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Document 52011XC1230(03)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011 (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 September 2011 to 31 October 2011 (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 September 2011 to 31 October 2011 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
OJ C 383, 30.12.2011, p. 17–61
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
30.12.2011 |
EN |
Official Journal of the European Union |
C 383/17 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2011/C 383/02
— 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 |
|
7.10.2011 |
Norvasc and associated names |
See Annex I |
See Annex I |
10.10.2011 |
|
20.10.2011 |
Synulox Lactating Cow Art 34 |
See Annex II |
See Annex II |
21.10.2011 |
|
13.9.2011 |
Dexrazoxane - Art 31 |
See Annex III |
See Annex III |
15.9.2011 |
|
2.9.2011 |
Diflucan and associated names - Art 30 |
See Annex IV |
See Annex IV |
5.9.2011 |
|
24.10.2011 |
Dexamethasone Alapis - Art 29 |
See Annex V |
See Annex V |
25.10.2011 |
— Refusal of a national marketing authorization
|
Date of the decision |
Name(s) of the medicinal product |
Holder(s) of the marketing authorization |
Member State concerned |
Date of notification |
|
22.9.2011 |
Canazole Clotrimazole Cream 1 % w/w - Art. 29 |
See Annex VI |
See Annex VI |
23.9.2011 |
— Suspension 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 |
|
22.9.2011 |
Canazole Clotrimazole Cream 1 % w/w - Art. 29 |
See Annex VI |
See Annex VI |
23.9.2011 |
|
16.9.2011 |
Goserelin cell pharm 3,6 mg Implantat and associated names |
See Annex VII |
See Annex VII |
20.9.2011 |
|
16.9.2011 |
Novimp 3,6 mg Implantat and associated names - Ref. Art.36 |
See Annex VIII |
See Annex VIII |
19.9.2011 |
|
16.9.2011 |
Novosis Goserelin 3,6 mg Implantat and associated names |
See Annex IX |
See Annex IX |
19.9.2011 |
(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 ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Norvasc 5 mg - Tabletten |
5 mg |
Tablet |
Oral use |
||||||
|
Austria |
|
Norvasc 10 mg - Tabletten |
10 mg |
Tablet |
Oral use |
||||||
|
Belgium |
|
Amlor |
5 mg |
Capsule, Hard |
Oral use |
||||||
|
Belgium |
|
Amlor |
10 mg |
Capsule, Hard |
Oral use |
||||||
|
Bulgaria |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Bulgaria |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Cyprus |
|
Norvasc |
5 mg |
Capsule, Hard |
Oral use |
||||||
|
Cyprus |
|
Norvasc |
10 |
Capsule, Hard |
Oral use |
||||||
|
Denmark |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Denmark |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Denmark |
|
Amlodipine Pfizer |
5 mg |
Tablet |
Oral use |
||||||
|
Denmark |
|
Amlodipine Pfizer |
10 mg |
Tablet |
Oral use |
||||||
|
Estonia |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Estonia |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Finland |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Finland |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
France |
|
Amlor |
5 mg |
Capsule, Hard |
Oral use |
||||||
|
France |
|
Amlor |
10 mg |
Capsule, Hard |
Oral use |
||||||
|
Germany |
|
Norvasc 5 mg |
5 mg |
Tablet |
Oral use |
||||||
|
Germany |
|
Norvasc 10 mg |
10 mg |
Tablet |
Oral use |
||||||
|
Greece |
|
Norvasc |
5 mg |
Capsule, Hard |
Oral use |
||||||
|
Greece |
|
Norvasc |
10 mg |
Capsule, Hard |
Oral use |
||||||
|
Hungary |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Hungary |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Iceland |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Iceland |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Ireland |
|
Istin |
5 mg |
Tablet |
Oral use |
||||||
|
Ireland |
|
Istin |
10 mg |
Tablet |
Oral use |
||||||
|
Ireland |
|
Amlodipine besilate 5 mg tablets |
5 mg |
Tablet |
Oral use |
||||||
|
Ireland |
|
Amlodipine besilate 10 mg tablets |
10 mg |
Tablet |
Oral use |
||||||
|
Italy |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Italy |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Italy |
|
Monopina |
5 mg |
Tablet |
Oral use |
||||||
|
Italy |
|
Monopina |
10 mg |
Tablet |
Oral use |
||||||
|
Latvia |
|
Norvasc 5 mg tabletes |
5 mg |
Tablet |
Oral use |
||||||
|
Latvia |
|
Norvasc 10 mg tabletes |
10 mg |
Tablet |
Oral use |
||||||
|
Lithuania |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Lithuania |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Lithuania |
