ISSN 1977-091X doi:10.3000/1977091X.C_2012.328.eng |
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Official Journal of the European Union |
C 328 |
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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 328/01 |
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2012/C 328/02 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
26.10.2012 |
EN |
Official Journal of the European Union |
C 328/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 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 328/01
— 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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3.9.2012 |
Inlyta |
Axitinib |
|
EU/1/12/777/001-006 |
Film-coated tablet |
L01XE17 |
5.9.2012 |
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3.9.2012 |
NovoThirteen |
catridecacog |
|
EU/1/12/775/001 |
Powder and solvent for solution for injection |
B02BD11 |
5.9.2012 |
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20.9.2012 |
Dacogen |
Decitabine |
|
EU/1/12/792/001 |
powder for concentrate for solution for infusion |
L01BC08 |
24.9.2012 |
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28.9.2012 |
Enurev Breezhaler |
glycopyrronium bromide |
|
EU/1/12/789/001-006 |
Inhalation powder, hard capsule |
R03BB06 |
3.10.2012 |
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28.9.2012 |
Seebri Breezhaler |
glycopyrronium bromide |
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EU/1/12/788/001-006 |
Inhalation powder, hard capsule |
R03BB06 |
3.10.2012 |
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28.9.2012 |
Tovanor Breezhaler |
glycopyrronium bromide |
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EU/1/12/790/001-006 |
Inhalation powder, hard capsule |
R03BB06 |
3.10.2012 |
— 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 |
||
10.9.2012 |
Advate |
|
EU/1/03/271/007-010 |
12.9.2012 |
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10.9.2012 |
Cialis |
|
EU/1/02/237/001-009 |
12.9.2012 |
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10.9.2012 |
Entacapone Teva |
|
EU/1/10/665/001-004 |
12.9.2012 |
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10.9.2012 |
JEVTANA |
|
EU/1/11/676/001 |
12.9.2012 |
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10.9.2012 |
Levetiracetam ratiopharm |
|
EU/1/11/702/001-031 |
12.9.2012 |
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10.9.2012 |
Norvir |
|
EU/1/96/016/001 EU/1/96/016/003-008 |
12.9.2012 |
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10.9.2012 |
Orgalutran |
|
EU/1/00/130/001-002 |
12.9.2012 |
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10.9.2012 |
Ozurdex |
|
EU/1/10/638/001 |
12.9.2012 |
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10.9.2012 |
Rasilamlo |
|
EU/1/11/686/001-056 |
12.9.2012 |
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10.9.2012 |
Rasitrio |
|
EU/1/11/730/001-060 |
12.9.2012 |
||
10.9.2012 |
Revlimid |
|
EU/1/07/391/001-006 |
12.9.2012 |
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10.9.2012 |
Sildenafil Teva |
|
EU/1/09/584/002-006 EU/1/09/584/008-012 EU/1/09/584/014-018 |
12.9.2012 |
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10.9.2012 |
Simponi |
|
EU/1/09/546/001-004 |
12.9.2012 |
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10.9.2012 |
Somavert |
|
EU/1/02/240/001-004 |
12.9.2012 |
||
10.9.2012 |
Tamiflu |
|
EU/1/02/222/001-005 |
12.9.2012 |
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10.9.2012 |
Trobalt |
|
EU/1/11/681/001-013 |
12.9.2012 |
||
10.9.2012 |
Xelevia |
|
EU/1/07/382/001-018 |
12.9.2012 |
||
11.9.2012 |
Clopidogrel ratiopharm |
|
EU/1/09/554/001-008 |
13.9.2012 |
||
11.9.2012 |
Docetaxel Teva |
|
EU/1/09/611/001-002 |
13.9.2012 |
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12.9.2012 |
Clopidogrel Krka |
|
EU/1/09/556/001-011 |
14.9.2012 |
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12.9.2012 |
Clopidogrel Krka d.d. |
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EU/1/09/562/001-009 |
14.9.2012 |
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12.9.2012 |
Clopidogrel TAD |
|
EU/1/09/555/001-009 |
14.9.2012 |
||
17.9.2012 |
Atripla |
|
EU/1/07/430/001-002 |
19.9.2012 |
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17.9.2012 |
Cervarix |
|
EU/1/07/419/001-012 |
19.9.2012 |
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17.9.2012 |
Clopidogrel ratiopharm GmbH |
|
EU/1/09/541/001-008 |
19.9.2012 |
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17.9.2012 |
Glubrava |
|
EU/1/07/421/001-009 |
19.9.2012 |
||
17.9.2012 |
Levetiracetam Accord |
|
EU/1/11/712/001-040 |
19.9.2012 |
||
17.9.2012 |
Replagal |
|
EU/1/01/189/001-006 |
19.9.2012 |
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20.9.2012 |
Azarga |
|
EU/1/08/482/001-002 |
24.9.2012 |
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20.9.2012 |
Leflunomide ratiopharm |
|
EU/1/10/654/001-004 |
24.9.2012 |
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20.9.2012 |
Mircera |
|
EU/1/07/400/008-013 EU/1/07/400/017-024 |
24.9.2012 |
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20.9.2012 |
Olanzapine Apotex |
|
EU/1/10/635/001-018 |
24.9.2012 |
