ISSN 1977-091X doi:10.3000/1977091X.C_2012.264.eng |
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Official Journal of the European Union |
C 264 |
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English edition |
Information and Notices |
Volume 55 |
Notice No |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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2012/C 264/01 |
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2012/C 264/02 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
31.8.2012 |
EN |
Official Journal of the European Union |
C 264/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 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 264/01
— 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 |
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20.7.2012 |
Bretaris Genuair |
aclidinium bromide |
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EU/1/12/781/001-003 |
Inhalation powder |
R03BB05 |
25.7.2012 |
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20.7.2012 |
Eklira Genuair |
aclidinium bromide |
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EU/1/12/778/001-003 |
Inhalation powder |
R03BB05 |
25.7.2012 |
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20.7.2012 |
Jentadueto |
linagliptin/metformin hydrochloride |
|
EU/1/12/780/001-028 |
Film-coated tablet |
A10BD11 |
25.7.2012 |
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23.7.2012 |
Fycompa |
Perampanel |
|
EU/1/12/776/001-016 |
Film-coated tablet |
N03AX22 |
25.7.2012 |
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23.7.2012 |
Kalydeco |
ivacaftor |
|
EU/1/12/782/001-002 |
Film-coated tablet |
Pending |
25.7.2012 |
— 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 |
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3.7.2012 |
Insuman |
|
EU/1/97/030/028-201 |
5.7.2012 |
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3.7.2012 |
Kinzalkomb |
|
EU/1/02/214/001-015 |
5.7.2012 |
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3.7.2012 |
MicardisPlus |
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EU/1/02/213/001-023 |
5.7.2012 |
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3.7.2012 |
Prevenar 13 |
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EU/1/09/590/001-006 |
5.7.2012 |
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4.7.2012 |
Arixtra |
|
EU/1/02/206/001-035 |
6.7.2012 |
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4.7.2012 |
Iasibon |
|
EU/1/10/659/001-010 |
6.7.2012 |
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4.7.2012 |
Potactasol |
|
EU/1/10/660/001-002 |
6.7.2012 |
||
6.7.2012 |
Ganfort |
|
EU/1/06/340/001-002 |
10.7.2012 |
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6.7.2012 |
Olazax |
|
EU/1/09/597/001-005 |
10.7.2012 |
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6.7.2012 |
Simulect |
|
EU/1/98/084/001-002 |
10.7.2012 |
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6.7.2012 |
Trizivir |
|
EU/1/00/156/002-004 |
10.7.2012 |
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12.7.2012 |
Edarbi |
|
EU/1/11/734/001-018 |
17.7.2012 |
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12.7.2012 |
Ipreziv |
|
EU/1/11/735/001-018 |
17.7.2012 |
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16.7.2012 |
Olanzapine Glenmark |
|
EU/1/09/587/001-017 |
18.7.2012 |
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20.7.2012 |
Arzerra |
|
EU/1/10/625/001 EU/1/10/625/003 |
24.7.2012 |
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20.7.2012 |
Avamys |
|
EU/1/07/434/001-003 |
24.7.2012 |
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20.7.2012 |
BeneFIX |
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EU/1/97/047/004-007 |
25.7.2012 |
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20.7.2012 |
Celsentri |
|
EU/1/07/418/001-010 |
25.7.2012 |
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20.7.2012 |
Cyanokit |
|
EU/1/07/420/001-002 |
25.7.2012 |
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20.7.2012 |
InductOs |
|
EU/1/02/226/001 |
25.7.2012 |
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20.7.2012 |
Intelence |
|
EU/1/08/468/001-002 |
24.7.2012 |
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23.7.2012 |
Afinitor |
|
EU/1/09/538/001-008 |
25.7.2012 |
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23.7.2012 |
Alimta |
|
EU/1/04/290/001-002 |
27.7.2012 |
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23.7.2012 |
Bridion |
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EU/1/08/466/001-002 |
25.7.2012 |
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23.7.2012 |
Cayston |
|
EU/1/09/543/001-002 |
25.7.2012 |
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23.7.2012 |
Epivir |
|
EU/1/96/015/001-005 |
27.7.2012 |
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23.7.2012 |
Eucreas |
|
EU/1/07/425/001-018 |
25.7.2012 |
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23.7.2012 |
Galvus |
|
EU/1/07/414/001-010 EU/1/07/414/018 |
27.7.2012 |
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23.7.2012 |
Humira |
|
EU/1/03/256/001-010 |
27.7.2012 |
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23.7.2012 |
Ketek |
|
EU/1/01/191/001-005 |
25.7.2012 |
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23.7.2012 |
Lumigan |
|
EU/1/02/205/001-004 |
25.7.2012 |
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23.7.2012 |
Oslif Breezhaler |
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EU/1/09/586/001-010 |
25.7.2012 |
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26.7.2012 |
Celvapan |
|
EU/1/08/506/001 |
30.7.2012 |
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26.7.2012 |
Esmya |
|
EU/1/12/750/001 |
30.7.2012 |
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26.7.2012 |
Evicel |
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EU/1/08/473/001-003 |
30.7.2012 |
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26.7.2012 |
Grepid |
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EU/1/09/535/001-016 |
