ISSN 1977-091X doi:10.3000/1977091X.C_2012.148.eng |
||
Official Journal of the European Union |
C 148 |
|
English edition |
Information and Notices |
Volume 55 |
Notice No |
Contents |
page |
|
IV Notices |
|
|
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
|
|
European Commission |
|
2012/C 148/01 |
||
2012/C 148/02 |
||
EN |
|
IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
25.5.2012 |
EN |
Official Journal of the European Union |
C 148/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 2012
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1) )
2012/C 148/01
— 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 |
|||||
13.4.2012 |
Bronchitol |
Mannitol |
|
EU/1/12/760/001-002 |
Inhalation powder, hard capsule |
R05CB16 |
18.4.2012 |
|||||
13.4.2012 |
Sabervel |
Irbesartan |
|
EU/1/12/765/001-006 |
Film-coated tablet |
C09CA04 |
17.4.2012 |
|||||
20.4.2012 |
Capecitabine Accord |
capecitabine |
|
EU/1/12/762/001-018 |
Film-coated tablet |
L01BC06 |
25.4.2012 |
|||||
20.4.2012 |
Capecitabine Krka |
capecitabine |
|
EU/1/12/763/001-018 |
Film-coated tablet |
L01BC06 |
25.4.2012 |
|||||
20.4.2012 |
Capecitabine Teva |
capecitabine |
|
EU/1/12/761/001-002 |
Film-coated tablet |
L01BC06 |
25.4.2012 |
|||||
20.4.2012 |
Nimenrix |
Meningococcal group A, C, W-135 and Y conjugate vaccine |
|
EU/1/12/767/001-007 |
Powder and solvent for solution for injection |
J07AH08 |
25.4.2012 |
|||||
20.4.2012 |
SANCUSO |
granisetron |
|
EU/1/12/766/001 |
Transdermal patch |
A04AA02 |
25.4.2012 |
|||||
20.4.2012 |
Zoledronic acid Actavis |
zoledronic acid |
|
EU/1/12/759/001-003 |
Concentrate for solution for infusion |
M05BA08 |
26.4.2012 |
|||||
24.4.2012 |
Signifor |
pasireotide |
|
EU/1/12/753/001-012 |
Solution for injection |
H01CB05 |
27.4.2012 |
— 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 |
|||||||
3.4.2012 |
Kinzalkomb |
|
EU/1/02/214/001-015 |
5.4.2012 |
|||||||
4.4.2012 |
Humira |
|
EU/1/03/256/001-010 |
10.4.2012 |
|||||||
4.4.2012 |
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 |
11.4.2012 |
|||||||
4.4.2012 |
Rebetol |
|
EU/1/99/107/001-005 |
11.4.2012 |
|||||||
4.4.2012 |
Telzir |
|
EU/1/04/282/001-002 |
11.4.2012 |
|||||||
10.4.2012 |
Vedrop |
|
EU/1/09/533/001-003 |
12.4.2012 |
|||||||
13.4.2012 |
Advagraf |
|
EU/1/07/387/001-026 |
17.4.2012 |
|||||||
13.4.2012 |
alli |
|
EU/1/07/401/007-016 |
17.4.2012 |
|||||||
13.4.2012 |
Champix |
|
EU/1/06/360/001-013 |
17.4.2012 |
|||||||
13.4.2012 |
Evoltra |
|
EU/1/06/334/001-005 |
17.4.2012 |
|||||||
13.4.2012 |
Foscan |
|
