ISSN 1725-2423
doi:10.3000/17252423.C_2011.128.eng
Official Journal
of the European Union
C 128
English edition
Information and Notices
Volume 54
29 April 2011
|
ISSN 1725-2423 doi:10.3000/17252423.C_2011.128.eng |
||
|
Official Journal of the European Union |
C 128 |
|
|
|
||
|
English edition |
Information and Notices |
Volume 54 |
|
Notice No |
Contents |
page |
|
|
IV Notices |
|
|
|
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
|
|
|
European Commission |
|
|
2011/C 128/01 |
||
|
2011/C 128/02 |
||
|
EN |
|
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
|
29.4.2011 |
EN |
Official Journal of the European Union |
C 128/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2011/C 128/01
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||
|
6.1.2011 |
Potactasol |
topotecan |
|
EU/1/10/660/001-002 |
powder for concentrate for solution for infusion |
L01XX17 |
10.1.2011 |
||
|
21.1.2011 |
Docetaxel Teva Pharma |
Docetaxel |
|
EU/1/10/662/001-002 |
Concentrate and solvent for solution for infusion |
L01CD02 |
26.1.2011 |
||
|
21.1.2011 |
Iasibon |
Ibandronic acid |
|
EU/1/10/659/001-010 |
Concentrate for solution for infusion Film-coated tablet |
M05BA06 |
25.1.2011 |
||
|
27.1.2011 |
Fluenz |
influenza vaccine (live attenuated, nasal) |
|
EU/1/10/661/001-002 |
Nasal spray, suspension |
J07BB03 |
1.2.2011 |
||
|
18.2.2011 |
Entacapone Teva |
entacapone |
|
EU/1/10/665/001-004 |
Film-coated tablet |
N04BX02 |
22.2.2011 |
||
|
28.2.2011 |
Daliresp |
roflumilast |
|
EU/1/11/668/001-003 |
Film-coated tablet |
R03DX07 |
2.3.2011 |
||
|
28.2.2011 |
Esbriet |
Pirfenidone |
|
EU/1/11/667/001-003 |
Capsule, hard |
L04AX05 |
2.3.2011 |
||
|
28.2.2011 |
Lamivudine / Zidovudine Teva |
Lamivudine/Zidovudine |
|
EU/1/10/663/001-002 |
Film-coated tablet |
J05AR01 |
2.3.2011 |
||
|
28.2.2011 |
Libertek |
roflumilast |
|
EU/1/11/666/001-003 |
Film-coated tablet |
R03DX07 |
2.3.2011 |
||
|
28.2.2011 |
Xiapex |
collagenase clostridium histolyticum |
|
EU/1/11/671/001 |
Powder and solvent for solution for injection |
M09AB02 |
2.3.2011 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||
|
6.1.2011 |
Invirase |
|
EU/1/96/026/001-002 |
10.1.2011 |
||
|
6.1.2011 |
Irbesartan HCT Winthrop |
|
EU/1/06/377/001-028 |
11.1.2011 |
||
|
6.1.2011 |
Irbesartan Winthrop |
|
EU/1/06/376/001-033 |
11.1.2011 |
||
|
6.1.2011 |
Lucentis |
|
EU/1/06/374/001 |
11.1.2011 |
||
|
6.1.2011 |
Rapamune |
|
EU/1/01/171/001 EU/1/01/171/007-010 EU/1/01/171/013-014 |
11.1.2011 |
||
|
6.1.2011 |
Resolor |
|
EU/1/09/581/001-008 |
11.1.2011 |
||
|
6.1.2011 |
Tepadina |
|
EU/1/10/622/001-002 |
11.1.2011 |
||
|
6.1.2011 |
Yttriga |
|
EU/1/05/322/001 |
10.1.2011 |
||
|
11.1.2011 |
IntronA |
|
EU/1/99/127/011-039 EU/1/99/127/041-044 |
18.1.2011 |
||
|
11.1.2011 |
Pantoloc Control |
|
EU/1/09/519/001-004 |
13.1.2011 |
||
|
11.1.2011 |
Rapiscan |
|
EU/1/10/643/001 |
13.1.2010 |
||
|
13.1.2011 |
Clopidogrel Winthrop |
|
EU/1/08/465/001-020 |
17.1.2011 |
||
|
13.1.2011 |
Copalia |
|
EU/1/06/372/037-039 |
17.1.2010 |
||
|
13.1.2011 |
INOmax |
|
EU/1/01/194/001-002 |
18.1.2011 |
||
|
13.1.2011 |
Iscover |
|
EU/1/98/070/001a-001b EU/1/98/070/002a-002b EU/1/98/070/003a-003b EU/1/98/070/004a-004b EU/1/98/070/005a-005b EU/1/98/070/006a-006b EU/1/98/070/007a-007b EU/1/98/070/008-010 EU/1/98/070/011a-011b EU/1/98/070/012 |
17.1.2011 |
||
|
13.1.2011 |
Nimvastid |
|
EU/1/09/525/001-050 |
17.1.2011 |
||
|
13.1.2011 |
Plavix |
|
EU/1/98/069/001a-001b EU/1/98/069/002a-002b EU/1/98/069/003a-003b EU/1/98/069/004a-004b EU/1/98/069/005a-005b EU/1/98/069/006a-006b EU/1/98/069/007a-007b EU/1/98/069/008-010 EU/1/98/069/011a-011b EU/1/98/069/012 |
17.1.2011 |
||
|
17.1.2011 |
Cancidas |
|
EU/1/01/196/001 EU/1/01/196/003 |
19.1.2011 |
||
|
17.1.2011 |
Kuvan |
|
EU/1/08/481/001-003 |
19.1.2011 |
||
|
17.1.2011 |
Nevanac |
|
EU/1/07/433/001 |
19.1.2011 |
||
|
21.1.2011 |
Abilify |
|
EU/1/04/276/001-020 EU/1/04/276/024-036 |
25.1.2011 |
||
|
21.1.2011 |
Adenuric |
|
EU/1/08/447/001-004 |
25.1.2011 |
||
|
21.1.2011 |
Arzerra |
|
EU/1/10/625/001-002 |
26.1.2011 |
||
|
21.1.2011 |
Cubicin |
|
EU/1/05/328/001-004 |
25.1.2011 |
||
|
21.1.2011 |
Enbrel |
|
EU/1/99/126/001-021 |
25.1.2011 |
||
|
21.1.2011 |
Humira |
|
EU/1/03/256/001-010 |
25.1.2011 |
||
|
21.1.2011 |
INOmax |
|
EU/1/01/194/001-002 |
25.1.2011 |
||
|
21.1.2011 |
Karvea |
|
EU/1/97/049/001-039 |
26.1.2011 |
||
|
21.1.2011 |
Kuvan |
|
EU/1/08/481/001-003 |
25.1.2011 |
||
|
21.1.2011 |
Mixtard |
|
EU/1/02/231/001-023 EU/1/02/231/036-037 |
25.1.2011 |
||
|
21.1.2011 |
Multaq |
|
EU/1/09/591/001-004 |
25.1.2011 |
||
|
21.1.2011 |
Olazax Disperzi |
|
EU/1/09/592/001-005 |
25.1.2011 |
||
|
21.1.2011 |
Pandemrix |
|
EU/1/08/452/001 |
26.1.2011 |
||
|
21.1.2011 |
Pradaxa |
|
EU/1/08/442/001-008 |
25.1.2011 |
||
|
21.1.2011 |
Rapamune |
|
EU/1/01/171/001 EU/1/01/171/007-010 EU/1/01/171/013-014 |
26.1.2011 |
||
|
21.1.2011 |
Rasilez |
|
EU/1/07/405/001-040 |
25.1.2011 |
||
|
21.1.2011 |
Revatio |
|
EU/1/05/318/002 |
25.1.2011 |
||
|
21.1.2011 |
Revlimid |
|
EU/1/07/391/001-004 |
26.1.2011 |
||
|
21.1.2011 |
RotaTeq |
|
EU/1/06/348/001-002 |
26.1.2011 |
||
|
21.1.2011 |
Sprimeo |
|
EU/1/07/407/001-020 |
26.1.2011 |
||
|
21.1.2011 |
Temomedac |
|
EU/1/09/605/001-012 |
26.1.2011 |
||
|
21.1.2011 |
Thymanax |
|
EU/1/08/498/001-008 |
25.1.2011 |
||
|
21.1.2011 |
Valdoxan |
|
EU/1/08/499/001-008 |
26.1.2011 |
||
|
21.1.2011 |
Yentreve |
|
EU/1/04/280/001-008 |
25.1.2011 |
||
|
24.1.2011 |
Apidra |
|
EU/1/04/285/001-036 |
27.1.2011 |
||
|
24.1.2011 |
Ceplene |
|
EU/1/08/477/001 |
27.1.2011 |
||
|
24.1.2011 |
Dafiro |
|
EU/1/06/371/001-039 |
27.1.2011 |
||
|
24.1.2011 |
Eucreas |
|
EU/1/07/425/001-018 |
27.1.2011 |
||
|
24.1.2011 |
Galvus |
|
EU/1/07/414/001-010 EU/1/07/414/018 |
27.1.2011 |
||
|
24.1.2011 |
Isentress |
|
EU/1/07/436/001-002 |
27.1.2011 |
||
|
24.1.2011 |
Jalra |
|
EU/1/08/485/001-011 |
27.1.2011 |
||
|
24.1.2011 |
Lantus |
|
EU/1/00/134/001-037 |
27.1.2011 |
||
|
24.1.2011 |
NutropinAq |
|
EU/1/00/164/003-005 |
27.1.2011 |
||
|
24.1.2011 |
Olanzapine Glenmark |
|
EU/1/09/587/001-017 |
27.1.2011 |
||
|
24.1.2011 |
Olanzapine Glenmark Europe |
|
EU/1/09/588/001-012 |
27.1.2011 |
||
|
24.1.2011 |
Optisulin |
|
EU/1/00/133/001-032 |
27.1.2011 |
||
|
24.1.2011 |
Pelzont |
|
EU/1/08/460/009-011 EU/1/08/460/013-014 |
26.1.2011 |
||
|
24.1.2011 |
Rotarix |
|
EU/1/05/330/001-011 |
27.1.2011 |
||
|
24.1.2011 |
SonoVue |
|
EU/1/01/177/002 |
27.1.2011 |
||
|
24.1.2011 |
Synflorix |
|
EU/1/09/508/001-010 |
27.1.2011 |
||
|
24.1.2011 |
Torisel |
|
EU/1/07/424/001 |
27.1.2011 |
||
|
24.1.2011 |
Tredaptive |
|
EU/1/08/459/009-011 EU/1/08/459/013-014 |
26.1.2011 |
||
|
24.1.2011 |
Trevaclyn |
|
EU/1/08/458/009-011 EU/1/08/458/013-014 |
26.1.2011 |
||
|
24.1.2011 |
Vistide |
|
EU/1/97/037/001 |
27.1.2011 |
||
|
24.1.2011 |
Xarelto |
|
EU/1/08/472/001-010 |
27.1.2011 |
||
|
24.1.2011 |
Xiliarx |
|
EU/1/08/486/001-011 |
27.1.2011 |
||
|
26.1.2011 |
Naglazyme |
|
EU/1/05/324/001-002 |
27.1.2011 |
||
|
27.1.2011 |
Adrovance |
|
EU/1/06/364/001-009 |
1.2.2011 |
||
|
27.1.2011 |
Alimta |
|
EU/1/04/290/001-002 |
1.2.2011 |
||
|
27.1.2011 |
Cymbalta |
|
EU/1/04/296/001-009 |
31.1.2011 |
||
|
27.1.2011 |
Herceptin |
|
EU/1/00/145/001 |
1.2.2011 |
||
|
27.1.2011 |
Icandra |
|
EU/1/08/484/001-018 |
1.2.2011 |
||
|
27.1.2011 |
Menveo |
|
EU/1/10/614/001 |
31.1.2011 |
||
|
27.1.2011 |
Nonafact |
|
EU/1/01/186/001-002 |
1.2.2011 |
||
|
27.1.2011 |
Orgalutran |
|
EU/1/00/130/001-002 |
31.1.2011 |
||
|
27.1.2011 |
Ranexa |
|
EU/1/08/462/001-012 |
1.2.2011 |
||
|
27.1.2011 |
Rasilez HCT |
|
EU/1/08/491/001-080 |
1.2.2011 |
||
|
27.1.2011 |
Regranex |
|
EU/1/99/101/001 |
31.1.2011 |
||
|
27.1.2011 |
Remicade |
|
EU/1/99/116/001-005 |
1.2.2011 |
||
|
27.1.2011 |
Ribavirin Mylan |
|
EU/1/10/634/001-004 |
23.2.2011 |
||
|
27.1.2011 |
RotaTeq |
|
EU/1/06/348/001-002 |
1.2.2011 |
||
|
27.1.2011 |
Sebivo |
|
EU/1/07/388/001-003 |
1.2.2011 |
||
|
27.1.2011 |
Simponi |
|
EU/1/09/546/001-004 |
31.1.2011 |
||
|
27.1.2011 |
Xeristar |
|
EU/1/04/297/001-008 |
1.2.2011 |
||
|
27.1.2011 |
Zomarist |
|
EU/1/08/483/001-018 |
1.2.2011 |
||
|
1.2.2011 |
Ariclaim |
|
EU/1/04/283/008-012 |
3.2.2011 |
||
|
1.2.2011 |
Emend |
|
EU/1/03/262/001-008 |
3.2.2011 |
||
|
1.2.2011 |
Exforge |
|
EU/1/06/370/001-039 |
3.2.2011 |
||
|
1.2.2011 |
Fosavance |
|
EU/1/05/310/001-009 |
3.2.2011 |
||
|
1.2.2011 |
Imprida |
|
EU/1/06/373/001-039 |
3.2.2011 |
||
|
1.2.2011 |
INCRELEX |
|
EU/1/07/402/001 |
3.2.2011 |
||
|
1.2.2011 |
Insulin Human Winthrop |
|
EU/1/06/368/001-168 |
3.2.2011 |
||
|
1.2.2011 |
Insuman |
|
EU/1/97/030/028-195 |
3.2.2011 |
||
|
1.2.2011 |
Irbesartan Teva |
|
EU/1/09/576/001-039 |
3.2.2011 |
||
|
1.2.2011 |
Nivestim |
|
EU/1/10/631/001-009 |
3.2.2011 |
||
|
1.2.2011 |
Orfadin |
|
EU/1/04/303/001-003 |
3.2.2011 |
||
|
1.2.2011 |
Riprazo |
|
EU/1/07/409/001-020 |
3.2.2011 |
||
|
1.2.2011 |
Votrient |
|
EU/1/10/628/001-004 |
3.2.2011 |
||
|
2.2.2011 |
Nplate |
|
EU/1/08/497/001-008 |
4.2.2011 |
||
|
2.2.2011 |
Prevenar |
|
EU/1/00/167/001-008 |
4.2.2011 |
||
|
2.2.2011 |
Prolia |
