4,0 g/0,5 g. 2g/250 mg. 4 g/500 mg. 4g/0,5g 2.25 G/VIAL. injection 4.5 G/VIAL. injection. injection

Transcription

1 ANNEX I List of the names, pharmaceutical forms, strengths of the medicinal products, route of, marketing authorisation holders in the Member States 1

2 Route of ) Austria Bulgaria Cyprus Cyprus Czech Republic Pfizer Corporation Austria Ges.m.b.H Floridsdorfer Hauptstraße 1, A-1210 Wien Austria Pfizer S.A. Boulevard de la Plaine Brussels Pfizer S.A. Boulevard de la Plaine Brussels Pfizer Hellas A.E. 243 Messoghion Avenue Neo Psychico Pfizer Hellas A.E. 243 Messoghion Avenue Neo Psychico Pfizer spol. s r.o. Stroupežnického 3191/17, Praha Smíchov, Czech Republic Tazonam 4,0 g/0,5 g - Trockenstechampullen 2g/250 mg poudre pour solution injectable 4g/500 mg poudre pour solution injectable (TAZOCIN 4 g/0,5 g powder for solution for / Piperacillin/Tazobactam) TAZOCIN EF TAZOCIN EF 2,25 g 4,0 g/0,5 g 2g/250 mg 4 g/500 mg 4g/0,5g 2.25 G/VIAL 4.5 G/VIAL 2,25 g Lyophilisate for solution for or powder for solution for / use use use 1 vial contains piperacillin sodium equivalent to 4.0g of piperacillin and sodium equivalent to 0.5g of. 2,085 g sodium piperacillin + 268,30 mg sodium 4,170 g sodium piperacillin + 536,60 mg sodium g piperacillin sodium equivalent to 4 g equivalent to 500 milligrams g sodium piperacillin equivalent to 2 g piperacillin and g sodium equivalent to g g sodium piperacillin equivalent to 4 g piperacillin and g sodium equivalent to 0.5 g. 2 g piperacillinum / 0,25 g um 2

3 Czech Republic Denmark Denmark Estonia Finland Finland France Pfizer spol. s r.o. Stroupežnického 3191/17, Praha Smíchov Czech Republic Pfizer ApS Lautrupvang Ballerup Denmark Pfizer ApS Lautrupvang Ballerup Denmark Pfizer Oy Tietokuja 4, Helsinki, Finland Pfizer Oy Tietokuja 4, Helsinki, Finland Pfizer, Coeur Défense - Tour A La Défense PARIS LA DEFENSE Cedex France 4,5 g TAZOCIN 4,5G 4,5 g 2 g/0,25 g 4 g/0,5 g 4000m g+500mg g 2 g/0,25 g 4 g/0,5 g TAZOCILLINE 2 g/250 mg, poudre pour solution 2g/250mg pour perfusion / / or / / use Infusion 4 g piperacillinum / 0,5 g um piperacillin 2 g, 0,25 g. piperacillin 4 g, 0,5 g 4,170 g piperacillin sodium equivalent to 4000 mg of equivalent to 500 mg of. Piperacillin. sodium g Tazobactam.sodium 0,2683 g Piperacillin. sodium g Tazobactam.sodium 0,5366 g Sodium piperacillin g sodium mg 3

4 France Germany Pfizer, Coeur Défense - Tour A La Défense PARIS LA DEFENSE Cedex France Pfizer Pharma GmbH Linkstr Berlin Germany TAZOCILLINE 4 g/500 mg, poudre pour solution 4g/500mg pour perfusion Tazobac EF 4g/0,5g 4g/0.5g Lyophilisate for or Infusion (Infusion, Injection) Sodium piperacillin g sodium mg 4 g piperacillin equivalent to 4.17 g piperacillin sodium 0.5 g equivalent to g sodium Hungary Pfizer Hellas A.E. 243 Messoghion Avenue Neo Psychico Pfizer Hellas A.E. 243 Messoghion Avenue Neo Psychico Wyeth Whitehall Export GmbH Storchengasse 1 A-1150 Vienna Austria TAZOCIN EF TAZOCIN EF 2+0,250 G/VIAL 4+0,500 G/VIAL 4,5 g injekció 4.5g or use use g sodium piperacillin equivalent to 2 g piperacillin and g sodium equivalent to g g sodium piperacillin equivalent to 4 g piperacillin and g sodium equivalent to 0.5 g g sodium equivalent to g and g piperacillin sodium equivalent to 4.00 g piperacillin 4

5 Ireland Ireland Italy Italy Latvia John Wyeth & Brother Limited Taplow, Maidenhead, Berks, SL6 0PH John Wyeth & Brother Limited Taplow, Maidenhead, Berks, SL6 0PH Wyeth Lederle S.p.A. Via Nettunense, 90 Aprilia (LT), 04011, Italy Wyeth Lederle S.p.A. Via Nettunense, 90 Aprilia (LT), 04011, Italy 2g/0.25g Powder for Solution for Injection or Infusion 4g/0.5g Powder for Solution for Injection or Infusion TAZOCIN TAZOCIN TAZOCIN 4,0g/0,5g pulveris injekciju vai infūziju šķīduma pagatavošanai 2g/0.25g 4g/0.5g 2g+0,250g 4g g 4,0g/0,500 mg or use use 2g piperacillin and 0.25g (both present as sodium salts). 4g piperacillin and 0.5g (both present as sodium salts). (equiv. to piperacillin 2g) 2085 mg Tazobactam sodium (equiv. to 250 mg) 268,3 mg (equiv. to piperacillin 4 g) 4170 mg Tazobactam sodium (equiv. to 500 mg) 536,6 mg g piperacillin sodium equivalent to 4g equivalent to 500 milligrams 5

