Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2021-09-29
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2021394EN.01000901.xml










29.9.2021   


EN


Official Journal of the European Union


C 394/9






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2021 to 31 August 2021
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2021/C 394/02)
—   Issuing, maintenance or modification of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




30.8.2021


Ronaxan and its associated names


doxycycline


See Annex I


See Annex I


31.8.2021




18.8.2021


Injectable veterinary medicinal products containing vitamin A for use in food producing species


Vitamin A (retinol and its esters)


See Annex II


See Annex II


19.8.2021




—   Suspension of a national marketing authorisation











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




18.8.2021


Injectable veterinary medicinal products containing vitamin A for use in food producing species


Vitamin A (retinol and its esters)


See Annex II


See Annex II


19.8.2021






(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 veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States












Member State EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Belgium







Boehringer Ingelheim Animal Health Belgium SA




Avenue Arnaud Fraiteurlaan, 15-23




1050 Brussels




Belgium






Ronaxan 20 mg


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Belgium







Boehringer Ingelheim Animal Health Belgium SA




Avenue Arnaud Fraiteurlaan, 15-23




1050 Brussels




Belgium






Ronaxan 100 mg


Doxycycline


100 mg


Tablets


Dogs


Oral use




Croatia







Boehringer Ingelheim Animal Health France SCS,




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 100 mg, tablete za pse


Doxycycline


100 mg


Tablets


Dogs


Oral use




Croatia







Boehringer Ingelheim Animal Health France SCS,




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 250 mg, tablete za pse


Doxycycline


250 mg


Tablets


Dogs


Oral use




Czechia







Boehringer Ingelheim Animal Health France SCS,




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 100 mg tablety


Doxycycline


100 mg


Tablets


Dogs


Oral use




Czechia







Boehringer Ingelheim Animal Health France SCS,




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 20 mg tablety


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Denmark







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52




2100 København Ø




Denmark






Ronaxan Vet.


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Denmark







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52




2100 København Ø




Denmark






Ronaxan Vet.


Doxycycline


100 mg


Tablets


Cats and dogs


Oral use




France







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan comprimes 20


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




France







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan comprimes 100


Doxycycline


100 mg


Tablets


Dogs


Oral use




France







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan comprimes 250


Doxycycline


250 mg


Tablets


Dogs


Oral use




Germany







Boehringer Ingelheim Vetmedica GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




Germany






Ronaxan 100


Doxycycline


100 mg


Tablets


Dogs


Oral use




Greece







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan, Δισκία 20 mg/tab


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Greece







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan, Δισκία 100 mg/tab


Doxycycline


100 mg


Tablets


Dogs


Oral use




Greece







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan, Δισκία 250 mg/tab


Doxycycline


250 mg


Tablets


Dogs


Oral use




Ireland







Boehringer Ingelheim Vetmedica GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




Germany






Ronaxan 100 mg Tablet


Doxycycline


100 mg


Tablets


Dogs


Oral use




Ireland







Boehringer Ingelheim Vetmedica GmbH




Binger Strasse 173




55216 Ingelheim am Rhein




Germany






Ronaxan 20 mg Tablet


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Italy







Boehringer Ingelheim Animal Health Italia S.p.A




Via Lorenzini n.8




Milano — 20139




Italy






Ronaxan, 20 mg compresse per cani e gatti


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Italy







Boehringer Ingelheim Animal Health Italia S.p.A




Via Lorenzini n.8




Milano — 20139




Italy






Ronaxan, 100 mg compresse per cani


Doxycycline


100 mg


Tablets


Dogs


Oral use




Italy







Boehringer Ingelheim Animal Health Italia S.p.A




Via Lorenzini n.8




Milano — 20139




Italy






Ronaxan, 250 mg compresse per cani


Doxycycline


250 mg


Tablets


Dogs


Oral use




Lithuania







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 20, tabletės


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Lithuania







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 100, tabletės


Doxycycline


100 mg


Tablets


Cats and dogs


Oral use




Luxembourg







Boehringer Ingelheim Animal Health Belgium SA




Arianelaan 16




1200 Brussel




Belgium






Ronaxan 20 mg


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Luxembourg







Boehringer Ingelheim Animal Health Belgium SA




Arianelaan 16




1200 Brussel




Belgium






Ronaxan 100 mg


Doxycycline


100 mg


Tablets


Dogs


Oral use




Malta







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan tablets 100


Doxycycline


100 mg


Tablets


Dogs


Oral use




Malta







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan tablets 20


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Norway







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52




2100 Copenhagen




Denmark






Ronaxan Vet


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Norway







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52




2100 Copenhagen




Denmark






Ronaxan Vet


Doxycycline


100 mg


Tablets


Cats and dogs


Oral use




Portugal







Boehringer Ingelheim Animal Health, Unipessoal, Lda.




Avenida de Pádua, no 11




1800-294 Lisboa




Portugal






Ronaxan 20 mg comprimidos para cães e gatos


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Portugal







Boehringer Ingelheim Animal Health, Unipessoal, Lda.




Avenida de Pádua, no 11




1800-294 Lisboa




Portugal






Ronaxan 100 mg comprimidos para cães


Doxycycline


100 mg


Tablets


Dogs


Oral use




Portugal







Boehringer Ingelheim Animal Health, Unipessoal, Lda.




Avenida de Pádua, no 11




1800-294 Lisboa




Portugal






Ronaxan 250 mg comprimidos para cães


Doxycycline


250 mg


Tablets


Dogs


Oral use




Romania







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 20 mg Tablet


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Romania







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 100 mg Tablet


Doxycycline


100 mg


Tablets


Dogs


Oral use




Romania







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 250 mg Tablet


Doxycycline


250 mg


Tablets


Dogs


Oral use




Slovakia







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 20 mg tablety


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Slovakia







Boehringer Ingelheim Animal Health France SCS




29 Avenue Tony Garnier




69007 Lyon




France






Ronaxan 100 mg tablet


Doxycycline


100 mg


Tablets


Dogs


Oral use




Spain







Boehringer Ingelheim Animal Health España S.A.U.




C/Prat de la Riba, 50




Sant Cugat del Valles Barcelona 08174




Spain






Ronaxan 20 mg comprimidos


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Spain







Boehringer Ingelheim Animal Health España S.A.U.




C/Prat de la Riba, 50




Sant Cugat del Valles Barcelona 08174




Spain






Ronaxan 100 mg comprimidos


Doxycycline


100 mg


Tablets


Dogs


Oral use




Sweden


Boehringer Ingelheim Animal Health Nordics A/S, Strødamvej 52, 2100 Copenhagen Ø, Denmark


Ronaxan vet.


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




Sweden


Boehringer Ingelheim Animal Health Nordics A/S, Strødamvej 52, 2100 Copenhagen Ø, Denmark


Ronaxan vet.


Doxycycline


100 mg


Tablets


Cats and dogs


Oral use




The Netherlands







Boehringer Ingelheim Animal Health Netherlands B.V.




Comensiusstraat 6




1817 MS Alkmaar




The Netherlands






Ronaxan 100 mg, tablet voor honden en katten


Doxycycline


100 mg


Tablets


Cats and dogs


Oral use




The Netherlands







Boehringer Ingelheim Animal Health Netherlands B.V.