|
EU/1/10/618/001-004 |
4.2.2011 |
||
|
2.2.2011 |
Replagal |
|
EU/1/01/189/001-006 |
4.2.2011 |
||
|
2.2.2011 |
Vantavo |
|
EU/1/09/572/001-009 |
4.2.2011 |
||
|
8.2.2011 |
Biopoin |
|
EU/1/09/565/001-028 |
10.2.2011 |
||
|
8.2.2011 |
Temodal |
|
EU/1/98/096/001-025 |
14.2.2011 |
||
|
9.2.2011 |
Cimzia |
|
EU/1/09/544/001-002 |
11.2.2011 |
||
|
9.2.2011 |
Karvezide |
|
EU/1/98/085/001-034 |
11.2.2011 |
||
|
9.2.2011 |
Olazax |
|
EU/1/09/597/001-005 |
11.2.2011 |
||
|
9.2.2011 |
Peyona |
|
EU/1/09/528/001-002 |
11.2.2011 |
||
|
9.2.2011 |
Tesavel |
|
EU/1/07/435/001-018 |
11.2.2011 |
||
|
9.2.2011 |
Xelevia |
|
EU/1/07/382/001-018 |
11.2.2011 |
||
|
11.2.2011 |
Aprovel |
|
EU/1/97/046/001-039 |
15.2.2011 |
||
|
11.2.2011 |
Azarga |
|
EU/1/08/482/001-002 |
15.2.2011 |
||
|
11.2.2011 |
Brinavess |
|
EU/1/10/645/001-002 |
15.2.2011 |
||
|
11.2.2011 |
Clopidogrel Krka |
|
EU/1/09/556/001-011 |
15.2.2011 |
||
|
11.2.2011 |
CoAprovel |
|
EU/1/98/086/001-034 |
15.2.2011 |
||
|
11.2.2011 |
Crixivan |
|
EU/1/96/024/001-005 EU/1/96/024/008 EU/1/96/024/010 |
15.2.2011 |
||
|
11.2.2011 |
Eporatio |
|
EU/1/09/573/001-028 |
15.2.2011 |
||
|
11.2.2011 |
Januvia |
|
EU/1/07/383/001-018 |
15.2.2011 |
||
|
11.2.2011 |
Rilonacept Regeneron |
|
EU/1/09/582/001 |
15.2.2011 |
||
|
11.2.2011 |
Zutectra |
|
EU/1/09/600/001 |
15.2.2011 |
||
|
11.2.2011 |
Zyllt |
|
EU/1/09/553/001-010 |
15.2.2011 |
||
|
18.2.2011 |
Actrapid |
|
EU/1/02/230/001-007 EU/1/02/230/016-017 |
22.2.2011 |
||
|
18.2.2011 |
Elaprase |
|
EU/1/06/365/001-003 |
22.2.2011 |
||
|
18.2.2011 |
Keppra |
|
EU/1/00/146/001-032 |
22.2.2011 |
||
|
18.2.2011 |
Mimpara |
|
EU/1/04/292/001-012 |
22.2.2011 |
||
|
18.2.2011 |
Optaflu |
|
EU/1/07/394/001-009 |
22.2.2011 |
||
|
18.2.2011 |
Renagel |
|
EU/1/99/123/005-013 |
22.2.2011 |
||
|
21.2.2011 |
Arzerra |
|
EU/1/10/625/001-003 |
25.2.2011 |
||
|
21.2.2011 |
Baraclude |
|
EU/1/06/343/001-007 |
28.2.2011 |
||
|
21.2.2011 |
Cervarix |
|
EU/1/07/419/001-012 |
25.2.2011 |
||
|
21.2.2011 |
Cialis |
|
EU/1/02/237/001-009 |
23.2.2011 |
||
|
21.2.2011 |
Clopidogrel Teva |
|
EU/1/09/540/001-016 |
24.2.2011 |
||
|
21.2.2011 |
Competact |
|
EU/1/06/354/001-011 |
23.2.2011 |
||
|
21.2.2011 |
Conbriza |
|
EU/1/09/511/001-005 |
23.2.2011 |
||
|
21.2.2011 |
Dukoral |
|
EU/1/03/263/001-003 |
1.3.2011 |
||
|
21.2.2011 |
Dynastat |
|
EU/1/02/209/001-008 |
23.2.2011 |
||
|
21.2.2011 |
Efficib |
|
EU/1/08/457/001-016 |
24.2.2011 |
||
|
21.2.2011 |
Enbrel |
|
EU/1/99/126/001-021 |
25.2.2011 |
||
|
21.2.2011 |
Firazyr |
|
EU/1/08/461/001-002 |
24.2.2011 |
||
|
21.2.2011 |
Glivec |
|
EU/1/01/198/001-013 |
28.2.2011 |
||
|
21.2.2011 |
Humira |
|
EU/1/03/256/001-010 |
23.2.2011 |
||
|
21.2.2011 |
Insulatard |
|
EU/1/02/233/005-007 |
25.2.2011 |
||
|
21.2.2011 |
Intanza |
|
EU/1/08/505/001-006 |
23.2.2011 |
||
|
21.2.2011 |
Ivemend |
|
EU/1/07/437/001-004 |
24.2.2011 |
||
|
21.2.2011 |
Janumet |
|
EU/1/08/455/001-016 |
24.2.2011 |
||
|
21.2.2011 |
Kineret |
|
EU/1/02/203/001-004 |
25.2.2011 |
||
|
21.2.2011 |
Levemir |
|
EU/1/04/278/001-003 |
28.2.2011 |
||
|
21.2.2011 |
Myozyme |
|
EU/1/06/333/001-003 |
28.2.2011 |
||
|
21.2.2011 |
Neupro |
|
EU/1/05/331/001-055 |
25.2.2011 |
||
|
21.2.2011 |
Pritor |
|
EU/1/98/089/001-022 |
25.2.2011 |
||
|
21.2.2011 |
PritorPlus |
|
EU/1/02/215/001-021 |
28.2.2011 |
||
|
21.2.2011 |
Protaphane |
|
EU/1/02/234/005-007 |
25.2.2011 |
||
|
21.2.2011 |
Protopic |
|
EU/1/02/201/001-006 |
28.2.2011 |
||
|
21.2.2011 |
Qutenza |
|
EU/1/09/524/001-002 |
25.2.2011 |
||
|
21.2.2011 |
Ranexa |
|
EU/1/08/462/001-012 |
25.2.2011 |
||
|
21.2.2011 |
Rasilez |
|
EU/1/07/405/001-040 |
25.2.2011 |
||
|
21.2.2011 |
Rasilez HCT |
|
EU/1/08/491/001-080 |
25.2.2011 |
||
|
21.2.2011 |
Remicade |
|
EU/1/99/116/001-005 |
25.2.2011 |
||
|
21.2.2011 |
Ribavirin Teva |
|
EU/1/09/509/001-004 |
24.2.2011 |
||
|
21.2.2011 |
Ribavirin Teva Pharma BV |
|
EU/1/09/527/001-016 |
24.2.2011 |
||
|
21.2.2011 |
Riprazo |
|
EU/1/07/409/001-020 |
28.2.2011 |
||
|
21.2.2011 |
Ristaben |
|
EU/1/10/621/001-018 |
24.2.2011 |
||
|
21.2.2011 |
Ristfor |
|
EU/1/10/620/001-016 |
24.2.2011 |
||
|
21.2.2011 |
Simponi |
|
EU/1/09/546/001-004 |
23.2.2011 |
||
|
21.2.2011 |
Sprimeo |
|
EU/1/07/407/001-020 |
28.3.2011 |
||
|
21.2.2011 |
Stocrin |
|
EU/1/99/111/001-005 EU/1/99/111/008-011 |
25.2.2011 |
||
|
21.2.2011 |
Tamiflu |
|
EU/1/02/222/001-004 |
23.2.2011 |
||
|
21.2.2011 |
Tysabri |
|
EU/1/06/346/001 |
23.2.2011 |
||
|
21.2.2011 |
Velmetia |
|
EU/1/08/456/001-016 |
24.2.2011 |
||
|
21.2.2011 |
Ventavis |
|
EU/1/03/255/001-008 |
23.2.2011 |
||
|
21.2.2011 |
Volibris |
|
EU/1/08/451/001-004 |
2.3.2011 |
||
|
21.2.2011 |
Zylagren |
|
EU/1/09/558/001-010 |
28.2.2011 |
||
|
21.2.2011 |
Zyprexa |
|
EU/1/96/022/016-017 |
23.2.2011 |
||
|
28.2.2011 |
Altargo |
|
EU/1/07/390/001-004 |
4.3.2011 |
||
|
28.2.2011 |
Aranesp |
|
EU/1/01/185/001-022 EU/1/01/185/031-111 |
4.3.2011 |
||
|
28.2.2011 |
Arixtra |
|
EU/1/02/206/001-035 |
2.3.2011 |
||
|
28.2.2011 |
Avastin |
|
EU/1/04/300/001-002 |
4.3.2011 |
||
|
28.2.2011 |
Baraclude |
|
EU/1/06/343/001-007 |
3.3.2011 |
||
|
28.2.2011 |
Clopidogrel Qualimed |
|
EU/1/09/557/001-010 |
4.3.2011 |
||
|
28.2.2011 |
Clopidogrel TAD |
|
EU/1/09/555/001-009 |
4.3.2011 |
||
|
28.2.2011 |
Fabrazyme |
|
EU/1/01/188/001-006 |
4.3.2011 |
||
|
28.2.2011 |
Firazyr |
|
EU/1/08/461/001-002 |
4.3.2011 |
||
|
28.2.2011 |
IDflu |
|
EU/1/08/507/001-006 |
3.3.2011 |
||
|
28.2.2011 |
Ilaris |
|
EU/1/09/564/001-002 |
4.3.2011 |
||
|
28.2.2011 |
Invanz |
|
EU/1/02/216/001-002 |
3.3.2011 |
||
|
28.2.2011 |
Kaletra |
|
EU/1/01/172/001-008 |
4.3.2011 |
||
|
28.2.2011 |
Kinzalkomb |
|
EU/1/02/214/001-015 |
2.3.2011 |
||
|
28.2.2011 |
Kinzalmono |
|
EU/1/98/091/001-014 |
2.3.2011 |
||
|
28.2.2011 |
Micardis |
|
EU/1/98/090/001-020 |
2.3.2011 |
||
|
28.2.2011 |
MicardisPlus |
|
EU/1/02/213/001-023 |
3.3.2011 |
||
|
28.2.2011 |
NovoMix |
|
EU/1/00/142/004-005 EU/1/00/142/009-025 |
3.3.2011 |
||
|
28.2.2011 |
Omnitrope |
|
EU/1/06/332/001-009 |
2.3.2011 |
||
|
28.2.2011 |
Onglyza |
|
EU/1/09/545/011-015 |
3.3.2011 |
||
|
28.2.2011 |
Onglyza |
|
EU/1/09/545/001-010 |
3.3.2011 |
||
|
28.2.2011 |
Osigraft |
|
EU/1/01/179/001 |
4.3.2011 |
||
|
28.2.2011 |
Osseor |
|
EU/1/04/287/001-006 |
4.3.2011 |
||
|
28.2.2011 |
PegIntron |
|
EU/1/00/131/001-050 |
3.3.2011 |
||
|
28.2.2011 |
PREZISTA |
|
EU/1/06/380/001-005 |
4.3.2011 |
||
|
28.2.2011 |
ProQuad |
|
EU/1/05/323/001-013 |
2.3.2011 |
||
|
28.2.2011 |
Protelos |
|
EU/1/04/288/001-006 |
4.3.2011 |
||
|
28.2.2011 |
Quadramet |
|
EU/1/97/057/001 |
4.4.2011 |
||
|
28.2.2011 |
RotaTeq |
|
EU/1/06/348/001-002 |
3.3.2011 |
||
|
28.2.2011 |
Siklos |
|
EU/1/07/397/001-004 |
3.3.2011 |
||
|
28.2.2011 |
Tracleer |
|
EU/1/02/220/001-006 |
3.3.2011 |
||
|
28.2.2011 |
Vedrop |
|
EU/1/09/533/001-003 |
3.3.2011 |
||
|
28.2.2011 |
Ytracis |
|
EU/1/03/250/001 |
4.3.2011 |
— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||
|
6.1.2011 |
Thelin |
|
EU/1/06/353/001-005 |
11.1.2011 |
||
|
1.2.2011 |
Clopidogrel 1A Pharma |
|
EU/1/09/542/001-007 |
3.2.2011 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2) ): Accepted
|
Date of the Décision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
||
|
27.1.2011 |
Hiprabovis IBR Marker Live |
Live gE<sup>-</sup> tk<sup>-</sup> double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL |
|
EU/2/10/114/001-002 |
Lyophilisate for suspension |
QI02AD01 |
1.2.2011 |
||
|
11.2.2011 |
Comfortis |
Spinosad |
|
EU/2/10/115/001-010 |
Chewable tablet |
QP53BX03 |
15.2.2011 |
||
|
18.2.2011 |
Activyl |
Indoxacarb |
|
EU/2/10/118/001-014 |
Spot-on solution |
QP53AX27 |
22.2.2011 |
||
|
18.2.2011 |
Cimalgex |
Cimicoxib |
|
EU/2/10/119/001-012 |
Tablet |
QM01AH93 |
24.2.2011 |
||
|
18.2.2011 |
Purevax Rabies |
Rabies recombinant canarypox virus (vCP65) |
|
EU/2/10/117/001-002 |
Suspension for injection |
QI06AX |
22.2.2011 |
||
|
21.2.2011 |
Melosus |
Meloxicam |
|
EU/2/10/116/001-004 |
Oral suspension |
QM01AC06 |
24.2.2011 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||
|
6.1.2011 |
Econor |
|
EU/2/98/010/004-006 EU/2/98/010/017-018 EU/2/98/010/021-025 |
11.1.2011 |
||
|
13.1.2011 |
Duvaxyn WNV |
|
EU/2/08/086/001-003 |
18.1.2011 |
||
|
13.1.2011 |
Palladia |
|
EU/2/09/100/001-003 |
17.1.2011 |
||
|
17.1.2011 |
Zolvix |
|
EU/2/09/101/001-010 |
19.1.2011 |
||
|
21.1.2011 |
Dicural |
|
EU/2/97/003/001-018 |
25.1.2011 |
||
|
21.1.2011 |
Zulvac 8 Ovis |
|
EU/2/09/104/001-002 |
26.1.2011 |
||
|
24.1.2011 |
Poulvac FluFend H5N3 RG |
|
EU/2/06/060/001-002 |
27.1.2011 |
||
|
24.1.2011 |
Rheumocam |
|
EU/2/07/078/001-010 |
26.1.2011 |
||
|
27.1.2011 |
Ingelvac CircoFLEX |
|
EU/2/07/079/001-004 |
1.2.2011 |
||
|
27.1.2011 |
Meloxidyl |
|
EU/2/06/070/005-007 |
1.2.2011 |
||
|
11.2.2011 |
SevoFlo |
|
EU/2/02/035/007 |
15.2.2011 |
— Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||
|
24.1.2011 |
Acticam |
|
EU/2/08/088/001-003 |
26.1.2011 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
|
The European Medicines Agency |
|
7, Westferry Circus, Canary Wharf |
|
UK - LONDON E14 4H |
(1) OJ L 136, 30.4.2004, p. 1.
