Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2014 to 31 March 2014 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2014-04-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014123EN.01000801.xml










25.4.2014   


EN


Official Journal of the European Union


C 123/8





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2014 to 31 March 2014
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
2014/C 123/02
—   Issuing, maintenance or modification of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




5.3.2014


Tibolona Aristo


See Annex I


See Annex I


See Annex I


6.3.2014




21.3.2014


Norbonex


See Annex II


See Annex II


See Annex II


25.3.2014




10.3.2014


Valebo


See Annex III


See Annex III


See Annex III


11.3.2014




5.3.2014


Tibocina


See Annex IV


See Annex IV


See Annex IV


6.3.2014




21.3.2014


Rocephin


See Annex V


See Annex V


See Annex V


25.3.2014




—   Refusal of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




28.3.2014


Barium selenate


See Annex VI


See Annex VI


See Annex VI


31.3.2014




—   Suspension of a national marketing authorization











Date of the decision


Name(s) of the medicinal product


INN (International Non-Proprietary Name)


Holder(s) of the marketing authorization


Member State concerned


Date of notification




28.3.2014


Barium selenate


See Annex VI


See Annex VI


See Annex VI


31.3.2014






(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.


ANNEX I

List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States











Member State EU/EEA


Applicant
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Germany


Aristo Pharma GmbH
Wallenroder Str. 8-10
D-13435 Berlin
Germany


Tibolon Aristo


2,5 mg


tablet


oral use




Spain


Aristo Pharma GmbH
Wallenroder Str. 8-10
D-13435 Berlin
Germany


Tibolona Aristo


2,5 mg


tablet


oral use







ANNEX II

List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States













Member State EU/EEA


Applicant


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Germany


Norbrook Laboratories Limited
Station Works
Camlough Road
Newry
Co. Down
BT35 6JP
Northern Ireland


Norbonex 5 mg/ml Pour-On Solution
for Beef and Dairy Cattle


Eprinomectin


5 mg/ml


Pour-on solution


Cattle


Topical use




The Netherlands


Norbrook Laboratories Limited
Station Works
Camlough Road
Newry
Co. Down
BT35 6JP
Northern Ireland


Norbonex 5 mg/ml Pour-On Solution
for Beef and Dairy Cattle


Eprinomectin


5 mg/ml


Pour-on solution


Cattle


Topical use




United Kingdom


Norbrook Laboratories Limited
Station Works
Camlough Road
Newry
Co. Down
BT35 6JP
Northern Ireland


Norbonex 5 mg/ml Pour-On Solution
for Beef and Dairy Cattle


Eprinomectin


5 mg/ml


Pour-on solution


Cattle


Topical use







ANNEX III

List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant in the Member States











Member State EU/EEA


Applicant
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Austria


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Tevabone 70 mg Tabletten und 1
Mikrogramm Weichkapseln


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Belgium


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Valebo 70 mg + 1 microgram
Tabletten + capsules, zacht


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Bulgaria


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Teвабон 70 mg таблетки и 1
микрограм меки капсули


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Denmark


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Tevabone


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




France


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Tevabone 70 mg et 1 microgramme, comprimé et capsule molle


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Germany


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Valebo 70 mg Tabletten und 1
Mikrogramm Weichkapseln


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Hungary


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Tevabone 70 mg tabletta és 1
mikrogramm lágy kapszula


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Ireland


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Teboneva 70 mg tablets and 1
microgram capsules, soft


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Netherlands


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Tevabone 70 mg tabletten en 1
microgram zachte capsules


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Portugal


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Tevabone


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Slovak Republic


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Tevabone 70 mg tablety a 1 mikrogram mäkké kapsuly


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Slovenia


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Valebo 70 mg tablete in 1
mikrogram mehke kapsule v
kombiniranem pakiranju


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




Spain


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Tevabone 70 mg comprimidos y 1
mcg capsulas blandas


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral




United Kingdom


TEVA Pharma B.V.
Computerweg 10,
3542DR Utrecht,
The Netherlands


Valebo 70 mg + 1 microgram
Tablets + Capsules, soft


70 mg
And
1 mcg


Tablets
And
Capsules, Soft


Oral







ANNEX IV

List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States











Member State EU/EEA


Applicant
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




Belgium


Aristo Pharma GmbH
Wallenroder Str. 8-10
D-13435 Berlin
Germany


Tibolinia


2,5 mg


tablet


oral use




Germany


Aristo Pharma GmbH
Wallenroder Str. 8-10
D-13435 Berlin
Germany


Tibolon Aristo Doublette


2,5 mg


tablet


oral use




Netherlands


Aristo Pharma GmbH
Wallenroder Str. 8-10
D-13435 Berlin
Germany


Tibolinia


2,5 mg


tablet


oral use




Spain


Aristo Pharma GmbH
Wallenroder Str. 8-10
D-13435 Berlin
Germany


Tibocina


2,5 mg


tablet


oral use







ANNEX V

List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States












Member State
EU/EEA


Marketing authorisation holder


(Invented) Name


Strength


Pharmaceutical form


Route of administration


Content
(concentration)