Comensiusstraat 6




1817 MS Alkmaar




The Netherlands






Ronaxan 20 mg, tablet voor honden en katten


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use




United Kingdom (Northern Ireland) 1
 (1)








Boehringer Ingelheim Animal Health UK Ltd,




Ellesfield Avenue, Bracknell




Berkshire




RG12 8YS




United Kingdom






Ronaxan 100 mg Tablet


Doxycycline


100 mg


Tablets


Dogs


Oral use




United Kingdom (Northern Ireland) (1)








Boehringer Ingelheim Animal Health UK Ltd,




Ellesfield Avenue, Bracknell




Berkshire




RG12 8YS




United Kingdom






Ronaxan 20 mg Tablet


Doxycycline


20 mg


Tablets


Cats and dogs


Oral use






(1)  For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.





ANNEX II
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration and marketing authorisation holders in the Member States
 



ANNEX IIA
List of authorised veterinary medicinal products recommended for variation of the marketing authorisations












Member State EU/EEA


Marketing authorisation holders


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E, Injektionslösung für Rind, Pferd, Schwein und Hund


Retinolpalmitat
All-rac alpha tocopherolacetat
Colecalciferol


176,47  mg (300 000  IU)
50 mg
2,5  mg (100 000  IU)


Solution for injection


Cattle, horses, pigs, dogs


For intramuscular and subcutaneous use




Austria







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Vitasol AD3E Injektionslösung für Tiere


Vitamin A als Retinol Palmitat
Vitamin D3 als colecalciferol
Vitamin E als all-rac-α-tocopherolacetat


50 000  I.E.
25 000  I.E.
20 mg


Solution for injection


Cattle, horses, pigs, dogs


For subcutaneous, intramuscular, in large animals also intravenous (slow, body warm) injection




Austria







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Vitasol AD3EC — Injektionslösung für Tiere


Vitamin A als Retinol Palmitat
Vitamin D3 als Colecalciferol
all-rac-α-Tocopherolacetat (Vit. E)
Ascorbinsäure (Vit. C)


50 000  I.E.
25 000  I.E.
30 mg
100 mg


Solution for injection


Cattle, horses, pigs, dogs


For intramuscular and subcutaneous use




Belgium







Zoetis Belgium s.a.




Rue Laid Burniat, 1




B-1348 Louvain-La-Neuve




Belgium






Duphafral AD3E


Vitamin A
Vitamin D3
Vitamin E


500 000  IU
50 000  IU
50 mg


Solution for injection


Cattle, horses, sheep, pigs


For intramuscular use




Belgium







V.M.D. n.v.




Hoge Mauw 900




B-2370 Arendonk




Belgium






Vitamine A+D3+E


Vitaminum A
Colecalciferolum
Alphatocopheroli acetas


50 000  IU
25 000  IU
20 mg


Solution for injection


Calf, sow, piglets


For intramuscular use




Bulgaria







Asklep-Pharma Ltd




Lyulin 7, bl. 711A, shop 3




Sofia




Bulgaria






Norovit


Vitamin A palmitate, Cholecalciferol (Vitamin D3), Vitamin E acetate, Thiamine hydrochloride (Vitamin B1), Riboflavin sodium phosphate (Vitamin B2), Pyridoxine hydrochloride (Vitamin B6), Nicotinamide, Dexpanthenol, Cyanocobalamin (Vitamin B12)


15 000  IU
25 μg
20 mg
10 mg
5 mg
3 mg
35 mg
25 mg
25 μg


Solution for injection


Cattle, horses, pigs, sheep


For intramuscular and subcutaneous use




Bulgaria







Biovet JSC




39, Petar Racov Str.




4550 Peshtera




Bulgaria






Vialiton solution for injection


Vitamin A; Vitamin D3; Vitamin Е


20 mg/ml (50 000  IU) 0,625  mg/ml (25 000  IU)
20 mg/ml


Solution for injection


Cattle, calves, chickens, horses, pigs, dogs, cats


For intramuscular, subcutaneous and oral use




Bulgaria







Vetprom AD




26, Otez Paissij Str.




2400 Radomir




Bulgaria






Vitamin AD3E solutio pro injectionibus


Vitamin A, Cholecalciferol, Alpha — Tocopheryl Acetate (Vit. E)


1 500 000  IU/100 ml
2 000 000  IU/100 ml
1 g/100 ml


Solution for injection


Cattle, sheep, goats, horses, pigs, piglets


For intramuscular, subcutaneous and oral use




Bulgaria







Provet S. A.




77, Posidonos Avenue




174 55 Alimos,




Attiki




Greece






Zingul inj.


Vitamin A (as palmitat);
Vitamin D3;
Vitamin E (as acetat)


50 000  IU/ml
25 000  IU/ml
50 mg/ml


Solution for injection


Cattle, goats, horses, pigs, sheep


For intramuscular use




Croatia







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E pro injectione, otopina za injekciju, za konje, goveda, svinje i pse


Retinol (vitamin A) palmitate,
All-rac alpha tocopheryl acetate
Cholecalciferol


176,47  mg (300 000  IU)
50 mg
100 mg


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Croatia







Krka — Farma d.o.o.




Radnička cesta 48




10000 Zagreb




Croatia






Vitamin AD3E, emulzija za injekciju, goveda, ovce, koze, konji, svinje, kunići, psi, mačke


Vitamin A (retinol) palmitate, cholecalciferol and all-rac-α-Tocopheryl acetate


50 000  IU/ml
25 000  IU/ml
20 mg/ml


Emulsion for injection


Cattle, sheep, goats, horses, pigs, rabbits, dogs, cats


For intramuscular and subcutaneous use




Cyprus







Fatro S.p.A.




Via Emilia 285




40064 Ozzano dell’Emilia




Bologna




Italy






Adecon injection
Ενέσιμο διάλυμα για βοοειδή, άλογα, χοίρους, πρόβατα και αίγες


Retinol acetate (Vitamin A)
Vitamin D3 Vitamin E


100 000  IU /ml
25 000  IU /ml
100 mg/ml


Solution for injection


Cattle, horses, pigs, sheep, goats


Intramuscular (may be administered orally)




Cyprus







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3E, ενέσιμο διάλυμα για άλογα, βοοειδή, χοίρους και σκύλους


Retinol palmitate
Vitamin D3 Vitamin E acetate


176,47  mg
100 mg per ml
50 mg per ml


Solution for injection


Cattle, pigs, horses, dogs


For subcutaneous or intramuscular use




Czechia







Kela NV




Sint Lenaartseweg 48




2320 Hoogstraten




Belgium






Adedri-kel injekční roztok


Retinol+
Colecalciferol


100 000  IU +50 000  IU


Solution for injection


Horses, cattle, pigs, sheep, goats, dogs, cats


For intramuscular and subcutaneous use




Czechia







Bioveta, a. s.




Komenského 212




683 23 Ivanovice na Hané




Czech Republic






ADE — vit injekční roztok


Retinol+
Tocopherol+
Ergocalciferol


1 ml:
100 000  IU + 30 mg + 100 000  IU


Solution for injection


Cattle, dogs, goats, horses, pigs, rabbits, sheep


For intramuscular use




Czechia







Pharmagal Ltd.