(2) OJ L 136, 30.4.2004, p. 1.
|
29.4.2011 |
EN |
Official Journal of the European Union |
C 128/19 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2011/C 128/02
— Issuing, maintenance or modification of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
21.2.2011 |
Tazocin |
See Annex I |
See Annex I |
23.2.2011 |
|
13.1.2011 |
Fortum and associated names |
See Annex II |
See Annex II |
17.1.2011 |
|
21.1.2011 |
Vascace plus and associated names |
See Annex III |
See Annex III |
24.1.2011 |
|
28.2.2011 |
fenofibrate, bezafibrate, ciprofibrate, gemfibrozil |
See Annex IV |
See Annex IV |
1.3.2011 |
|
27.1.2011 |
Modafinil containing medicinal products |
See Annex V |
See Annex V |
31.1.2011 |
|
6.1.2011 |
Lucentis |
Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
These Decisions are addressed to the Member States |
10.1.2011 |
|
28.2.2011 |
Xiapex |
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom |
These Decisions are addressed to the Member States |
1.3.2011 |
|
21.1.2011 |
Revatio |
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom |
These Decisions are addressed to the Member States |
25.1.2011 |
|
28.2.2011 |
Daliresp |
Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
These Decisions are addressed to the Member States |
1.3.2011 |
|
28.2.2011 |
Esbriet |
InterMune Europe Ltd, Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom |
These Decisions are addressed to the Member States |
1.3.2011 |
|
28.2.2011 |
Libertek |
Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
These Decisions are addressed to the Member States |
1.3.2011 |
|
28.1.2011 |
Siklos |
ADDMEDICA, 101, rue Saint Lazare, Paris 75009, France |
These Decisions are addressed to the Member States |
4.3.2011 |
— Refusal of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
21.2.2011 |
Galantamine STADA and ass. names |
See Annex VI |
See Annex VI |
24.2.2011 |
(1) OJ L 311, 28.11.01, p. 67.
ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorisation Holder |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
|||||||
|
Austria |
|
Tazonam 4,0 g/0,5 g - Trockenstechampullen |
4,0 g/0,5 g |
Lyophilisate for solution for injection or infusion |
Intravenous |
1 injection vial contains piperacillin sodium equivalent to 4,0 g of piperacillin and tazobactam sodium equivalent to 0,5g of tazobactam. |
|||||||
|
Belgium |
|
Tazocin 2 g/250 mg poudre pour solution injectable |
2 g/250 mg |
Powder for solution for injection |
Intravenous |
2,085 g sodium piperacillin + 268,30 mg sodium tazobactam |
|||||||
|
Belgium |
|
Tazocin 4g/500 mg poudre pour solution injectable |
4 g/500 mg |
Powder for solution for injection |
Intravenous |
4,170 g sodium piperacillin + 536,60 mg sodium tazobactam |
|||||||
|
Bulgaria |
|
(TAZOCIN 4 g/0,5 g powder for solution for injection/infusion Piperacillin/Tazobactam) |
4 g/0,5 g |
powder for solution for injection/infusion |
Intravenous |
4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam. |
|||||||
|
Cyprus |
|
TAZOCIN® EF |
2,25 G/VIAL |
Powder for solution for injection |
Intravenous use |
2,085 g sodium piperacillin equivalent to 2 g piperacillin and 0,2683 g sodium tazobactam equivalent to 0,250 g tazobactam. |
|||||||
|
Cyprus |
|
TAZOCIN® EF |
4,5 G/VIAL |
Powder for solution for injection |
Intravenous use |
4,17 g sodium piperacillin equivalent to 4 g piperacillin and 0,5366 g sodium tazobactam equivalent to 0,5 g tazobactam. |
|||||||
|
Czech Republic |
|
Tazocin 2,25 g |
2,25 g |
Powder for solution for injection |
Intravenous use |
2 g piperacillinum/0,25 g tazobactamum |
|||||||
|
Czech Republic |
|
Tazocin 4,5 g |
4,5 g |
Powder for solution for injection |
Intravenous use |
4 g piperacillinum/0,5 g tazobactamum |
|||||||
|
Denmark |
|
Tazocin |
2 g/0,25 g |
Powder for solution for injection/infusion |
Intravenous |
Piperacillin sodium corresponding to piperacillin 2 g, tazobactam sodium corresponding to tazobactam 0,25 g. |
|||||||
|
Denmark |
|
Tazocin |
4 g/0,5 g |
Powder for solution for injection/infusion |
Intravenous |
Piperacillin sodium corresponding to piperacillin 4 g, tazobactam sodium corresponding to tazobactam 0,5 g |
|||||||
|
Estonia |
|
TAZOCIN 4,5G |
4 000 m g+500 mg g |
Powder for solution for injection or infusion |
Intravenous |
4,170 g piperacillin sodium equivalent to 4 000 mg of piperacillin and 0,5366 g tazobactam sodium equivalent to 500 mg of tazobactam. |
|||||||
|
Finland |
|
Tazocin |
2 g/0,25 g |
Powder for solution for injection/infusion |
Intravenous |
Piperacillin. sodium 2,085 g Tazobactam.sodium 0,2683 g |
|||||||
|
Finland |
|
Tazocin |
4 g/0,5 g |
Powder for solution for injection/infusion |
Intravenous |
Piperacillin. sodium 4,170 g Tazobactam.sodium 0,5366 g |
|||||||
|
France |
|
TAZOCILLINE 2 g/250 mg, poudre pour solution pour perfusion |
2 g/250 mg |
Powder for solution for infusion |
Infusion |
Sodium piperacillin 2,085 g sodium tazobactam 268,300 mg |
|||||||
|
France |
|
TAZOCILLINE 4 g/500 mg, poudre pour solution pour perfusion |
4 g/500 mg |
Powder for solution for infusion |
Infusion |
Sodium piperacillin 4,170 g sodium tazobactam 536,600 mg |
|||||||
|
Germany |
|
Tazobac EF 4 g/0,5 g |
4 g/0,5 g |
Lyophilisate for injection or infusion |
Intravenous (Infusion, Injection) |
4 g piperacillin equivalent to 4,17 g piperacillin sodium 0,5 g tazobactam equivalent to 0,5366 g tazobactam sodium |
|||||||
|
Greece |
|
TAZOCIN® EF |
2 + 0,250 G/VIAL |
Powder for solution for injection |
Intravenous use |
2,085 g sodium piperacillin equivalent to 2 g piperacillin and 0,2683 g sodium tazobactam equivalent to 0,250 g tazobactam. |
|||||||
|
Greece |
|
TAZOCIN® EF |
4 + 0,500 G/VIAL |
Powder for solution for injection |
Intravenous use |
4,17 g sodium piperacillin equivalent to 4 g piperacillin and 0,5366 g sodium tazobactam equivalent to 0,5 g tazobactam. |
|||||||
|
Hungary |
|
Tazocin 4,5 g injekció |
4,5 g |
Powder for solution for injection or infusion |
Intravenous |
0,5366 g tazobactam sodium equivalent to 0,500 g tazobactam and 4,170 g piperacillin sodium equivalent to 4,00 g piperacillin |
|||||||
|
Ireland |
|
Tazocin2 g/0,25 g Powder for Solution for Injection or Infusion |
2 g/0,25 g |
Powder for Solution for Injection or Infusion |
Intravenous |
2 g piperacillin and 0,25 g tazobactam (both present as sodium salts). |
|||||||
|
Ireland |
|
Tazocin4 g/0,5 g Powder for Solution for Injection or Infusion |
4 g/0,5 g |
Powder for Solution for Injection or Infusion |
Intravenous |
4 g piperacillin and 0,5 g tazobactam (both present as sodium salts). |
|||||||
|
Italy |
|
TAZOCIN |
2 g + 0,250 g |
Powder for solution for infusion |
Intravenous use |
Piperacillin sodium (equiv. to piperacillin 2 g) 2 085 mg Tazobactam sodium (equiv. to tazobactam 250 mg) 268,3 mg |
|||||||
|
Italy |
|
TAZOCIN |
4 g + 0,500 g |
Powder for solution for infusion |
Intravenous use |
Piperacillin sodium (equiv. to piperacillin 4 g) 4 170 mg Tazobactam sodium (equiv. to tazobactam 500 mg) 536,6 mg |
|||||||
|
Latvia |
|
TAZOCIN 4,0 g/0,5 g pulveris injekciju vai infūziju šķīduma pagatavošanai |
4,0 g/0,500 mg |
Powder for solution for injection or infusion |
Intravenous |
4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam |
|||||||
|
Lithuania |
|
TAZOCIN |
4,0 g/0,5 g |
Powder for solution for injection or infusion |
Intravenous |
4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam |
|||||||
|
Luxembourg |
|
Tazocin 2 g/250 mg poudre pour solution injectable |
2 g/250 mg |
Powder for Solution for Injection or Infusion |
Intravenous |
2,085 g sodium piperacillin + 268,30 mg sodium tazobactam |
|||||||
|
Luxembourg |
|
Tazocin 4g/500 mg poudre pour solution injectable |
4g/500 mg |
Powder for Solution for Injection or Infusion |
Intravenous |
4,170 g sodium piperacillin + 536,60 mg sodium tazobactam |
|||||||
|
Malta |
|
Tazocin 2 g/0,25 g Powder for Solution for Injection or Infusion |
2 g/0,25 g |
Powder for Solution for Injection or Infusion |
Intravenous |
TAZOCIN 2 g/0,25 g contains 2 active ingredients; piperacillin 2 g and tazobactam 0,25 g both present as sodium salts. |
|||||||
|
Malta |
|
TAZOCIN 4 g/0,5 g Powder for Solution for Injection or Infusion |
4 g/0,5 g |
Powder for Solution for Injection or Infusion |
Intravenous |
TAZOCIN 4 g/0,5 g contains 2 active ingredients; piperacillin 4 g and tazobactam 0,5 g both present as sodium salts. |
|||||||
|
Netherlands |
|
Tazocin® 2 g/250 mg |
2 g/250 mg |
Powder for solution for injection |
Intravenous |
Sodium piperacillin and sodium tazobactam, equivalent to 2 g piperacillin and 250 mg tazobactam. |
|||||||
|
Netherlands |
|
Tazocin® 4 g/500 mg |
4 g/500 mg |
Powder for solution for injection |
Intravenous |
Sodium piperacillin and sodium tazobactam, equivalent to 4 g piperacillin and 500 mg tazobactam |
|||||||
|
Norway |
|
Tazocin |
2 g/0,25 g |
Powder for solution for injection/infusion |
Intravenous |
Piperacillin sodium corresponding to piperacillin 2 g, tazobactam sodium corresponding to tazobactam. 0,25 g |
|||||||
|
Norway |
|
Tazocin |
4 g/0,5 g |
Powder for solution for injection/infusion |
Intravenous |
Piperacillin sodium corresponding to piperacillin 4 g, tazobactam sodium corresponding to tazobactam 0,5 g. |
|||||||
|
Poland |
|
Tazocin |
2 g + 0,25 g |
Powder for solution for injection or infusion |
Intravenous |
2 g piperacillin (in form of piperacillin sodium) and 0,25 g tazobactam (in form of tazobactam sodium). |
|||||||
|
Poland |
|
Tazocin |
4 g + 0,5 g |
Powder for solution for injection or infusion |
Intravenous |
4 g piperacillin (in form of piperacillin sodium) and 0,5 g tazobactam (in form of tazobactam sodium). |
|||||||
|
Portugal |
|
Tazobac |
2 000 mg + 250 mg |
Powder for solution for injection |
Intravenous use |
2,085 g of piperacillin sodium equivalent to 2 g of piperacillin and 0,2683 g of tazobactam sodium equivalent to 250 mg of tazobactam |
|||||||
|
Portugal |
|
Tazobac |
4 000 mg + 500 mg |
Powder for solution for injection |
Intravenous use |
4,170 g of piperacillin sodium equivalent to 4 g of piperacillin and 0,5366 g of tazobactam sodium equivalent to 500 mg of tazobactam |
|||||||
|
Romania |
|
Tazocin 2,25 g, liofilizat pentru soluție injectabilă/perfuzabilă |
2,00/0,25 g |
Lyophilised powder for solution for injection or infusion |
Intravenous |
Piperacillin 2,00 g as piperacillin sodium and tazobactam 0,25 g as tazobactam sodium. |
|||||||
|
Romania |
|
Tazocin 4,5 g, liofilizat pentru soluție injectabilă/perfuzabilă |
4,00/0,5 g |
Lyophilised powder for solution for injection or infusion |
Intravenous |
Piperacillin 4,00 g as piperacillin sodium and tazobactam 0,5 g as tazobactam sodium. |
|||||||
|
Slovak Republic |
|
Tazocin 2,25 g |
2,25 g |
Powder for solution for injection and infusion |
Intravenous |
contains 2,085 g piperacillin sodium equivalent to 2 g piperacillin and 0,2683 g tazobactam sodium equivalent to 250 milligrams tazobactam |
|||||||
|
Slovak Republic |
|
Tazocin 4,5 g |
4,5 g |
Powder for solution for injection and infusion |
Intravenous |
contains 4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam |
|||||||
|
Slovenia |
|
TAZOCIN 4,5 g prašek za raztopino za injiciranje ali infundiranje |
4,0 g/0,5 g |
Powder for solution for injection or infusion. |
Intravenous |
4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 mg tazobactam. |
|||||||
|
Spain |
|
Tazocel 2/0,25 g Polvo para solución inyectable |
2/0,25 g |
Powder for injectable solution |
Intravenous |
Piperacillin (in the form of piperacillin sodium) 2 g Tazobactam (in the form of tazobactam sodium) 0,25 g |
|||||||
|
Spain |
|
Tazocel 4/0,5 g Polvo para solución inyectable |
4/0,5 g |
Powder for injectable solution |
Intravenous |
Piperacillin (in the form of piperacillin sodium) 4 g Tazobactam (in the form of tazobactam sodium) 0,50 g |
|||||||
|
Sweden |
|
Tazocin |
2 g/0,25 g |
Powder for solution for injection/infusion |
Intravenous |
Piperacillin sodium corresponding to piperacillin 2 g and tazobactam sodium corresponding to tazobactam 0,25 g |
|||||||
|
Sweden |
|
Tazocin |
4 g/0,5 g |
Powder for solution for injection/infusion |
Intravenous |
Piperacillin sodium corresponding to piperacillin 4 g and tazobactam sodium corresponding to tazobactam 0,5 g |
|||||||
|
United Kingdom |
|
TAZOCIN 2 g/0,25 g Powder for Solution for Injection or Infusion |
2,25 g |
Powder for Solution for Injection or Infusion |