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20.9.2012 |
Optaflu |
|
EU/1/07/394/001-009 |
24.9.2012 |
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20.9.2012 |
Prialt |
|
EU/1/04/302/001-004 |
24.9.2012 |
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20.9.2012 |
Sutent |
|
EU/1/06/347/001-008 |
24.9.2012 |
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20.9.2012 |
Tasigna |
|
EU/1/07/422/001-012 |
24.9.2012 |
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20.9.2012 |
Tesavel |
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EU/1/07/435/001-018 |
24.9.2012 |
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20.9.2012 |
Torisel |
|
EU/1/07/424/001 |
24.9.2012 |
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20.9.2012 |
VELCADE |
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EU/1/04/274/001-002 |
24.10.2012 |
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20.9.2012 |
Xeloda |
|
EU/1/00/163/001-002 |
24.9.2012 |
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24.9.2012 |
alli |
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EU/1/07/401/007-016 |
26.9.2012 |
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24.9.2012 |
Elaprase |
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EU/1/06/365/001-003 |
26.9.2012 |
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24.9.2012 |
Komboglyze |
|
EU/1/11/731/004-005 EU/1/11/731/010-011 EU/1/11/731/013-014 |
24.9.2012 |
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24.9.2012 |
Nevanac |
|
EU/1/07/433/001 |
26.9.2012 |
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24.9.2012 |
PecFent |
|
EU/1/10/644/001-006 |
27.9.2012 |
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24.9.2012 |
Pramipexole Accord |
|
EU/1/11/728/001-010 |
24.9.2012 |
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24.9.2012 |
Revasc |
|
EU/1/97/043/001-003 |
26.9.2012 |
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24.9.2012 |
Torisel |
|
EU/1/07/424/001 |
26.9.2012 |
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24.9.2012 |
Xenical |
|
EU/1/98/071/001-006 |
26.9.2012 |
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28.9.2012 |
Irbesartan Zentiva |
|
EU/1/06/376/001-039 |
3.10.2012 |
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28.9.2012 |
Matever |
|
EU/1/11/711/001-030 |
3.10.2012 |
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28.9.2012 |
Pegasys |
|
EU/1/02/221/001-016 |
3.10.2012 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
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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28.9.2012 |
Libertek |
|
– |
4.10.2012 |
— 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 |
||
10.9.2012 |
Rivastigmine Teva |
|
EU/1/09/513/001-020 |
12.9.2012 |
— 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 |
||
3.9.2012 |
BTVPUR AlSap 8 |
|
EU/2/09/094/001-005 |
5.9.2012 |
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10.9.2012 |
TruScient |
|
EU/2/11/136/001 |
12.9.2012 |
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10.9.2012 |
Veraflox |
|
EU/2/10/107/001-014 |
12.9.2012 |
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11.9.2012 |
Porcilis PCV |
|
EU/2/08/091/001-010 |
13.9.2012 |
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28.9.2012 |
SevoFlo |
|
EU/2/02/035/007 |
5.10.2012 |
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.
26.10.2012 |
EN |
Official Journal of the European Union |
C 328/8 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2012/C 328/02
— 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 |
17.9.2012 |
Nuflor 300 mg/ml |
See Annex I |
See Annex I |
18.9.2012 |
28.9.2012 |
Yvidually and associated names |
See Annex II |
See Annex II |
3.10.2012 |
11.9.2012 |
Mifepristone Linepharma and associated names |
See Annex III |
See Annex III |
13.9.2012 |
10.9.2012 |
Zinacef and associated names |
See Annex IV |
See Annex IV |
11.9.2012 |
3.9.2012 |
Trimetazidine |
See Annex V |
See Annex V |
4.9.2012 |
(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 FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
Member State EU/EEA |
Applicant |
Name |
Pharmaceutical form |
Strength |
Animal species |
Route of administration |
||||
Belgium |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
Denmark |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
France |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
Germany |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
Greece |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
Ireland |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
Italy |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
Luxembourg |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
The Netherlands |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
Portugal |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
Spain |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
||||
United Kingdom |
|
Nuflor 300 mg/ml solution for injection for cattle and sheep |
Solution for injection |
300 mg/ml |
Cattle and sheep |
Cattle – subcutaneous and intramuscular Sheep – intramuscular |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Member State EU/EEA |
Applicant |
Invented Name |
Strength |