Murgašova 5,




949 01 Nitra




Slovak Republic






Triavit injekční roztok


Retinol+
Tocopherol+
Colecalciferol


1 ml:
100 000  IU
50 mg
50 000  IU


Solution for injection


Horses, cattle, pigs, sheep, dogs, rabbits, poultry


For intramuscular and subcutaneous use




Czechia







Alfasan International B.V.




Kuipersweg 9




Woerden




Utrecht




The Netherlands






Vitamin AD3E Alfasan injekční roztok


Retinol+
Tocopherol+
Colecalciferol


1 ml:
300 000  IU
50 mg
100 000  IU


Solution for injection


Cattle, goats, horses, pigs, sheep


For intramuscular and subcutaneous use




Estonia







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E bela-pharm


Retinol+
Tocopherol+
Colecalciferol


1ml:
300 000  IU (176,47  mg)
50 mg
100 000  IU (100 mg)


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Estonia







Alfasan International B.V.




Kuipersweg 9




Woerden




Utrecht




The Netherlands






Vitamin AD3E forte


Retinol+
Tocopherol+
Colecalciferol


1ml:
500 000  IU+
50 mg+
75 000  IU


Solution for injection


Cattle, cats, dogs, goats, horses, sheep


For intramuscular and subcutaneous use




Estonia







Interchemie Werken De Adelaar Eesti AS




Vanapere tee 14, Püünsi küla




Viimsi vald, Harju maakond




74013




Estonia






Vitol-140


Retinol+
Tocopherol+
Colecalciferol


1 ml:
80 000  IU+
20 mg+
40 000  IU


Solution for injection


Cattle, horses, pigs, sheep


For intramuscular use




France







Virbac




1ere Avenue 2065 M — L.I.D.




06516 Carros Cedex




France






Ad-Ject


Retinol palmitate,
Cholecalciferol,
Alpha-tocopherol (as acetate)


500 000  IU/ml
75 000  IU/ml
45,6  mg/ml


Solution for injection


Cattle, sheep, pigs


For intramuscular use




France







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3E Solution for injection for horses, cattle, pigs and dogs


Retinol palmitate,
Cholecalciferol concentrate (oily form),
All-rac-alpha-tocopheryl acetate


176,47  mg/ml
100 mg/ml
50 mg/ml


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




France







Dopharma France




23, Rue du Prieuré




Saint Herblon




44150 Vair sur Loire




France






Cofavit 500


Retinol (as propionate),
Cholecalciferol,
Alpha-tocopherol (as acetate)


500 000  IU/ml
75 000  IU/ml
45,55  mg/ml


Solution for injection


Cattle, sheep, goats, pigs, rabbits


For intramuscular and subcutaneous use




France







Laboratoires Biové




3 Rue de Lorraine




62510 Arques




France






Trivitase


Retinol palmitate,
Cholecalciferol,
Alpha-tocopherol (as acetate)


500 000  IU/ml
75 000  IU/ml
50 mg/ml


Solution for injection


Cattle, sheep, goats, pigs


For intramuscular use




Germany







Serumwerk Bernburg AG




Hallesche Landstrasse 105b




06406 Bernburg




Germany






Ursovit AD3EC, wässrig pro inj.


Retinol palmitate
Colecalciferol
Alpha-tocopherol acetate
Ascorbic acid


1 ml:
30 mg (50 000  IU)
0,125  mg
30 mg
100 mg


Solution for injection


Cattle, cats, horses, minks, pigs, sheep, goats, rabbits, dogs


For intramuscular and subcutaneous use




Germany







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E pro injectione


Retinol palmitate
(Vitamin A)
All-rac alpha tocopheryl acetate
Cholecalciferol


176,47  mg (300 000  IU)
50 mg
100 mg


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Germany







AniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Vitamin ADE aniMedica


Retinol palmitate
(Vitamin A)
Colecalciferol
All-rac-alpha-Tocopherolacetat


176,47  mg (300 000  IU)
2,5  mg
50 mg


Solution for injection


Cattle, pigs, sheep, goats, horses, dogs


For intramuscular use




Greece







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3E, solution for injection for horses, cattle, pigs, and dogs


Vitamin A
Vitamin D3 Vitamin E acetate


176,47  mg/ml
100 mg/ml
50 mg/ml


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Greece







A.Nikolakopoulos A.E,




115 Galatsiou Avenue,




Galatsi 11146




Athens




Greece






Bremervit AD3E


Vitamin A
Vitamin D3 Vitamin E acetate


(300 000  IU+ 100 000  IU+50 mg)/ml


Solution for injection


Cattle, horses, pregnant sow, calves, foals, pigs, sheep, goats, piglets, lambs


For intramuscular use




Greece







Erfar SA




Altani & Mikras Asias 2 St.,




15351 Pallini Attikis




Athens




Greece






Adepur


Vitamin A Vitamin D3 Vitamin E acetate


(50 000  IU +25 000  IU + 20 mg)/ml


Solution for injection


Cattle, horses, pigs, sheep, goats, calves, lambs, piglets


For intramuscular use




Greece







Hellafarm AE




1st km Paiania-Markopoulou Avenue




19002 Paiania




Attiki




Athens




Greece






Labiasol AD3E-500


Vitamin A Propionate Vitamin D3 Vitamin E


(500 000  IU +75 000  IU+ 50 IU)/ml


Suspension for injection


Cattle, goats, sheep, pigs, horses


For intramuscular use




Greece







Intervet Hellas S.A.




63, Agiou Dimitriou str,




GR-174 56 Alimos, Athens




Greece






Turlin AD3E


Vitamin A Palmitate
Vitamin D3
Vitamin E


(50 000  IU +25 000  IU + 20 mg)/ml


Solution for injection


Cattle, horses, pigs, goats, sheep, poultry


For intramuscular and subcutaneous use




Greece







Hellafarm AE




1st km Paiania-Markopoulou Avenue




19002 Paiania




Attiki




Athens




Greece






Vitamin AD3E/New Vet


Vitamin A Palmitate
Vitamin D3
Vitamin E


(50 000  IU+25 000  IU+ 20 mg)/ml


Solution for injection


Cattle, calves, pigs, horses, sheep, goats, piglets


For intramuscular use




Greece







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




The Netherlands






Vitamine AD3E/Eurovet


Vitamin A Palmitate
Vitamin D3
Vitamin E


(80 000  IU +40 000  IU + 20 mg)/ml


Solution for injection


Cattle, horses, sheep, goats, pigs, dogs, cats


For intramuscular and subcutaneous use




Greece







Anafasis LTD




3 Santorinis St,




Pallouriotissa




1048 Nicosia




Cyprus






Vitamins AD3E/Anafasis


Vitamin A palmitate
Vitamin D3
Vitamin E


(50 000  IU +25 000  IU + 20 mg)/ml


Solution for injection


Cattle, horses, pigs, sheep, goats


For intramuscular, intravenous use




Greece







Anafasis LTD




3 Santorinis St,




Pallouriotissa




1048 Nicosia




Cyprus






Vitamins AD3E/Anafasis


Vitamin A palmitate Vitamin D3
Vitamin E


(300 000  IU+ 100 000  IU + 50 mg)/ml


Solution for injection


Cattle, horses, pigs, sheep, goats, dogs


For intramuscular, intravenous use




Greece







Provet S. A.