Intravenous |
Piperacillin 2 g and tazobactam 250 mg both present as sodium salts. |
|||||||
|
United Kingdom |
|
TAZOCIN 4 g/0,5 g Powder for Solution for Injection or Infusion |
4,5 g |
Powder for Solution for Injection or Infusion |
Intravenous |
Piperacillin 4 g and tazobactam 500 mg both present as sodium salts. |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorisation Holder |
(Invented) name |
Strength |
Pharmaceutical Form |
Route of administration |
Content (concentration) |
||||||
|
Austria |
|
Fortum 0,5 g - Trockenstechampullen |
500mg |
Powder for injection |
Intravenous or intramuscular use |
|
||||||
|
Fortum 1 g - Trockenstechampullen |
1g |
Powder for injection |
Intravenous or intramuscular use |
|
||||||||
|
Fortum 2 g - Trockenstechampullen |
2 g |
Powder for injection/infusion |
Intravenous use |
|
||||||||
|
Belgium |
|
Glazidim |
500 mg |
Powder for solution for Injection |
For Intravenous or Intramuscular use |
|
||||||
|
Glazidim |
1 g |
Powder for solution for Infusion |
For intravenous use |
|
||||||||
|
Glazidim |
1 g |
Powder for solution for Injection |
For Intravenous or Intramuscular use |
|
||||||||
|
Glazidim |
2 g |
Powder for solution for infusion |
For intravenous use |
|
||||||||
|
Glazidim |
2 g |
Powder for solution for injection |
For intravenous use |
|
||||||||
|
Bulgaria |
|
Fortum |
1 g |
Powder for solution for Injection |
For intravenous or intramuscular use |
|
||||||
|
Cyprus |
|
Fortum |
1 g |
Powder for Injection |
For intravenous use |
Vials contain 1g ceftazidime (as pentahydrate) |
||||||
|
Czech Republic |
|
Fortum 500mg |
500 mg |
Powder for solution for injection |
For intravenous use |
|
||||||
|
Fortum 1g |
1 g |
Powder for solution for injection |
For intravenous use |
|
||||||||
|
Fortum 2g |
2 g |
Powder for solution for injection |
For intravenous use |
|
||||||||
|
Denmark |
|
Fortum |
500 mg |
Powder for Injection |
For intravenous use |
|
||||||
|
Fortum |
1 g |
Powder for Injection |
For intravenous use |
|
||||||||
|
Fortum |
2 g |
Powder for Injection |
For intravenous use |
|
||||||||
|
Estonia |
|
Fortum |
1 g |
Powder for solution for injection /infusion |
For intramuscular or intravenous use |
1g |
||||||
|
Finland |
|
Glazidim |
500 mg |
Powder for solution for Injection |
For intramuscular or intravenous use |
Vials contain 500 mg ceftazidime (as pentahydrate) |
||||||
|
Glazidim |
1 g |
Powder for solution for injection |
For intramuscular or intravenous use |
Vials contain 1 g ceftazidime (as pentahydrate) |
|||||||
|
Glazidim |
1 g |
Powder for solution for injection/infusion |
For intramuscular or intravenous use |
Vials contain 1 g ceftazidime (as pentahydrate) |
|||||||
|
Glazidim |
2 g |
Powder for solution for injection/infusion |
For intramuscular or intravenous use |
Vials contain 2 g ceftazidime (as pentahydrate) |
|||||||
|
Glazidim |
3 g |
Powder for solution for injection/infusion |
For intramuscular or intravenous use |
Vials contain 3 g ceftazidime (as pentahydrate) |
|||||||
|
France |
|
Fortum enfants et nourrisons |
250 mg |
Powder for solution for injection |
For intravenous or intramuscular use |
295 mg |
||||||
|
Fortum enfants et nourrisons |
500 mg |
Powder for solution for injection |
For intravenous or intramuscular use |
591 mg |
||||||||
|
Fortumset |
1 g |
Powder for solution for infusion (IV) |
For intravenous use |
1 182 mg |
||||||||
|
Fortum |
1 g |
Powder for solution for Injection |
For intravenous or intramuscular use |
1 182mg |
||||||||
|
Fortumset |
2 g |
Powder for solution for infusion (IV) |
For intravenous use |
2 364 mg |
||||||||
|
Fortum |
2 g |
Powder for solution for injection (IV) |
For intravenous use |
2 364 mg |
||||||||
|
Germany |
|
Fortum |
500 mg |
Powder for solution for injection or infusion |
For intravenous and intramuscular use |
|
||||||
|
Fortum |
1 g |
Powder for solution for injection or infusion |
For intravenous and intramuscular use |
|
||||||||
|
Fortum |
2 g |
Powder for solution for injection or infusion |
For intravenous use |
|
||||||||
|
Greece |
|
Solvetan |
1 g |
Powder for injection |
For intramuscular or intravenous use |
|
||||||
|
Solvetan |
2 g |
Powder for injection |
For intravenous use |
|
||||||||
|
Hungary |
|
Fortum |
500 mg |
Powder for injection |
For intravenous use |
|
||||||
|
Fortum |
1 g |
Powder for injection |
For intravenous use |
|
||||||||
|
Fortum |
2 g |
Powder for infusion |
For intravenous use |
|
||||||||
|
Iceland |
|
Fortum |
1 g |
Powder for solution for injection |
For intravenous or intramuscular use |
|
||||||
|
Fortum |
2 g |
Powder for solution for infusion |
For intravenous use |
|
||||||||
|
Ireland |
|
Fortum |
500 mg |
Powder for solution for injection |
For intravenous or intramuscular injection |
Reconstituted solution contains 500mg ceftazidime |
||||||
|
Fortum |
1 g |
Powder for solution for injection or infusion, vial |
For intravenous or intramuscular injection or infusion |
Reconstituted solution contains 1g ceftazidime |
||||||||
|
Fortum |
1 g |
Powder for infusion, monovial |
For infusion |
Reconstituted solution contains 1g ceftazidime |
||||||||
|
Fortum |
2 g |
Powder for solution for injection or infusion, vial |
For intravenous or intramuscular injection or infusion |
Reconstituted solution contains 2g ceftazidime |
||||||||
|
Fortum |
2 g |
Powder for infusion, monovial |
For infusion |
Reconstituted solution contains 2g ceftazidime |
||||||||
|
Italy |
|
Glazidim |
250 mg/ml |
Powder and solvent for solution for injection |
For intramuscular use |
|
||||||
|
Glazidim |
500 mg/1,5 ml |
Powder and solvent for solution for injection |
For intramuscular use |
|
||||||||
|
Glazidim |
1 g/3 ml |
Powder and solvent for solution for injection |
For intramuscular use |
|
||||||||
|
Glazidim |
1 g/10 ml |
Powder and solvent for solution for injection |
For intravenous use |
|
||||||||
|
Glazidim |
2 g |
Powder for solution for infusion |
For intravenous use |
|
||||||||
|
Glazidim |
1 g/100 ml |
Powder and solvent for solution for infusion (Monovial) |
For intravenous use |
|
||||||||
|
Glazidim |
2 g/100 ml |
Powder and solvent for solution for infusion (Monovial) |
For intravenous use |
|
||||||||
|
Glazidim |
1 g |
Powder for solution for infusion (Monovial) |
For intravenous use |
|
||||||||
|
Glazidim |
2 g |
Powder for solution for infusion (Monovial) |
For intravenous use |
|
||||||||
|
Panzid |
1 g/3 ml |
Powder and solvent for solution for injection |
For intramuscular use |
|
|||||||
|
Latvia |
|
Fortum 1 g powder for solution for injection or infusion |
1 g |
Powder for solution for injection or infusion |
For intravenous use or intramuscular use |
1 g ceftazidime (as ceftazidime pentahydrate) |
||||||
|
Lithuania |
|
Fortum |
500 mg |
Powder and solvent for solution for injection |
Intravenous use or intramuscular use |
|
||||||
|
Fortum |
1 g |
Powder and solvent for solution for injection |
Intravenous use or intramuscular use |
|
||||||||
|
Fortum |
2 g |
Powder for solution for injection or infusion |
Intravenous use |
|
||||||||
|
Fortum |
3 g |
Powder for solution for injection or infusion |
Intravenous use |
|
||||||||
|
Luxembourg |
|
Glazidim |
500 mg |
Powder for solution for injection |
For Intravenous or Intramuscular use |
|
||||||
|
Glazidim |
1 g |
Powder for solution for infusion |
For intravenous use |
|
||||||||
|
Glazidim |
1 g |
Powder for solution for injection |
For Intravenous or Intramuscular use |
|
||||||||
|
Glazidim |
2 g |
Powder for solution for infusion |
For intravenous use |
|
||||||||
|
Glazidim |
2 g |
Powder for solution for injection |
For intravenous use |
|
||||||||
|
Malta |
|
Fortum |
1g per vial |
Powder for solution for injection |
For intravenous or Intramuscular use |
|
||||||
|
Netherlands |
|
Fortum |
500 mg |
Powder for solution for injection |
For intravenous or intramuscular use |
|
||||||
|
Fortum |
1 g |
Powder for solution for injection |
For intravenous or intramuscular use |
|
||||||||
|
Fortum |
2 g |
Powder for solution for injection |
For intravenous use |
|
||||||||
|
Norway |
|
Fortum |
500 mg |
Powder for infusion/injection |
For intravenous or intramuscular use |
|
||||||
|
Fortum |
1 g |
Powder for infusion/injection |
For intravenous or intramuscular use |
|
||||||||
|
Fortum |
2 g |
Powder for infusion/injection |
For intravenous use |
|
||||||||
|
Poland |
|
Fortum |
250 mg |
Powder for solution for injection |
For intramuscular or intravenous use |
|
||||||
|
Fortum |
500 mg |
Powder for solution for injection |
For intramuscular or intravenous use |
|
||||||||
|
Fortum |
1 g |
Powder for solution for injection and infusion |
For intramuscular or intravenous use |
|
||||||||
|
Fortum |
2 g |
Powder solution for injection and infusion |
For intravenous use |
|
||||||||
|
Portugal |
|
Cefortam |
500 mg/1,5 ml |
Powder and solvent for solution for injection |
For intravenous or intramuscular use |
|
||||||
|
Cefortam |
1 g/3 ml |
Powder and solvent for solution for injection |
For intravenous or intramuscular use |
|
||||||||
|
Cefortam |
2 g |
Powder for solution for injection |
For intravenous use |
|
||||||||
|
Romania |
|
Fortum |
500 mg |
Powder for injection |
For intravenous or intramuscular use |
|
||||||
|
Fortum |
1 g |
Powder for injection |
For intravenous or intramuscular use |
|
||||||||
|
Fortum |
1 g |
Powder for injection |
For intravenous or intramuscular use |
|
||||||||
|
Fortum |
1 g |
Powder for injection |
For intravenous or intramuscular use |
|
||||||||
|
Fortum |
2 g |
Powder for injection or infusion |
For intravenous or intramuscular use |
|
||||||||
|
Slovak Republic |
|
Fortum |
500 mg |
Powder for injection |
For intravenous use |
|
||||||
|
Fortum |
1 g |
Powder for infusion |
For intravenous use |
|
||||||||
|
Fortum |
2 g |
Powder for infusion |
For intravenous use |
|
||||||||
|
Slovenia |
|
Fortum |
1 g |
Powder for injection or infusion |
For intravenous use |
|
||||||
|
Fortum Monovial |
1 g |
Powder for infusion |
For intravenous use |
|
||||||||
|
Spain |
|
Fortam IM/IV |
500 mg |
Powder for injection |
For intravenous use/IM |
|
||||||
|
Fortam IV |
1 g |
Powder for injection |
For intravenous use |
|
||||||||
|
Fortam 1 g |
1 g |
Powder for injection |
For intravenous use/IM |
|
||||||||
|
Fortam IV |
2 g |
Powder for infusion |
For intravenous use |
|
||||||||
|
Sweden |
|
Fortum |
250 mg |
Powder for solution for injection |
For intramuscular or intravenous use |
250 mg ceftazidime (as pentahydrate) |
||||||
|
Fortum |
500 mg |
Powder for solution for injection |
For intramuscular or intravenous use |
500 mg ceftazidime (as pentahydrate) |
||||||||
|
Fortum |
1 g |
Powder for solution for injection |
For intramuscular or intravenous use |
1 g ceftazidime (as pentahydrate) |
||||||||
|
Fortum |
1 g |
Powder for solution for infusion |
For intravenous use |
1 g ceftazidime (as pentahydrate) |
||||||||
|
Fortum |
1 g Monovial |
Powder for solution for infusion |
For intravenous use |
1 g ceftazidime (as pentahydrate) |
||||||||
|
Fortum |
2 g Monovial |
Powder for solution for infusion |
For intravenous use |
2 g ceftazidime (as pentahydrate) |
||||||||
|
Fortum |
2 g |
Powder for solution for injection/infusion |
For intravenous use |
2 g ceftazidime (as pentahydrate) |
||||||||
|
United Kingdom |
|
Fortum |
250 mg |
Powder for injection |
intravenous use and intramuscular use |
118 mg per gram of ceftazidime |
||||||
|
Fortum |
500 mg |
Powder for injection |
intravenous use and intramuscular use |
118 mg per gram of ceftazidime |
||||||||
|
Fortum |
1 g |
Powder for injection |
intravenous use and intramuscular use |
118 mg per gram of ceftazidime |
||||||||
|
Fortum |
2 g and 3 g + 2 g Monovial |
Powder for infusion |
intravenous use and intramuscular use |
118 mg per gram of ceftazidime |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorisation Holder |
(Invented) Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||
|
Austria |
|
Inhibace plus «Roche» - Filmtabletten |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Belgium |
|
Co-Inhibace |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Czech Republic |
|
Inhibace Plus |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Germany |
|
Dynorm Plus |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Greece |
|
Vascace Plus |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Hungary |
