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)
Date: 2012-06-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012190EN.01001201.xml










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







CSL Behring GmbH




Emil-von-Behring-Straße 76




35041 Marburg an der Lahn




Germany






Vivaglobin 160 mg/ml Injektionslösung (subkutane Anwendung)


160 mg/ml


solution for injection


subcutaneous use




Belgium







CSL Behring GMBH




Emil-von-Behring-Str. 76




35041 Marburg




Germany






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




Denmark







CSL Behring GmbH,




Emil-von-Behring-Strasse 76,




35041 Marburg,




Germany






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




Finland







CSL Behring GmbH,




Emil-von-Behring-Strasse 76,




35041 Marburg,




Germany






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




France







CSL BEHRING SA - PARIS




44 rue Cambronne




75015 Paris,




France






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




Germany







CSL Behring GmbH,




Emil von Behring Strasse 76,




35041 Marburg






Vivaglobin


Solution for infusion, 160 mg/ml


solution for infusion


subcutaneous use




Greece







CSL BEHRING ΜΕΠΕ




XATZHGIANNI MEKSI 5




ATHENS 11528






VIVAGLOBIN


16 % (W/V)
[150-170 MG]


solution for injection


subcutaneous use




Hungary







CSL Behring GmbH




Emil-von-Behring-str. 76.




35041 Marburg




Germany






Vivaglobin 160 mg/ml oldatos injekció szubkután alkalmazásra


160 mg/ml solution for injection (subcutaneous use)


solution for injection


subcutaneous use




Italy







CSL BEHRING GmbH




Emil von Behring Str 76




D-35041 Marburg-Germany






VIVAGLOBIN


160 MG/ML


solution for injection


subcutaneous use




Luxembourg







CSL BEHRING GMBH 76




EMIL-VON-BEHRING-STRASSED




35041 MARBURG






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




The Netherlands







CSL Behring GmbH,




Emil v. Behring Str. 76,




35041 Marburg,




Germany






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




Norway







CSL Behring GmbH,




Emil-von-Behring-Str. 76,




35041 Marburg,




Germany






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




Poland







CSL Behring GmbH,




Emil-von-Behring-Str. 76,




35041 Marburg,




Germany






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




Portugal







CSL Behring GmbH




Emil-von-Behring Strasse, 76




D-35041 Marburg




Germany






Vivaglobin


160 mg/ml


solution for injection


subcutaneous use




Spain







CSL BEHRING, GMBH




Emil von Bhering Strasse, 76




35041 Marburg,




Germany






VIVAGLOBIN 160 mg/ml para inyección (uso subcutáneo)


160 mg/ml


solution for injection


subcutaneous use




Sweden







CSL Behring GmbH,




Emil-von-Behring-Strasse 76




35041 Marburg,




Tyskland






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







Novartis Pharma GmbH




Stella-Klein Loew-Weg 17




1020 Vienna




Austria






Femara 2,5 mg – Filmtabletten


2,5 mg


film-coated tablet


Oral




Belgium







Novartis Pharma N.V.




Medialaan, 40 bus 1, 1800 Vilvoorde




Belgium






Femara


2,5 mg


film-coated tablet


Oral




Bulgaria







Novartis Pharma GmbH




Roonstrasse 25




90429 Nuernberg




Germany






Femara


2,5 mg


film-coated tablet


Oral




Cyprus







Novartis Pharmaceuticals UK Limited




Frimley Business Park,




Frimley,




Camberley,




Surrey GU16 7SR




United Kingdom






Femara


2,5 mg


film-coated tablet


Oral




Czech Republic







Novartis s.r.o.,




Gemini, budova B




Na Pankráci 1724/129




140 00 Prague 4




Czech Republic






Femara


2,5 mg


film-coated tablet


Oral




Denmark







Novartis Healthcare A/S




Lyngbyvej 172,




2100 København Ø




Denmark






Femar


2,5 mg


film-coated tablet


Oral




Estonia







Novartis Finland Oy




Metsänneidonkuja 10




02130 Espoo




Finland






Femara


2,5 mg


film-coated tablet


Oral




Finland







Novartis Finland Oy




Metsänneidonkuja 10




02130 Espoo




Finland






Femar


2,5 mg


film-coated tablet


Oral




France







Novartis Pharma S.A.S.