EU/1/01/197/003-005 |
17.4.2012 |
|||||||
13.4.2012 |
Pradaxa |
|
EU/1/08/442/001-014 |
17.4.2012 |
|||||||
13.4.2012 |
Prometax |
|
EU/1/98/092/001-026 |
17.4.2012 |
|||||||
13.4.2012 |
Revatio |
|
EU/1/05/318/001 |
17.4.2012 |
|||||||
13.4.2012 |
Revlimid |
|
EU/1/07/391/001-004 |
17.4.2012 |
|||||||
13.4.2012 |
Soliris |
|
EU/1/07/393/001 |
17.4.2012 |
|||||||
13.4.2012 |
Tyverb |
|
EU/1/07/440/001-006 |
17.4.2012 |
|||||||
13.4.2012 |
Viramune |
|
EU/1/97/055/001-009 |
17.4.2012 |
|||||||
13.4.2012 |
Volibris |
|
EU/1/08/451/001-004 |
17.4.2012 |
|||||||
20.4.2012 |
Abraxane |
|
EU/1/07/428/001 |
24.4.2012 |
|||||||
20.4.2012 |
Aclasta |
|
EU/1/05/308/001-002 |
25.4.2012 |
|||||||
20.4.2012 |
Aflunov |
|
EU/1/10/658/001-002 |
26.4.2012 |
|||||||
20.4.2012 |
Altargo |
|
EU/1/07/390/001-004 |
26.4.2012 |
|||||||
20.4.2012 |
Apidra |
|
EU/1/04/285/001-036 |
26.4.2012 |
|||||||
20.4.2012 |
Ceplene |
|
EU/1/08/477/001 |
24.4.2012 |
|||||||
20.4.2012 |
Circadin |
|
EU/1/07/392/001-003 |
25.4.2012 |
|||||||
20.4.2012 |
Exelon |
|
EU/1/98/066/001-026 |
26.3.2012 |
|||||||
20.4.2012 |
Focetria |
|
EU/1/07/385/001-002 EU/1/07/385/004 |
26.4.2012 |
|||||||
20.4.2012 |
HALAVEN |
|
EU/1/11/678/001-002 |
25.4.2012 |
|||||||
20.4.2012 |
Helixate NexGen |
|
EU/1/00/144/001-005 |
25.4.2012 |
|||||||
20.4.2012 |
Humira |
|
EU/1/03/256/002-010 |
25.4.2012 |
|||||||
20.4.2012 |
Insulin Human Winthrop |
|
EU/1/06/368/001-015 EU/1/06/368/020-024 EU/1/06/368/029-033 EU/1/06/368/037-042 EU/1/06/368/047-051 EU/1/06/368/056-057 EU/1/06/368/088-102 EU/1/06/368/113-150 EU/1/06/368/163-168 |
25.4.2012 |
|||||||
20.4.2012 |
Insuman |
|
EU/1/97/030/028-195 |
26.4.2012 |
|||||||
20.4.2012 |
IOA |
|
EU/1/11/689/001-002 |
24.4.2012 |
|||||||
20.4.2012 |
Iressa |
|
EU/1/09/526/001-002 |
26.4.2012 |
|||||||
20.4.2012 |
Kogenate Bayer |
|
EU/1/00/143/004-013 |
25.4.2012 |
|||||||
20.4.2012 |
Lantus |
|
EU/1/00/134/001-037 |
25.4.2012 |
|||||||
20.4.2012 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-008 |
26.4.2012 |
|||||||
20.4.2012 |
NovoNorm |
|
EU/1/98/076/004-006 EU/1/98/076/011-013 EU/1/98/076/018-020 EU/1/98/076/022-024 |
26.3.2012 |
|||||||
20.4.2012 |
Opgenra |
|
EU/1/08/489/001-002 |
24.4.2012 |
|||||||
20.4.2012 |
Optimark |
|
EU/1/07/398/001-014 |
26.3.2012 |
|||||||
20.4.2012 |
Optisulin |
|
EU/1/00/133/001-032 |
25.4.2012 |
|||||||
20.4.2012 |
Pelzont |
|
EU/1/08/460/001-014 |
25.4.2012 |
|||||||
20.4.2012 |
Prandin |
|
EU/1/00/162/003-005 EU/1/00/162/009-011 EU/1/00/162/015-017 EU/1/00/162/019-021 |
26.4.2012 |
|||||||