Belgium


N.V. Roche S.A.
Rue Dante 75
1070 Bruxelles
Belgium


Rocephine


2 g


Powder for solution for infusion


Intravenous use


2 g




Belgium


N.V. Roche S.A.
Rue Dante 75
1070 Bruxelles
Belgium


Rocephine


1 g


Powder and solvent for solution for IM injection


Intramuscular use


1 g




Belgium


N.V. Roche S.A.
Rue Dante 75
1070 Bruxelles
Belgium


Rocephine


1 g


Powder and solvent for solution for IV injection


Intravenous use


1 g




Denmark


Roche a/s
Industriholmen 59,
DK-2650 Hvidovre,
Danmark


Rocephalin


2 g


Concentrate for solution for infusion


Intravenous use


2 g




Denmark


Roche a/s
Industriholmen 59,
DK-2650 Hvidovre,
Danmark


Rocephalin


1 g


Powder and solvent for solution for injection


Intramuscular or intravenous use


1 g




Denmark


Roche a/s
Industriholmen 59,
DK-2650 Hvidovre,
Danmark


Rocephalin


500 mg


Powder and solvent for solution for injection


Intramuscular or intravenous use


500 mg




Finland


Roche Oy
Klovinpellontie 3
PL 12
02181 Espoo
Finland


Rocephalin cum lidocain


1 g


Powder and solvent for solution for injection


Intramuscular use or intravenous use


1 g




Finland


Roche Oy
Klovinpellontie 3
PL 12
02181 Espoo
Finland


Rocephalin cum lidocain


500 mg


Powder and solvent for solution for injection


Intramuscular use or intravenous use


500 mg




France


Roche
52 Boulevard du Parc
92521 NEUILLY SUR SEINE cedex
France


Rocephine 1g/10 ml, powder and solvent for solution for injection (IV, SC)


1 g/10 ml


Powder and solvent for solution for injection


Intravenous use or subcutaneous use


1 g




France


Roche
52 Boulevard du Parc
92521 NEUILLY SUR SEINE cedex
France


Rocephine 1 g/3.5 ml, powder and solvent for solution for injection (IM, SC)


1 g/3.5 ml


Powder and solvent for solution for injection


Intramuscular use or subcutaneous use


1 g




France


Roche
52 Boulevard du Parc
92521 NEUILLY SUR SEINE cedex
France


Rocephine 500 mg/2ml, powder and solvent for solution for injection (IM, SC)


500 mg/2 ml


Powder and solvent for solution for injection


Intramuscular use or subcutaneous use


500 mg




France


Roche
52 Boulevard du Parc
92521 NEUILLY SUR SEINE cedex
France


Rocephine 500 mg/5ml, powder and solvent for solution for injection (IV, SC)


