# C_2010111EN.01001601.xml

| 30.4.2010 | EN | Official Journal of the European Union | C 111/16 |
| --- | --- | --- | --- |

30.4.2010

EN

Official Journal of the European Union

C 111/16

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

1

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

2

)

2010/C 111/03

—   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 | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 20.1.2010 | Extraneal | See Annex I | See Annex I | 22.1.2010 |
| 26.1.2010 | Antiadiposo — iodocasein/thiamine nitrate | See Annex II | See Annex II | 27.1.2010 |
| 25.1.2010 | Poulvac Bursa Plus and associated names | See Annex III | See Annex III | 26.1.2010 |
| 8.1.2010 | Revlimid | Celgene Europe Limited |
| Riverside House |
| Riverside Walk |
| Windsor |
| Berkshire |
| SL4 1NA |
| UNITED KINGDOM |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

20.1.2010

Extraneal

See Annex I

See Annex I

22.1.2010

26.1.2010

Antiadiposo — iodocasein/thiamine nitrate

See Annex II

See Annex II

27.1.2010

25.1.2010

Poulvac Bursa Plus and associated names

See Annex III

See Annex III

26.1.2010

8.1.2010

Revlimid

Celgene Europe Limited

Riverside House

Riverside Walk

Windsor

Berkshire

SL4 1NA

UNITED KINGDOM

This Decision is addressed to the Member States

11.1.2010

29.1.2010

Urorec

| Recordati Ireland Ltd. |
| --- |
| Raheens East |
| Ringaskiddy Co. Cork |
| IRELAND |

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

IRELAND

This Decision is addressed to the Member States

1.2.2010

29.1.2010

Silodyx

| Recordati Ireland Ltd. |
| --- |
| Raheens East |
| Ringaskiddy Co. Cork |
| IRELAND |

Recordati Ireland Ltd.

Raheens East

Ringaskiddy Co. Cork

IRELAND

This Decision is addressed to the Member States

1.2.2010

—   Refusal of a national marketing authorization

Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 29.1.2010 | Teicoplanin Hospira and associated names | See Annex IV | See Annex IV | 2.2.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

29.1.2010

Teicoplanin Hospira and associated names

See Annex IV

See Annex IV

2.2.2010

—   Suspension of a national marketing authorization

Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 27.1.2010 | APPM Respipharm | See Annex V | See Annex V | 28.1.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

27.1.2010

APPM Respipharm

See Annex V

See Annex V

28.1.2010

---

(1)  OJ L 311, 28.11.2001, p. 67.

1

(2)  OJ L 311, 28.11.2001, p. 1.

2

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing autorisation Holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Baxter Vertriebs GmbH |
| Landstraßer Hauptstraße 99/Top2A |
| 1031 Wien |
| ÖSTERREICH |

Member State EU/EEA

Marketing autorisation Holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Austria

Baxter Vertriebs GmbH

Landstraßer Hauptstraße 99/Top2A

1031 Wien

ÖSTERREICH

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Belgium

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| BELGIQUE/BELGIË |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

BELGIQUE/BELGIË

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Denmark

| Baxter A/S |
| --- |
| Gydevang 43 |
| 3450 Allerød |
| DANMARK |

Baxter A/S

Gydevang 43

3450 Allerød

DANMARK

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Finland

| Baxter Oy |
| --- |
| P.O. Box 270 |
| Valimotie 15A |
| FI-00381 Helsinski |
| SUOMI/FINLAND |

Baxter Oy

P.O. Box 270

Valimotie 15A

FI-00381 Helsinski

SUOMI/FINLAND

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

France

| Baxter S.A.S |
| --- |
| 6 av. Louis Pasteur |
| 78310 Maurepas |
| FRANCE |

Baxter S.A.S

6 av. Louis Pasteur

78310 Maurepas

FRANCE

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Germany

| Baxter Deutschland GmbH |
| --- |
| Edissontrasse 3—4 |
| 85716 Unterschleissheim |
| DEUTSCHLAND |

Baxter Deutschland GmbH

Edissontrasse 3—4

85716 Unterschleissheim

DEUTSCHLAND

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Greece

| Diophar A.E. |
| --- |
| Kiphissias 368 |
| 152 33 Halandri Athens |
| GREECE |

Diophar A.E.