|
Inhibace Plus |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Italy |
|
Inibace Plus |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Luxembourg |
|
Co-Inhibace |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Poland |
|
Inhibace Plus |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Portugal |
|
Inibace Plus |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
|||||
|
Spain |
|
Inhibace Plus |
5 mg/12,5 mg |
Film-coated tablets |
Oral use |
ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
AT - Austria |
|
Apteor 160 mg - Filmtabletten |
160 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Fenolip retard 250 mg - Kapseln |
250 mg |
prolonged release capsule, hard |
oral |
||||||
|
AT - Austria |
|
Lipanthyl Nanopartikel 145 mg - Filmtabletten |
145 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Lipanthyl supra 160 mg - Filmtabletten |
160 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Lipcor 200 mg - Kapseln |
200 mg |
capsule, hard |
oral |
||||||
|
AT - Austria |
|
Lipsin 100 mg - Kapseln |
100 mg |
capsule, hard |
oral |
||||||
|
AT - Austria |
|
Lipsin retard 250 mg - Kapseln |
250 mg |
prolonged release capsule, hard |
oral |
||||||
|
BE - Belgium |
|
DOCFENOFI 200 |
200 mg |
CAPSULES |
oral |
||||||
|
BE - Belgium |
|
FENOFIBRAAT EG 200 MG |
200 mg |
CAPSULES |
oral |
||||||
|
BE - Belgium |
|
FENOFIBRAAT EG 100 MG |
100 mg |
CAPSULES |
oral |
||||||
|
BE - Belgium |
|
FENOFIBRAAT EG 200 MG |
200 mg |
CAPSULES |
oral |
||||||
|
BE - Belgium |
|
FENOFIBRAAT JUBILANT 200 MG CAPSULES |
200 mg |
CAPSULES |
oral |
||||||
|
BE - Belgium |
|
FENOFIBRATE APOTEX 200 MG |
200 mg |
CAPSULES |
oral |
||||||
|
BE - Belgium |
|
FENOFIBRATE MYLAN 200 MG MICRONISED |
200 mg |
Capsule, hard |
oral |
||||||
|
BE - Belgium |
|
FENOFIBRATE SANDOZ 200 MG |
200 mg |
CAPSULES |
oral |
||||||
|
BE - Belgium |
|
FENOGAL 200 LIDOSE |
200 mg |
capsule, hard |
oral |
||||||
|
BE - Belgium |
|
FENOGAL 267 MG LIDOSE |
267 mg |
capsule hard |
oral |
||||||
|
BE - Belgium |
|
FENOSUP LIDOSE 160 MG |
160 mg |
capsule hard |
oral |
||||||
|
BE - Belgium |
|
LIPANTHYL 200 MICRONISED |
200 mg |
capsule, hard |
oral |
||||||
|
BE - Belgium |
|
LIPANTHYL 267 MICRONISED |
267 mg |
capsule, hard |
oral |
||||||
|
BE - Belgium |
|
LIPANTHYL 67 MICRONISED |
67 mg |
capsule, hard |
oral |
||||||
|
BE - Belgium |
|
LIPANTHYL SUPRA 215MG |
215 mg |
film-coated tablet |
oral |
||||||
|
BE - Belgium |
|
LIPANTHYL SUPRA 160 MG |
160 mg |
film-coated tablet |
oral |
||||||
|
BE - Belgium |
|
LIPANTHYLNANO 145MG |
145 mg |
film-coated tablet |
oral |
||||||
|
BE - Belgium |
|
LIPERIAL 145MG |
145 mg |
film-coated tablet |
oral |
||||||
|
BG - Bulgaria |
|
Lipanthyl Supra |
160 mg |
Modified-release tablet |
Oral use |
||||||
|
BG - Bulgaria |
|
Lipanthyl 200 M |
200 mg |
Capsule, hard |
Oral use |
||||||
|
BG - Bulgaria |
|
Lipanthyl 267 M |
267 mg |
Capsule, hard |
Oral use |
||||||
|
CY - Cyprus |
|
LIPIDIL MICRONISED HARD CAPSULES 267mg |
267 mg |
capsules |
oral |
||||||
|
CY - Cyprus |
|
LIPIDIL MICRONISED HARD CAPSULES 200mg |
200 mg |
capsules |
oral |
||||||
|
CZ - Czech Republic |
|
LIPANTHYL 267 M |
267 mg |
capsule, hard |
oral use |
||||||
|
CZ - Czech Republic |
|
LIPANTHYL NT 145 MG |
145 MG |
Film-coated tablet |
oral use |
||||||
|
CZ - Czech Republic |
|
LIPANTHYL SUPRA 160 MG |
160 MG |
Modified-release tablet |
oral use |
||||||
|
CZ - Czech Republic |
|
LIPANTHYL 200 M |
200 MG |
capsule, hard |
oral use |
||||||
|
CZ - Czech Republic |
|
LIPANTHYL S 215 MG |
215 MG |
Film-coated tablet |
oral use |
||||||
|
CZ - Czech Republic |
|
LIPOHEXAL 250 RETARD |
250 MG |
Modified-release capsule,hard |
oral use |
||||||
|
CZ - Czech Republic |
|
FENOFIX 267 MG |
267 MG |
capsule, hard |
oral use |
||||||
|
CZ - Czech Republic |
|
FENOFIX 200 MG |
200 MG |
capsule, hard |
oral use |
||||||
|
CZ - Czech Republic |
|
FEBIRA 200 |
200 MG |
capsule, hard |
oral use |
||||||
|
CZ - Czech Republic |
|
LIPIREX 267 MG |
267 MG |
capsule, hard |
oral use |
||||||
|
CZ - Czech Republic |
|
LIPIREX 200MG |
200 MG |
capsule, hard |
oral use |
||||||
|
CZ - Czech Republic |
|
SUPRELIP |
200 MG |
capsule, hard |
oral use |
||||||
|
CZ - Czech Republic |
|
APO-FENO |
200 MG |
capsule, hard |
oral use |
||||||
|
DE - Germany |
|
Fenofibrat AbZ 100mg Hartkapseln |
100 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat AbZ 250 mg Retardkapseln |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat AL 250 retard |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenobeta 250 retard |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
Normalip pro |
200 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat-CT 100mg Hartkapseln |
100 mg |
Capsule |
oral |
||||||
|
DE - Germany |
|
Fenofibrat-CT 250mg Retardkapseln |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat 200 Heumann |
200 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat 250 retard Heumann |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
FENOFIBRAT HEXAL 160 mg Hartkapseln |
160 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat Hexal 200 mg Hartkapseln |
200 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofanton 250 mg Hartkapseln, retardiert |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
Durafenat |
100 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
durafenat MF 200 mg |
200 mg |
Modified-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
durafenat retard |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat-ratiopharm 250 mg Retardkapseln |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat-ratiopharm 100 mg Hartkapseln |
100 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
Fenofibrat Sandoz 200mg Hartkapseln |
200 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
Apteor 160 mg Filmtablette |
160 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Elipsia 145 mg Filmtabletten |
145 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Liperial 145 mg Filmtablette |
145 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Lipidil - Ter 160 mg Filmtablette |
160 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Lipidil 145 ONE |
145 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Lipidil 200mg |
200 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
Xafenor 145 mg Filmtablette |
145 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Fenofibrat STADA 250 mg Hartkapseln, retardiert |
250 mg |
Prolonged-release capsule, hard |
oral |
||||||
|
DE - Germany |
|
CiL 160 mg |
160 mg |
Capsule, hard |
oral |
||||||
|
DE - Germany |
|
CIL 200 mg |
200 mg |
Capsule |
oral |
||||||
|
EL - Greece |
|
LIPIDIL |
200 MG/CAP |
HARD CAPSULES |
ORAL |
||||||
|
EL - Greece |
|
LIPIDIL (NT) |
145 MG/TAB |
Film-coated tablet |
ORAL |
||||||
|
EL - Greece |
|
FENOBRAT |
160 MG/CAP |
HARD CAPSULES |
ORAL |
||||||
|
ES - Spain |
|
APTEOR |
145 mg |
film coated tablets |
oral |
||||||
|
ES - Spain |
|
APTEOR |
160 mg |
film coated tablets |
oral |
||||||
|
ES - Spain |
|
Fenofibrato KernPharma |
160 mg |
capsules |
oral |
||||||
|
ES - Spain |
|
FENOFIBRATO RANBAXY |
160 mg |
film coated tablets |
oral |
||||||
|
ES - Spain |
|
FENOFIBRATO RANBAXY |
200 mg |
capsules |
oral |
||||||
|
ES - Spain |
|
FENOFIBRATO RANBAXYGEN |
200 mg |
capsules |
oral |
||||||
|
ES - Spain |
|
Liparison Retard |
250 mg |
capsules |
oral |
||||||
|
ES - Spain |
|
PANLIPAL |
145 mg |
film coated tablets |
oral |
||||||
|
ES - Spain |
|
SECALIP |
145 mg |
film coated tablets |
oral |
||||||
|
ES - Spain |
|
SECALIP |
200 mg |
capsules |
oral |
||||||
|
ES - Spain |
|
SECALIP |
250 mg |
capsules |
oral |
||||||
|
ES - Spain |
|
SECALIP SUPRA |
160 mg |
film coated tablets |
oral |
||||||
|
ET - Estonia |
|
LIPANTHYL |
200 mg |
capsule |
oral use |
||||||
|
ET - Estonia |
|
FENOLIP |
160 mg |
capsule, hard |
oral use |
||||||
|
FI - Finland |
|
CIL |
160 mg |
capsules, hard |
Oral use |
||||||
|
FI - Finland |
|
FENOSUP LIDOSE |
160 mg |
capsules, hard |
Oral use |
||||||
|
FI - Finland |
|
LIPANTHYL PENTA |
145 mg |
film-coated tablet |
Oral use |
||||||
|
FI - Finland |
|
LIPANTHYL SUPRA |
160 mg |
film-coated tablet |
Oral use |
||||||
|
FI - Finland |
|
LIPANTHYL SUPRA |
215 mg |
film-coated tablet |
Oral use |
||||||
|
FR - France |
|
CENCARAN 140 mg, gélule |
140 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CENCARAN 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FEGENOR 140 mg, gélule |
140 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FEGENOR 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FEGENOR 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENATHOL 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOCOR 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ACTAVIS 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ALMUS 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ALMUS 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ALMUS 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ALTER 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ALTER 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ARROW 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ARROW 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ARROW 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE BIOGARAN 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE BIOGARAN 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE BIOGARAN 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE BIOGARAN 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE BIOGARAN 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE CEHEL PHARMA 140 mg, gélule |
140 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE CRISTERS 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE CRISTERS 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE CRISTERS 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE DCI PHARMA 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE DCI PHARMA 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE DEBAT CARDIO 140 mg, gélule |
140 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE EG 145 mg, comprimé |
145 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE EG 160 mg, comprimé pelliculé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE EG 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE EG 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ENIREX 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE TEVA 145 mg, comprimé |
145 mg pour 1 comprimé |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ETHYPHARM 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ETHYPHARM 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE EXPANPHARM 200 mg, comprimé |
200 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE EXPANPHARM 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE EXPANPHARM 67 mg, comprimé |
67 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE EXPANPHARM 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE FOURNIER 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE FOURNIER 145 mg, comprimé pelliculé |
145 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE FOURNIER 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE FOURNIER 200 MICRONISE, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE FOURNIER 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE FOURNIER 67 MICRONISE, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE G GAM 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE G GAM 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE GALENIX 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE IVAX 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE IVAX 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE IVAX 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE IVAX 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE MILGEN 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE MILGEN 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE MYLAN 100 mg, gélule |
100,00 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE MYLAN 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE MYLAN 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE MYLAN 300 mg, gélule |