2 & 4, rue Lionel Terray,




92500 Rueil Malmaison Cédex




France






Fémara 2,5 mg comprimé pelliculé


2,5 mg


film-coated tablet


Oral




Germany







Novartis Pharma GmbH




Roonstraße 25




90429 Nürnberg




Germany






Femara 2,5 mg Filmtabletten


2,5 mg


film-coated tablet


Oral




Greece







Novartis (Hellas) S.A.C.I.




12 km of National Road Athens,




Lamia No 1,




14451 Metamorphosis,




Athens




Greece






FEMARA


2,5 mg


film-coated tablet


Oral




Hungary







Novartis Hungária Kft. Pharma




1114 Budapest,




Bartók Béla út 43-47




Hungary






Femara 2,5 mg filmtabletta


2,5 mg


film-coated tablet


Oral




Iceland







Novartis Healthcare A/S




Lyngbyvej 172,




2100 København Ø




Denmark






Femar


2,5 mg


film-coated tablet


Oral




Ireland







Novartis Pharmaceuticals UK Limited




Frimley Business Park,




Frimley,




Camberley,




Surrey GU16 7SR




United Kingdom






Femara 2,5 mg Film-coated Tablets


2,5 mg


film-coated tablet


Oral




Italy







Novartis Europharm Ltd




Wimblehurst Road




RH12 5 Ab - Horsham (West Sussex)




United Kingdom






Femara


2,5 mg


film-coated tablet


Oral




Latvia







Novartis Finland Oy




Metsänneidonkuja 10,




02130 Espoo




Finland






Femara 2,5 mg apvalkotās tabletes


2,5 mg


film-coated tablet


Oral




Lithuania







Novartis Finland Oy




Metsänneidonkuja 10,




02130 Espoo




Finland






Femara


2,5 mg


film-coated tablet


Oral




Luxembourg







Novartis Pharma GmbH




Roonstraße 25




90429 Nürnberg,




Germany






Femara


2,5 mg


film-coated tablet


Oral




Malta







Novartis Pharmaceuticals UK Limited




Frimley Business Park,




Frimley,




Camberley,




Surrey GU16 7SR




United Kingdom






Femara


2,5 mg


film-coated tablet


Oral




Netherlands







Novartis Pharma B.V.




Raapopseweg 1,




6824 DP Arnhem




The Netherlands






Femara


2,5 mg


film-coated tablet


Oral




Norway







Novartis Norge AS




Postboks 4284 Nydalen,




0401 Oslo




Norway






Femar


2,5 mg


film-coated tablet


Oral




Poland







Novartis Pharma GmbH




Roonstraße 25




90429 Nürnberg,




Germany






Femara


2,5 mg


film-coated tablet


Oral




Portugal







Novartis Farma - Produtos Farmacêuticos S.A.




Rua do Centro Empresarial,




Edif. 8, Quinta da Beloura




2710-444 Sintra




Portugal






Femara


2,5 mg


film-coated tablet


Oral




Romania







Novartis Pharma GmbH




Roonstraße 25




90429 Nürnberg,




Germany






Femara 2,5 mg comprimate filmate


2,5 mg


film-coated tablet


Oral




Slovak Republic







Novartis, s.r.o.




Gemini, budova B




Na Pankráci 1724,/129




14000 Prague 4,




Czech Republic






Femara


2,5 mg


film-coated tablet


Oral




Slovenia







Novartis Pharma GmbH




Roonstraße 25




90429 Nürnberg,




Germany






Femara 2,5 mg filmsko obložene tablete


2,5 mg


film-coated tablet


Oral




Spain







Laboratorios Padró, S.A.




Gran Via de les Corts Catalanes, No 764




08013 Barcelona




Spain






Loxifan 2,5 mg comprimidos recubiertos con película


2,5 mg


film-coated tablet


Oral









Novartis Farmacéutica, S.A.