Pharmaceutical form |
Route of administration |
||||
Austria |
|
Delivrie 0,02 mg/3 mg Filmtabletten |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Belgium |
|
Yvidually |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Bulgaria |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Cyprus |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Czech Republic |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Denmark |
|
Delivrie |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Estonia |
|
Yvidually |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Finland |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
France |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Germany |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Greece |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Hungary |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Iceland |
|
Delivrie |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Ireland |
|
Delivrie |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Italy |
|
Yvidually |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Latvia |
|
Yvidually 0,02 mg/3 mg apvalkotās tabletes |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Lithuania |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Luxembourg |
|
Delivrie |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Malta |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
The Netherlands |
|
Yvidually |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Norway |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Poland |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Portugal |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Romania |
|
Yvidually |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Slovak Republic |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Slovenia |
|
Flexyess |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Spain |
|
Delivrie |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
Sweden |
|
Delivrie |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
||||
United Kingdom |
|
Delivrie |
ethinylestradiol: 0.02 mg Drospirenone: 3 mg |
film-coated tablet |
Oral use |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Member State EU/EEA |
Marketing authorisation holder |
Applicant |
Name |
Strength |
Pharmaceutical form |
Route of administration |
|||
Denmark |
|
|
Mifepriston Linepharma |
200 mg |
Tablet |
Oral use |
|||
Finland |
|
|
Mifepristone Linepharma |
200 mg |
Tablet |
Oral use |
|||
France |
|
|
Mifepristone Linepharma 200 mg comprimé |
200 mg |
Tablet |
Oral use |
|||
Iceland |
|
|
Mifepristone Linepharma 200 mg Tafla |
200 mg |
Tablet |
Oral use |
|||
Norway |
|
|
Mifepristone Linepharma |
200 mg |
Tablet |
Oral use |
|||
Sweden |
|
|
Mifepristone Linepharma |
200 mg |
Tablet |
Oral use |
|||
United Kingdom |
|
|
Mifepristone Linepharma 200 mg tablet |
200 mg |
Tablet |
Oral use |
ANNEX IV
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 |
|
Curocef 1 500 mg - Trockenstechampullen |
1,5 g |
Powder for Injection or Infusion |
Intravenous Use |
Injection: 1,5 g/15 ml Infusion: 1,5 g/15 ml + 50 ml or 100 ml |
||||||
Austria |
|
Curocef 1 500 mg - Trockensubstanz zur Infusionsbereitung |
1,5 g |
Powder for Infusion |
Intravenous Use |
1,5 g/15 ml + 50 ml or 100 ml |
||||||
Austria |
|
Curocef 250 mg - Trockenstechamupllen |
250 mg |
Powder for Injection |
Intramuscular Use or Intravenous Use |
250 mg/1 ml or 250 mg/2-5 ml |
||||||
Austria |
|
Curocef 750 mg - Trockenstechampullen |
750 mg |
Powder for Injection |
Intramuscular Use or Intravenous Use |
750 mg/3 ml or 750 mg/6-10 ml |
||||||
Belgium |
|
Zinacef |
1,5 g |
Powder for Solution for Infusion |
Intravenous Use |
1,5 g 50 ml |
||||||
Belgium |
|
Zinacef |
1,5 g |
Powder for Solution for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Belgium |
|
Zinacef |
750 mg |
Powder for Solution for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Bulgaria |
|
Zinacef |
1,5 g |
Powder for Solution for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Bulgaria |
|
Zinacef |
750 mg |
Powder for Solution for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Bulgaria |
|
Zinacef |
750 mg |
Powder for Solution for Injection |
Intramuscular Use |
750 mg 3 ml |
||||||
Cyprus |
|
Zinacef |
1,5 g |
Powder for Infusion |
Intravenous Use |
1,5 g 50 ml |
||||||
Cyprus |
|
Zinacef |
1,5 g |
Powder for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Cyprus |
|
Zinacef |
750 mg |
Powder for Infusion |
Intravenous Use |
750 mg 6 ml |
||||||
Cyprus |
|
Zinacef |
750 mg |
Powder for Injection |
Intramuscular Use |
750 mg 3 ml |
||||||
Czech Republic |
|
Zinacef 1,5 g |
1,5 g |
Powder for Injection |
Intravenous Use |
1,5 g 50 ml |
||||||
Czech Republic |
|
Zinacef 1,5 g |
1,5 g |
Powder for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Czech Republic |
|
Zinacef 750 mg |
750 mg |
Powder for Injection |
Intramuscular Use |
750 mg 3 ml |
||||||
Czech Republic |
|
Zinacef 750 mg |
750 mg |
Powder for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Denmark |
|
Zinacef |
1,5 g |
Powder for Solution for Infusion |
Intravenous Use |
1,5 g 50 ml |
||||||
Denmark |
|
Zinacef |
1,5 g |
Powder for Solution for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Denmark |