|
Norvasc |
5 mg |
Capsule, Hard |
Oral use |
||||||
|
Lithuania |
|
Norvasc |
10 mg |
Capsule, Hard |
Oral use |
||||||
|
Luxembourg |
|
Amlor |
5 mg |
Capsule, Hard |
Oral use |
||||||
|
Luxembourg |
|
Amlor |
10 mg |
Capsule, Hard |
Oral use |
||||||
|
Malta |
|
Istin |
5 mg |
Tablet |
Oral use |
||||||
|
Malta |
|
Istin |
10 mg |
Tablet |
Oral use |
||||||
|
Netherlands |
|
Norvasc 5 |
5 mg |
Tablet |
Oral use |
||||||
|
Netherlands |
|
Norvasc 10 |
10 mg |
Tablet |
Oral use |
||||||
|
Norway |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Norway |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Poland |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Poland |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Portugal |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Portugal |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Romania |
|
Norvasc 5 mg capsule |
5 mg |
Capsule, Hard |
Oral use |
||||||
|
Romania |
|
Norvasc 10 mg capsule |
10 mg |
Capsule, Hard |
Oral use |
||||||
|
Romania |
|
Norvasc 5 mg |
5 mg |
Tablet |
Oral use |
||||||
|
Romania |
|
Norvasc 10 mg |
10 mg |
Tablet |
Oral use |
||||||
|
Slovak Republic |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Slovak Republic |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
Slovenia |
|
Norvasc 5 mg tablete |
5 mg |
Tablet |
Oral use |
||||||
|
Slovenia |
|
Norvasc 10 mg tablete |
10 mg |
Tablet |
Oral use |
||||||
|
Spain |
|
Norvas 5 mg comprimidos |
5 mg |
Tablet |
Oral use |
||||||
|
Spain |
|
Norvas 10 mg comprimidos |
10 mg |
Tablet |
Oral use |
||||||
|
Spain |
|
Amlodipino Pharmacia 5 mg comprimidos |
5 mg |
Tablet |
Oral use |
||||||
|
Spain |
|
Amlodipino Pharmacia 10 mg comprimidos |
10 mg |
Tablet |
Oral use |
||||||
|
Sweden |
|
Norvasc |
5 mg |
Tablet |
Oral use |
||||||
|
Sweden |
|
Norvasc |
10 mg |
Tablet |
Oral use |
||||||
|
United Kingdom |
|
Istin |
5 mg |
Tablet |
Oral use |
||||||
|
United Kingdom |
|
Istin |
10 mg |
Tablet |
Oral use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, WITHDRAWAL PERIOD, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing Authorisation Holder |
Name |
INN |
Strengths |
Pharmaceutical form |
Animal species |
Withdrawal period (meat and milk) |
||||||
|
Austria |
|
Synulox comp - Injektoren für Kühe |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat and offal: 4 days, milk: 3 days |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Bulgaria |
|
Synulox Lactating Cow |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk: 60 hours In combination with SYNULOX RTU: Meat: 42 days. Milk: 60 hours. |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Cyprus |
|
SYNULOX LC |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Edible tissues: 4 days Milk: 72 Hours |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Czech Republic |
|
SYNULOX LC 260 mg intramam. suspension for cattle |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk 84 hours (7 milkings) |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
France |
|
SYNULOX INTRAMAMMAIRE |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk: 2 days |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Greece |
|
SYNULOX LC |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 3 days Milk: 72 hours |
||||||
|
Clavulanic acid (as potassium clavulanate) |
10 mg |
||||||||||||
|
Prednisolone |
50 mg |
||||||||||||
|
Hungary |
|
SYNULOX LC tőgyinfúzió |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Edible tissues: 4 days Milk: 60 hours |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Ireland |
|
Synulox Lactating Cow Intramammary suspension. |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat and offal: 7 Days Milk: 60 Hours Meat: 7 days Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment. When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking). In combination with SYNULOX RTU: Meat: 42 days. Milk: 80 hours. |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Italy |
|
SYNULOX ENDOMAMMARIO |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 4 days Milk: 108 hours |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Latvia |
|
Synulox LC Suspensija ievadīšanai tesmenī laktējošām govīm |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment. When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking). In combination with SYNULOX RTU: Meat: 42 days. Milk: 60 hours. |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Lithuania |
|