300,00 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE MYLAN 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE QUALIMED 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE QUALIMED 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE QUALIMED 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RANBAXY 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RANBAXY 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RANBAXY 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RATIOPHARM 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RATIOPHARM 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RATIOPHARM 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RATIOPHARM 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RPG 100 mg, gélule |
100,00 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RPG 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RPG 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RPG 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE SANDOZ 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE SANDOZ 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE SANDOZ 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE SANDOZ 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE SANDOZ 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE TEVA 100 mg, gélule |
100,00 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE TEVA 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE TEVA 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE TEVA 300 mg, gélule |
300,00 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE TEVA 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WINTHROP 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WINTHROP 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WINTHROP 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WYVERN 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WYVERN 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WYVERN MEDICAL 160 mg, comprimé pelliculé |
160,0 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WYVERN MEDICAL 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WYVERN MEDICAL 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ZYDUS 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ZYDUS 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ZYDUS 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE ZYDUS 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WINTHROP 145 mg, comprimé |
145 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE QUALIMED 145 mg, comprimé |
145 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE RATIOPHARM 145 mg, comprimé |
145 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOX 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOX 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE SANDOZ 145 mg, comprimé |
145 mg |
tablet |
oral use |
||||||
|
FR - France |
|
GENOTHYL 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
LIPANTHYL 140 MICRONISE, gélule |
140 mg |
capsule |
oral use |
||||||
|
FR - France |
|
LIPANTHYL 145 mg, comprimé pelliculé |
145 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
LIPANTHYL 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
LIPANTHYL 200 micronisé, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
LIPANTHYL 67 Micronisé, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE BIOGARAN 145 mg, comprimé |
145 mg |
tablet |
oral use |
||||||
|
FR - France |
|
LIPILFEN 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE MYLAN 145 mg, comprimé |
145 mg |
tablet |
oral use |
||||||
|
FR - France |
|
FENOFIBRATE WINTHROP 160 mg, comprimé |
160 mg |
tablet |
oral use |
||||||
|
FR - France |
|
LIPIPHARM 145 mg, comprimé |
145 mg |
tablet |
oral use |
||||||
|
FR - France |
|
LIPIREX 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
LIPIREX 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
LIVESAN 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
LIVESAN 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
PANLIPAL 145 mg, comprimé pelliculé |
145 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
SECALIP 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
SECALIP 200 mg, gélule |
200 mg |
capsule |
oral use |
||||||
|
FR - France |
|
SECALIP 300 mg, gélule |
300 mg |
capsule |
oral use |
||||||
|
FR - France |
|
SECALIP 67 mg, gélule |
67 mg |
capsule |
oral use |
||||||
|
FR - France |
|
SUBSTICHOL 160 mg, comprimé pelliculé |
160 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
WYVEBRATE 160 mg, comprimé pelliculé |
160,0 mg |
film-coated tablet |
oral use |
||||||
|
HU - Hungary |
|
Fenobrat |
250 mg |
prolonged-release capsule |
oral |
||||||
|
HU - Hungary |
|
Fenoswiss |
160 mg |
hard capsule |
oral |
||||||
|
HU - Hungary |
|
Lipidil Supra |
160 mg |
film-coated tablet |
oral |
||||||
|
HU - Hungary |
|
Lipidil Supra |
215 mg |
film-coated tablet |
oral |
||||||
|
HU - Hungary |
|
Lipanthyl NT |
145 mg |
film-coated tablet |
oral |
||||||
|
HU - Hungary |
|
Lipidil |
267 mg |
hard capsule |
oral |
||||||
|
IE - Ireland |
|
Lipantil Micro 67 mg capsules, hard |
67 mg |
hard capsules |
oral use |
||||||
|
IE - Ireland |
|
Lipantil Micro 200 mg capsules, hard |
200 mg |
hard capsules |
oral use |
||||||
|
IE - Ireland |
|
Lipantil Micro 267 mg capsules, hard |
267 mg |
hard capsules |
oral use |
||||||
|
IE - Ireland |
|
Lipantil Supra 145mg film-coated tablets |
145 mg |
film-coated tablets |
oral use |
||||||
|
IE - Ireland |
|
Lipantil Supra 160mg film-coated tablets |
160 mg |
film-coated tablets |
oral use |
||||||
|
IE - Ireland |
|
Lipantil Supra 215 mg film-coated tablets |
215 mg |
film-coated tablets |
oral use |
||||||
|
IT - Italy |
|
Lipsin |
200 mg |
Capsule |
Oral |
||||||
|
IT - Italy |
|
Fulcro |
200 mg |
Capsule |
Oral |
||||||
|
IT - Italy |
|
Tilene |
100 mg |
Capsule |
Oral |
||||||
|
IT - Italy |
|
Nolipax |
100 mg |
Capsule |
Oral |
||||||
|
IT - Italy |
|
Lipofene |
100 mg |
Capsule |
Oral |
||||||
|
IT - Italy |
|
Fenofibrato Winthrop |
200 mg |
Capsule |
Oral |
||||||
|
IT - Italy |
|
Fulcrosupra |
145 mg |
Film-coated tablet |
Oral |
||||||
|
IT - Italy |
|
Fulcrosupra |
160 mg |
Film-coated tablet |
Oral |
||||||
|
IT - Italy |
|
Fenolibs |
145 mg |
Film-coated tablet |
Oral |
||||||
|
IT - Italy |
|
Liperial |
145 mg |
Film-coated tablet |
Oral |
||||||
|
LT - Lithuania |
|
Fenolip |
160 mg |
capsule, hard |
oral use |
||||||
|
LT - Lithuania |
|
Lipanthyl 200 M |
200 mg |
capsule, hard |
oral use |
||||||
|
LU - Luxembourg |
|
Fegenor |
67 mg |
capsule, hard |
oral |
||||||
|
LU - Luxembourg |
|
Fegenor |
200 mg |
capsule, hard |
oral |
||||||
|
LU - Luxembourg |
|
Fenogal-200 |
200 mg |
capsule, hard |
oral |
||||||
|
LU - Luxembourg |
|
Fenogal-267 |
267 mg |
capsule, hard |
oral |
||||||
|
LU - Luxembourg |
|
Fenofibrate EG |
67 mg |
capsule, hard |
oral |
||||||
|
LU - Luxembourg |
|
Lipanthyl 67 Micronised |
67 mg |
capsule, hard |
oral |
||||||
|
LU - Luxembourg |
|
Lipanthyl 200 Micronised |
200 mg |
capsule, hard |
oral |
||||||
|
LU - Luxembourg |
|
Lipanthyl 267 Micronised |
267 mg |
capsule, hard |
oral |
||||||
|
LU - Luxembourg |
|
Lipanthyl Supra |
160 mg |
film-coated tablet |
oral |
||||||
|
LU - Luxembourg |
|
Lipanthyl Supra |
215 mg |
film-coated tablet |
oral |
||||||
|
LU - Luxembourg |
|
Lipanthyl Nano |
145 mg |
film-coated tablet |
oral |
||||||
|
LU - Luxembourg |
|
Liperial |
145 mg |
film-coated tablet |
oral |
||||||
|
LV - Latvia |
|
Fenolip 160 mg hard capsules |
160 mg |
Capsules, hard |
Oral use |
||||||
|
LV - Latvia |
|
Lipanthyl 200 mg hard capsules |
200 mg |
Capsules, hard |
Oral use |
||||||
|
PL - Poland |
|
Apo-Feno 100 |
100 mg |
capsules |
oral |
||||||
|
PL - Poland |
|
Apo-Feno 200M |
200 mg |
capsules, hard |
oral |
||||||
|
PL - Poland |
|
Fenardin |
267 mg |
capsules, hard |
oral |
||||||
|
PL - Poland |
|
Fenardin |
160 mg |
capsules, hard |
oral |
||||||
|
PL - Poland |
|
Fenoratio 100 |
100 mg |
capsules |
oral |
||||||
|
PL - Poland |
|
Fenoratio Retard |
250 mg |
Prolonged-release capsules |
oral |
||||||
|
PL - Poland |
|
Grofibrat |
100 mg |
capsules |
oral |
||||||
|
PL - Poland |
|
Grofibrat 200 |
200 mg |
capsules |
oral |
||||||
|
PL - Poland |
|
Lipanthyl |
100 mg |
capsules |
oral |
||||||
|
PL - Poland |
|
Lipanthyl 200M |
200 mg |
capsules |
oral |
||||||
|
PL - Poland |
|
Lipanthyl 267M |
267 mg |
capsules |
oral |
||||||
|
PL - Poland |
|
Lipanthyl NT 145 |
145 mg |
film-coated tablets |
oral |
||||||
|
PL - Poland |
|
Lipanthyl Supra 160 |
160 mg |
film-coated tablets |
oral |
||||||
|
PL - Poland |
|
Lipanthyl Supra 215 mg |
215 mg |
film-coated tablets |
oral |
||||||
|
PL - Poland |
|
Xafenor 145 |
145 mg |
film-coated tablets |
Oral |
||||||
|
PT - Portugal |
|
Catalip |
200 mg |
capsule |
Oral |
||||||
|
PT - Portugal |
|
Lipofen |
100 mg |
capsule |
Oral |
||||||
|
PT - Portugal |
|
Supralip 160 mg |
160 mg |
modified released tablet |
Oral |
||||||
|
PT - Portugal |
|
Apteor |
160 mg |
modified released tablet |
Oral |
||||||
|
PT - Portugal |
|
Catalip 267 Micronizado |
267 mg |
capsule |
Oral |
||||||
|
PT - Portugal |
|
Fenofibrato Winthrop 200 mg Cápsulas |
200 mg |
capsule |
Oral |
||||||
|
PT - Portugal |
|
Fenofibrato Alpharma 200 mg Cápsulas |
200 mg |
capsule |
Oral |
||||||
|
PT - Portugal |
|
Supralip 145 mg |
145 mg |
Filmcoated tablet |
Oral |
||||||
|
PT - Portugal |
|
Lipanthyl 145 mg |
145 mg |
Filmcoated tablet |
Oral |
||||||
|
PT - Portugal |
|
Apteor 145 mg |
145 mg |
Filmcoated tablet |
Oral |
||||||
|
PT - Portugal |
|
Fenofibrato Winthrop 267 mg Cápsulas |
267 mg |
capsule |
Oral |
||||||
|
RO - Romania |
|
LIPANTHYL® 100 |
100 mg |
capsule |
oral use |
||||||
|
RO - Romania |
|
FENOX 160 mg |
160 mg |
modified-release film-coated tablets |
oral use |
||||||
|
RO - Romania |
|
LIPIVIM |
200 mg |
capsules (with micronised powder) |
oral use |
||||||
|
RO - Romania |
|
LIPANTHYL 67 M capsule |
67 mg |
capsules |
oral use |
||||||
|
RO - Romania |
|
LIPANTHYL 267 M capsule |
267 mg |
capsules |
oral use |
||||||
|
RO - Romania |
|
LIPOFIB 160 mg |
160 mg |
capsules |
oral use |
||||||
|
RO - Romania |
|
LIPOFIB 200 mg |
200 mg |
capsules |
oral use |
||||||
|
RO - Romania |
|
LIPANTHYL PENTA 145 mg |
145 mg |
film-coated tablets |
oral use |
||||||
|
RO - Romania |
|
TRICOR 145 mg |
145 mg |
film-coated tablets |
oral use |
||||||
|
RO - Romania |
|
LIPOFIB 67 mg |
67 mg |
capsules |
oral use |
||||||
|
RO - Romania |
|
FENOFIBRAT TERAPIA 200 mg |
200 mg |
capsules |
oral use |
||||||
|
RO - Romania |
|
LIPOFIB 267 mg |
267 mg |
capsules |
oral use |
||||||
|
RO - Romania |
|
FENOFIBRAT LPH 200 mg |
200 mg |
capsules (micronised powder) |
oral use |
||||||
|
RO - Romania |
|
FENOFIBRAT TERAPIA 160 mg |
160 mg |
film-coated tablets |
oral use |
||||||
|
RO - Romania |
|
LIPANTHYL SUPRA 160 mg |
160 mg |
modified-release film-coated tablets |
oral use |
||||||
|
RO - Romania |
|
LIPANTIL NANO 145 mg |
145 mg |
film-coated tablets |
oral use |
||||||
|
RO - Romania |
|
Lipanthyl 200 M |
200 mg |
capsules |
oral use |
||||||
|
SE - Sweden |
|
Lipanthyl® |
67 mg |
hard capsule |
oral |
||||||
|
SE - Sweden |
|
Lipanthyl® |
200 mg |
hard capsule |
oral |
||||||
|
SE - Sweden |
|
Lipanthyl® |
267 mg |
hard capsule |
oral |
||||||
|
SI - Slovenia |
|
Katalip 250 mg trde kapsule |
250 mg |
capsule, hard |
oral use |
||||||
|
SK - Slovakia |
|
Febira 200 |
200 mg |
Capsule |
Oral |
||||||
|
SK - Slovakia |
|
Fenofibrate - AS 267 mg |
267 mg |
Capsule, hard |
Oral |
||||||
|
SK - Slovakia |
|
Fenofix 200 |
200 mg |
Capsule |
Oral |
||||||
|
SK - Slovakia |
|
Fenolip |
160 mg |
Capsule, hard |
Oral |
||||||
|
SK - Slovakia |
|
LIPANTHYL 200 M |
200 mg |
Capsule, hard |
Oral |
||||||
|
SK - Slovakia |
|
LIPANTHYL 267 M |
267 mg |
Capsule, hard |
Oral |
||||||
|
SK - Slovakia |
|
LIPANTHYL NT 145 mg |
145 mg |
Film coated tablet |
Oral |
||||||
|
SK - Slovakia |
|
LIPANTHYL SUPRA 160 mg |
160 mg |
Film coated tablet |
Oral |
||||||
|
SK - Slovakia |
|
LIPANTHYL SUPRA 215 mg |
215 mg |
Film coated tablet |
Oral |
||||||
|
SK - Slovakia |
|
SUPRELIP |
200 mg |
Capsule, hard |
Oral |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 67MG CAPSULES |
67 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 200MG CAPSULES |
200 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 200MG CAPSULES |
200 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOGAL 200MG CAPSULES |
200 mg |
CAPSULE |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE MICRO 267MG CAPSULES |
267 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 67MG CAPSULES |