Kiphissias 368

152 33 Halandri Athens

GREECE

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Ireland

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford |
| IP24 3SE |
| UNITED KINGDOM |

Baxter Healthcare Ltd

Caxton Way

Thetford

IP24 3SE

UNITED KINGDOM

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Italy

| Baxter S.p.A. |
| --- |
| Piazzale dell’Industria 20 |
| 00144 Roma RM |
| ITALIA |

Baxter S.p.A.

Piazzale dell’Industria 20

00144 Roma RM

ITALIA

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Luxembourg

| Baxter S.A. |
| --- |
| Boulevard R. Branquart 80 |
| 7680 Lessines |
| BELGIQUE/BELGIË |

Baxter S.A.

Boulevard R. Branquart 80

7680 Lessines

BELGIQUE/BELGIË

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Netherlands

| Baxter B.V |
| --- |
| Kobaltweg 49 |
| 3542 CE Utrecht |
| NEDERLAND |

Baxter B.V

Kobaltweg 49

3542 CE Utrecht

NEDERLAND

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Portugal

| Baxter Médico Farmacêutica Lda |
| --- |
| Sintra Business Park |
| Zona Industrial da Abrunheira |
| Edificio 10 |
| 2710-089 Sintra |
| PORTUGAL |

Baxter Médico Farmacêutica Lda

Sintra Business Park

Zona Industrial da Abrunheira

Edificio 10

2710-089 Sintra

PORTUGAL

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Spain

| Baxter S.L |
| --- |
| Poligono Industrial Sector 14 |
| C/ Pouet de Camilo, 2 |
| 46394 Ribarroja del Turia (Valencia) |
| ESPAÑA |

Baxter S.L

Poligono Industrial Sector 14

C/ Pouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

ESPAÑA

Extraneal

Icodextrina 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

Sweden

| Baxter AB |
| --- |
| Box 63 |
| SE-164 94 Kista |
| SVERIGE |

Baxter AB

Box 63

SE-164 94 Kista

SVERIGE

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

United Kingdom

| Baxter Healthcare Ltd |
| --- |
| Caxton Way |
| Thetford |
| IP24 3SE |
| UNITED KINGDOM |

Baxter Healthcare Ltd

Caxton Way

Thetford

IP24 3SE

UNITED KINGDOM

Extraneal

Icodextrin 7,5 %

Solution for peritoneal dialysis

Intraperitoneal use

---

ANNEX II

LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES (EEA)

Iodocasein/thiamine containing medicinal products with marketing authorisation in the European Union

| Member State | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Italy | TEOFARMA SRL |
| Via Fratelli Cervi 8 |
| Valle Salimbene |
| 27010 Pavia PV |
| ITALIA |

Member State

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

Italy

TEOFARMA SRL

Via Fratelli Cervi 8

Valle Salimbene

27010 Pavia PV

ITALIA

ANTIADIPOSO

125 mg + 12,33 mg

Coated tablet

Oral use

---

ANNEX III

THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE, WITHDRAWAL PERIOD, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Applicant/Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Route of administration | Recommended dose | Withdrawal period
  (meat) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Belgium | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Bulgaria | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Czech Republic | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Denmark | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Estonia | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Spain | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Germany | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Greece | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Hungary | Fort Dodge Animal Health | Poulvac Bursa Plus vakcina A.U.V. | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Ireland | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Italy | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Latvia | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Lithuania | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| The Netherlands | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Poland | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Portugal | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Romania | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Slovakia | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| Slovenia | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |
| United Kingdom | Fort Dodge Animal Health | Poulvac Bursa Plus | lyophilisate for suspension in drinking water | Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose | Chickens from 10 days of age | For oral administration in drinking water | One dose from 10 days of age | Zero days |

Member State

Applicant/Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Route of administration

Recommended dose

Withdrawal period

(meat)

Belgium

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Bulgaria

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Czech Republic

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Denmark

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Estonia

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Spain

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Germany

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Greece

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Hungary

Fort Dodge Animal Health

Poulvac Bursa Plus vakcina A.U.V.

