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Document 52012XC0629(03)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 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 May 2012 to 31 May 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 May 2012 to 31 May 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
OJ C 190, 29.6.2012, p. 12–33
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
29.6.2012 |
EN |
Official Journal of the European Union |
C 190/12 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 2012
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )
2012/C 190/02
— 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 |
7.5.2012 |
Vivaglobin and associated names |
See Annex I |
See Annex I |
8.5.2012 |
22.5.2012 |
Femara and associated names |
See Annex II |
See Annex II |
23.5.2012 |
25.5.2012 |
Priorix and associated names |
See Annex III |
See Annex III |
30.5.2012 |
25.5.2012 |
Prontax 5 Mg/ml |
See Annex IV |
See Annex IV |
30.5.2012 |
25.5.2012 |
Prontax 10 Mg/ml |
See Annex V |
See Annex V |
29.5.2012 |
(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, 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 |
|
Vivaglobin 160 mg/ml Injektionslösung (subkutane Anwendung) |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Belgium |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Denmark |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Finland |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
France |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Germany |
|
Vivaglobin |
Solution for infusion, 160 mg/ml |
solution for infusion |
subcutaneous use |
||||
Greece |
|
VIVAGLOBIN |
16 % (W/V) [150-170 MG] |
solution for injection |
subcutaneous use |
||||
Hungary |
|
Vivaglobin 160 mg/ml oldatos injekció szubkután alkalmazásra |
160 mg/ml solution for injection (subcutaneous use) |
solution for injection |
subcutaneous use |
||||
Italy |
|
VIVAGLOBIN |
160 MG/ML |
solution for injection |
subcutaneous use |
||||
Luxembourg |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
The Netherlands |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Norway |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Poland |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Portugal |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Spain |
|
VIVAGLOBIN 160 mg/ml para inyección (uso subcutáneo) |
160 mg/ml |
solution for injection |
subcutaneous use |
||||
Sweden |
|
Vivaglobin |
160 mg/ml |
solution for injection |
subcutaneous use |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH 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 |
|
Femara 2,5 mg – Filmtabletten |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Belgium |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Bulgaria |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Cyprus |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Czech Republic |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Denmark |
|
Femar |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Estonia |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Finland |
|
Femar |
2,5 mg |
film-coated tablet |
Oral |
|||||||
France |
|
Fémara 2,5 mg comprimé pelliculé |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Germany |
|
Femara 2,5 mg Filmtabletten |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Greece |
|
FEMARA |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Hungary |
|
Femara 2,5 mg filmtabletta |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Iceland |
|
Femar |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Ireland |
|
Femara 2,5 mg Film-coated Tablets |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Italy |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Latvia |
|
Femara 2,5 mg apvalkotās tabletes |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Lithuania |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Luxembourg |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Malta |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Netherlands |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Norway |
|
Femar |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Poland |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Portugal |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Romania |
|
Femara 2,5 mg comprimate filmate |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Slovak Republic |
|
Femara |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Slovenia |
|
Femara 2,5 mg filmsko obložene tablete |
2,5 mg |
film-coated tablet |
Oral |
|||||||
Spain |
|
Loxifan 2,5 mg comprimidos recubiertos con película |
2,5 mg |
film-coated tablet |
Oral |
|||||||
|
Femara 2,5 mg comprimidos recubiertos con película |
2,5 mg |
film-coated tablet |
Oral |
||||||||
Sweden |
|
Femar |
2,5 mg |
film-coated tablet |
Oral |
|||||||
United Kingdom |
|
Femara 2,5 mg Tablets |
2,5 mg |
film-coated tablet |
Oral |
ANNEX III
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Member State EU/EEA |
Marketing authorisation holder |
(Invented) Name |
Strength (1) |
Pharmaceutical form |
Route of administration |
||||||||||
Austria |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Austria |
|
Priorix |
|
Powder in vials and solvent in prefilled-syringes for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Belgium |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Bulgaria |
|
Priorix |
|
Powder and solvent for suspension for injection |
Subcutaneous use Intramuscular use |
||||||||||
Cyprus |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Czech Republic |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Denmark |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Estonia |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Finland |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
France |
|
Priorix powder and solvent for solution for injection in a pre-filled syringe Measles, mumps, and rubella vaccine (live) |
|
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||