|
Zinacef |
250 mg |
Powder for Solution for Injection |
Intramuscular Use |
250 mg 1 ml |
||||||
Denmark |
|
Zinacef |
250 mg |
Powder for Solution for Injection |
Intravenous Use |
250 mg 2 ml |
||||||
Denmark |
|
Zinacef |
750 mg |
Powder for Solution for Infusion |
Intramuscular Use |
750 mg 3 ml |
||||||
Denmark |
|
Zinacef |
750 mg |
Powder for Solution for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Estonia |
|
Zinacef |
1,5 g |
Powder for solution for injection |
Intravenous use, intramuscular use |
1,5 g |
||||||
Estonia |
|
Zinacef |
750 mg |
Powder for solution for injection |
Intravenous use, intramuscular use |
750 mg |
||||||
Finland |
|
Zinacef |
1,5 g |
Powder for solution/suspension for injection/infusion |
Intravenous Use |
1,5 g/15 ml |
||||||
Finland |
|
Zinacef |
1,5 g |
Powder for solution/suspension for injection/infusion |
Intravenous Use |
1,5 g/50-100 ml |
||||||
Finland |
|
Zinacef |
250 mg |
Powder for solution/suspension for injection |
Intramuscular Use |
250 mg/2 ml |
||||||
Finland |
|
Zinacef |
250 mg |
Powder for solution/suspension for injection/infusion |
Intravenous Use |
250 mg/2 ml |
||||||
Finland |
|
Zinacef |
750 mg |
Powder for solution/suspension for injection |
Intramuscular Use |
750 mg/3 ml |
||||||
Finland |
|
Zinacef |
750 mg |
Powder for solution/suspension for injection |
Intravenous Use |
750 mg/6 ml |
||||||
France |
|
Zinnat |
1,5 g |
Powder for solution for Infusion |
Intravenous Use |
1,5 g 50 ml |
||||||
France |
|
Zinnat |
250 mg |
Powder for solution for Injection |
Intravenous Use and Intramuscular use (Only one MA for 250 mg strength) |
250 mg |
||||||
France |
|
Zinnat |
750 mg |
Powder and solvent for suspension for Injection |
Intramuscular Use |
750 mg |
||||||
France |
|
Zinnat |
750 mg |
Powder for solution for Injection |
Intravenous Use and Intramuscular use |
750 mg |
||||||
Greece |
|
Zinacef |
1,5 g |
Powder for Infusion |
Intravenous Use |
1,5 g/VIAL |
||||||
Greece |
|
Zinacef |
250 mg |
Powder for Injection |
Intravenous Use Intramuscular Use |
250 mg/VIAL |
||||||
Greece |
|
Zinacef |
750 mg |
Powder for Injection |
Intravenous Use Intramuscular Use |
750 mg/VIAL |
||||||
Hungary |
|
Zinacef |
1,5 g |
Powder for Injection |
Intravenous Use |
1,5 g |
||||||
Hungary |
|
Zinacef |
250 mg |
Solution for injection |
Intravenous Use |
250 mg + 1 x 2 ml solvent |
||||||
Hungary |
|
Zinacef |
250 mg |
Powder for Injection |
Intramuscular Use |
250 mg |
||||||
Hungary |
|
Zinacef |
750 mg |
Solution for injection |
Intravenous Use |
750 mg + 1 x 6 ml solvent |
||||||
Hungary |
|
Zinacef |
750 mg |
Powder for Injection |
Intramuscular Use |
750 mg |
||||||
Iceland |
|
Zinacef |
1,5 g |
Powder for Infusion |
Intravenous Use |
1,5 g 50 ml |
||||||
Iceland |
|
Zinacef |
1,5 g |
Powder for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Iceland |
|
Zinacef |
750 mg |
Powder for Infusion |
Intramuscular Use |
750 mg 3 ml |
||||||
Iceland |
|
Zinacef |
750 mg |
Powder for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Ireland |
|
Zinacef |
1,5 g |
Powder for injection or solution for infusion |
Intravenous Use |
1,5 g |
||||||
Ireland |
|
Zinacef |
250 mg |
Powder for solution or suspension for injection |
Intravenous or Intramuscular Use |
250 mg |
||||||
Ireland |
|
Zinacef |
750 mg |
Powder for solution for injection |
Intravenous or IntramuscularUse |
750 mg |
||||||
Italy |
|
Curoxim |
250 mg |
Powder and solvent for suspension for Injection |
Intramuscular Use |
250 mg/ml |
||||||
Italy |
|
Curoxim |
500 mg |
Powder and solvent for suspension for Injection |
Intramuscular Use |
500 mg/2 ml |
||||||
Italy |
|
Curoxim |
750 mg |
Powder and solvent for suspension for Injection |
Intramuscular Use |
750 mg/3 ml |
||||||
Italy |
|
Curoxim |
1 g |
Powder and solvent for suspension for Injection |
Intravenous Use |
1 g/10 ml |
||||||
Italy |
|
Curoxim |
1 g |
Powder and solvent for suspension for Injection |
Intramuscular Use |
1 g/4 ml |
||||||
Italy |
|
Curoxim |
2 g |
Powder for solution for Infusion |
Intravenous Use |
2 g |
||||||
Italy |
|
Curoxim |
1,5 g |
Powder for solution for Infusion |
Intravenous Use |
1,5 g |
||||||
Italy |
|
Curoxim |
750 mg |
Powder for solution for Infusion |
Intravenous Use |
750 mg |
||||||
Lithuania |
|
Zinacef |
1,5 g |
Powder for Injection |
Intravenous Use/Intramuscular Use |
|
||||||
Lithuania |
|
Zinacef |
250 mg |
Powder and Solvant for Solution for Injection |
Intravenous Us/Intramuscular Use |
|
||||||
Lithuania |
|
Zinacef |
750 mg |
Powder and Solvant for Solution for Injection |
Intravenous Use/Intramuscular Use |
|
||||||
Luxembourg |
|
Zinacef |
1,5 g |
Powder for Solution for Infusion |
Intravenous Use |
1,5 g 50 ml |
||||||
Luxembourg |
|
Zinacef |
1,5 g |
Powder for Solution for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Luxembourg |
|
Zinacef |
750 mg |
Powder for Solution for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Luxembourg |
|
Zinacef |
750 mg |
Powder for Solution for Infusion |
Intravenous Use |
750 mg 50 ml |
||||||
Luxembourg |
|
Zinacef |
750 mg |
Powder for Solution for Injection |
Intramuscular Use |
750 mg 3 ml |
||||||
Malta |
|
Zinacef |
250 mg |
Powder for suspension for Injection |