77 Posidonos Avenue




174 55 Alimos




Attiki




Greece






Zingul


Vitamin A (as palmitate)
Vitamin D3
Vitamin E


(50 000  IU+25 000  IU + 50 mg)/ml


Solution for injection


Cattle, horses, pigs, sheep, goats


For intramuscular use




Hungary







Kela NV




Sint Lenaartseweg 48




2320 Hoogstraten




Belgium






Neovit AD3E injekció A.U.V.


Vitamin A,
cholecalciferol, alpha tocopherol acetate


100 000  IU/ml
50 000  IU/ml
5 mg/ml


Solution for injection


Cattle, cats, dogs, goats, horses, pigs, sheep


For intramuscular and subcutaneous use




Hungary







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3E 176,47 /2,5 /50 mg/ml oldatos injekció lovak, szarvasmarhák, sertések, kutyák számára A.U.V.


Vitamin A, vitamin D3, vitamin E


300 000  IU/ml
100 000  IU/ml
50 mg/ml


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Hungary







Bio-Vet Kft.




4487 Tiszatelek,




Kossuth u. 151.




Hungary






Ferriade injekció A.U.V.


Iron-dextran, vitamin A,
vitamin D3, vitamin E


100 mg/ml
10 000  IU/ml
1 000  IU/ml
10 mg/ml


Solution for injection


Calves, lambs, piglets


For intramuscular and subcutaneous use




Hungary







UNIVET Ltd.




Tullyvin, Cootehill, Co. Cavan,




Ireland






Multivitamines oldatos injekció A.U.V.


Vitamin A, vitamin B1, B2, B6, B12, D3, E, nicotinamide, D-panthenol


1 ml:
15 000  IU
10 mg
5 mg
3 mg
50 μg
1 000  IU
10 mg
35 mg
25 mg


Solution for injection


Cattle, pigs


For intramuscular use




Hungary


Bremer Pharma GmbH Werkstrasse 42, 34414 Warburg, Germany


Vitamin AD3E injekció A.U.V.


Vitamin A,
cholecalciferol, vitamin E


50 000  IU/ml,
25 000  IU/ml,
20 mg/ml


Solution for injection


Horses, cattle, pigs, dogs, cats


For intramuscular use




Iceland







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E pro injectione


Retinol Palmitate, Colecalciferolum INN, all-rac-alpha-Tocopheryl Acetate


176,47  mg/ml
100 mg/ml
50 mg/ml


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Ireland







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3E, solution for injection for horses, cattle, pigs, and dogs


Retinol palmitate (Vitamin A)
Vitamin D3 Vitamin E acetate


176,47  mg/ml (300 000  IU)
100 mg/ml
50 mg/ml


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Ireland


Chem-Pharm, Ballyvaughan, Co. Clare, Ireland


Multivitamin Injection


Vitamin A Palmitate
Vitamin D3 (Cholecalciferol)
Vitamin E (Alpha tocopheryl acetate)
Vitamin B1 (Thiamine hydrochloride)
Vitamin B2 (Riboflavin Sodium Phosphate)
Vitamin B6 (Pyridoxine)
Nicotinamide
Dexpanthenol
Vitamin B12 (Cyanocobalamin)


1 ml:
15 000  IU
25 μg
20 mg
10 mg
5 mg
3 mg
35 mg
25 mg
25 μg


Solution for injection


Cattle, sheep, pigs


For intramuscular and subcutaneous use




Italy







Ceva Salute Animale S.p.A.




Viale Colleoni 15




20864 Agrate Brianza (MB)




Italy






Fosforilene Plus, soluzione iniettabile per vitelli, equini, suini, agnelli


Phosphorylcholamine
retinol palmitate
d, l-alpha-tocopheryl acetate
sodium selenite


40 mg/ml
10 000  IU/ml
30 mg/ml
0,4  mg/ml


Solution for injection


Calves, horses, pigs, lambs


For intramuscular use




Italy







Fatro S.p.A.




Via Emilia 285




40064 Ozzano dell’Emilia




Bologna




Italy






Adecon, soluzione iniettabile per bovini, equini, suini, ovi-caprini


Retinol acetate (vitamin A)
cholecalciferol (vitamin D3)
alpha-tocopherol equal to alpha-tocopherol acetate (vitamin E)


100 000  IU/ml;
25 000  IU/ml; 100 mg/ml


Solution for injection


Cattle, horses, pigs, sheep, goats


For intramuscular use (may be administered orally)




Italy







Ceva Salute Animale S.p.A.




Viale Colleoni 15




20864 Agrate Brianza (MB)




Italy






Adisole A-D-E, soluzione iniettabile per bovini, suini, ovini, equini


Vitamin A palmitate
vitamin D 3
vitamin E acetate


100 000  IU/ml
25 000  IU/ml
100 mg/ml


Solution for injection


Cattle, pigs, sheep, horses


For intramuscular use




Italy







Fatro S.p.A.




Via Emilia 285




40064 Ozzano dell’Emilia




Bologna




Italy






Idrade, emulsione iniettabile per bovini, equini, suini, ovini


Retinol propionate (vit. A)
cholecalciferol (vit. D3)
d, l-alpha tocopherol acetate (vit. E)


500 000  IU
75 000  IU
50 mg


Emulsion for injection


Cattle, horses, pigs, sheep


For intramuscular and subcutaneous use




Italy







Izo S.r.l. a socio unico




Via San Zeno 99/A




25124 Brescia




Italy






Izotrevit, soluzione iniettabile per bovini, ovini e suini


Retinol
Ergocalciferol
d-l-α-tocopherol


500 000  IU/ml
75 000  IU/ml
50 IU/ml


Solution for injection


Cattle, pigs, sheep


For deep intramuscular or intraruminal use: cattle
Intramuscular use: pigs
Subcutaneous use: sheep subcutaneously




Italy







Labiana Life Sciences S.A.




