26 October 2017 EMA/716519/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): frovatriptan
Procedure No.: PSUSA/00001484/201703
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country)
Allegro® 2,5 mg Filmtabletten AURADOL 2,5 mg compresse rivestite con film AURADOL 2,5 mg compresse rivestite con film AURADOL 2,5 mg compresse rivestite con film DORLISE 2,5 mg comprimidos revestidos por película DORLISE 2,5 mg comprimidos revestidos por película DORLISE 2,5 mg comprimidos revestidos por película DORLISE 2,5 mg comprimidos revestidos por película DORLISE 2,5 mg comprimidos revestidos por película DORLISE 2,5 mg comprimidos revestidos por película DORLISE 2,5 mg comprimidos revestidos por película EUMITAN 2,5 mg – Filmtabletten Forvey 2,5 mg comprimidos recubiertos con película FROMEN 2,5 mg, potahované tablety FROMIREX 2,5 mg filmomhulde tabletten FROTAN 2,5 mg filmsko obložene tablete FROTAN 2,5 mg filmsko obložene tablete FROTAN 2,5 mg filmsko obložene tablete FROTAN 2,5 mg filmsko obložene tablete FROTAN 2,5 mg filmsko
MRP/DCP Authorisation number
National Authorisation Number
FR/H/0199/001
52682.00.00
FR/H/0199/001
035673021
FR/H/0199/001
035673033
FR/H/0199/001
035673019
FR/H/0199/001
3901188
FR/H/0199/001
3900685
FR/H/0199/001
3900784
FR/H/0199/001
3900883
FR/H/0199/001
4908588
FR/H/0199/001
3901089
FR/H/0199/001
3900982
FR/H/0195/001
1-24486
FR/H/0195/001
65.009
FR/H/0199/001
33/030/05-C
FR/H/0199/001
RVG 27212
FR/H/0199/001
H/05/00660/005
FR/H/0199/001
H/05/00660/004
FR/H/0199/001
H/05/00660/006
FR/H/0199/001 FR/H/0199/001
H/05/00660/007 H/05/00660/001
List of nationally authorised medicinal products EMA/716519/2017
MAH of product in the member state
BERLIN-CHEMIE AG ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. ISTITUTO LUSO FARMACO D'ITALIA S.P.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL
Member State where product is authorised
DE IT IT IT PT PT PT PT PT PT PT AT ES CZ NL SI SI SI SI SI
Page 2/7
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
FR/H/0199/001
H/05/00660/002
FR/H/0199/001
H/05/00660/003
Frovalon 2,5 mg filmtabletta
FR/H/0199/001
OGYI-T-9671/06
Frovalon 2,5 mg filmtabletta
FR/H/0199/001
OGYI-T-9671/05
Frovalon 2,5 mg filmtabletta
FR/H/0199/001
OGYI-T-9671/02
Frovalon 2,5 mg filmtabletta
FR/H/0199/001
OGYI-T-9671/01
Frovalon 2,5 mg filmtabletta
FR/H/0199/001
OGYI-T-9671/03
Frovalon 2,5 mg filmtabletta
FR/H/0199/001
OGYI-T-9671/04
Frovalon 2,5 mg filmtabletta Frovamen 2,5 mg filmom obalené tablety FROVAMIG 2,5 mg Filmtabletten FROVATEX 2,5 mg comprimés pelliculés FROVATEX 2,5 mg comprimés pelliculés FROVATEX 2,5 mg comprimés pelliculés FROVATEX 2,5 mg filmomhulde tabletten FROVATEX 2,5 mg filmomhulde tabletten
FR/H/0199/001
OGYI-T-9671/07
FR/H/0199/001
07/0035/05-S
FR/H/0199/001
1-24487
FR/H/0199/001
BE240344
FR/H/0199/001
BE240353
FR/H/0199/001
0951/09020212
FR/H/0199/001