SYNULOX LC, intramaminė suspensija |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk: 60 hours In combination with SYNULOX RTU: Meat: 42 days. Milk: 60 hours. |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Norway |
|
Synulox comp. vet |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary emulsion |
Cattle |
Meat: 6 days Milk: 5 days |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Poland |
|
SYNULOX L.C. (200 mg + 50 mg + 10 mg)/3 g, zawiesina dowymieniowa, bydło |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat and offal: 4 days Milk: 60 hours |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Portugal |
|
SYNULOX LC suspensão intramamária para bovinos em lactação |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat and offal: 14 days Milk: 2 days |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Romania |
|
SYNULOX LC, amoxicilină, acid clavulanic, prednisolon, suspensie intramamara pentru vaci in lactatie |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat and offal: 7 days Milk: 60 hours In combination with SYNULOX RTU: Meat: 42 days. Milk: 14 days. |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Slovak Republic |
|
Synulox LC 260 mg intramammary suspension |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk: 84 hours (7 milkings) |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Slovenia |
|
SYNULOX LC intramamarna suspenzija za krave v laktaciji |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat and offal: 7 days Milk: 60 hours |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
Spain |
|
SYNULOX LC |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk: 60 hours or 5 milking |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
The Netherlands |
|
Avuloxil |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk: 4 days |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
||||||||||||
|
United Kingdom |
|
Synulox Lactating Cow Intramammary Suspension |
Amoxicillin (as amoxicillin trihydrate) |
200 mg |
Intramammary suspension |
Cattle |
Meat: 7 days Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment. When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking). In combination with SYNULOX RTU: Meat: 42 days. Milk: 60 hours. |
||||||
|
Clavulanic acid (as potassium clavulanate) |
50 mg |
||||||||||||
|
Prednisolone |
10 mg |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
Product name |
Strength |
Pharmaceutical form |
Route of administration |
||||||||||
|
Austria |
|
Cardioxane 500 mg - Pulver zur Herstellung einer Infusionslösung |
500 mg |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Austria |
|
Cyrdanax 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung |
20 mg |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Austria |
|
Enaxozar 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung |
20 mg |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Czech Republic |
|
Cardioxane |
500 mg |
Powder for solution for injection |
Intravenous use |
||||||||||
|
Czech Republic |
|
Cyrdanax 20 mg/ml prášek pro přípravu infuzního roztoku |
20 mg |
Powder for solution for injection |
Intravenous use |
||||||||||
|
Germany |
|
CARDIOXANE 500 mg, Pulver zur Herstellung einer Infusionslösung |
500 mg |
Powder for solution for infusion |
Intravenous (not otherwise specified) |
||||||||||
|
Germany |
|
Cyrdanax 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung |
20 mg |
Powder for solution for injection |
Intravenous use |
||||||||||
|
Germany |
|
Enaxozar 20 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung |
20 mg |
Powder for solution for injection |
Intravenous use |
||||||||||
|
Denmark |
|
Cardioxane |
500 mg |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Greece |
|
CARDIOXANE |
500 mg/vial |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Spain |
|
CARDIOXANE 500 mg polvo para solucion para perfusion |
500 mg |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Finland |
|
Cardioxane |
500 mg |
powder for solution for infusion |
Intravenous use |
||||||||||
|
France |
|
CARDIOXANE 500 mg, poudre pour solution pour perfusion |
500 mg |
powder for solution for infusion |
Intravenous use |
||||||||||
|
France |
|
DEXRAZOXANE CYATHUS 20 mg/ml, poudre pour solution pour perfusion |
20 mg |
Powder for solution for injection |
Intravenous use |
||||||||||
|
Hungary |
|
CARDIOXANE |
500 mg |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Hungary |
|
Procard 20 mg/ml Por oldatos infúzióhoz |