Intravenous Use |
250 mg 2 ml |
||||||
Malta |
|
Zinacef |
250 mg |
Powder for suspension for Injection |
Intramuscular Use |
250 mg 1 ml |
||||||
Malta |
|
Zinacef |
750 mg |
Powder for suspension for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Malta |
|
Zinacef |
750 mg |
Powder for suspension for Injection |
Intramuscular Use |
750 mg 3 ml |
||||||
Netherlands |
|
Zinacef |
1,5 g |
Powder for suspension for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Netherlands |
|
Zinacef |
1,5 g |
Powder for suspension for Infusion |
Intravenous Use |
1,5 g 100 ml |
||||||
Netherlands |
|
Zinacef |
250 mg |
Powder for suspension for Injection |
Intravenous Use Intrarmuscular Use |
250 mg 2 ml (intravenous) 250 mg 1 ml (intramuscular) |
||||||
Netherlands |
|
Zinacef |
750 mg |
Powder for suspension for Injection |
Intravenous Use Intrarmuscular Use |
750 mg 6 ml (intravenous) 750 mg 3 ml (intramuscular) |
||||||
Norway |
|
Zinacef |
1,5 g |
Powder for Infusion |
Intravenous Use |
1,5 g 50 ml |
||||||
Norway |
|
Zinacef |
1,5 g |
Powder for Injection |
Intravenous Use |
1,5 g 15 ml |
||||||
Norway |
|
Zinacef |
250 mg |
Powder for Injection |
Intermuscular Use |
250 mg 1 ml |
||||||
Norway |
|
Zinacef |
250 mg |
Powder for Injection |
Intravenous Use |
250 mg 2 ml |
||||||
Norway |
|
Zinacef |
750 mg |
Powder for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Norway |
|
Zinacef |
750 mg |
Powder for Injection |
Intermuscular Use |
750 mg 3 ml |
||||||
Poland |
|
Zinacef |
1,5 g |
Powder for solution for injection and infusion |
Intravenous Use |
1,5 g/15 ml 1,5 g/50-100 ml 1,5 g (Monovial) |
||||||
Poland |
|
Zinacef |
750 mg |
Powder for suspension for injection or solution for injection and infusion |
Intramuscular Use, Intravenous Use |
750 mg/3 ml IM 750 mg/6 ml IV 750 mg IV (Monovial) |
||||||
Portugal |
|
Curoxime |
750 mg |
Powder and solvent for solution for injection |
Intravenous Use |
750 mg 6 ml |
||||||
Portugal |
|
Curoxime |
750 mg |
Powder and solvent for solution for injection |
Intramuscular Use |
750 mg 3 ml |
||||||
Romania |
|
Zinacef |
750 mg |
Powder for Injection |
Intravenous Use |
750 mg 6 ml |
||||||
Romania |
|
Zinacef |
750 mg |
Powder for Injection |
Intramuscular Use |
750 mg 3 ml |
||||||
Slovenia |
|
Zinacef 1 500 mg prašek za raztopino za injiciranje ali infundiranje |
1,5 g |
Powder for Solution for injection or Infusion |
Intravenous Use |
1,5 g 15 ml/ 1,5 g 50 ml |
||||||
Slovenia |
|
Zinacef 750 mg prašek za raztopino za injiciranje ali infundiranje |
750 mg |
Powder for solution for injection or infusion |
Intramuscular Use/Intravenous Use |
750 mg/3 ml 750 mg 6 ml |
||||||
Sweden |
|
Zinacef |
|
Powder for solution for Infusion |
Intravenous Use |
|
||||||
Sweden |
|
Zinacef |
|
Powder for solution for Injection |
Intravenous Use |
|
||||||
Sweden |
|
Zinacef |
|
Powder for Solution/Suspension for Injection |
Intramuscular Use |
|
||||||
United Kingdom |
|
Zinacef |
1,5 g |
Powder for Injection |
Intravenous Use and intramuscular use |
|
||||||
United Kingdom |
|
Zinacef |
250 mg |
Powder for Injection |
Intravenous Use and intramuscular use |
|
||||||
United Kingdom |
|
Zinacef |
750 mg |
Powder for Injection |
Intravenous Use and intramuscular use |
|
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Member State EU/EEA |
Marketing authorisation holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
|||||||
Austria |
|
Vastarel 35 mg - Filmtabletten mit veränderter Wirkstofffreisetzung |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Bulgaria |
|
Preductal MR |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Bulgaria |
|
Prectazidine MR |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Bulgaria |
|
Vascotasin |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Bulgaria |
|
Trimetazidine-ratiopharm |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Bulgaria |
|
Predozone |
20 mg |
Coated tablet |
Oral use |
|||||||
Bulgaria |
|
Trimductal |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Bulgaria |
|
Trimetazigen MR |
35 mg |
Prolonged - release tablet |
Oral use |
|||||||
Bulgaria |
|
Apstar |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Bulgaria |
|
Moduxin MR |
35 mg |
Prolonged release tablets |
Oral use |
|||||||
Bulgaria |
|
Trimeluzine |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Cyprus |
|
VASTAREL 20 mg |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Cyprus |
|
VASTAREL |
20 mg/ml |
Oral drops |
Oral use |
|||||||
Cyprus |
|
VASTAREL MR |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Czech Republic |
|
PREDUCTAL MR |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Czech Republic |
|
TRIMETAZIDIN ACTAVIS 35 MG |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Czech Republic |
|
TRIMETAZIDIN MYLAN 35 MG |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Czech Republic |
|
TRIMETAZIDIN SANDOZ 35 MG |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Czech Republic |
|
PORTORA 35 MG TABLETY S PRODLOUŽENÝM UVOLŇOVÁNÍM |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Czech Republic |
|
TRIMETAZIDIN TEVA RETARD 35 MG |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Denmark |
|
Vastarel |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Estonia |