30.7.2012 |
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26.7.2012 |
Onbrez Breezhaler |
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EU/1/09/593/001-010 |
30.7.2012 |
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26.7.2012 |
Pradaxa |
|
EU/1/08/442/001-016 |
30.7.2012 |
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26.7.2012 |
Silapo |
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EU/1/07/432/001-022 |
30.7.2012 |
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26.7.2012 |
Votubia |
|
EU/1/11/710/001-007 |
30.7.2012 |
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26.7.2012 |
Zalasta |
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EU/1/07/415/001-056 |
30.7.2012 |
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31.7.2012 |
Enbrel |
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EU/1/99/126/001-022 |
3.8.2012 |
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31.7.2012 |
Isentress |
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EU/1/07/436/001-002 |
3.8.2012 |
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31.7.2012 |
NovoRapid |
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EU/1/99/119/001 EU/1/99/119/003 EU/1/99/119/005-015 EU/1/99/119/017-023 |
3.8.2012 |
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31.7.2012 |
Tyverb |
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EU/1/07/440/001-007 |
2.8.2012 |
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31.7.2012 |
Victrelis |
|
EU/1/11/704/001-002 |
3.8.2012 |
— 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 |
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4.7.2012 |
Sprimeo |
|
EU/1/07/407/001-040 |
6.7.2012 |
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6.7.2012 |
Sprimeo HCT |
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EU/1/11/683/001-080 |
10.7.2012 |
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16.7.2012 |
Regranex |
|
EU/1/99/101/001 |
18.7.2012 |
— 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 |
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16.7.2012 |
Nobivac L4 |
— |
|
EU/2/12/143/001-005 |
Suspension for injection |
QI07AB01 |
18.7.2012 |
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23.7.2012 |
Cardalis |
Benazepril hydrochloride, Spironolactone |
|
EU/2/12/142/001-006 |
Tablet |
QC09BA07 |
25.7.2012 |
— 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 |
||
4.7.2012 |
Proteq West Nile |
|
EU/2/11/129/001-004 |
6.7.2012 |
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6.7.2012 |
Vaxxitek HVT+ IBD |
|
EU/2/02/032/001-002 |
10.7.2012 |
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12.7.2012 |
Ingelvac CircoFLEX |
|
EU/2/07/079/001-008 |
17.7.2012 |
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12.7.2012 |
Novem |
|
EU/2/04/042/001-014 |
17.7.2012 |
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20.7.2012 |
ProMeris |
|
EU/2/06/064/001-004 |
25.7.2012 |
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20.7.2012 |
ProMeris Duo |
|
EU/2/06/065/001-010 |
25.7.2012 |
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.
(2) OJ L 136, 30.4.2004, p. 1.
31.8.2012 |
EN |
Official Journal of the European Union |
C 264/9 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2012/C 264/02
— 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 |
31.7.2012 |
Tavanic and associated names |
See Annex I |
See Annex I |
2.8.2012 |
— Refusal of 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 |
6.7.2012 |
Ethinylestradiol-Drospirenone 24 + 4 and associated names |
See Annex II |
See Annex II |
10.7.2012 |
(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, 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 |
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Austria |
|
Tavanic 250 mg Filmtabletten |
250 mg |
Film-coated tablets |
Oral use |
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Austria |
|
Tavanic 500 mg Filmtabletten |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Austria |
|
Tavanic Infusionsflasche |
5 mg/ml |
Solution for infusion |
Intravenous use |
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Belgium |
|
Tavanic 250 mg filmomhulde tabletten |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Belgium |
|
Tavanic 500 mg filmomhulde tabletten |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Belgium |
|
Tavanic 5 mg/ml oplossing voor infusie |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Bulgaria |
|
Tavanic |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Bulgaria |
|
Tavanic |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Bulgaria |
|
Tavanic |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Cyprus |
|
Tavanic |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Cyprus |
|
Tavanic |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Cyprus |
|
Tavanic |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Czech Republic |
|
Tavanic i.v. |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Estonia |
|
Tavanic |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Estonia |
|
Tavanic |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Estonia |
|
Tavanic |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Finland |
|
Tavanic |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Finland |
|
Tavanic |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Finland |
|
Tavanic |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
France |
|
TAVANIC 250 mg comprimé pelliculé sécable |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
France |
|
TAVANIC 500 mg comprimé pelliculé sécable |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
France |
|
TAVANIC 5 mg/ml solution pour perfusion |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Germany |
|
Tavanic 250 mg Filmtabletten |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Germany |
|
Tavanic 500 mg Filmtabletten |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Germany |
|