20 mg |
Powder for solution for injection |
Intravenous use |
||||||||||
|
Ireland |
MAH:
Mailing address:
|
Cardioxane |
500 mg |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Italy |
|
CARDIOXANE |
500 mg |
powder for solution for infusion |
Intravenous use |
||||||||||
|
Lithuania |
|
Cardioxane |
500 mg |
Powder for solution for infusion |
Intravenous use |
||||||||||
|
Luxembourg |
|
CARDIOXANE |
500 mg |
POWDER FOR SOLUTION FOR INFUSION |
Intravenous use |
||||||||||
|
Netherlands |
|
Cardioxane 500 mg |
500 mg |
powder for solution for infusion |
Intravenous use |
||||||||||
|
Norway |
|
Cardioxane |
500 mg |
Powder for solution for infusion |
injection |
||||||||||
|
Poland |
|
Cardioxane |
500 mg |
powder for solution for infusion |
Intravenous use |
||||||||||
|
Portugal |
|
Cardioxane |
500 mg |
powder for solution for infusion |
Intravenous use |
||||||||||
|
Romania |
|
CYRDANAX 20 mg/ml |
20 mg/ml |
powder for solution for infusion |
Intravenous use |
||||||||||
|
Slovakia |
|
CARDIOXANE |
500 mg |
powder for solution for infusion |
Intravenous use |
||||||||||
|
United Kingdom |
|
Cardioxane |
500 mg |
powder for solution for infusion |
Intravenous 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 |
|
Diflucan 50 mg - Kapseln |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Austria |
|
Diflucan 100 mg - Kapseln |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Austria |
|
Diflucan 150 mg - Kapseln |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Austria |
|
Fungata 150 mg - Kapsel |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Austria |
|
Diflucan 200 mg - Kapseln |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Austria |
|
Diflucan 50 mg/5 ml - Trockensaft |
50 mg/5 ml |
Powder for oral Suspension |
Oral use |
10 mg/ml |
||||||
|
Austria |
|
Diflucan 200 mg/5 ml - Trockensaft |
200 mg/5 ml |
Powder for oral Suspension |
Oral use |
40 mg/ml |
||||||
|
Austria |
|
Diflucan 100 mg - Infusionsflaschen |
100 mg/50 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Austria |
|
Diflucan 200 mg - Infusionsflaschen |
200 mg/100 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Austria |
|
Diflucan 400 mg - Infusionsflaschen |
400 mg/200 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Belgium |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Belgium |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Belgium |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Belgium |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Belgium |
|
Diflucan |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Belgium |
|
Diflucan |
200 mg/5 ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
Belgium |
|
Diflucan |
200 mg/100 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Belgium |
|
Diflucan |
400 mg/200 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Bulgaria |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Bulgaria |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Bulgaria |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Cyprus |
|
Fungustatin |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Cyprus |
|
Fungustatin |
100 mg/50 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Czech Republic |
|
Diflucan 50 mg |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Czech Republic |
|
Diflucan 100 mg |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Czech Republic |
|
Diflucan 150 mg |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Czech Republic |
|
Diflucan I.V. |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Denmark |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Denmark |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Denmark |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Denmark |
|
Diflucan |
10 mg/ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Denmark |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Estonia |
|
Diflucan 150 mg |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Estonia |
|
Diflucan 2 mg/ml |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Finland |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Finland |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Finland |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Finland |
|
Diflucan |
10 mg/ml |
Powder for Oral Suspension |
Oral use |
10 mg/ml |
||||||
|
Finland |
|
Diflucan |
40 mg/ml |
Powder for Oral Suspension |
Oral use |
40 mg/ml |
||||||
|