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Ireland

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Italy

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Latvia

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Lithuania

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

The Netherlands

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Poland

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Portugal

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Romania

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Slovakia

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

Slovenia

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

United Kingdom

Fort Dodge Animal Health

Poulvac Bursa Plus

lyophilisate for suspension in drinking water

Live Infectious Bursal Disease virus, strain V877 — 102.2-103.4 EID50 per dose

Chickens from 10 days of age

For oral administration in drinking water

One dose from 10 days of age

Zero days

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | | Hospira UK Limited |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content (concentration)

Austria

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin Hospira 200 mg

Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung

200 mg

Powder and solvent for solution for injection or infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

(66,7 mg/ml)

Austria

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin Hospira 400 mg

Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung

400 mg

Powder and solvent for solution for injection or infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

(133,4 mg/ml)

Germany

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin Mayne Hospira 200 mg

Trockensubstanz

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Germany

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin Mayne Hospira 400 mg

Trockensubstanz

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

Ireland

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin 200 mg

Powder and Solvent for Solution for Injection or Infusion

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Ireland

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin 400 mg

Powder and Solvent for Solution for Injection or Infusion

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

Italy

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Italy

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

Portugal

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira 200 mg

Pó e solvente para solução injectável ou solução para perfusão

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Portugal

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira 400 mg

Pó e solvente para solução injectável ou solução para perfusão

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

Spain

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira 200 mg

Polvo y disolvente para solución inyectable o para perfusión

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

200 mg/vial

Spain

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanina Hospira 400 mg

Polvo y disolvente para solución inyectable o para perfusión

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use (injection or infusion)

Intramuscular use

400 mg/vial

United Kingdom

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin 200 mg

Powder and Solvent for Solution for Injection or Infusion

200 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use

200 mg/vial

United Kingdom

| Hospira UK Limited |
| --- |
| Queensway |
| Royal Leamington Spa |
| Warwickshire |
| CV31 3RW |
| UNITED KINGDOM |

Hospira UK Limited

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UNITED KINGDOM

Teicoplanin 400 mg

Powder and Solvent for Solution for Injection or Infusion

400 mg

Powder and Solvent for Solution for Injection or Infusion

Intravenous use

400 mg/vial

---

ANNEX V

NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Applicant or Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose | Withdrawal period |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Slovak Republic (1) | Pharmagal Bio, s.r.o. |
| Murgašova 5 |
| 949 01 Nitra |
| SLOVENSKO/SLOVAKIA |

Member State

Applicant or Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Withdrawal period

Slovak Republic (1)

Pharmagal Bio, s.r.o.

Murgašova 5

949 01 Nitra

SLOVENSKO/SLOVAKIA

APPM Respipharm

Suspension for injection

Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:

| | Actinobacillus pleuropneumoniae

  serotype 2 ≥ 4,8 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 9 ≥ 5,2 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 11 ≥ 4,9 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
   (2)

| | Pasteurella multocida

  serotype A ≥ 2,1 log2
   (2) |
| --- | --- |

Pasteurella multocida

serotype A ≥ 2,1 log2
   (2)

Pigs

Intramuscularly deep into the neck muscle.

| | Pregnant sows: | Primary vaccination: First injection 4-5 weeks before expected farrowing.
  Second injection at least 2 weeks before expected farrowing. |
| --- | --- | --- |

Pregnant sows:

Primary vaccination: First injection 4-5 weeks before expected farrowing.

Second injection at least 2 weeks before expected farrowing.

| | Booster: One injection 2-3 weeks before each farrowing. |
| --- | --- |

Booster: One injection 2-3 weeks before each farrowing.

| | Weaned piglets: | First injection: At the age of 6-8 weeks. |
| --- | --- | --- |

Weaned piglets:

First injection: At the age of 6-8 weeks.

| | Revaccination: After 14-21 days. |
| --- | --- |

Revaccination: After 14-21 days.

| | Pregnant sows:
  Vaccine dose: 3 ml |
| --- | --- |

Pregnant sows:

Vaccine dose: 3 ml

| | Weaned piglets:
  Vaccine dose: 2 ml |
| --- | --- |

Weaned piglets:

Vaccine dose: 2 ml

Zero days

Spain

| Pharmagal Bio, s.r.o. |
| --- |
| Murgašova 5 |
| 949 01 Nitra |
| SLOVENSKO/SLOVAKIA |

Pharmagal Bio, s.r.o.