20.4.2012 |
Preotact |
|
EU/1/06/339/001-003 |
25.4.2012 |
|||||||
20.4.2012 |
Prolia |
|
EU/1/10/618/001-004 |
24.4.2012 |
|||||||
20.4.2012 |
ProQuad |
|
EU/1/05/323/001-013 |
26.4.2012 |
|||||||
20.4.2012 |
Rasilamlo |
|
EU/1/11/686/001-056 |
24.4.2012 |
|||||||
20.4.2012 |
Rasilez |
|
EU/1/07/405/001-040 |
24.4.2012 |
|||||||
20.4.2012 |
Riprazo |
|
EU/1/07/409/001-040 |
24.4.2012 |
|||||||
20.4.2012 |
Riprazo HCT |
|
EU/1/11/680/001-080 |
24.4.2012 |
|||||||
20.4.2012 |
Samsca |
|
EU/1/09/539/001-004 |
24.4.2012 |
|||||||
20.4.2012 |
Sebivo |
|
EU/1/07/388/001-003 |
26.4.2012 |
|||||||
20.4.2012 |
Silodyx |
|
EU/1/09/607/001-014 |
24.4.2012 |
|||||||
20.4.2012 |
Sprimeo |
|
EU/1/07/407/001-040 |
24.4.2012 |
|||||||
20.4.2012 |
Sprimeo HCT |
|
EU/1/11/683/001-080 |
24.4.2012 |
|||||||
20.4.2012 |
Tracleer |
|
EU/1/02/220/001-006 |
26.4.2012 |
|||||||
20.4.2012 |
Tredaptive |
|
EU/1/08/459/001-014 |
25.4.2012 |
|||||||
20.4.2012 |
Trevaclyn |
|
EU/1/08/458/001-014 |
25.4.2012 |
|||||||
20.4.2012 |
Urorec |
|
EU/1/09/608/001-014 |
24.4.2012 |
|||||||
20.4.2012 |
Ventavis |
|
EU/1/03/255/001-008 |
26.4.2012 |
|||||||
20.4.2012 |
Vfend |
|
EU/1/02/212/001-026 |
25.4.2012 |
|||||||
20.4.2012 |
Victoza |
|
EU/1/09/529/001-005 |
24.4.2012 |
|||||||
20.4.2012 |
Vidaza |
|
EU/1/08/488/001 |
24.4.2012 |
|||||||
20.4.2012 |
Xenical |
|
EU/1/98/071/001-006 |
24.4.2012 |
|||||||
20.4.2012 |
Yttriga |
|
EU/1/05/322/001-002 |
26.4.2012 |
|||||||
20.4.2012 |
Zoely |
|
EU/1/11/690/001-002 |
24.4.2012 |
|||||||
24.4.2012 |
Menveo |
|
EU/1/10/614/001-003 |
27.4.2012 |
|||||||
24.4.2012 |
Rasilez HCT |
|
EU/1/08/491/001-080 |
27.4.2012 |
|||||||
24.4.2012 |
Temomedac |
|
EU/1/09/605/001-012 |
27.4.2012 |
|||||||
26.4.2012 |
Revolade |
|
EU/1/10/612/001-006 |
30.4.2012 |
|||||||
26.4.2012 |
Yervoy |
|
EU/1/11/698/001-002 |
30.4.2012 |
— 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 |
|||||
20.4.2012 |
PhotoBarr |
|
EU/1/04/272/001-002 |
25.4.2012 |
|||||
24.4.2012 |
Refludan |
|
EU/1/97/035/001-004 |
27.4.2012 |
— 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 |
|||||
10.4.2012 |
Slentrol |
|
EU/2/07/071/001-003 |
12.4.2012 |
|||||
13.4.2012 |
Cerenia |
|
EU/2/06/062/005 |
17.4.2012 |
|||||
20.4.2012 |
BTVPUR AlSap 1 |
|
EU/2/10/112/001-005 |
25.4.2012 |
|||||
20.4.2012 |
BTVPUR AlSap 1-8 |
|
EU/2/10/113/001-005 |
25.4.2012 |
|||||
20.4.2012 |
Loxicom |
|
EU/2/08/090/001-027 |
24.4.2012 |
|||||
20.4.2012 |
Meloxivet |
|
EU/2/07/077/001-005 |
25.4.2012 |
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.