500 mg/5 ml


Powder and solvent for solution for injection


Intravenous use or subcutaneous use


500 mg




Germany


Roche Pharma AG
Emil-Barell-Str. 1
79639 Grenzach-Wyhlen
Germany


Rocephin zur Infusion 2 g


2 g


Powder for solution for infusion


Intravenous use


2 g




Germany


Roche Pharma AG
Emil-Barell-Str. 1
79639 Grenzach-Wyhlen
Germany


Rocephin i.v. 1g


1 g


Powder and solvent for solution for injection


Intravenous use


1 g




Germany


Roche Pharma AG
Emil-Barell-Str. 1
79639 Grenzach-Wyhlen
Germany


Rocephin 500 mg


500 mg


Powder and solvent for solution for injection


Intramuscular or intravenous use


500 mg




Greece


Roche (Hellas) SA
4, Alamanas & Delfon Str.,
Maroussi 15125,
Attiki
Greece


Rocephin


2 g


Powder for solution for Infusion


Intravenous use


2 g




Greece


Roche (Hellas) SA
4, Alamanas & Delfon Str.,
Maroussi 15125,
Attiki
Greece


Rocephin


1 g


Powder and solvent for solution for Injection


intravenous use


1 g




Greece


Roche (Hellas) SA
4, Alamanas & Delfon Str.,
Maroussi 15125,
Attiki
Greece


Rocephin


1 g


Powder and solvent for solution for Injection


Intramuscular use


1 g




Hungary


Roche (Hungary) Ltd.
Edison utca 1
Budaörs
H-2040
Hungary


Rocephin


1 g


Powder and solvent for solution for injection


Intravenous use


1000 mg




Hungary


Roche (Hungary) Ltd.
Edison utca 1
Budaörs
H-2040
Hungary


Rocephin


500 mg


Powder and solvent for solution for injection


Intramuscular use


500 mg




Hungary


Roche (Hungary) Ltd.
Edison utca 1
Budaörs
H-2040
Hungary


Rocephin


250 mg


Powder and solvent for solution for injection


Intramuscular use


250 mg




Iceland


Roche a/s
Industriholmen 59,
DK-2650 Hvidovre,
Danmark


Rocephalin


2 g


Concentrate for solution for infusion


Intravenous use


2 g




Iceland


Roche a/s
Industriholmen 59,
DK-2650 Hvidovre,
Danmark


Rocephalin


1 g


Powder and solvent for solution for injection


Intramuscular or intravenous use


1 g




Ireland


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Rocephin


1 g


Powder for solution for injection or infusion


Intramuscular or intravenous use


1 g




Ireland


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Rocephin


1 g


Powder and solvent for solution for IM injection


Intramuscular use


1 g




Italy


Roche S.p.A.
Piazza Durante 11
20131 Milano
Italy


Rocefin


2 g


Powder for solution for infusion


Intravenous use


2 g




Italy


Roche S.p.A.
Piazza Durante 11
20131 Milano
Italy


Rocefin


1 g


Powder and solvent for solution for injection


intravenous use


1 g




Italy


Roche S.p.A.
Piazza Durante 11
20131 Milano
Italy


Rocefin


1 g


Powder and solvent for solution for injection


Intramuscular use


1 g




Italy


Roche S.p.A.
Piazza Durante 11
20131 Milano
Italy


Rocefin


500 mg


Powder and solvent for solution for injection


Intramuscular use


500 mg




Italy


Roche S.p.A.
Piazza Durante 11
20131 Milano
Italy


Rocefin


250 mg


Powder and solvent for solution for injection


Intramuscular use


250 mg




Latvia


Roche Latvija SIA
8b G.Astras Street, Riga, LV1082,
Latvia


Rocephin 1 g pulveris injekciju šķīduma pagatavošanai


1 g


Powder for solution for injection


Intramuscular or intravenous use


1 g




Luxembourg


N.V. Roche S.A.
Rue Dante 75
1070 Bruxelles
Belgium


Rocephine


2 g


Powder for solution for infusion


Intravenous use


2 g




Luxembourg


N.V. Roche S.A.
Rue Dante 75
1070 Bruxelles
Belgium


Rocephine


1 g


Powder and solvent for solution for IV injection


Intravenous use


1 g




Luxembourg


N.V. Roche S.A.
Rue Dante 75
1070 Bruxelles
Belgium


Rocephine


1 g


Powder and solvent for solution for IM injection


Intramuscular use


1 g




Malta


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Rocephin


2 g


Powder for solution for infusion


Intravenous use


2 g




Malta


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Rocephin


1 g


Powder for solution for injection


Intramuscular or intravenous use


1 g




Malta


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Rocephin


250 mg


Powder for solution for injection


Intramuscular or intravenous use


250 mg




Netherlands


Roche Nederland B.V.
Beneluxlaan 2a,
3446 GR Woerden
Netherlands


Rocephin 2 i.v.


2 g


Powder for solution for infusion


Intravenous use


2 g




Netherlands


Roche Nederland B.V.
Beneluxlaan 2a,
3446 GR Woerden
Netherlands


Rocephin 1 i.m.


1 g


Powder for solution for injection


Intramuscular use


1 g




Netherlands


Roche Nederland B.V.
Beneluxlaan 2a,
3446 GR Woerden
Netherlands


Rocephin 1 i.v.


1 g


Powder for solution for injection


Intravenous use


1 g




Netherlands


Roche Nederland B.V.
Beneluxlaan 2a,
3446 GR Woerden
Netherlands


Rocephin 0,5 i.v.


500 mg


Powder for solution for injection


Intravenous use


500 mg




Netherlands


Roche Nederland B.V.
Beneluxlaan 2a,
3446 GR Woerden
Netherlands


Rocephin 0,25 i.m.