Venus, 26




Terrassa




08228 Barcelona




Spain






Labhidro AD3E 100 N


Retinol acetate (vitamin A)
cholecalciferol (vitamin D3)
d-l alpha-tocopheril acetate (vitamin E)


10 000 000  IU/100 ml
5 000 000  IU/100 ml
10 g/100 ml


Solution for injection


Cattle, pigs, sheep, goats, horses


For intramuscular use




Italy







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E pro injectione, soluzione iniettabile per equini, bovini, suini e cani


Retinol palmitate (Vitamin A)
all-rac alpha tocopheryl acetate (Vitamin E)
Cholecalciferol (Vitamin D)


176,47  mg (300 000  IU)
50 mg
2,5  mg (100 000  IU)


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Latvia







Krka, d.d., Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Vitamin AD3E Krka injection emulsija injekcijām liellopiem, zirgiem, cūkām, aitām, kazām, trušiem,
suņiem un kaķiem


Retinyl palmitate (Vitamin A);
Cholecalciferol (vitamin D3);
Tocopheryl acetate (vitamin E)


50 000  IU/ml
25 000  IU/ml
20 mg/ml


Emulsion for injection


Cattle, horses, pigs, sheep, goats, rabbits, dogs, cats, foals, piglets, calves, goat kids, lambs


For intramuscular and subcutaneous use




Latvia







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E pro injectione šķīdums injekcijām zirgiem, liellopiem, cūkām un suņiem


Retinol palmitate
All-rac alpha tocopheryl acetate
Oily solution of cholecalciferol 100.00 mg
(contains 2.5 mg cholecalciferol; equivalent to 100,000  I.U. Vitamin D3)


176,47  mg (300 000  IU)
50 mg
2,5  mg (100 000  IU)


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Latvia







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Vitasol AD3EC šķīdums injekcijām zirgiem, liellopiem, cūkām un suņiem


Vitamin A (retinyl propionate), Vitamin D3 (cholecalciferol), Vitamin E (DL-α-tocopheryl acetate), Vitamin C (ascorbinic acid)


50 000  IU
25 000  IU
30 mg
100 mg


Solution for injection


Horses, cattle, pigs, dogs


For intramuscular and subcutaneous use




Lithuania







UAB Interchemie werken




De Adelaar LT




Vinčų g. 3-48




46297 Kaunas




Lithuania






Introvit, injekcinis tirpalas galvijams, arkliams, ožkoms, avims ir kiaulėms


Vit. A, retinol oil+ vit. D3, cholecalciferol+ vit.E, alpha-tocopherol acetate+vit.B1, thiamine hydrochloride+vit. B2, riboflavin sodium phosphate+vit. B6, pyridoxine hydrochloride+ vit. B12, cyanocobalamin+ dexpanthenol+ nicotinamide+ biotin+ choline chloride+ lysine hydrochloride+ DL-methionine


15 000  IU +7 500  IU + 20 mg + 10 mg + 5 mg + 3 mg + 60 μg + 25 mg + 50 mg + 125 μg +12,5  mg + 7 mg + 5 mg


Solution for injection


Cattle,
horses,
calves, foals, goats,
sheep,
lambs,
pigs


For intramuscular and subcutaneous use




Lithuania







Bioveta, a. s.




Komenského 212




683 23 Ivanovice na Hané




Czech Republic






Multivit–Mineral, injekcinis tirpalas


Retinol + cholecalciferol + vitamin E + thiamine + riboflavin + pyridoxine + cyanocobalamin + dexpanthenol + nicotinic acid+ inositol + methionine + choline citrate + magnesium hypophosphite hexahydrate + cobalt chloride + copper sulfate + zinc sulfate


50 000  IU +25 000  IU + 4 mg + 10 mg +0,04  mg + 2 mg +0,01  mg + 2 mg + 5 mg + 2 mg + 5 mg + 5 mg + 1 mg +0,02  mg +0,1  mg +0,1  mg


Solution for injection


Cattle, horses, sheep, pigs, goats, dogs, chickens, turkeys, ducks, geese, pigeons, exotic birds


For intramuscular, subcutaneous and oral use




Lithuania







Krka, d.d., Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Vitamin AD3E Krka, injekcinė emulsija


Retinol palmitate
cholecalciferol
α-tocopheryl acetate


50 000  IU/ml
25 000  IU/ml
20 mg/ml


Emulsion for injection


Cattle, horses, pigs, sheep, goats, rabbits, dogs, cats


For intramuscular and subcutaneous use




Lithuania







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E, injekcinis tirpalas


Retinol palmitate+ Cholecalciferol+ α-tocopheryl acetate


176,47  mg (300 000  IU)
2,5  mg (100 000  IU)
50 mg


Solution for injection


Cattle, calves, pigs, piglets, weaned piglets, horses, dogs


For intramuscular and subcutaneous use




Lithuania







UAB Interchemie werken




De Adelaar LT




Vinčų g. 3-48




46297 Kaunas




Lithuania






Vitol-140, injekcinis tirpalas


Retinol palmitate (vit. A)+ cholecalciferol (vit. D3) + alpha-tocopherol acetate (vit. E)


1 ml:
80 000  IU+
40 000  IU+
20 mg


Solution for injection


Cattle, calves, sheep, goats, horses, pigs, dogs, cats


For intramuscular and subcutaneous use




Lithuania







Dopharma B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Vitol-Ject Forte, injekcinis tirpalas


Retinol propionate + cholecalciferol + thiamine hydrochloride+
riboflavin sodium phosphate+
pyridoxine hydrochloride+
cyanocobalamin+
ascorbic acid+
α-tocopherol acetate+
D-panthenol+
nicotinamide


50 000  IU+
25 000  IU+
2,5  mg+
2 mg+
1,25  mg+
3 μg+
2 mg+
4 mg+
3 mg+
12,5  mg


Solution for injection


All animals


For intramuscular use




Malta







Fatro S.p.A.




Via Emilia 285




40064 Ozzano dell’Emilia




Bologna




Italy






Adecon,
solution for injection for cattle, horses, pigs, sheep and goats


Retinol acetate, Cholecalciferol, α- tocopherol


100 000  IU
25 000  IU
100 mg


Solution for injection


Cattle, goats, horses, pigs, sheep


For Intramuscular use or oral administration




Malta







Interchemie werken ‘De Adelaar’ B.V.




Metaalweg 8,




5404 CG Venray




The Netherlands






Introvit


Retinol palmitate, cholecalciferol, α-tocopherol acetate, thiamine hydrochloride, riboflavine sodium phosphate, pyridoxine hydrochloride, cyanocobalamin, Dexpanthenol, Nicotinamide, Biotin, Choline chloride, Lysine hydrochloride, DL- Methionine


15 000  IU,
7 500  IU,
20 mg,
10 mg,
5 mg,
3 mg,
60 μg,
25 mg,
50 mg,
125 mcg,
12,5  mg,
7 mg,
5 mg


Solution for injection


Cattle, calves, foals, goats, horses, lambs, pigs, sheep


For intravenous or subcutaneous use




Malta







Labiana Life Sciences S.A




Carrer de Venus, 26




08228 Terrassa (Barcelona)




Spain






Labhidro AD3E Injectable


Vitamin A, Vitamin D3, Vitamin E (all-rac-α-tocopheryl acetate)


500 000  UI,
75 000  UI,
50 mg


Solution for injection


Cattle, goats, horses, pigs, sheep


For intramuscular use




Malta







Labiana Life Sciences S.A




Carrer de Venus, 26




08228 Terrassa (Barcelona)




Spain






NOV-A-VIT 500


Vitamin A (retiinol propionate), cholecalciferol, All-rac-α-tocopheryl acetate (Vitamin E)


500 000  IU,
75 000  IU,
50 mg


Emulsion for injection


Cattle, goats, pigs, sheep


For intramuscular use




Malta







Kepro B.V.




Maagdenburgstraat 17




7421 ZA Deventer




The Netherlands






Vita Flash Inj.