Murgašova 5

949 01 Nitra

SLOVENSKO/SLOVAKIA

APPM Respipharm

Suspension for injection

Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:

| | Actinobacillus pleuropneumoniae

  serotype 2 ≥ 4,8 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 9 ≥ 5,2 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 11 ≥ 4,9 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
   (2)

| | Pasteurella multocida

  serotype A ≥ 2,1 log2
   (2) |
| --- | --- |

Pasteurella multocida

serotype A ≥ 2,1 log2
   (2)

Pigs

Intramuscularly deep into the neck muscle.

| | Pregnant sows: | Primary vaccination: First injection 4-5 weeks before expected farrowing.
  Second injection at least 2 weeks before expected farrowing. |
| --- | --- | --- |

Pregnant sows:

Primary vaccination: First injection 4-5 weeks before expected farrowing.

Second injection at least 2 weeks before expected farrowing.

| | Booster: One injection 2-3 weeks before each farrowing. |
| --- | --- |

Booster: One injection 2-3 weeks before each farrowing.

| | Weaned piglets: | First injection: At the age of 6-8 weeks. |
| --- | --- | --- |

Weaned piglets:

First injection: At the age of 6-8 weeks.

| | Revaccination: After 14-21 days. |
| --- | --- |

Revaccination: After 14-21 days.

| | Pregnant sows:
  Vaccine dose: 3 ml |
| --- | --- |

Pregnant sows:

Vaccine dose: 3 ml

| | Weaned piglets:
  Vaccine dose: 2 ml |
| --- | --- |

Weaned piglets:

Vaccine dose: 2 ml

Zero days

Poland

Pharmagal Bio, s.r.o.

Murgašova 5

949 01 Nitra

SLOVENSKO/SLOVAKIA

APPM Respipharm

Suspension for injection

Strains of Actinobacillus pleuropneumoniae producing Apx I, Apx II and Apx III toxins:

| | Actinobacillus pleuropneumoniae

  serotype 2 ≥ 4,8 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 2 ≥ 4,8 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 9 ≥ 5,2 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 9 ≥ 5,2 log2
   (2)

| | Actinobacillus pleuropneumoniae

  serotype 11 ≥ 4,9 log2
   (2) |
| --- | --- |

Actinobacillus pleuropneumoniae

serotype 11 ≥ 4,9 log2
   (2)

| | Pasteurella multocida

  serotype A ≥ 2,1 log2
   (2) |
| --- | --- |

Pasteurella multocida

serotype A ≥ 2,1 log2
   (2)

Pigs

Intramuscularly deep into the neck muscle.

| | Pregnant sows: | Primary vaccination: First injection 4-5 weeks before expected farrowing.
  Second injection at least 2 weeks before expected farrowing. |
| --- | --- | --- |

Pregnant sows:

Primary vaccination: First injection 4-5 weeks before expected farrowing.

Second injection at least 2 weeks before expected farrowing.

| | Booster: One injection 2-3 weeks before each farrowing. |
| --- | --- |

Booster: One injection 2-3 weeks before each farrowing.

| | Weaned piglets: | First injection: At the age of 6-8 weeks. |
| --- | --- | --- |

Weaned piglets:

First injection: At the age of 6-8 weeks.

| | Revaccination: After 14-21 days. |
| --- | --- |

Revaccination: After 14-21 days.

| | Pregnant sows:
  Vaccine dose: 3 ml |
| --- | --- |

Pregnant sows:

Vaccine dose: 3 ml

| | Weaned piglets:
  Vaccine dose: 2 ml |
| --- | --- |

Weaned piglets:

Vaccine dose: 2 ml

Zero days

---

(1)  Marketing Authorisation granted.

(2)  Mean titre of agglutination antibodies after vaccination in rabbits.

---