Finland |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
France |
|
Fluconazole Pfizer |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
France |
|
Triflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
France |
|
Fluconazole Pfizer |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
France |
|
Triflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
France |
|
Fluconazole Pfizer |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
France |
|
Fluconazole Pfizer |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
France |
|
Triflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
France |
|
Fluconazole Pfizer |
50 mg/5 ml |
Powder for Oral Suspension |
Oral use |
10 mg/ml |
||||||
|
France |
|
Triflucan |
50 mg/5 ml |
Powder for Oral Suspension |
Oral use |
10 mg/ml |
||||||
|
France |
|
Triflucan |
200 mg/5 ml |
Powder for Oral Suspension |
Oral use |
40 mg/ml |
||||||
|
France |
|
Triflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Germany |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Germany |
|
Diflucan Derm |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Germany |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Germany |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Germany |
|
Fungata |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Germany |
|
Diflucan Trockensaft |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Germany |
|
Diflucan i.v.-100 mg |
100 mg/50 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Germany |
|
Diflucan i.v.-200 mg |
200 mg/100 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Germany |
|
Diflucan i.v.-400 mg |
400 mg/200 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Germany |
|
Diflucan Derm Saft |
5 mg/ml |
Syrup |
Oral use |
5 mg/ml |
||||||
|
Germany |
|
Diflucan Saft |
5 mg/ml |
Syrup |
Oral use |
5 mg/ml |
||||||
|
Greece |
|
Fungustatin |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Greece |
|
Fungustatin |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Greece |
|
Fungustatin |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Greece |
|
Fungustatin |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Greece |
|
Fungustatin |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Greece |
|
Fungustatin |
200 mg/5 ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
Greece |
|
Fungustatin |
100 mg/50 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Greece |
|
Fungustatin |
200 mg/100 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Greece |
|
Fungustatin |
50 mg/25 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Hungary |
|
Diflucan 50 mg kemény kapszula |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Hungary |
|
Diflucan 100 mg kemény kapszula |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Hungary |
|
Diflucan 150 mg kemény kapszula |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Hungary |
|
Diflucan 200 mg kemény kapszula |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Hungary |
|
Diflucan 10 mg/ml por belsőleges szuszpenzióhoz |
50 mg/5 ml |
Powder for Oral suspension |
Oral use |
10 mg/ml |
||||||
|
Hungary |
|
Diflucan 40 mg/ml por belsőleges szuszpenzióhoz |
200 mg/5 ml |
Powder for Oral Suspension |
Oral use |
40 mg/ml |
||||||
|
Hungary |
|
Diflucan 2 mg/ml oldatos infúzió |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Iceland |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Iceland |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Iceland |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Iceland |
|
Diflucan |
10 mg/ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Iceland |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Ireland |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Ireland |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Ireland |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Ireland |
|
Diflucan |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Ireland |
|
Diflucan |
200 mg/5 ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
Ireland |
|
Diflucan |
200 mg/100 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Ireland |
|
Diflucan |
50 mg/25 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Italy |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Italy |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Italy |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Italy |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Italy |
|
