02/00895/008 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG
SI
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List of nationally authorised medicinal products EMA/211991/2020
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
S.A. Lercapress 20 mg filmsko obložene tablete
not available H/02/00895/010 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
SI
Lercapress 20 mg filmsko obložene tablete
not available H/02/00895/006 MENARINI INTERNATIONAL OPERATIONS
LUXEMBOURG S.A.
SI
Lercaton 10 mg filmtabletta not available OGYI-T-8077/05
BERLIN-CHEMIE AG HU Lercaton 10 mg filmtabletta not available
OGYI-T-8077/03 BERLIN-CHEMIE AG HU Lercaton 10 mg filmtabletta not
available OGYI-T-8077/02 BERLIN-CHEMIE AG HU Lercaton 10 mg
filmtabletta not available OGYI-T-8077/01 BERLIN-CHEMIE AG HU
Lercaton 10 mg filmtabletta not available OGYI-T-8077/06
BERLIN-CHEMIE AG HU ZANEDIP 10 mg compresse rivestite con film
UK/H/0132/001 033224027 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 10 mg compresse rivestite con film
UK/H/0132/001 033224039 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 10 mg compresse rivestite con film
UK/H/0132/001 033224041 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 10 mg compresse rivestite con film
UK/H/0132/001 033224054 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 20 mg compresse rivestite con film
UK/H/0132/002 033224078 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 20 mg compresse UK/H/0132/002 033224080 RECORDATI
INDUSTRIA IT
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List of nationally authorised medicinal products EMA/211991/2020
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
rivestite con film CHIMICA E FARMACEUTICA S.P.A.
ZANEDIP 20 mg compresse rivestite con film
UK/H/0132/002 033224092 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 20 mg compresse rivestite con film
UK/H/0132/002 033224104 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 20 mg compresse rivestite con film
UK/H/0132/002 033224116 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 20 mg compresse rivestite con film
UK/H/0132/002 033224128 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 20 mg compresse rivestite con film
UK/H/0132/002 033224130 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 20 mg compresse rivestite con film
UK/H/0132/002 033224142 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANIDIP®10 mg - Filmtabletten NL/H/4790/001 1-21844 KWIZDA
PHARMA GMBH AT ZANIDIP®20 mg - Filmtabletten NL/H/4790/002 1-26285
KWIZDA PHARMA GMBH AT ZANEDIP 10 mg compresse rivestite con
film
UK/H/0132/001 033224015 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
ZANEDIP 20 mg compresse rivestite con film
UK/H/0132/002 033224066 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
IT
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List of nationally authorised medicinal products EMA/211991/2020
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
ZANIDIP 10 mg comprimidos recubiertos con película
UK/H/0132/001 61.653 CASEN RECORDATI, S.L. ES
ZANIDIP 20 mg comprimidos recubiertos con película
UK/H/0132/002 65.379 CASEN RECORDATI, S.L. ES
ZANIDIP 10 mg film-coated tablets
NL/H/4790/001 PL 04595/0005 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
UK
ZANIDIP 20 mg film-coated tablets
NL/H/4790/002 PL 04595/0010 RECORDATI INDUSTRIA CHIMICA E
FARMACEUTICA S.P.A.
UK
Zanidip 10 mg, comprimés pelliculés
UK/H/0132/001 2010010689 ZAMBON NV LU
Zanidip 10 mg filmomhulde tabletten
UK/H/0132/001 BE185832 ZAMBON NV BE
Zanidip 10 mg, comprimés pelliculés
UK/H/0132/001 BE185832 ZAMBON NV BE
Zanidip 20 mg, comprimés pelliculés
UK/H/0132/002 2010010690 ZAMBON NV LU
Zanidip 20 mg filmomhulde tabletten
UK/H/0132/002 BE259165 ZAMBON NV BE
Zanidip 20 mg, comprimés pelliculés
UK/H/0132/002 BE259165 ZAMBON NV BE
ZANIDIP 10 mg filmdragerade tabletter
UK/H/0132/001 13259 MEDA AB SE
ZANIDIP 20 mg filmdragerade tabletter
UK/H/0132/002 19046 MEDA AB SE
ZANICOR 10, comprimidos revestidos por película
not available 2511681 BGP PRODUCTS UNIPESSOAL, LDA.
PT
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List of nationally authorised medicinal products EMA/211991/2020
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
ZANICOR 10, comprimidos revestidos por película
not available 2511780 BGP PRODUCTS UNIPESSOAL, LDA.
PT
ZANICOR 10, comprimidos revestidos por película
not available 2511889 BGP PRODUCTS UNIPESSOAL, LDA.
PT
ZANICOR 10, comprimidos revestidos por película
not available 2511988 BGP PRODUCTS UNIPESSOAL, LDA.
PT
ZANICOR 10, comprimidos revestidos por película
not available 2871184 BGP PRODUCTS UNIPESSOAL, LDA.
PT
ZANICOR 10, comprimidos revestidos por película
not available 2512085 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4339487 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4339586 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4339685 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4339784 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4339883 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4339982 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4340089 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4340188 BGP PRODUCTS UNIPESSOAL, LDA.
PT
Zanicor 20 mg comprimidos revestidos por película
UK/H/0132/002 4340287 BGP PRODUCTS UNIPESSOAL, LDA.
PT
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List of nationally authorised medicinal products EMA/211991/2020
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
ZANIDIP 10 mg επικαλυμμένα με λεπτό υμένιο δισκία.
UK/H/0132/001 74512/18-11-2008 RECORDATI IRELAND LTD. GR
ZANIDIP 20 mg επικαλυμμένα με λεπτό υμένιο δισκία
UK/H/0132/002 74514/18-11-2008 RECORDATI IRELAND LTD. GR
Lerdip 10 mg, filmomhulde tabletten
NL/H/4790/001 RVG 20813 RECORDATI IRELAND LTD. NL
Lerdip 20 mg, filmomhulde tabletten
NL/H/4790/002 RVG 28644 RECORDATI IRELAND LTD. NL
Zanidip 20 mg –kalvopäällysteiset tabletit
NL/H/4790/002 17837 RECORDATI IRELAND LTD. FI
Zanidip 10 mg –kalvopäällysteiset tabletit
NL/H/4790/001 12469 RECORDATI IRELAND LTD. FI
Corifeo® 20 mg Filmtabletten NL/H/4790/002 48835.01.00 RECORDATI
PHARMA GMBH DE Corifeo® 10 mg Filmtabletten NL/H/4790/001
48835.00.00 RECORDATI PHARMA GMBH DE Zanidip, filmovertrukne
tabletter UK/H/0132/001 18427 MYLAN DENMARK APS DK Zanidip,
filmovertrukne tabletter UK/H/0132/002 34482 MYLAN DENMARK APS DK
Lercanidipine Hydrochloride 10 mg film-coated tablets
not available PL 25258/0087 GLENMARK PHARMACEUTICALS EUROPE
LIMITED
UK
Lercanidipine Hydrochloride 20 mg film-coated tablets
not available PL 25258/0088 GLENMARK PHARMACEUTICALS EUROPE
LIMITED
UK