25.5.2012 |
EN |
Official Journal of the European Union |
C 148/12 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 2012
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2012/C 148/02
— 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 |
24.4.2012 |
Orlistat |
See Annex I |
See Annex I |
26.4.2012 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX I
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Member State /EEA |
Marketing Authorisation Holder |
Invented name |
Strength |
Pharmaceutical Form |
Route of administration |
|||||||
Belgium |
|
Orlistat EG |
60 mg |
capsule, hard |
oral use |
|||||||
Belgium |
|
Orlistat EG |
120 mg |
capsule, hard |
oral use |
|||||||
Belgium |
|
Orlistat Polpharma |
60 mg |
capsule, hard |
oral use |
|||||||
Belgium |
|
Orlistat Polpharma |
120 mg |
capsule, hard |
oral use |
|||||||
Belgium |
|
Orlistat Sandoz |
60 mg |
capsule, hard |
oral use |
|||||||
Belgium |
|
Orlistat Sandoz |
120 mg |
capsule, hard |
oral use |
|||||||
Bulgaria |
|
Orlistat Polpharma |
60 mg |
capsule, hard |
oral use |
|||||||
Bulgaria |
|
Orlistat Polpharma |
120 mg |
capsule, hard |
oral use |
|||||||
Bulgaria |
|
Orlistat Teva |
60 mg |
capsule, hard |
oral use |
|||||||
Bulgaria |
|
Orlistat Teva |
120 mg |
capsule, hard |
oral use |
|||||||
Czech Republic |
|
Orlistat Sandoz 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
Czech Republic |
|
Orlistat Sandoz 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
Czech Republic |
|
Orlistat Teva 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
Czech Republic |
|
Orlistat Teva 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
Denmark |
|
Orlistat "Sandoz" |
60 mg |
capsule, hard |
oral use |
|||||||
Denmark |
|
Orlistat "Teva" |
60 mg |
capsule, hard |
oral use |
|||||||
Denmark |
|
Orlistat "Teva" |
120 mg |
capsule, hard |
oral use |
|||||||
Estonia |
|
ORLISTAT TEVA 60 MG |
60 mg |
capsule, hard |
oral use |
|||||||
Estonia |
|
ORLISTAT TEVA 120 MG |
120 mg |
capsule, hard |
oral use |
|||||||
Estonia |
|
ORLISTAT POLPHARMA 60 MG |
60 mg |
capsule, hard |
oral use |
|||||||
Estonia |
|
ORLISTAT POLPHARMA 120 MG |
120 mg |
capsule, hard |
oral use |
|||||||
Estonia |
|
ORLISTAT SANDOZ 60 MG |
60 mg |
capsule, hard |
oral use |
|||||||
Estonia |
|
ORLISTAT SANDOZ 120 MG |
120 mg |
capsule, hard |
oral use |
|||||||
Finland |
|
Orlistat ratiopharm |
120 mg |
capsule, hard |
oral use |
|||||||
Finland |
|
Orlistat ratiopharm |
60 mg |
capsule, hard |
oral use |
|||||||
Finland |
|
Orlistat Sandoz |
60 mg |
capsule, hard |
oral use |
|||||||
Finland |
|
Orlistat Stada |
120 mg |
capsule, hard |
oral use |
|||||||
Finland |
|
Orlistat Stada |
60 mg |
capsule, hard |
oral use |
|||||||
France |
|
ORLISTAT SANDOZ 120 mg, gélule |
120 mg |
capsule, hard |
oral use |
|||||||
France |
|
ORLISTAT SANDOZ 60 mg, gélule |
60 mg |
capsule, hard |
oral use |
|||||||
France |
|
ORLISTAT EG 120 mg, gélule |
120 mg |
capsule, hard |
oral use |
|||||||
France |
|
ORLISTAT EG 60 mg, gélule |
60 mg |
capsule, hard |
oral use |
|||||||
France |
|
ORLISTAT TEVA 120 mg, gélule |
120 mg |
capsule, hard |
oral use |
|||||||
France |
|
ORLISTAT TEVA 60 mg, gélule |
60 mg |
capsule, hard |
oral use |
|||||||
Germany |
|
Orlistat AL 60 mg Hartkapseln |
60 mg |
capsule, hard |
oral use |
|||||||
Germany |
|
Orlistat HEXAL 120 mg Hartkapseln |
120 mg |