Diflucan |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Italy |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Latvia |
|
Diflucan 50 mg kapsulas |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Latvia |
|
Diflucan 150 mg kapsulas |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Latvia |
|
Diflucan 2 mg/ml šķīdums infūzijām |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Lithuania |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Lithuania |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Lithuania |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Lithuania |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Luxembourg |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Luxembourg |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Luxembourg |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Luxembourg |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Luxembourg |
|
Diflucan |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Luxembourg |
|
Diflucan |
200 mg/5 ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
Luxembourg |
|
Diflucan |
200 mg/100 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Luxembourg |
|
Diflucan |
400 mg/200 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Malta |
|
Diflucan |
50 mg/25 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Malta |
|
Diflucan |
200 mg/100 ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Netherlands |
|
Diflucan 50 |
50 mg |
Capsule |
Oral use |
N/A |
||||||
|
Netherlands |
|
Diflucan 100 |
100 mg |
Capsule |
Oral use |
N/A |
||||||
|
Netherlands |
|
Diflucan 150 |
150 mg |
Capsule |
Oral use |
N/A |
||||||
|
Netherlands |
|
Diflucan 200 |
200 mg |
Capsule |
Oral use |
N/A |
||||||
|
Netherlands |
|
Diflucan suspensie 50 |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Netherlands |
|
Diflucan suspensie 200 |
200 mg/5 ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
Netherlands |
|
Diflucan I.V. |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Norway |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Norway |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Norway |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Norway |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Norway |
|
Diflucan |
50 mg/5 ml |
Powder for Oral Suspension |
Oral use |
10 mg/ml |
||||||
|
Norway |
|
Diflucan |
200 mg/5 ml |
Powder for Oral Suspension |
Oral use |
40 mg/ml |
||||||
|
Norway |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Poland |
|
Diflucan |
50 mg |
Capsule, |
Oral use |
N/A |
||||||
|
Poland |
|
Diflucan |
150 mg |
Capsule, |
Oral use |
N/A |
||||||
|
Poland |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Portugal |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Portugal |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Portugal |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Portugal |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Portugal |
|
Diflucan |
10 mg/ml |
Powder for oral Suspension |
Oral use |
10 mg/ml |
||||||
|
Portugal |
|
Diflucan |
40 mg/ml |
Powder for oral Suspension |
Oral use |
40 mg/ml |
||||||
|
Portugal |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Romania |
|
Diflucan 50 mg |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Romania |
|
Diflucan 150 mg |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Romania |
|
Diflucan 50 mg/5 ml |
50 mg/5 ml |
Powder for oral Suspension |
Oral use |
10 mg/ml |
||||||
|
Romania |
|
Diflucan 2 mg/ml |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Slovak Republic |
|
Diflucan 50 mg |
50 mg |
Capsule |
Oral use |
N/A |
||||||
|
Slovak Republic |
|
Diflucan 100 mg |
100 mg |
Capsule |
Oral use |
N/A |
||||||
|
Slovak Republic |
|
Diflucan 150 mg |
150 mg |
Capsule |
Oral use |
N/A |
||||||
|
Slovak Republic |
|
Diflucan P.O.S. 50 mg/5 ml |
50 mg/5 ml |
Powder for Oral Suspension |
Oral use |
10 mg/ml |
||||||
|
Slovak Republic |
|
Diflucan P.O.S. 200 mg/5 ml |
200 mg/5 ml |
Powder for Oral Suspension |
Oral use |
40 mg/ml |
||||||
|
Slovak Republic |
|
Diflucan IV 2 mg/ml |
2 mg/ml |
Solution for Intravenous Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Slovenia |
|
Diflucan 50 mg trde kapsule |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Slovenia |
|
Diflucan 100 mg trde kapsule |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Slovenia |
|
Diflucan 150 mg trde kapsule |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Slovenia |
|