Vitamin A, Vitamin D3, Vitamin E acetate, Vitamin B1 HCl, Vitamin B2 phosphate sodium, Vitamin B3, Vitamin B6 HCl, Vitamin B12, Vitamin C, D-Panthenol


50 000  IU,
25 000  IU,
4 mg,
2,5  mg
2 mg,
12,5  mg,
1,25  mg,
30 μg,
2 mg,
3 mg


Solution for injection


Cattle, calves, foals, goats, horses, lambs, piglets, pigs, sheep


For intramuscular and subcutaneous use




Malta


Interchemie werken ‘'De Adelaar’' LT, Vincu g. 3-48, Kaunas, Lithuania


Vitol-140


Retinol palmitate, Cholecalciferol, α- tocopherol acetate


80 000  IU,
40 000  IU,
20 mg


Solution for injection


Cattle, calves, sheep, goats, horses, pigs, dogs, cats


For intramuscular or subcutaneous use




Norway







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3E vet


Retinol palmitate
Vitamin D3 Vitamin E acetate


176,47  mg (300 000  IU)
100 mg/ml
50 mg/ml


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Poland







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




The Netherlands






Witamina AD3E 80/40/20 pro.inj.


Vitaminum A
Cholekalcyferolum
int-rac-alfa-Tocopherylis acetas


(80 000  IU+40 000  IU + 20 mg)/ml


Solution for injection


Horses, cattle, pigs, sheep, goats, dogs, cats


For intramuscular use




Portugal







Zoetis Portugal, Lda




Lagoas Park Edifício 10,




2740-271 Porto Salvo




Portugal






Duphafral Multi


Vitamin A palmitate
Cholecalciferol (vitamin D3)
a-tocopherol acetate (vitamin E)
Thiamine hydrochloride (vitamin B1)
Riboflavin (vitamin B2 as sodium phosphate)
Pyridoxine hydrochloride (vitamin B6)
Cyanocobalamin (vitamin B12)
Nicotinamide
D-panthenol


15 000  IU
7 500  IU
20 mg
10 mg
5 mg
3 mg
20 μg
35 mg
25 mg


Solution for injection


Cats, dogs, visions
Newly born from: cattle, goats, horses, pigs, sheep


For intramuscular use




Portugal







Divasa-Farmavic, S.A.




Ctra. Sant Hipòlit, km 71




08503 Gurb — Vic




Barcelona




Spain






Polivit AD3E Solução Injectável para bovinos, suínos, ovinos, caprinos, equinos, cães e gatos. Vitamina A, Vitamina D3, Vitamina E


Vitamin A
Vitamin D3
Vitamin E


500 000  IU/ml
75 000  IU/ml
50 IU/ml


Solution for injection


Cattle, cats, dogs, goats, horses, pigs, sheep


For intramuscular use




Portugal







Vetlima




Sociedade Distribuidora de Produtos Agro-Pecuários, S.A.




Centro Empresarial da Rainha, Lote 27




2050-501 Vila Nova da Rainha




Portugal






Vitalbion solução injetável para bovinos, ovinos e suínos


Vitamin A
Vitamin D3
Vitamin E


500 000  IU/ml
75 000  IU/ml
50 mg


Solution for injection


Cattle, pigs, sheep


For intramuscular use




Portugal







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E pro injectione, solução injetável para equídeos, bovinos, suínos e cães


Retinol palmitate
Vitamin D3 Vitamin E acetate


176,47  mg/ml (300 000  IU)
100 mg/ml
50 mg/ml


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Romania







Interchemie werken ‘De Adelaar’ B.V.




Metaalweg 8,




5404 CG Venray




The Netherlands






Introvit


Vitamin A (retinol palmitate) Vitamin D3 (cholecalciferol) VitaminE (α- tocoferol acetate) Vitamin B1 (thiamine HCl) Vitamin B2 (Riboflavin sodium fosfate) Vitamin B6 (Pyridoxine HCl) Vitamin B12 (Cyancobalamin) D-panthenol Nicotinamide Folic acid
Choline chloride
Biotin
D, L — methionine
L- lysine HCl


15 000  IU
7 500  IU
20 mg
10 mg
5 mg
3 mg
60 μg
25 mg
50 mg
150 μg
12,5  mg
125 μg
5 mg
7 mg


Solution for injection


Cattle, horses, goats, sheep, pigs


For intramuscular and subcutaneous use




Romania







Dutch Farm International BV,




Nieuw Walden 112, 1394 PE Nederhorst den Berg




The Netherlands






Multivit inj.


Vitamin A concentrate
Oily concentrate cholecalciferol (vitamin D3) Tocoferol acetate (vitamin E)
Thiamine HCl (vitamin B1) Riboflavin sodium fosfate (vitamin B2)
Pyridoxine HCl (vitamin B6)
Cyancobalamin (vitamin B12)
Ascorbic acid (vitamin C)
Nicotinamide
D-panthenol


50 000 IU
25 000 IU
4 mg
2,5  mg
2 mg
1,25  mg
30 μg
2 mg
12,5  mg
3 mg


Solution for injection


Horses, foals, cattle, calves, lambs, piglets, sows, chickens, pigeons


For intramuscular and subcutaneous use




Romania







S.C. Romvac Company S.A.




Şos. Centurii, nr. 7




Voluntari




Romania






Multivitarom


Choline,
Vitamin A
Vitamin B1
Vitamin B2
Vitamin B3
Vitamin B5
Vitamin B6
Vitamin C
Vitamin D3
Vitamin E,
Vitamin B12


0,25  mg/ml,
20 000  IU
0,1  mg/ml
0,08  mg/ml
0,35  mg/ml
0,50  mg/ml
0,10  mg/ml
50 mg/ml
200 IU/ml
8 IU /ml
0,50  mg/ml


Solution for injection


Cattle, horses, goats, sheep, pigs, dogs, cats


For intramuscular use




Romania







S. C. Pasteur — Filiala Filipesti S.A




str. Principala,




nr.Jud




Prahova




Romania






Multi-vita-vet


Vitamin A (retinol palmitate)
Vitamin D3 (cholecalciferol)
Vitamin E (tocoferol acetate)
Vitamin B1 (Thiamine HCl)
Vitamin B2 (Riboflavin sodium phosphate)
Vitamin B3 (Nicotinamide)
Vitamin B6 (Pyridoxine HCl)
Vitamin B12 (Cyancobalamin)
Vitamin B5 (D-panthenol)


1 ml:
15 000  IU
1 100  IU
20 mg
10 mg
7 mg
35 mg
3,5  mg
0,005  mg
25 mg


Solution for injection


Cattle, horses, sheep, goats, pigs, dogs, cats


For intramuscular and subcutaneous use




Romania







Kepro B.V.




Maagdenburgstraat 17




7421 ZA Deventer




The Netherlands






Vitaflash


Vitamin A (retinol palmitate)
Vitamin B1 HCl (thiamine HCl)
Vitamin B2 (riboflavin sodium phosphate)
Vitamin B3 (nicotinamide)
Vitamin B6 (pyridoxine HCl)
Vitamin C (ascorbic acid)
Vitamin D3 (cholecalciferol)
Vitamin E acetate (α-tocoferol acetate)
Vitamin B12 (Cyancobalamine)
Vitamin B5 (D-panthenol)


1 ml:
50 000  IU
2,5  mg
2 mg
12,5  mg
1,25  mg
2 mg
25 000  IU
4 mg
30 μg
3 mg


Solution for injection


Cattle, horses, sheep, pigs


For intramuscular and subcutaneous use




Romania







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Vitamin AD3E


Vitamin A
Vitamin D3
Vitamin E


176,47  mg (300 000  IU)
2,50  mg (100 000  IU)
50 mg


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Romania







S.C. Romvac Company S.A.