capsule, hard |
oral use |
|||||||
Germany |
|
Orlistat HEXAL 60 mg Hartkapseln |
60 mg |
capsule, hard |
oral use |
|||||||
Germany |
|
Orlistat-ratiopharm 120 mg Hartkapseln |
120 mg |
capsule, hard |
oral use |
|||||||
Germany |
|
Orlistat-ratiopharm 60 mg Hartkapseln |
60 mg |
capsule, hard |
oral use |
|||||||
Italy |
|
ORLSTAT EUROGENERICI |
60 mg |
capsule, hard |
oral use |
|||||||
Italy |
|
ORLISTAT EG |
120 mg |
capsule, hard |
oral use |
|||||||
Latvia |
|
Orlistat Sandoz |
60 mg |
capsule, hard |
oral use |
|||||||
Latvia |
|
Orlistat Sandoz |
120 mg |
capsule, hard |
oral use |
|||||||
Latvia |
|
Orlistat Polpharma |
60 mg |
capsule, hard |
oral use |
|||||||
Latvia |
|
Orlistat Polpharma |
120 mg |
capsule, hard |
oral use |
|||||||
Latvia |
|
Orlistat Teva |
60 mg |
capsule, hard |
oral use |
|||||||
Latvia |
|
Orlistat Teva |
120 mg |
capsule, hard |
oral use |
|||||||
Lithuania |
|
Orlistat Teva |
60 mg |
capsule, hard |
oral use |
|||||||
Lithuania |
|
Orlistat Teva |
120 mg |
capsule, hard |
oral use |
|||||||
Lithuania |
|
Orlistat Sandoz |
120 mg |
capsule, hard |
oral use |
|||||||
Lithuania |
|
Orlistat Sandoz |
60 mg |
capsule, hard |
oral use |
|||||||
Lithuania |
|
Orlistat Polpharma |
60 mg |
capsule, hard |
oral use |
|||||||
Lithuania |
|
Orlistat Polpharma |
120 mg |
capsule, hard |
oral use |
|||||||
Norway |
|
Orlistat Teva |
60 mg |
capsule, hard |
oral use |
|||||||
Norway |
|
Orlistat Teva |
120 mg |
capsule, hard |
oral use |
|||||||
Norway |
|
Orlistat Sandoz |
60 mg |
capsule, hard |
oral use |
|||||||
Poland |
|
Orlistat Polpharma 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
Poland |
|
Orlistat Sandoz 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
Poland |
|
Orlistat STADA 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
Poland |
|
Orlistat Teva 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
Poland |
|
Orlistat Polpharma 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
Poland |
|
Orlistat Sandoz 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
Poland |
|
Orlistat STADA 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
Portugal |
|
Orlistato Ciclum |
60 mg |
capsule, hard |
oral use |
|||||||
Portugal |
|
Orlistato Ciclum |
120 mg |
capsule, hard |
oral use |
|||||||
Portugal |
|
Orlistato Ratiopharm |
60 mg |
capsule, hard |
oral use |
|||||||
Portugal |
|
Orlistato Ratiopharm |
120 mg |
capsule, hard |
oral use |
|||||||
Romania |
|
Sulixa |
60 mg |
capsule, hard |
oral use |
|||||||
Romania |
|
Orlistat Polpharma |
120 mg |
capsule, hard |
oral use |
|||||||
Slovak Republic |
|
Orlistat Teva 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
Slovak Republic |
|
Orlistat Teva 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
Slovak Republic |
|
Orlistat Polpharma 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
Slovak Republic |
|
Orlistat Polpharma 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
Sweden |
|
Orlistat Sandoz |
60 mg |
capsule, hard |
oral use |
|||||||
The Netherlands |
|
Orlistat Sandoz 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
The Netherlands |
|
Orlistat Sandoz 120 mg |
120 mg |
capsule, hard |
oral use |
|||||||
United Kingdom |
|
TEVA UK Orlistat capsules 60 mg |
60 mg |
capsule, hard |
oral use |
|||||||
United Kingdom |
|
TEVA UK Orlistat capsules 120 mg |
120 mg |
capsule, hard |
oral use |