BE240344
FR/H/0199/001
BE240353
FROVATEX 2,5 mg Filmtabletten
FR/H/0199/001
BE240344
FROVATEX 2,5 mg Filmtabletten
FR/H/0199/001
BE240353
obložene tablete FROTAN 2,5 mg filmsko obložene tablete FROTAN 2,5 mg filmsko obložene tablete
List of nationally authorised medicinal products EMA/716519/2017
MAH of product in the member state
OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Member State where product is authorised
SI SI HU HU HU HU HU HU HU SK AT BE BE LU BE BE BE BE
Page 3/7
Product Name (in authorisation country)
FROVEX 2.5 mg film-coated tablets ISIMIG 2,5 mg, comprimé pelliculé ISIMIG 2,5 mg, comprimé pelliculé ISIMIG 2,5 mg, comprimé pelliculé ISIMIG 2,5 mg, comprimé pelliculé Migard 2,5 mg apvalkotās tabletes MIGARD 2,5 mg comprimés pelliculés MIGARD 2,5 mg comprimés pelliculés MIGARD 2,5 mg comprimés pelliculés MIGARD 2,5 mg comprimidos revestidos por película MIGARD 2,5 mg comprimidos revestidos por película MIGARD 2,5 mg comprimidos revestidos por película MIGARD 2,5 mg comprimidos revestidos por película MIGARD 2,5 mg comprimidos revestidos por película MIGARD 2,5 mg comprimidos revestidos por película MIGARD 2,5 mg comprimidos revestidos por película Migard 2,5 mg filmdragerad tablett MIGARD 2,5 mg filmdragerade tabletter Migard 2,5 mg filmom obalené
MRP/DCP Authorisation number
National Authorisation Number
FR/H/0199/001
PA 865/9/1
FR/H/0195/001
34009 355 617 5 6
FR/H/0195/001
34009 377 829 5 1
FR/H/0195/001
34009 355 616 9 5
FR/H/0195/001
34009 563 244 3 9
FR/H/0195/001
05-0053
FR/H/0195/001
BE239574
FR/H/0195/001
BE239565
FR/H/0195/001
0951/09020213
FR/H/0195/001
4908687
FR/H/0195/001
3900487
FR/H/0195/001
3900081
FR/H/0195/001
3900388
FR/H/0195/001
3900289
FR/H/0195/001
3900586
FR/H/0195/001
3900180
FR/H/0195/001
16913
FR/H/0195/001 FR/H/0195/001
17881 07/0034/05-S
List of nationally authorised medicinal products EMA/716519/2017
MAH of product in the member state
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL
Member State where product is authorised
IE FR FR FR FR LV BE BE LU PT PT PT PT PT PT PT FI SE SK
Page 4/7
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
FR/H/0195/001
BE239565
FR/H/0195/001
BE239574
FR/H/0195/001
RVG 27211
FR/H/0195/001
5363-I-775/09
FR/H/0195/001
5363-I-777/09
FR/H/0195/001
5363-I-776/09
Migard 2,5 mg filmtabletta
FR/H/0195/001
OGYI-T-10078/02
Migard 2,5 mg filmtabletta
FR/H/0195/001
OGYI-T-10078/03
Migard 2,5 mg filmtabletta
FR/H/0195/001
OGYI-T-10078/06
Migard 2,5 mg filmtabletta
FR/H/0195/001
OGYI-T-10078/01
Migard 2,5 mg filmtabletta
FR/H/0195/001
OGYI-T-10078/04
Migard 2,5 mg filmtabletta
FR/H/0195/001
OGYI-T-10078/05
Migard 2,5 mg filmtabletta
FR/H/0195/001
OGYI-T-10078/07
MIGARD 2,5 mg Filmtabletten
FR/H/0195/001
BE239574
MIGARD 2,5 mg Filmtabletten MIGARD 2,5 mg filmuhúðaðar töflur MIGARD 2,5 mg kalvopäällysteiset tabletit Migard 2,5 mg plėvele dengtos tabletės
