# C_2014123EN.01000801.xml

| 25.4.2014 | EN | Official Journal of the European Union | C 123/8 |
| --- | --- | --- | --- |

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))

1

2

2014/C 123/02

—   Issuing, maintenance or modification of a national marketing authorization

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 |

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

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 |

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

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 |

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

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(1)  OJ L 311, 28.11.01, p. 67.

1

(2)  OJ L 311, 28.11.01, p. 1.

2

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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 |

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 |

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 |

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 |

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 |

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 |

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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(1)  Marketing authorisation not granted

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