67 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 200MG CAPSULES |
200 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 267MG CAPSULES |
267 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 67MG CAPSULES |
67 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 200MG CAPSULES |
200 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 267MG CAPSULES |
267 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
LIPANTIL MICRO 67 |
67 mg |
CAPSULE |
oral use |
||||||
|
UK - United Kingdom |
|
SUPRALIP 160 FILM-COATED TABLETS |
160 mg |
FILM-COATED TABLET |
oral use |
||||||
|
UK - United Kingdom |
|
LIPANTIL MICRO 200 |
200 mg |
CAPSULE |
oral use |
||||||
|
UK - United Kingdom |
|
LIPANTIL® MICRO 267 |
267 mg |
CAPSULE |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 200MG CAPSULES |
200 mg |
CAPSULE, HARD |
oral use |
||||||
|
UK - United Kingdom |
|
FENOFIBRATE 267MG CAPSULES |
267 mg |
CAPSULE, HARD |
oral use |
Bezafibrate containing medicinal products with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
AT - Austria |
|
Bezafibrat „Arcana“ retard 400 mg - Filmtabletten |
400 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Bezafibrat „Genericon“ 200 mg - Dragees |
200 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Bezafibrat „Genericon“ retard 400 mg - Filmtabletten |
400 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Bezafibrat „1A Pharma“ retard 400 mg - Filmtabletten |
400 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Bezafibrat „ratiopharm“ retard 400 mg - Filmtabletten |
400 mg |
prolonged-release tablet |
oral |
||||||
|
AT - Austria |
|
Bezalip 200 mg - Filmtabletten |
200 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Bezalip retard 400 mg - Filmtabletten |
400 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Bezaretard „Genericon“ 400 mg - Filmtabletten |
400 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Bezastad 200 mg - Filmtabletten |
200 mg |
film-coated tablet |
oral |
||||||
|
AT - Austria |
|
Bezastad retard 400 mg - Filmtabletten |
400 mg |
film-coated tablet |
oral |
||||||
|
BE - Belgium |
|
CEDUR |
200 mg |
coated tablet |
oral |
||||||
|
BE - Belgium |
|
EULITOP 400 MG |
400 mg |
tablet |
oral |
||||||
|
CY - Cyprus |
|
LACROMID 200 FC TABLETS 200 mg |
200 mg |
tablets |
oral |
||||||
|
CY - Cyprus |
|
ZAFIBRAL FC TABLETS 200 mg |
200 mg |
tablets |
oral |
||||||
|
DE - Germany |
|
Bezafibrat 400 ret-1 A Pharma |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat AbZ 200 mg Filmtabletten |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat AbZ 400 mg Retardtabletten |
400 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Cedur |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Cedur retard |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat AL 200 |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat AL 400 retard |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Regadrin B |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezabeta 400 retard |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat-CT 200 mg Filmtabletten |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat-CT 400 mg Retardtabletten |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezadoc PB retard 400 mg |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
Germany |
Bezadoc retard 400 mg |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Befibrat 200 mg Dragees |
200 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Befibrat 400 mg retard Filmtabletten |
400 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat 200 Heumann |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat 400 retard Heumann |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat HEXAL 400 mg retard Retardtabletten |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat dura 400 mg Retardtabletten |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat-ratiopharm 200 mg Filmtabletten |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat-ratiopharm 400 mg Retardtabletten |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat Sandoz 400 mg Retardtabletten |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat Stada 200 mg überzogene Tabletten |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezafibrat Stada 400 mg Retardtabletten |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Lipox Bezafibrat 400 mg Retardtabletten |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Lipox Bezafibrat 400 mg Retardtabletten |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
DE - Germany |
|
Bezagamma 200 |
200 mg |
Film-coated tablet |
oral |
||||||
|
DE - Germany |
|
Bezagamma 400 retard |
400 mg |
Prolonged-release tablet |
oral |
||||||
|
EL - Greece |
|
BEZALIP |
400 MG/TAB |
PROLONGED RELEASE TABLETS |
oral |
||||||
|
ES - Spain |
|
EULITOP |
200 mg |
tablets |
oral |
||||||
|
ES - Spain |
|
EULITOP RETARD |
400 mg |
film coated tablets |
oral |
||||||
|
ES - Spain |
|
DIFATEROL RETARD |
400 mg |
film coated tablets |
oral |
||||||
|
FI - Finland |
|
BEZALIP |
400 mg |
prolonged-release tablet |
Oral use |
||||||
|
FR - France |
|
BEFIZAL 200 mg, comprimé pelliculé |
200 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée |
400 mg |
Prolonged-release tablet |
oral use |
||||||
|
FR - France |
|
BEZAFIBRATE ACTAVIS 200 mg, comprimé pelliculé |
200 mg |
film-coated tablet |
oral use |
||||||
|
FR - France |
|
BEZAFIBRATE ACTAVIS L.P. 400 mg, comprimé enrobé à libération prolongée |
400 mg |
Prolonged-release tablet |
oral use |
||||||
|
HU - Hungary |
|
Bezalip |
400mg |
modified-release film-coated tablet |
oral |
||||||
|
IT - Italy |
|
Bezalip |
400 mg |
Prolonged release coated tablet |
Oral |
||||||
|
IT - Italy |
|
Bezalip |
200 mg |
Film-coated tablet |
Oral |
||||||
|
IT - Italy |
|
Bezafibrato Eg |
400 mg |
Prolonged release tablet |
Oral |
||||||
|
IT - Italy |
|
Hadiel |
400 mg |
Prolonged release coated tablet |
Oral |
||||||
|
LU - Luxembourg |
|
Benzafibrat Hexal Retard |
400 mg |
film-coated tablet |
oral |
||||||
|
LU - Luxembourg |
|
Cedur |
200 mg |
film-coated tablet |
oral |
||||||
|
LU - Luxembourg |
|
Eulitop |
400 mg |
tablet |
oral use |
||||||
|
MT - Malta |
|
Befibrat |
400 mg |
Retard coated tablets |
Oral |
||||||
|
NL - Netherlands |
|
Bezalip, tabletten 200 mg, RVG 15982 |
200 mg |
tablets |
oral |
||||||
|
NL - Netherlands |
|
Bezalip Retard, tabletten met gereguleerde afgifte 400 mg, RVG 18388 |
400 mg |
modified release tablets |
oral |
||||||
|
PT - Portugal |
|
Bezalip |
200 mg |
film-coated tablet |
Oral |
||||||
|
PT - Portugal |
|
Bezalip Retard |
400 mg |
Prolonged-released tablet |
Oral |
||||||
|
RO - Romania |
|
BEZAFIBRAT ARENA 200 mg |
200 mg |
tablets |
oral use |
||||||
|
RO - Romania |
|
BEZAFIBRAT SLAVIA 200 mg |
200 mg |
tablets |
oral use |
||||||
|
RO - Romania |
|
REGADRIN® B |
200 mg |
coated tablets |
oral use |
||||||
|
SE - Sweden |
|
Bezalip® |
200 mg |
filmcoated tablet |
oral |
||||||
|
SE - Sweden |
|
Bezalip® Retard |
400 mg |
depo tablet |
oral |
||||||
|
UK - United Kingdom |
|
BEZALIP |
200 mg |
COATED TABLET |
oral use |
||||||
|
UK - United Kingdom |
|
BEZALIP MONO |
400 mg |
MODIFIED-RELEASE TABLET |
oral use |
||||||
|
UK - United Kingdom |
|
ZIMBACOL XL |
400 mg |
MODIFIED-RELEASE TABLET |
oral use |
||||||
|
UK - United Kingdom |
|
BEZAGEN XL TABLETS 400MG |
400 mg |
TABLET |
oral use |
||||||
|
UK - United Kingdom |
|
BEZAFIBRATE TABLETS 200 MG |
200 mg |
FILM-COATED TABLET |
oral use |
||||||
|
UK - United Kingdom |
|
BEZAFIBRATE TABLETS 200 MG |
200 mg |
TABLET |
oral use |
||||||
|
UK - United Kingdom |
|
BEZAFIBRATE 200MG TABLETS |
200 mg |
FILM-COATED TABLET |
oral use |
||||||
|
UK - United Kingdom |
|
BEZATARD XL 400MG MODIFIED RELEASE TABLETS |
400 mg |
MODIFIED-RELEASE TABLET |
oral use |
Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
BE - Belgium |
|
CIPROFIBRATE MYLAN 100 MG |
100 mg |
capsule, hard |
oral |
||||||
|
BE - Belgium |
|
HYPERLIPEN 100 MG |
100 mg |
capsule, hard |
oral |
||||||
|
BG - Bulgaria |
|
Lipanor |
100 mg |
Capsule, hard |
Oral use |
||||||
|
CY - Cyprus |
|
MODALIM TABLETS 100 mg |
100 mg |
tablets |
oral |
||||||
|
CZ - Czech Republic |
|
LIPANOR |
100 MG |
capsule, hard |
|
||||||
|
EL - Greece |
|
SAVILEN |
100 MG/CAP |
HARD CAPSULES |
ORAL |
||||||
|
ET - Estonia |
|
LIPANOR |
100 mg |
capsule, hard |
oral use |
||||||
|
FR - France |
|
LIPANOR 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE ALMUS 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE ARROW 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE BIOGARAN 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE MYLAN 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE QUALIMED 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE RATIOPHARM 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE REF 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE RPG 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE SANDOZ 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE TEVA 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
FR - France |
|
CIPROFIBRATE WINTHROP 100 mg, gélule |
100 mg |
capsule |
oral use |
||||||
|
HU - Hungary |
|
Lipanor |
100 mg |
hard capsule |
oral |
||||||
|
LT - Lithuania |
|
Lipanor |
100 mg |
capsule, hard |
oral use |
||||||
|
LU - Luxembourg |
|
Hyperlipen |
100 mg |
capsule, hard |
oral |
||||||
|
LV - Latvia |
|
Lipanor 100 mg capsules, hard |
100 mg |
Capsules, hard |
Oral use |
||||||
|
NL - Netherlands |
|
Modalim, tabletten 100 mg, RVG 17863 |
100 mg |
tablets |
oral |
||||||
|
PL - Poland |
|
Lipanor |
100 mg |
capsules |
oral |
||||||
|
PT - Portugal |
|
Lipanor |
100 mg |
capsule |
Oral |
||||||
|
PT - Portugal |
|
Fibranin |
100 mg |
capsule |
Oral |
||||||
|
RO - Romania |
|
LIPANOR® 100 mg |
100 mg |
capsules |
oral use |
||||||
|
SK - Slovakia |
|
LIPANOR 100 mg |
100 mg |
Capsule |
Oral |
||||||
|
UK - United Kingdom |
|
CIPROFIBRATE 100MG TABLETS |
100 mg |
Tablet |
Oral Use |
Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union
|
Member State (EU/EEA) |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||||
|
AT - Austria |
|
Gevilon 450 mg - Filmtabletten |
450 mg |
film-coated tablet |
oral |
||||||||
|
CY - Cyprus |
|
IPOLIPID CAPSULES 300mg |
300 mg |
capsules |
oral |
||||||||
|
CY - Cyprus |
|
IPOLIPID CAPSULES 600mg |
600 mg |
capsules |
oral |
||||||||
|
CY - Cyprus |
|
LIPOFOR CAPSULES 300mg |
300 mg |
capsules |
oral |
||||||||
|
CY - Cyprus |
|
LIPOFOR CAPSULES 600mg |
600 mg |
capsules |
oral |
||||||||
|
DE - Germany |
|
Gemfi 450-1 A Pharma |
450 mg |
Film-coated tablet |
oral |
||||||||
|
DE - Germany |
|
Gemif 600-1 A Pharma |
600 mg |
Film-coated tablet |
oral |
||||||||
|
DE - Germany |
|
Gevilon 600mg |
600 mg |
Film-coated tablet |
oral |
||||||||
|
DE - Germany |
|
Gevilon Uno |
900 mg |
Film-coated tablet |
oral |
||||||||
|
DE - Germany |
|
Lipox Gemfi 450mg |
450 mg |
Film-coated tablet |
oral |
||||||||
|
DE - Germany |
|
Lipox Gemfi 600mg |
600 mg |
Film-coated tablet |
oral |
||||||||
|
DK - Denmark |
|
Gemfibrozil «Alternova» |
600 mg |
film coated tablets |
oral |
||||||||
|
DK - Denmark |
|
Gemfibrozil «Alternova» |
900 mg |
film coated tablets |
oral |
||||||||
|
DK - Denmark |
|
Lopid |
300 mg |
Hard capsules |
oral |
||||||||
|
DK - Denmark |
|
Lopid |
450 mg |
Film coated tablets |
oral |
||||||||
|
DK - Denmark |
|
Lopid |
600 mg |
Film coated tablets |
oral |
||||||||
|
EL - Greece |
|
LOPID |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
LOPID |
900 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
HOBATOLEX |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
FIBROLIP |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
GEMLIPID-MEDICHROM |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
PRELISIN |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
NOXOBRAN |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
NOXOBRAN |
900 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
LISOLIP |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
TEROSTRANT |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
PARNOXIL |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
FIBROSPES |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
EKLIPID |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
ANTILIPID |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