Germany |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Greece |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Hungary |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Iceland |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Ireland |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Italy |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Latvia |
|
Priorix pulveris un šķīdinātājs injekciju šķīduma pagatavošanai |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Lithuania |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Luxembourg |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Malta |
Trading as
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Netherlands |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use |
||||||||||
Norway |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Poland |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Portugal |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Romania |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Slovak Republic |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Slovenia |
|
Priorix prašek in vehikel za raztopino za injiciranje |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Spain |
|
Priorix polvo y disolvente en jeringa precargada para solución inyectable |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
Sweden |
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
||||||||||
United Kingdom |
Trading as
|
Priorix |
|
Powder and solvent for solution for injection |
Subcutaneous use Intramuscular use |
(1) Strength applicable for all countries
After reconstitution, 1 dose (0,5 ml) contains:
Live attenuated measles virus (Schwarz strain) |
not less than 103.0 CCID50 |
Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain) |
not less than 103.7 CCID50 |
Live attenuated rubella virus (Wistar RA 27/3 strain) |
not less than 103.0 CCID50 |
ANNEX IV
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT IN THE MEMBER STATES
Member State EU/EEA |
Applicant |
Name |
Pharmaceutical form |
INN/Strength |
Animal species |
Route of administration |
Recommended dose |
Withdrawal periods |
||||
Austria |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Bulgaria |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Denmark |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Spain |
|
Dectomax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Finland |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
France |
|
Prontax 5 mg/ml solution pour pour on pour bovins |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Hungary |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Ireland |
|
Dectomax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Iceland |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
The Netherlands |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Norway |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Poland |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Portugal |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Romania |
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Sweden |
(Applicant)
|
Prontax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
||||
Slovenia |
|
Dectomax 5 mg/ml Pour-On Solution for Cattle |
Pour-on solution |
Doramectin 5 mg/ml |
Cattle |
topical - on the back of the animal |
1 ml per 10 kg bodyweight |
CATTLE: Meat and offal: 35 days. Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving |
ANNEX V
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIODS, APPLICANT IN THE MEMBER STATES
Member State EU/EEA |
Applicant |
Name |
Pharmaceutical form |
INN/Strength |
Animal species |
Route of administration |
Recommended dose |
Withdrawal periods |
|||||||
Austria |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Bulgaria |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Cyprus |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs – intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Czech Republic |
|
DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Denmark |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs – intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Estonia |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Greece |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
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Spain |
|
DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Finland |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
France |
|
Prontax 10 mg/ml solution injectable pour bovins, ovins et porcins |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Hungary |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Ireland |
|
Dectomax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Iceland |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Latvia |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Lithuania |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Malta |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
The Netherlands |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Norway |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Poland |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Portugal |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
|
|||||||
Romania |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Sweden |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Slovenia |
|
Dectomax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |
|||||||
Slovakia |
|
Prontax 10 mg/ml solution for injection for cattle, sheep and pigs |
Solution for injection |
Doramectin 10 mg/ml |
Cattle, sheep and pigs |
Cattle - subcutaneous Sheep and pigs - intramuscular |
Cattle and sheep - 1 ml per 50 kg bodyweight Pigs - 1 ml per 33 kg bodyweight |
CATTLE: Meat and offal: - withdrawal period: 54 days. Milk: - The product is not permitted for use in lactating cows used to produce milk for human consumption. Do not use in dry dairy cows including pregnant dairy heifers within 60 days prior to calving. SHEEP: Meat and offal: - withdrawal period: 63 days. Milk: - The product is not permitted for use in lactating sheep used to produce milk for human consumption. Do not use in dry dairy ewes including pregnant dairy ewe lambs within 70 days prior to lambing. PIGS: Meat and offal: - withdrawal period 56 days. |