Diflucan 10 mg/ ml prašek za peroralno suspenzijo |
10 mg/ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Slovenia |
|
Diflucan 40 mg/ml prašek za peroralno suspenzijo |
40 mg/ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
Slovenia |
|
Diflucan 2 mg/ml raztopina za infundiranje |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Spain |
|
Diflucan 50 mg cápsulas duras |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Spain |
|
Diflucan 100 mg cápsulas duras |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Spain |
|
Diflucan 150 mg cápsulas duras |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Spain |
|
Diflucan 200 mg cápsulas duras |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Spain |
|
Diflucan 50 mg/5 ml polvo para suspensión oral |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Spain |
|
Diflucan 200 mg/5 ml polvo para suspensión oral |
200 mg/5 ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
Spain |
|
Diflucan 2 mg/ml solución para perfusión |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
Sweden |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Sweden |
|
Diflucan |
100 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Sweden |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Sweden |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
Sweden |
|
Diflucan |
10 mg/ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
Sweden |
|
Diflucan |
40 mg/ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
Sweden |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
||||||
|
United Kingdom |
|
Diflucan |
50 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
United Kingdom |
|
Diflucan |
150 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
United Kingdom |
|
Diflucan |
200 mg |
Capsule, Hard |
Oral use |
N/A |
||||||
|
United Kingdom |
|
Diflucan |
50 mg/5 ml |
Powder for Suspension |
Oral use |
10 mg/ml |
||||||
|
United Kingdom |
|
Diflucan |
200 mg/5 ml |
Powder for Suspension |
Oral use |
40 mg/ml |
||||||
|
United Kingdom |
|
Diflucan |
2 mg/ml |
Solution for Infusion |
Intravenous use |
2 mg/ml |
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATIONS, APPLICANTS IN THE MEMBER STATES
|
Member State EU/EEA |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
Content (concentration) |
|||||
|
Belgium |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
|||||
|
Bulgaria |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
|||||
|
Cyprus |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
|||||
|
Germany |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
|||||
|
Greece |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
|||||
|
Malta |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
|||||
|
Portugal |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
|||||
|
Romania |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
|||||
|
United Kingdom |
|
Dexamethasone Alapis |
0,4 mg/ml |
Oral solution |
Oral use |
1 Bottle × 150 ml |
ANNEX VI
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT / MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
Applicant |
(Invented) Name |
Strength |
Pharmaceutical form |
Route of administration |
Content (concentration) |
||
|
Ireland |
|
|
Canazole Clotrimazole Cream 1 % w/w |
1 % w/w |
Cream |
Cutaneous Use |
100 mg/ml |
||
|
United Kingdom |
|
|
Canazole Clotrimazole Cream 1 % w/w |
1 % w/w |
Cream |
Cutaneous Use |
100 mg/ml |
ANNEX VII
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||||
|
Austria |
|
Novogos 3,6 mg Implantat |
3,6 mg |
implant, pre-filled syringe |
subcutaneous use |
||||||
|
Germany |
|
Goserelin cell pharm 3,6 mg Implantat |
3,6 mg |
implant |
subcutaneous use |
||||||
|
United Kingdom |
|
Novgos 3,6 mg Implant |
3,6 mg |
implant |
subcutaneous use |
ANNEX VIII
LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
Austria |
|
Novimp 3,6 mg Implantat |
3,6 mg |
implant, pre-filled syringe |
subcutaneous use |
||||
|
Germany |
|
Novimp 3,6 mg Implantat |
3,6 mg |
implant |
subcutaneous use |
||||
|
United Kingdom |
|
Novimp 3,6 mg Implant |
3,6 mg |
implant |
subcutaneous use |
ANNEX IX
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Route of administration |
||||
|
Austria |
|
Goserelin Novosis 3,6 mg Implantat |
3,6 mg |
implant, pre-filled syringe |
subcutaneous use |
||||
|
Germany |
|
Novosis Goserelin 3,6 mg Implantat |
3,6 mg |
implant |
subcutaneous use |
||||
|
United Kingdom |
|
Gosacin 3,6 mg Implant |
3,6 mg |
implant |
subcutaneous use |