|
TRIMETAZIDINE MR SERVIER |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Estonia |
|
PREDUCTAL MR |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Estonia |
|
TRIMETAZIDINE ACTAVIS |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Estonia |
|
TRIMETAZIDINE TEVA 35 MG |
35 mg |
Film-coated tablet |
Oral use |
|||||||
Estonia |
|
ZIDMETIN |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE ALMUS |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE BIOGARAN |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE BIOGARAN |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE BIOGARAN |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE CRISTERS |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE QUALIMED |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE QUALIMED |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
VASTAREL |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
VASTAREL |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
France |
|
VASTAREL |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRANETIZ |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIGEMAX |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE BGR |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE CLL PHARMA |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE IGEN |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE IPSOR |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE IPSOR |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE ISOMED |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE MILGEN |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE MILGEN |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE RATIOPHARM |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE SUBSTIPHARM |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE ZYDUS |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE ZYDUS |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMEVENI |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE TEVA |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE TEVA |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE TEVA |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE WINTHROP |
20 mg |
Film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE WINTHROP |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE WINTHROP |
35 mg |
Modified-release film coated tablet |
Oral use |
|||||||
France |
|
RIMETAZE |
20 mg |
Film coated tablet |
Oral use |
|||||||
France |
|
RIMETAZE |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE MYLAN |
20 mg |
Film coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE MYLAN |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE MYLAN |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE SANDOZ |
20 mg |
Film coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE SANDOZ |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE ACTAVIS |
20 mg |
Film coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE QUALIMED |
20 mg |
Film coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE ISOMED |
20 mg |
Coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE EG |
20 mg |
Film coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE EG |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE EG |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE ARROW |
20 mg |
Film coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE ARROW |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE RATIOPHARM |
20 mg |
Coated tablet |
Oral use |
|||||||
France |
|
TRIMETAZIDINE RATIOPHARM |
20 mg/ml |
Oral solution |
Oral use |
|||||||
France |
|
TRIMETAZIDINE SANDOZ |
35 mg |
modified-release film-coated tablet |
Oral use |
|||||||
Germany |
|
Trimetazidin-ratiopharm 35 mg Retardtabletten |
35 mg |
Prolonged release tablet |
Oral use |
|||||||
Germany |
|
Mephatrim 35 mg Retardtabletten |
35 mg |
Prolonged release tablet |
Oral use |
|||||||
Greece |
|
NOVAZIDINE |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
Greece |
|
ZIDIN |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
Greece |
|
VASTAREL |
20 mg/tab |
Film-coated tablet |
Oral use |
|||||||
Greece |
|
VASTAREL |
20 mg/ml |
Oral drops, solution |
Oral use |
|||||||
Greece |
|
VASTAREL |
35 mg/tab |
Controlled release tablet |
Oral use |
|||||||
Hungary |
|
Moduxin MR |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Hungary |
|
Preductal MR |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Hungary |
|
Adexor MR |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Hungary |
|
APSTAR 35 mg retard tabletta |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Hungary |
|
TRIMETAZIDIN- RATIOPHARM 35 mg retard tabletta |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Hungary |
|
TRIMETAZIDINE MYLAN 35 mg retard tabletta |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Hungary |
|
VASCOTASIN 35 mg módosított hatóanyagleadású tabletta |
35 mg |
modified release tablet |
Oral use |
|||||||
Hungary |
|
TRIMETAZIDINE SANDOZ 35 mg retard tabletta |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Ireland |
|
Vastarel |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Ireland |
|
Trimetazidine |
35 mg |
Prolonged-release film-coated tablet |
