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Document 52012XC1130(09)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
OJ C 371, 30.11.2012, p. 26–36
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
30.11.2012 |
EN |
Official Journal of the European Union |
C 371/26 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 2012
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2012/C 371/04
— 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 |
|
10.10.2012 |
Aminocaproic acid containing medicinal products (antifibrynolitics) |
See Annex I |
See Annex I |
12.10.2012 |
|
8.10.2012 |
Mometasone Furoate Sandoz and associated names |
See Annex II |
See Annex II |
9.10.2012 |
|
10.10.2012 |
Tranexamic acid containing medicinal products (antifibrynolitics) |
See Annex III |
See Annex III |
12.10.2012 |
|
8.10.2012 |
Baytril |
See Annex IV |
See Annex IV |
9.10.2012 |
(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.
ANNEX I
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Aminocaproic acid 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 |
|||||
|
ES - Spain |
|
CAPROAMIN FIDES 4 g SOLUCIÓN INYECTABLE |
4 g/10 ml |
solution for injection |
intravenous use |
|||||
|
HU - Hungary |
|
Acepramin |
4 g/10 ml |
solution for infusion |
intravenous use |
|||||
|
PT - Portugal |
|
Epsicaprom 25 |
2 500 mg/10 ml |
Solution for infusion |
intravenous use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES
|
Member State EU/EEA |
Applicant |
Name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Belgium |
|
Mometasone Sandoz 50 mcg/dosis neusspray, suspensie |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Czech Republic |
|
Mommox 0,05 mg/dávku |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Denmark |
|
Mometasone Sandoz |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Estonia |
|
Nasometin |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Finland |
|
Mometasone furoate Sandoz |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
France |
|
MOMETASONE Sandoz 50 microgrammes/dose, suspension pour pulvérisation nasale |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Germany |
|
Mometasonfuroat Sandoz 50 Mikrogramm/Sprühstoß Nasenspray, Suspension |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Greece |
|
Mometasone Furoate/Sandoz |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Hungary |
|
Mometason Sandoz 50 mikrogramm/adag oldatos orrspray |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Italy |
|
MOMETASONE FUROATO SANDOZ 50 microgrammi/erogazione, spray nasale |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Luxembourg |
|
Mometason Sandoz 50 mcg/dose spray nasale |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Netherlands |
|
Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Norway |
|
Mometasone Sandoz |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Poland |
|
Nasometin |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Portugal |
|
Mometasona Sandoz |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Romania |
|
Mometazonă furoat Sandoz 50 micrograme/doza, spray nazal, suspensie |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Slovak Republic |
|
Mometasone Sandoz 50 mikrogramov |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Slovenia |
|
FUMOMO 50 mikrogramov/vpih pršilo za nos, suspenzija |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Spain |
|
Mometasona Sandoz 50 mcg/dosis suspensión para nebulización nasal |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
Sweden |
|
Mometasone Sandoz |
50 microgram/dose |
nasal spray, suspension |
nasal use |
||||||
|
United Kingdom |
|
Mometasone Furoate 50 micrograms/dose, nasal spray, suspension |
50 microgram/dose |
nasal spray, suspension |
nasal use |
ANNEX III
LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Tranexamic acid 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 |
|
Cyklokapron - Ampullen |
0,5 g/5 ml |
Solution for injection |
intravenous use |
|||||
|
BE - Belgium |
|
Cyklokapron |
100 mg/5 ml |
Solution for injection |
intravenous use |
|||||
|
BE - Belgium |
|
Exacyl 500 |
500 mg/5 ml |
Solution for injection |
intravenous use |
|||||
|
CY - Cyprus |
|
AZEPTIL INJECTION 500 MG/5 ML |
500 MG/5 ML |
INJECTION |
intravenous use |
|||||
|
CY - Cyprus |
|
AZEPTIL INJECTION 250 MG/5 ML |
250 MG/5 ML |
INJECTION |
intravenous use |
|||||
|
CZ - Czech Republic |
|
Exacyl |
100 mg/ml |
Solution for injection |
intravenous use |
|||||
|
DE - Germany |
|
Cyklokapron-Injektionslösung |
500 mg/5 ml |
Solution for injection |
intravenous use |
|||||
|
DK - Denmark |
|
Tranexamsyre ‘Pfizer’ |
100 mg/ml |
Solution for injection |
intravenous use |
|||||
|
EL - Greece |
|
TRANSAMIN |
500 MG/5 ML |
Solution for Injection or infusion |
intravenous use |
|||||
|
ES - Spain |
|
AMCHAFIBRIN 500 mg SOLUCIÓN INYECTABLE |
500 mg/5 ml |
solution for injection |
intravenous use |
|||||
|
ET - Estonia |
|
CYKLOKAPRON |
100 mg/ml |
solution for injection |
intravenous use |
|||||
|
FI - Finland |
|
CAPRILON |
100 mg/ml |
Solution for injection |
intravenous use |
|||||
|
FR - France |
|
Exacyl 0,5 g/5 ml I.V., solution injectable |
0,5 g/5 ml |
solution for injection |
intravenous use |
|||||
|
HU - Hungary |
|
Exacyl |
0,5 g/5 ml |
solution for injection |
intravenous use |
|||||
|
IE - Ireland |
|
Cyklokapron 500 mg/5 ml solution for injection or infusion |
100 mg/ml |
Solution for injection |
intravenous use |
|||||
|
IS - Iceland |
|
Tranexamsyre ‘Pfizer’ |
100 mg/ml |
Solution for injection |
intravenous use |
|||||
|
IT - Italy |
|
UGUROL |
500 mg/5 ml |
solution for injection |
intravenous use |
|||||
|
IT - Italy |
|
TRANEX |
500 mg/5 ml |
solution for injection |
intravenous use |
|||||
|
IT - Italy |
|
ACIDO TRANEXAMICO BIOINDUTRIA L.I.M. |
500 mg/5 ml |
solution for injection |
intravenous use |
|||||
|
LU - Luxembourg |
|
EXACYL |
500 mg/5 ml |
solution for injection |
intravenous use |
|||||
|
LU - Luxembourg |
|
Cyklokapron |
100 mg/ml |
Solution for injection |
Intravenous use |
|||||
|
NL - Netherlands |
|
Cyklokapron, oplossing voor injectie 100 mg/ml |
100 mg/ml |
solution for injection |
intravenous use |
|||||
|
NO - Norway |
|
CYKLOKAPRON |
100 mg/ml |
injection for solution |
intravenous use |
|||||
|
PL - Poland |
|
Exacyl |
100 mg/ml |
solution for infusion |
intravenous use |
|||||
|
PL - Poland |
|
Exacyl |
100 mg/ml |
solution for infusion |
intravenous use |
|||||
|
SE - Sweden |
|
Cyklokapron |
100 mg/ml |
Solution for injection |
intravenous use |
|||||
|
UK - United Kingdom |
|
CYKLOKAPRON INJECTION 500 MG/ML |
500 mg/ml |
Solution for Injection |
intravenous use |
ANNEX IV
Condition of the marketing authorisations
The National Competent Authorities shall ensure that the following condition is fulfilled by the marketing authorisation holders:
|
— |
The marketing authorisation holders should substantiate the dosing regimen in rabbits taking into account the current MIC distribution for the target pathogens, the variability in pharmacokinetics resulting from administration of enrofloxacin via the drinking water to groups of rabbits under field conditions and with the goal to ensure sustainable effective treatment. |
|
— |
Residue depletion studies should be provided for any proposed new dosage regimen. A shorter or lower dose regimen than the current 10 mg/kg for 5 days needs to be substantiated by new clinical data. |
The results of those studies should be provided to the relevant Authorities for assessment not later than 18 months after the Commission Decision on this referral procedure.