Şos. Centurii, nr. 7




Voluntari




Romania






Vitamin AD3E


Vitamin A
Vitamin D3
Vitamin E


50 000  IU/ml,
5 000  IU/ml,
20 mg/ml


Solution for injection


Cattle, horses, sheep, goats, pigs, poultry, dogs, cats, pigeons


For intramuscular and subcutaneous use




Romania







S. C. Pasteur — Filiala Filipesti S.A




str. Principala,




nr. Jud




Prahova




Romania






Vitamina AD3E


Vitamin A (as palmitate)
Vitamin D3 (cholecalciferol) Vitamin E (as α-tocopherol acetate)


100 000  IU/ml
10 000  IU/ml
50 IU/ml


Solution for injection


Cattle, horses, goats, rabbits, sheep, pigs, dogs, cats


For intramuscular and subcutaneous use




Romania







Interchemie Werken De Adelaar Eesti AS




Vanapere tee 14, Püünsi küla




Viimsi vald, Harju maakond




74013




Estonia






Vitol-140


Vitamin A (retinol palmitate)
Vitamin D3 (cholecalciferol)
Vitamin E (α-tocopherol acetate)


80 000  IU/ml
40 000  IU/ml
20 mg/ml


Solution for injection


Cattle, horses, sheep, goats, pigs, dogs, cats


For intramuscular and subcutaneous use




Romania







Alapis S.A.




19 300 Aspropyrgos




Mailbox 26




Athens




Greece






Zingul AD3E


Vitamin A
Vitamin D3 Vitamin E


50 000  IU/ml
25 000  IU/ml
50 mg/ml


Solution for injection


Cattle, horses, goats, sheep, pigs


For intramuscular use




Slovakia







Bioveta, a. s.




Komenského 212




683 23 Ivanovice na Hané




Czech Republic






ADE-vit Injekčný roztok


Retinoli propionas-Ergocalciferolum Tocoferoli alfa acetas


1 ml:
100 000  IU
100 000  IU
30 mg


Solution for injection


Cattle, dogs, goats, horses, pigs, rabbits, sheep


For intramuscular use




Slovakia







Pharmagal Ltd.




Murgašova 5,




949 01 Nitra




Slovak Republic






Triavit injekčný roztok


Retinoli palmitas
Colecalciferolum
Tocoferoli alfa acetas


1 ml:
100 000  IU
50 000  IU
50 mg


Solution for injection


Cattle, horses, calves, pigs, foals, lambs, piglets, dogs, rabbits, poultry


For intramuscular and subcutaneous use




Slovakia







Richter Pharma AG




Feldgasse 19




4600 Wels




Austria






Vitasol AD3EC injekčný roztok


Retinoli palmitas
Colecalciferolum
Tocoferoli alfa acetas
Acidum ascorbicum


1 ml:
50 000  IU
25 000  IU
30 mg
100 mg


Solution for injection


Horses, cattle, pigs, dogs


For intramuscular and subcutaneous use




Slovenia







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3E, raztopina za injiciranje za konje, govedo, prašiče in pse


Retinol palmitate (vitamin A) Vitamin D3 Vitamin E acetate


176,47  mg (300 000  IU)
100 mg per ml
50 mg per ml


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Slovenia







Krka, d.d., Novo mesto




Šmarješka cesta 6




8501 Novo mesto




Slovenia






Vitamin AD3E Krka emulzija za injiciranje za govedo, konje, prašiče, ovce, koze, kunce, pse in mačke


Vitamin A
Cholecalciferol
Tocopheryl acetate (vitamin E)


50 000  IU/ml
25 000  IU/ml
20 mg/ml


Emulsion for injection


Cattle, horses, pigs, sheep, goats, dogs, cats, rabbits


For intramuscular and subcutaneous use




Spain







S.P Veterinaria, S.A.




Ctra. Reus-Vinyols, km 4.1,




Riudoms (Tarragona)




Spain






ADEX-3-emulsion inyectable


Vitamin A (retinyl palmitate)
Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


50 000  IU
25 000  IU
20 mg


Emulsion for injection


Cattle, goats, horses (foals), pigs, sheep


For intramuscular use




Spain







S.P Veterinaria, S.A.




Ctra. Reus-Vinyols, km 4.1,




Riudoms (Tarragona)




Spain






ADEX-3-Forte


Vitamin A (retinyl propionate)
Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


500 000  IU
75 000  UI
50 mg


Solution for injection


Cattle, goats, pigs, sheep


For intramuscular and subcutaneous use




Spain







Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3


Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


176,47  mg
100 mg
50 mg


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use




Spain


Laboratorios Ovejero, S.A., Ctra. Leon-Vilecha No. 30, 24192 Leon, Spain


Biosvita AD3E parenteral emulsion inyectable


Vitamin A (retinyl palmitate)
All-rac-α-tocopheryl acetate (vitamin E)
Cholecalciferol (vitamin D3)


75 000  IU
15 000  UI
30 mg


Emulsion for injection


Cattle, sheep, goats, pigs, horses


For intramuscular use




Spain







Laboratorios Hipra,




S.A. Avda. La Selva, 135




Amer — Gerona




17170




Spain






Hipravit-AD3E Forte


Vitamin A (retinyl palmitate)
Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


500 000  IU
75 000  UI
50 mg


Solution for injection


Cattle, pigs, sheep, horses, rabbits


For intramuscular use




Spain







Labiana Life Sciences S.A.




Venus, 26




Terrassa




08228 Barcelona




Spain






Labhidro AD3E Solucion inyectable


Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


500 000  IU
75 000  UI
50 mg


Solution for injection


Cattle, horses, pigs, sheep


For intramuscular use




Spain







Labiana Life Sciences S.A.




Venus, 26




Terrassa




08228 Barcelona




Spain






NOV-A-VIT emulsion inyectable


Vitamin A (retinyl propionate) Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


500 000  IU
75 000  IU
50 mg


Emulsion for injection


Cattle, goats, pigs, sheep


For intramuscular use




Spain







Divasa-Farmavic, S.A.




Ctra. Sant Hipòlit, km 71




08503 GURB — VIC




Barcelona




Spain






Polivit AD3E solucion inyectable


Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


500 000  IU
75 000  IU
50 IU


Solution for injection


Cattle, sheep, pigs


For intramuscular use




Spain







Laboratorios Ovejero, S.A.,




Ctra. Leon-Vilecha 30, 24192 Leon,




Spain






Polyfil


Phosphorylcholine, retinol, vitamin B12, vitamin E


80 g
5 000  IU
0,05  mg
20 g


Emulsion for injection


Cattle, horses, pigs


For intramuscular use




Spain







Fatro Iberica, S.L. Constitucion, 1 — Planta baja, 3 Sant Just Desvern (Barcelona) 08960




Spain






Vetidina AD3E


Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


500 000  IU
75 000  UI
50 mg


Solution for injection


Cattle, pigs, sheep


For intramuscular use




Spain







Cenavisa, S.L.