Oral use |
|||||||
Ireland |
|
Vastarel |
35 mg |
Prolonged-release film-coated tablet |
Oral use |
|||||||
Italy |
|
VASTAREL |
20 mg |
Coated tablet |
Oral use |
|||||||
Latvia |
|
Moduxin 35 mg ilgstošās darbības tabletes |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Latvia |
|
Trimetazidine Actavis 35 mg ilgstošās darbības tabletes |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Latvia |
|
Preductal MR 35 mg ilgstošās darbības apvalkotās tabletes |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Latvia |
|
Trimetazidine MR Servier 35 mg ilgstošās darbības apvalkotās tabletes |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Latvia |
|
Trimetazidine Teva 35 mg ilgstošās darbības tabletes |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Latvia |
|
Zidmetin 35 mg ilgstošās darbības tabletes |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Lithuania |
|
Zidmetin |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Lithuania |
|
Preductal MR |
35 mg |
Modified-release film-coated tablet tablet |
Oral use |
|||||||
Lithuania |
|
Trimetazidine MR Servier |
35 mg |
Modified-release film-coated tablet tablet |
Oral use |
|||||||
Lithuania |
|
Trimetazidine-Teva |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Lithuania |
|
Trimetazidine Actavis |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Luxembourg |
|
Vastarel-20 |
20 mg |
Coated tablet |
Oral use |
|||||||
Luxembourg |
|
Vastarel |
20 mg/ml |
Drops |
Oral use |
|||||||
Luxembourg |
|
Vastarel-35 |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Malta |
|
VASTAREL 20 mg |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Malta |
|
VASTAREL MR |
35 mg |
Modified release film coated tablet |
Oral use |
|||||||
Poland |
|
Cyto-Protectin MR |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Poland |
|
Trimeductan MR |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Poland |
|
Metazydyna |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Poland |
|
Preductal |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Poland |
|
Preductal MR |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Poland |
|
Protevasc SR |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Poland |
|
Trimetaratio |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Poland |
|
Trimetazidine-ratiopharm PR |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Poland |
|
Cyto-Protectin MR |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Poland |
|
Portora |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Poland |
|
Trimedal |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Poland |
|
Dimesar |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Portugal |
Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal |
Vastarel |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal |
Vastarel |
20 mg/ml |
Oral solution |
Oral use |
|||||||
Portugal |
Sanofi-Aventis - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal |
Trimetazidina Zentiva |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal |
Trimetazidina Labesfal 20 mg Comprimidos Revestidos |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés Portugal |
Trimetazidina Mylan |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal |
Trimetazidina Generis 20 mg Comprimidos Revestidos |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Servier Portugal - Especialidades Farmacêuticas, Lda. Av. António Augusto de Aguiar, 128 1069-133 Lisboa Portugal |
Vastarel LM |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Portugal |
Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo 3045-016 Coimbra Portugal |
Trimetazidina Bluepharma 20 mg Comprimidos |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Vida - Produtos Farmacêuticos, S.A. Rua da Estação, 42 - Vala do Carregado 2600-726 Castanheira do Ribatejo Portugal |
Trimetazidina Vida |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Helm Portugal, Lda. Estrada Nacional n.o 10, Km 140, 260 2695-066 Bobadela - Loures Portugal |
Trimetazidina Baldacci 20 mg Comprimidos |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo Portugal |
Trimetazidina Mepha 20 mg Comprimidos Revestidos |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Jaba Recordati, S. A. Lagoas Park, Edificio 5, Torre C, Piso 3 2740-298 Porto Salvo Portugal |
Trimetazidina Jaba 20 mg Comprimidos revestidos |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
Teva Pharma - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 1 - 3o 2740-264 Porto Salvo Portugal |
Trimetazidina Teva |
20 mg |
Coated tablets |
Oral use |
|||||||
Portugal |
|
Tacirel LM |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Portugal |
Cinfa Portugal, Lda. Av.Tomás Ribeiro, 43 - Bloco 1, 4o B - Edifício Neopark 2790-221 Carnaxide Portugal |
Trimetazidina Cinfa 20 mg Comprimidos revestidos por película |
20 mg |
Film-coated tablets |
Oral use |
|||||||
Portugal |
Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide Portugal |
Trimetazidina Ratiopharm |
20 mg |
Film-coated tablets |
Oral use |
|||||||
Portugal |
Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide Portugal |
Trimetazidina Ratiopharm |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Generis Farmacêutica, S.A. Rua João de Deus, 19 2700-487 Amadora Portugal |