Gran Via de les Corts Catalanes, No 764




08013 Barcelona




Spain






Femara 2,5 mg comprimidos recubiertos con película


2,5 mg


film-coated tablet


Oral




Sweden







Novartis Sverige AB




Kemistvägen 1B, Box 1150,




18311 Täby,




Sweden






Femar


2,5 mg


film-coated tablet


Oral




United Kingdom







Novartis Pharmaceuticals UK Limited




Trading as Ciba Laboratories




Frimley Business Park,




Frimley,




Camberley,




Surrey GU16 7SR




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







GlaxoSmithKline Pharma GmbH




Albert Schweitzer-Gasse 6




A-1140 Wien




Austria






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Austria







GlaxoSmithKline Pharma GmbH




Albert Schweitzer-Gasse 6




A-1140 Wien




Austria






Priorix


 


Powder in vials and solvent in prefilled-syringes for solution for injection


Subcutaneous use
Intramuscular use




Belgium







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Bulgaria







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for suspension for injection


Subcutaneous use
Intramuscular use




Cyprus







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Czech Republic







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Denmark







GlaxoSmithKline Pharma A/S




Nykær 68




DK-2605 Brøndby




Denmark






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Estonia







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Finland







GlaxoSmithKline Biologicals SA




Rue de l’Institut 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




France







Laboratoire GlaxoSmithKline




100 route de Versailles




78163 Marly-le-Roi Cedex




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







GlaxoSmithKline GmbH & Co. KG




Theresienhöhe 11




D-80339 München




Germany






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Greece







GlaxoSmithKline AEBE




266 Kifisias avenue




152 32 Halandri




Greece






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Hungary







GlaxoSmithKline Kft.




1124 Budapest




Csörsz u 43




Hungary






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Iceland







GlaxoSmithKline ehf.




Thverholt 14




105 Reykjavik




Iceland






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way




Rathfarnham




Dublin 16




Ireland






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Italy







GlaxoSmithKline S.p.A.




Via A. Fleming, 2




37135 Verona




Italy






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Latvia







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix
pulveris un šķīdinātājs injekciju šķīduma pagatavošanai


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Lithuania







UAB ‘GlaxoSmithKline Lietuva’




Goštauto 40A




LT-01112, Vilnius




Lithuania






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Luxembourg







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Malta







SmithKline Beecham plc




Great West Road,




Brentford,




Middlesex TW8 9GS




Trading as





GlaxoSmithKline UK




Stockley Park West




Uxbridge




Middlesex




UB11 1BT




United Kingdom






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Netherlands







GlaxoSmithKline BV




Huis ter Heideweg 62




3705 LZ Zeist




The Netherlands






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use




Norway







GlaxoSmithKline AS




Forskningsveien 2a




Postboks 180 Vinderen




0319 Oslo




Norway






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Poland







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Portugal







Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.




Rua Dr. António Loureiro Borges, 3




Arquiparque – Miraflores




1495-131 Algés




Portugal






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Romania







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Slovak Republic







GlaxoSmithKline Biologicals s.a.




Rue de l’Institut, 89




1330 Rixensart




Belgium






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Slovenia







GSK d.o.o.,




Ljubljana,




Knezov štradon 90,




1000 Ljubljana




Slovenia






Priorix
prašek in vehikel za raztopino za injiciranje


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Spain







GlaxoSmithKline, S.A.




C/Severo Ochoa, 2




28760 Tres Cantos (Madrid)




Spain






Priorix
polvo y disolvente en jeringa precargada para solución inyectable


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




Sweden







GlaxoSmithKline AB,




Box 516,




169 29 Solna




Sweden






Priorix


 


Powder and solvent for solution for injection


Subcutaneous use
Intramuscular use




United Kingdom







SmithKline Beecham plc




980 Great West Road,




Brentford,




Middlesex TW8 9GS




United Kingdom




Trading as





GlaxoSmithKline UK




Stockley Park West




Uxbridge




Middlesex UB11 1BT




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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)





Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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.




Spain







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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.








Romania







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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







Pfizer Limited Veterinary Medical Research & Development




Sandwich




Kent CT13 9NJ




United Kingdom






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.