FR/H/0195/001
BE239565
FR/H/0195/001
IS/1/04/060/01
FR/H/0195/001
16913
FR/H/0195/001
LT/1/05/0204/006
tablety MIGARD 2,5 mg filmomhulde tabletten MIGARD 2,5 mg filmomhulde tabletten MIGARD 2,5 mg filmomhulde tabletten MIGARD 2,5 mg filmsko obložene tablete MIGARD 2,5 mg filmsko obložene tablete MIGARD 2,5 mg filmsko obložene tablete
List of nationally authorised medicinal products EMA/716519/2017
MAH of product in the member state
OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Member State where product is authorised
BE BE NL SI SI SI HU HU HU HU HU HU HU BE BE IS FI LT
Page 5/7
Product Name (in authorisation country)
Migard 2,5 mg plėvele dengtos tabletės Migard 2,5 mg plėvele dengtos tabletės Migard 2,5 mg plėvele dengtos tabletės Migard 2,5 mg plėvele dengtos tabletės Migard 2,5 mg plėvele dengtos tabletės Migard 2,5 mg plėvele dengtos tabletės Migard 2,5 mg tabletki powlekane MIGARD 2,5 mg tabletter, filmdrasjerte Migard 2,5 mg, filmovertrukne tabletter MIGARD 2.5 mg film-coated tablets Migard, 2,5 mg õhukese polümeerikattega tabletid Migard® 2,5 mg Filmtabletten MIGRALIN® Επικαλυμμένο με λεπτό υμένιο δισκίο 2,5mg/TAB MIGUAR 2.5 mg film-coated tablets PITUNAL® Επικαλυµµένο µε λεπτό υµένιο δισκίο 2,5mg/TAB RILAMIG 2,5 mg compresse rivestite con film RILAMIG 2,5 mg compresse rivestite con film RILAMIG 2,5 mg compresse rivestite con film TIGREAT 2,5 mg filmuhúðaðar
MRP/DCP Authorisation number
National Authorisation Number
FR/H/0195/001
LT/1/05/0204/002
FR/H/0195/001
LT/1/05/0204/004
FR/H/0195/001
LT/1/05/0204/001
FR/H/0195/001
LT/1/05/0204/003
FR/H/0195/001
LT/1/05/0204/007
FR/H/0195/001
LT/1/05/0204/005
FR/H/0195/001
11408
FR/H/0195/001
04-2946
FR/H/0195/001
33100
FR/H/0195/001
PL 16239/0017
FR/H/0195/001
463805
FR/H/0195/001
52681.00.00
FR/H/0199/001
15931
FR/H/0195/001
PA 865/8/1
FR/H/0195/001
15932
FR/H/0195/001
035674023
FR/H/0195/001
035674011
FR/H/0195/001 FR/H/0199/001
035674035 IS/1/04/059/01
List of nationally authorised medicinal products EMA/716519/2017
MAH of product in the member state
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL
Member State where product is authorised
LT LT LT LT LT LT PL NO DK UK EE DE GR IE GR IT IT IT IS
Page 6/7
Product Name (in authorisation country)
töflur TIGREAT 2,5 mg, comprimé pelliculé TIGREAT 2,5 mg, comprimé pelliculé TIGREAT 2,5 mg, comprimé pelliculé TIGREAT 2,5 mg, comprimé pelliculé Релиева 2,5 mg филмирани таблетки
MRP/DCP Authorisation number
National Authorisation Number
FR/H/0199/001
34009 361 564 7 0
FR/H/0199/001
34009 357 554 0 7
FR/H/0199/001
34009 357 553 4 6
FR/H/0199/001
34009 357 555 7 5
not available
20040485
List of nationally authorised medicinal products EMA/716519/2017
MAH of product in the member state
OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Member State where product is authorised
FR FR FR FR BG
Page 7/7