Trimetazidina Generis |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Teva Pharma - Produtos Farmacêuticos, Lda Lagoas Park, Edifício 1 - 3o 2740-264 Porto Salvo Portugal |
Trimetazidina Teva |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Labesfal - Laboratórios Almiro, S.A. Zona Industrial do Lagedo 3465-157 Santiago de Besteiros Portugal |
Trimetazidina Labesfal |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal |
Trimetazidina Sandoz |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Mepha - Investigação, Desenvolvimento e Fabricação Farmacêutica, Lda. Lagoas Park, Edifício 5 A - Piso 2 2740-298 Porto Salvo Portugal |
Trimetazidina Mepha LP |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Bluepharma Genéricos - Comércio de Medicamentos, S.A. São Martinho do Bispo 3045-016 Coimbra Portugal |
Trimetazidina Bluepharma LP |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Sandoz Farmacêutica, Lda. Alameda da Beloura, Edifício 1, 2o - Escritório 15 2710-693 Sintra Portugal |
Trimetazidina Itraxel |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
|
Lupamadazine |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Mylan, Lda. Rua Doutor António Loureiro Borges, Edíficio Arquiparque 1, R/C Esqo 1499-016 Algés Portugal |
Trimetazidina Mylan |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Portugal |
Sanofi-Aventis - Produtos Farmacêuticos, Lda. Empreendimento Lagoas Park, Edifício 7 - 3o Piso 2740-244 Porto Salvo Portugal |
Zilutra |
35 mg |
Prolonged-release tablets |
Oral use |
|||||||
Romania |
|
Trimetazidina Mylan |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Romania |
|
DILATAN MR 35 mg, comprimate filmate cu eliberare modificată, 35 mg |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Romania |
|
DILATAN 20 mg, comprimate filmate, 20 mg |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Romania |
|
TRIMETAZIDIN VIM SPECTRUM 20 mg, capsule |
20 mg |
Capsule |
Oral use |
|||||||
Romania |
|
PREDUCTAL MR 35 mg, comprimate filmate cu eliberare modificată |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Romania |
|
PREDUCTAL 20 mg, comprimate filmate |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Romania |
|
MODUXIN MR 35 mg, comprimate filmate cu eliberare prelungită |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Romania |
|
MODUXIN 20 mg, comprimate filmate |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Romania |
|
TRIMETAZIDINA 20 mg, drajeuri |
20 mg |
Coated tablet |
Oral use |
|||||||
Romania |
|
TRIMETAZIDINĂ LPH 35 mg, comprimate filmate cu eliberare modificată |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Romania |
|
TRIMETAZIDINĂ LPH 20 mg, comprimate filmate |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Romania |
|
Oxcardin 20 mg, comprimate filmate |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Romania |
|
Oxcardin MR 35 mg, comprimate filmate cu eliberare modificată |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Romania |
|
APSTAR 35 mg comprimate cu eliberare prelungită |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Romania |
|
TRIMELUZINE 35 mg comprimate cu eliberare prelungită |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Slovak Republic |
|
Trimetazidin-ratiopharm 20 mg |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Slovak Republic |
|
Trimetazidin ratiopharm retard 35 mg |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Slovak Republic |
|
Angitrim |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Slovak Republic |
|
Adexor |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Slovak Republic |
|
PREDUCTAL MR |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Slovak Republic |
|
Trimetazidin Mylan 35 mg |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Slovak Republic |
|
Trimetazidin - DemlGroup PR 35 mg |
35 mg |
Prolonged-release film-coated tablet |
Oral use |
|||||||
Slovak Republic |
|
Vascotazin 35 mg |
35 mg |
Modified-release tablet |
Oral use |
|||||||
Slovak Republic |
|
Apstar 35 mg tablety s predĺženým uvoľňovaním |
35 mg |
Prolonged-release tablet |
Oral use |
|||||||
Slovenia |
|
PREDUCTAL MR 35 mg filmsko oblozene tablete s prirejenim sproscanjem |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Slovenia |
|
TRIMETAZIDIN SERVIER 35 mg filmsko obložene tablete s prirejenim sproščanjem |
35 mg |
Modified-release film-coated tablet |
Oral use |
|||||||
Spain |
|
TRIMETAZIDINA DAVUR 20 mg comprimidos recubiertos EFG |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Spain |
|
TRIMETAZIDINA RIMAFAR 20 mg comprimidos recubiertos EFG |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Spain |
|
TRIMETAZIDINA RATIOPHARM 20 mg comprimidos recubiertos con película EFG |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Spain |
|
IDAPTAN 20 mg comprimidos recubiertos con película |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Spain |
|
IDAPTAN 20 mg/ml solución oral |
20 mg/ml |
Oral solution |
Oral use |
|||||||
Spain |
|
TRIMETAZIDINA CINFA 20 mg comprimidos recubiertos con película EFG |
20 mg |
Film-coated tablet |
Oral use |
|||||||
Spain |
|
TRIMETAZIDINA PENSA 20 mg comprimidos recubiertos con película EFG |
20 mg |
Film-coated tablet |
Oral use |