EL - Greece |
|
GINETON |
600 MG/TAB |
Film coated tablet |
ORAL |
||||||||
|
ES - Spain |
|
GEMFIBROZILO BEXAL |
600 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
GEMFIBROZILO FERMON |
600 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
GEMFIBROZILO FERMON |
900 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
GEMFIBROZILO STADA |
600 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
GEMFIBROZILO STADA |
900 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
GEMFIBROZILO UR |
900 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
GEMFIBROZILO UR |
600 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
LOPID |
600 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
LOPID |
900 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
TRIALMIN |
600 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
TRIALMIN |
900 mg |
film coated tablets |
oral |
||||||||
|
ES - Spain |
|
PILDER |
600 mg |
film coated tablets |
oral |
||||||||
|
FI - Finland |
|
LOPID |
300 mg |
capsules, hard |
Oral use |
||||||||
|
FI - Finland |
|
LOPID |
600 mg |
capsules, hard |
Oral use |
||||||||
|
FR - France |
|
LIPUR 450 mg, comprimé pelliculé |
450 mg |
film-coated tablet |
oral use |
||||||||
|
HU - Hungary |
|
Minilip |
600 mg |
film-coated tablet |
oral |
||||||||
|
HU - Hungary |
|
Innogem |
300 mg |
hard capsule |
oral |
||||||||
|
HU - Hungary |
|
Innogem |
600 mg |
film-coated tablet |
oral |
||||||||
|
IE - Ireland |
UK ADDRESS:
|
Lopid 300 mg capsules |
300 mg |
hard capsules |
oral use |
||||||||
|
IE - Ireland |
UK ADDRESS:
|
Lopid 600 mg film-coated tablets |
600 mg |
film-coated tablets |
oral use |
||||||||
|
IS - Iceland |
|
Lopid |
600 mg |
Film-coated tablet |
Oral |
||||||||
|
IS - Iceland |
|
Lopid |
300 mg |
Capsule, hard |
Oral |
||||||||
|
IT - Italy |
|
Lipogen |
900 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Lipogen |
1 200 mg |
Granules |
Oral |
||||||||
|
IT - Italy |
|
Genozil |
600 mg |
Film coated tablet |
Oral |
||||||||
|
IT - Italy |
|
Genozil |
900 mg |
Film coated tablet |
Oral |
||||||||
|
IT - Italy |
|
Fibrocit |
900 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Fibrocit |
600 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
900 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
600 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil Eg |
900 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil Eg |
600 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil Eg |
1 200 mg |
Granules |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
900 mg |
Coated tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
600 mg |
Coated tablet |
Oral |
||||||||
|
IT - Italy |
|
Lopid |
900 mg |
Coated tablet |
Oral |
||||||||
|
IT - Italy |
|
Lopid |
600 mg |
Coated tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
900 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
600 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
1 200 mg |
Granules |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
900 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
600 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Genlip |
900 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Genlip |
600 mg |
Tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
900 mg |
Film-coated tablet |
Oral |
||||||||
|
IT - Italy |
|
Gemfibrozil |
600 mg |
Film-coated tablet |
Oral |
||||||||
|
NL - Netherlands |
|
Lopid 300 mg, harde capsules, RVG 32546 |
300 mg |
capsules, hard |
oral |
||||||||
|
NL - Netherlands |
|
Lopid 450 mg, filmomhulde tabletten, RVG 32547 |
450 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Lopid 600, filmomhulde tabletten 600 mg, RVG 13827 |
600 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Lopid 900, filmomhulde tabletten 900 mg, RVG 16455 |
900 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil 600 PCH, omhulde tabletten 600 mg, RVG 25031 |
600 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil 900 PCH, omhulde tabletten 900 mg, RVG 25032 |
900 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Actavis 600 mg tabletten, omhulde tabletten, RVG 26283 |
600 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Actavis 900 mg tabletten, omhulde tabletten, RVG 26284 |
900 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Apotex 600 mg, tabletten, RVG 24878 |
600 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Apotex 900 mg, tabletten, RVG 24879 |
900 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil CF 600 mg, omhulde tabletten, RVG 25184 |
600 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil CF 900 mg, omhulde tabletten, RVG 25185 |
900 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Mylan 600 mg, tabletten, RVG 29616 |
600 mg |
tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Mylan 900 mg, tabletten, RVG 29617 |
900 mg |
tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Ratiopharm 600 mg, omhulde tabletten, RVG 29232 |
600 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Ratiopharm 900 mg, omhulde tabletten, RVG 29233 |
900 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Sandoz 600 mg, filmomhulde tabletten, RVG 21426 |
600 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Sandoz tablet 600, omhulde tabletten 600 mg, RVG 25182 |
600 mg |
filmcoated tablets |
oral |
||||||||
|
NL - Netherlands |
|
Gemfibrozil Sandoz tablet 900, omhulde tabletten 900 mg, RVG 25183 |
900 mg |
filmcoated tablets |
oral |
||||||||
|
PT - Portugal |
|
Lipoite Forte |
600 mg |
coated tablet |
Oral |
||||||||
|
PT - Portugal |
|
Lopid |
300 mg |
capsule |
Oral |
||||||||
|
PT - Portugal |
|
Lopid 600 |
600 mg |
film-coated tablet |
Oral |
||||||||
|
PT - Portugal |
|
Gemfibrozil Generis |
600 mg |
film-coated tablet |
Oral |
||||||||
|
PT - Portugal |
|
Gemfibrozil Generis |
900 mg |
film-coated tablet |
Oral |
||||||||
|
SE - Sweden |
|
Gemfibrozil Sandoz |
450 mg |
filmcoated tablet |
oral |
||||||||
|
SE - Sweden |
|
Gemfibrozil Sandoz |
600mg |
filmcoated tablet |
oral |
||||||||
|
SE - Sweden |
|
Lopid |
300 mg |
hard capsule |
oral |
||||||||
|
SE - Sweden |
|
Lopid |
450 mg |
filmcoated tablet |
oral |
||||||||
|
SE - Sweden |
|
Lopid |
600 mg |
filmcoated tablet |
oral |
||||||||
|
SI - Slovenia |
|
Elmogan 450 mg filmsko obložene tablete |
450 mg |
film-coated tablet |
oral use |
||||||||
|
SK - Slovakia |
Medochemie Ltd. 1-10 Constantinoupoleos St. P.O. Box: 51409 3505 Limassol Cyprus |
IPOLIPID |
300 mg |
Capsule |
Oral |
||||||||
|
UK - United Kingdom |
|
LOPID CAPSULES 300 MG |
300 mg |
CAPSULE |
oral use |
||||||||
|
UK - United Kingdom |
|
LOPID TABLETS 600 MG |
600 mg |
COATED TABLET |
oral use |
||||||||
|
UK - United Kingdom |
|
GEMFIBROZIL TABLETS 600 MG |
600 mg |
COATED TABLET |
oral use |
||||||||
|
UK - United Kingdom |
|
GEMFIBROZIL CAPSULES 300 MG |
300 mg |
CAPSULE |
oral use |
||||||||
|
UK - United Kingdom |
|
GEMFIBROZIL TABLETS 600 MG |
600 mg |
FILM-COATED TABLET |
oral use |
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State |
Marketing Authorisation Holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
|||||
|
Austria |
|
Modasomil 100 mg - Tabletten |
100 mg |
tablets |
oral use |
|||||
|
Austria |
|
Modafinil TEVA 100 mg Tabletten |
100 mg |
tablet |
oral use |
|||||
|
Belgium |
|
MODAFINIL TEVA 100MG |
100 mg |
tablets |
oral use |
|||||
|
Belgium |
|
PROVIGIL |
100 mg |
tablets |
oral use |
|||||
|
Cyprus |
|
MODIODAL |
100 MG |
tablets |
oral use |
|||||
|
Czech Republic |
|
Modafinil-Teva 100 mg |
100 mg |
tablets |
oral use |
|||||
|
Czech Republic |
|
Vigil |
100 mg |
tablets |
oral use |
|||||
|
Denmark |
|
Modiodal |
100 mg |
tablets |
oral use |
|||||
|
Denmark |
|
Modafinil ‘Teva’ |
100 mg |
tablets |
oral use |
|||||
|
Finland |
|
MODAFINIL |
100 mg |
tablets |
oral use |
|||||
|
Finland |
|
MODAFINIL |
200 mg |
tablets |
oral use |
|||||
|
France |
|
MODIODAL 100 mg, comprimé |
100 mg |
tablets |
oral use |
|||||
|
France |
|
MODAFINIL LAFON 100 mg, comprimé |
100 mg |
tablets |
oral use |
|||||
|
France |
|
MODAFINIL TEVA 100 mg, comprimé |
100 mg |
tablets |
oral use |
|||||
|
Germany |
|
Vigil 100 mg Tabletten |
100 mg |
tablets |
oral use |
|||||
|
Greece |
|
MODIODAL |
100 MG/TAB |
tablets |
oral use |
|||||
|
Hungary |
|
VIGIL |
100 mg |
tablets |
oral use |
|||||
|
Iceland |
|
Modiodal |
100 mg |
tablets |
oral use |
|||||
|
Ireland |
|
PROVIGIL 100 mg tablets |
100 MG |
tablets |
oral use |
|||||
|
Ireland |
|
PROVIGIL 200 mg tablets |
200 MG |
tablets |
oral use |
|||||
|
Ireland |
|
Modafinil Teva 100mg tablet |
100 MG |
tablets |
oral use |
|||||
|
Italy |
|
PROVIGIL |
100 mg |
tablets |
oral use |
|||||
|
Italy |
|
MODAFINIL TEVA |
100 mg |
tablets |
oral use |
|||||
|
Luxembourg |
|
PROVIGIL |
100 mg |
tablets |
oral use |
|||||
|
Netherlands |
|
Modiodal, 100 mg tabletten |
100 mg |
tablets |
oral use |
|||||
|
Poland |
|
Vigil |
100 mg |
tablets |
oral use |
|||||
|
Portugal |
|
Modiodal |
100 mg |
tablets |
oral use |
|||||
|
Portugal |
|
Modafinil Generis |
100 mg |
tablets |
oral use |
|||||
|
Slovakia |
|
Modafinil-Teva 100 mg |
100 mg |
tablets |
oral use |
|||||
|
Slovakia |
|
VIGIL 100 mg |
100 mg |
tablets |
oral use |
|||||
|
Spain |
|
MODIODAL |
100 mg |
tablets |
oral use |
|||||
|
Spain |
|
MODAFINILO TEVA |
100 mg |
tablets |
oral use |
|||||
|
Sweden |
|
Modiodal® |
100 mg |
tablets |
oral use |
|||||
|
Sweden |
|
Modafinil Teva |
100 mg |
tablets |
oral use |
|||||
|
United Kingdom |
|
Provigil 100mg Tablets |
100mg |
tablets |
oral use |
|||||
|
United Kingdom |
|
Provigil 200mg Tablets |
200 mg |
tablets |
oral use |
|||||
|
United Kingdom |
|
Modafinil 100mg Tablets |
100 mg |
tablets |
oral use |
ANNEX VI
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
|
Member State EU/EEA |
Applicant |
Invented Name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||
|
Austria |
|
Galantamin STADA 8 mg Retardtabletten |
8 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Austria |
|
Galantamin STADA 16 mg Retardtabletten |
16 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Austria |
|
Galantamin STADA 24 mg Retardtabletten |
24 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Czech Republic |
|
GALASTAD 8 mg |
8 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Czech Republic |
|
GALASTAD 16 mg |
16 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Czech Republic |
|
GALASTAD 24 mg |
24 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Denmark |
|
Galantamin STADA |
8 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Denmark |
|
Galantamin STADA |
16 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Denmark |
|
Galantamin STADA |
24 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Finland |
|
Galantamine Stada |
8 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Finland |
|
Galantamine Stada |
16 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Finland |
|
Galantamine Stada |
24 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Ireland |
|
GALANTAX XL 8 mg prolonged-release tablets |
8 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Ireland |
|
GALANTAX XL 16 mg prolonged-release tablets |
16 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Ireland |
|
GALANTAX XL 24 mg prolonged-release tablets |
24 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Portugal |
|
Galantamina Ciclum |
8 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Portugal |
|
Galantamina Ciclum |
16 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Portugal |
|
Galantamina Ciclum |
24 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Slovak Republic |
|
Galantamine Tiefenbacher 8 mg tablety s predĺženým uvoľňovaním |
8 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Slovak Republic |
|
Galantamine Tiefenbacher 16 mg tablety s predĺženým uvoľňovaním |
16 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Slovak Republic |
|
Galantamine Tiefenbacher 24 mg tablety s predĺženým uvoľňovaním |
24 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Spain |
|
GALANTAMINA Tiefenbacher 8 mg comprimidos de liberación prolongada |
8 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Spain |
|
GALANTAMINA Tiefenbacher 16 mg comprimidos de liberación prolongada |
16 mg |
Prolonged-release tablet |
Oral use |
|||||
|
Spain |
|
GALANTAMINA Tiefenbacher 24 mg comprimidos de liberación prolongada |
24 mg |
Prolonged-release tablet |
Oral use |