Tavanic 5 mg/ml Infusionslösung |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Greece |
|
Tavanic |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Greece |
|
Tavanic |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Greece |
|
Tavanic |
5 mg/1 ml |
Solution for infusion |
Intravenous use |
||||||||||
Hungary |
|
Tavanic |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Hungary |
|
Tavanic |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Hungary |
|
Tavanic |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Ireland |
|
Tavanic 250 mg film-coated tablets |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Ireland |
|
Tavanic 500 mg film-coated tablets |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Ireland |
|
Tavanic 5 mg/ml solution for infusion |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Italy |
|
TAVANIC |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Italy |
|
TAVANIC |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Italy |
|
TAVANIC |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Lithuania |
|
Tavanic |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Lithuania |
|
Tavanic |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Lithuania |
|
Tavanic |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Luxembourg |
|
Tavanic 250 mg comprimés pelliculés |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Luxembourg |
|
Tavanic 500 mg comprimés pelliculés |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Luxembourg |
|
Tavanic 5 mg/ml solution pour perfusion |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Malta |
|
Tavanic 250 mg film coated tablets |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Malta |
|
Tavanic 500 mg film coated tablets |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Malta |
|
Tavanic 5 mg/ml solution for infusion |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Netherlands |
|
Tavanic 250 |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Netherlands |
|
Tavanic 500 |
500 mg |
Film-coated tablet |
Oral use |
||||||||||
Netherlands |
|
Tavanic IV |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Poland |
|
Tavanic 250 |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Poland |
|
Tavanic 500 |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Poland |
|
Tavanic |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Portugal |
|
TAVANIC |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Portugal |
|
TAVANIC |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Portugal |
|
TAVANIC |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Slovak Republic |
|
Tavanic 500 mg |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Slovak Republic |
|
Tavanic i.v. 500 mg |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Slovenia |
|
Tavanic 250 mg filmsko obložene tablete |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Slovenia |
|
Tavanic 500 mg filmsko obložene tablete |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Slovenia |
|
Tavanic 5 mg/ml raztopina za infundiranje |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Spain |
|
Tavanic 500 mg comprimidos recubiertos con película |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Spain |
|
Tavanic 5 mg/ml solución para perfusión |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
Sweden |
|
Tavanic |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
Sweden |
|
Tavanic |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
Sweden |
|
Tavanic |
5 mg/ml |
Solution for infusion |
Intravenous use |
||||||||||
United Kingdom |
(Trading as:
|
Tavanic 250 mg film-coated tablets |
250 mg |
Film-coated tablets |
Oral use |
||||||||||
United Kingdom |
(Trading as:
|
Tavanic 500 mg film-coated tablets |
500 mg |
Film-coated tablets |
Oral use |
||||||||||
United Kingdom |
(Trading as:
|
Tavanic 5 mg/ml solution for infusion |
5 mg/ml |
Solution for infusion |
Intravenous use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT(S), ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Member State EU/EEA |
Marketing authorisaton holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
|||||
Austria |
|
Eloine 0,02 mg/3 mg Filmtabletten |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Bulgaria |
|
ELOINE |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Cyprus |
|
LINATERA FC TABLETS |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Czech Republic |
|
ELOINE 0,02 MG/3 MG POTAHOVANÉ TABLETY |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Denmark |
|
Eloine |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Finland |
|
Linatera |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
France |
|
RIMENDIA 0,02 mg/3 mg comprimé pelliculé |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Germany |
|
Eloine 0,02 mg/3 mg Filmtabletten |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Greece |
|
LINATERA |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Iceland |
|
Eloine |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Italy |
|
ELOINE |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Malta |
|
ELOINE 0.02 mg/3 mg film coated tablets |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Norway |
|
Eloine |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Poland |
|
Linatera |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Portugal |
|
Linatera |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Slovak Republic |
|
Linatera |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Slovenia |
|
Linatera 0,02 mg/3 mg filmsko obložene tablete |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Spain |
|
ELOINE 0,02 mg/3 mg comprimidos recubiertos con película |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
Sweden |
|
Eloine |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
The Netherlands |
|
Ethinylestradiol/Drospirenon 24 + 4 0,02 mg/3 mg Berlipharm, filmomhulde tabletten |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |
|||||
United Kingdom |
|
ELOINE Film-Coated Tablets 0.02 mg/3 mg |
0,02 mg/3 mg |
Film-coated tablet |
Oral use |