Cami Pedra Estela s/n




Reus (Tarragona)




43205




Spain






Vitacen AD3E


Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


500 000  IU
75 000  UI
50 mg


Solution for injection


Cattle, sheep, goats, pigs, horses


For intramuscular use




Spain







Chemical Iberica Productos Veterinarios, S.L., CR. Burgos-Portugal, Km. 256, Calzada de Don Diego (Salamanca), 37448,




Spain






Vitachemical ADE Masivo


Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


30 000  UI
10 000  UI
12,5  mg


Solution for injection


Cattle, pigs, sheep, goats, horses


For intramuscular use




Spain







Industrial Veterinaria, s.a.




C/ Esmeralda 19




Esplugues de Llobregat




08950 Barcelona




Spain






Vitamina AD3E Solucion inyectable


Vitamin A (retinyl palmitate)
Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


500 000  IU
75 000  IU
50 mg


Solution for injection


Cattle, sheep, goats, pigs


For intramuscular use




Spain







Super's Diana, S.L.




Ctra. C-17, km 17




08150 Parets del Vallès




Barcelona




Spain






Vitaminas ADE Super's Diana solución inyectable


Vitamin A (retinyl palmitate)
Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


100 000  IU
50 000  IU
50 mg


Solution for injection


Cattle, pigs, sheep, horses, poultry (broilers, duck broilers, turkeys for meat production), dogs


For intramuscular use




Spain







Laboratorios e Industrias Iven, S.A.




Luís I, 56




28031 Madrid




Spain






Vitamiven A-D-E Solución inyectable


Vitamin A (retinyl palmitate) Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)


300 000  IU
100 000  IU
50 mg


Solution for injection


Cattle, sheep, goats, horses, pigs


For intramuscular use




Spain







Laboratorios e Industrias Iven, S.A.




Luís I, 56




28031 Madrid




Spain






Vitamiven complejo solucion inyectable


Vitamin A (retinyl palmitate)
Cholecalciferol (vitamin D3)
All-rac-α-tocopheryl acetate (vitamin E)
thiamine hydrochloride (vitamin B1)
Riboflavin sodium phosphate (vitamin B2)
Nicotinamide (vitamin B3)
Dexpanthenol (vitamin B5)
Pyridoxine hydrochloride (vitamin B6)
Cyanocobalamin (vitamin B12)


30 000  IU
10 000  IU
5 mg
25 mg
4 mg
50 mg
25 mg
20 mg
0,05  mg


Solution for injection


Cattle, sheep, goats, horses, pigs, dogs, cats


For intramuscular use




Sweden







Pharmaxim AB




Stenbrovägen 32




253 68 Helsingborg




Sweden






Ultrasan vet


RRR-alpha-tocopheryl acetate, ergocalciferol, retinol palmitate


1 ml:
100 mg,
50 000  IU,
100 000  IU


Solution for injection


Horses, cattle, sheep, dogs, pigs


For intramuscular use




The Netherlands







Kombivet B.V.




Raadhuisstraat 124 Hoogerheide




The Netherlands






Adedri-Kel (100 + 50 + 5)


Vitamine A
Cholecalciferol
Alfa-tocopherolacetate


100 000  IU
50 000  IU
5 mg


Solution for injection


Cattle, horses, pigs, sheep, goats


For intramuscular use




The Netherlands







Aesculaap Groothandel B.V.




Mijlstraat 35 Boxtel




5281 LJ




The Netherlands






Aescavit


Cholecalciferol
Cyanocobalamin
sodiumpantothenate
Nicotinamid
Retinolacetate
Riboflavin Sodiumphosphate Anhydrate
Thiaminehydrochlorid
Tocoferol, DL-alfa acetate


25 000  IU/ml
20 μg/ml
2,8  mg/ml
10 mg/ml
25 000  IU/ml
0,7  mg/ml
10 mg/ml
5 mg/ml


Solution for injection


Horses, foals, cattle, pigs, piglets, sheep, lambs, cats, minks


For intramuscular and subcutaneous use




The Netherlands







Alfasan Nederland B.V.




Kuipersweg 9 Woerden




3449 JA




The Netherlands






Multivitamin Pro inj.


Vitamin A
Cholecalciferole
Alfa-tocoferolacetate
Thiaminhydrochlorid
Riboflavin sodiumphosphate
Pyridoxin hydrochlorid
Cyanocobalamin
Nicotinamid
D-panthenole


15 000 IU
1 000  IU
20 mg
10 mg
6,85  mg
3 mg
50 μg
35 mg
25 mg


Solution for injection


Cattle, lambs, pigs, piglets


For intramuscular use




The Netherlands







Alfasan Nederland B.V.




Kuipersweg 9 Woerden




3449 JA




The Netherlands






Vitamine AD3 80/40 Pro inj.


Vitamin A
Cholecaliferole
Alfa-tocoferolacetate


80 000  IU
40 000  IU
10 mg


Solution for injection


Cattle, calves, horses, foals, sheep, goats, pigs, piglets, dogs, cats


For intramuscular and subcutaneous use




The Netherlands







Alfasan Nederland B.V.




Kuipersweg 9 Woerden




3449 JA




The Netherlands






Vitamine AD3 80/40, oplossing voor injectie


Vitamin A
Cholecaliferole
Alfa-tocooferolacetate


80 000  IU
40 000  IU
10 mg


Solution for injection


Cattle, calves, horses, foals, sheep, goats, pigs, piglets


For intramuscular and subcutaneous use




The Netherlands







Alfasan Nederland B.V.




Kuipersweg 9 Woerden




3449 JA




The Netherlands






Vitamine AD3E 450.000 Pro inj.


Vitamin A
Cholecaliferole
Alfa-tocooferolacetate


300 000  IU
100 000  IU
50 mg


Solution for injection


Cattle, calves, horses, foals, pigs, piglets, sheep, goats


For intramuscular and subcutaneous use




United Kingdom (Northern Ireland) (1)








Bela-pharm GmbH & Co. KG




Lohner Str. 19




49377 Vechta




Germany






Belavit AD3E, Solution for Injection for horses, cattle, pigs, and dogs


Retinol palmitate
All-rac alpha tocopheryl acetate
Oily solution of cholecalciferol


176,47  mg
50 mg
100 mg


Solution for injection


Cattle, pigs, horses, dogs


For intramuscular and subcutaneous use






(1)  For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.




ANNEX IIB
List of authorised veterinary medicinal products recommended for suspension of the marketing authorisation












Member State EU/EEA


Marketing authorisation holders


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




France







Ceva Santé Animale




10 Av. de le Ballestiere




33500 Libourne




France






Multivit 500


Retinol (as propionate),
Cholecalciferol,
Alpha-tocopherol (as acetate)


500 000  IU per ml
75 000  IU per ml
50 mg per ml


Solution for injection


Cattle, sheep, pigs


For subcutaneous use