250 mg


Powder for solution for injection


Intramuscular use


250 mg




Portugal


Roche Farmacêutica Química, Lda.,
Estrada Nacional 249-1,
2720-413 Amadora,
Portugal


Rocephin


2 g


Powder for solution for infusion


Intravenous use


2 g




Portugal


Roche Farmacêutica Química, Lda.,
Estrada Nacional 249-1,
2720-413 Amadora,
Portugal


Rocephin


1000 mg/10 ml


Powder and solvent for solution for injection


intravenous use


1 g




Portugal


Roche Farmacêutica Química, Lda.,
Estrada Nacional 249-1,
2720-413 Amadora,
Portugal


Rocephin


1000 mg/3,5 ml


Powder and solvent for solution for injection


Intramuscular use


1 g




Portugal


Roche Farmacêutica Química, Lda.,
Estrada Nacional 249-1,
2720-413 Amadora,
Portugal


Rocephin


500 mg/2 ml


Powder and solvent for solution for injection


Intramuscular use


500 mg




Portugal


Roche Farmacêutica Química, Lda.,
Estrada Nacional 249-1,
2720-413 Amadora,
Portugal


Rocephin


250 mg/2 ml


Powder and solvent for solution for injection


Intramuscular use


250 mg




Romania


Roche România SRL
Piaţa Presei Libere, Nr. 3-5,
Clădirea City Gate–Turnul de Sud, Etajele 4A, 5 şi 6,
Sector 1, Bucureşti,
România


Rocephin 2 g pulbere pentru soluţie perfuzabilă


2 g


Powder for solution for infusion


Intravenous use


2 g




Sweden


Roche AB
Box 47327
100 74 Stockholm
Sweden


Rocephalin


2 g


Powder for solution for infusion


Intravenous use


2 g




Sweden


Roche AB
Box 47327
100 74 Stockholm
Sweden


Rocephalin


1 g


Powder and solvent for solution for injection


Intramuscular or intravenous use


1 g




Sweden


Roche AB
Box 47327
100 74 Stockholm
Sweden


Rocephalin


1 g


Powder and solvent for solution for injection


Intramuscular use


1 g




United Kingdom


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Rocephin


2 g


Powder for solution for injection/infusion


Intramuscular or intravenous use


2 g




United Kingdom


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Rocephin


1 g


Powder for solution for injection


Intramuscular or intravenous use


1 g




United Kingdom


Roche Products Limited,
6 Falcon Way, Shire Park,
Welwyn Garden City,
AL7 1TW,
United Kingdom


Rocephin


250 mg


Powder for solution for injection


Intramuscular or intravenous use


250 mg







ANNEX VI

List of the names, pharmaceutical forms, strength of the veterinary medicinal products, animal species, route of administration, withdrawal period and applicant/marketing authorisation holders in the member states















Member State EU/EEA


Applicant/Marketing Authorisation Holder


Name


INN


Pharmaceutical form


Strength


Animal species


Route of administration


Recommended dose


Withdrawal period




Belgium


Cross Vetpharm Group Limited
Broomhill Road Tallaght,
Dublin 24
Ireland


Selenate Long Acting 50 mg/ml, suspension injectable pour bovins


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Czech Republic


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


SELENATE Long Acting 50 mg/ml injekční suspenze pro skot


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Germany (1)



Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selenate LA 5%


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Denmark


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selongatum Long Acting, Suspension til injektion


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Estonia


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selenate Long Acting, 50 mg/ml, süstesuspensioon veistele


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Spain


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Dalmasel L.A. 50 mg/ml, suspensión inyectable para bovino


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




France


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


SELENATE LA SUSPENSION INJECTABLE 50 MG/ML POUR BOVINS


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Ireland


Tairgi Tread-Lia Baile na Sceilge Teo Ballinskelligs
Killarney
Co. Kerry
Ireland


B.V.P. Barium Selenate Injection


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 mg Se/kg body weight corresponding to the following: Cattle (adult): 6-10 ml Cattle (young): 3-8 ml Calves: 1-2 ml


Meat and offal: 31 days
Milk: Zero days




Ireland


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selenate Long Acting 50 mg/ml Suspension for Injection for Cattle


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Lithuania


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


SELENATE LONG ACTING 50 mg/ml injekcinė suspensija galvijams


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Latvia


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selenate Long Acting 50 mg/ml suspensija injekcijām liellopiem


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Poland


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selenate Long Acting 50 mg/ml zawiesina do wstrzykiwań dla bydła


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Romania


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selenate Long Acting 50 mg/ml Suspensie injectabilă pentru bovine


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Slovakia


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


SELENATE Long Acting 50 mg/ml injekcná suspenzia pre hovädzí dobytok


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




Sweden


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selongatum vet. 50 mg/ml injektionsvätska, suspension för nötkreatur


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg body weight


Meat and offal: 31 days
Milk: Zero days




United Kingdom


Cross Vetpharm Group Limited
Broomhill Road Tallaght
Dublin 24
Ireland


Selenate Long Acting 50 mg/ml Suspension for Injection for Cattle


Barium selenate


Suspension for injection


50 mg/ml


Cattle


Subcutaneous injection


1 ml per 50 kg bodyweight


Meat and offal: 31 days
Milk: Zero days






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