6 Lithuania Luxembourg Luxembourg Malta Malta Netherlands Pfizer S.A. Boulevard de la Plaine Brussels Pfizer S.A. Boulevard de la Plaine Brussels John Wyeth & Brother Limited Taplow Maidenhead Berkshire SL6 0PH John Wyeth & Brother Limited Taplow Maidenhead Berkshire SL6 0PH Pfizer B.V. Rivium westlaan LD Capelle a/d IJssel The Netherlands TAZOCIN 2g/250 mg poudre pour solution injectable 4g/500 mg poudre pour solution injectable 2g/0.25 g TAZOCIN 4g/0.5g 2 g/ 250 mg 4,0g/0,5g 2g/250 mg 4g/500 mg 2g/0.25g 4g/0.5g 2g /250 mg or g piperacillin sodium equivalent to 4g equivalent to 500 milligrams 2,085 g sodium piperacillin + 268,30 mg sodium 4,170 g sodium piperacillin + 536,60 mg sodium TAZOCIN 2g/0.25g contains 2 active ingredients; piperacillin 2g and 0.25g both present as sodium salts. TAZOCIN 4g/0.5g contains 2 active ingredients; piperacillin 4g and 0.5g both present as sodium salts. Sodium piperacillin and sodium, equivalent to 2 g piperacillin and 250 mg. 6

7 Netherlands Norway Norway Poland Poland Portugal Pfizer B.V. Rivium westlaan LD Capelle a/d IJssel The Netherlands Pfizer AS Postboks Lysaker Norway Pfizer AS Postboks Lysaker Norway Instituto Pasteur de Lisboa, S.A. Rua Dr. António Loureiro Borges, 2 Arquiparque - Miraflores ALGÉS Portugal 4 g/ 500 mg 4 g/500mg 2 g/0,25 g 4 g/0,5 g 2g + 0,25g 4g + 0,5g Tazobac 2000mg mg / / or or use Sodium piperacillin and sodium, equivalent to 4 g piperacillin and 500 mg piperacillin 2 g,. 0,25 g piperacillin 4 g, 0,5 g. 2 g piperacillin (in form of piperacillin sodium) and 0,25 g (in form of sodium). 4 g piperacillin (in form of piperacillin sodium) and 0,5 g (in form of sodium) g of piperacillin sodium equivalent to 2 g of piperacillin and g of equivalent to 250 mg of 7

8 Portugal Romania Romania Slovak Republic Slovak Republic Slovenia Instituto Pasteur de Lisboa, S.A. Rua Dr. António Loureiro Borges, 2 Arquiparque - Miraflores ALGÉS Portugal Tazobac 2,25 g, liofilizat pentru soluţie injectabilă/ perfuzabilă 4,5 g, liofilizat pentru soluţie injectabilă/ perfuzabilă 4000mg mg 2,00/0,25g 4,00/0,5g 2,25g 2.25g 4,5g 4.5g TAZOCIN 4,5 g prašek za raztopino za injiciranje ali infundiranje 4.0g/0.5g Lyophilised powder for solution for or Lyophilised powder for solution for or and and or. use g of piperacillin sodium equivalent to 4 g of of equivalent to 500 mg of Piperacillin 2.00 g as piperacillin sodium and 0.25 g as sodium. Piperacillin 4.00 g as piperacillin sodium and 0.5 g as sodium. contains 2.085g piperacillin sodium equivalent to 2g piperacillin and g equivalent to 250 milligrams contains g piperacillin sodium equivalent to 4g equivalent to 500 milligrams g piperacillin sodium equivalent to 4 g sodium equivalent to 500 mg. 8

9 Spain Spain Sweden Sweden Wyeth Farma S.A. Ctra. Burgos, Km 23 - Desvío Tazocel 2/0,25 g Algete Km 1 Polvo para San Sebastián de los solución Reyes (Madrid) inyectable Spain Wyeth Farma S.A. Ctra. Burgos, Km 23 - Desvío Tazocel 4/0,5 g Algete Km 1 Polvo para San Sebastián de los solución Reyes (Madrid), inyectable Spain Pfizer AB Vetenskapsvägen Sollentuna, Sweden Pfizer AB Vetenskapsvägen Sollentuna, Sweden John Wyeth & Brother Limited Taplow Maidenhead Berkshire SL6 0PH TAZOCIN 2g/0.25g 2/0,25 g 4/0,5 g 2 g/0,25 g 4 g/0,5 g 2.25g Powder for injectable solution Powder for injectable solution / / Piperacillin (in the form of piperacillin sodium) 2 g Tazobactam (in the form of ) 0.25 g Piperacillin (in the form of piperacillin sodium) 4 g Tazobactam (in the form of ) 0.50 g piperacillin 2 g and 0,25 g piperacillin 4 g and 0,5 g Piperacillin 2g and 250mg both present as sodium salts. 9

10 Route of ) John Wyeth & Brother Limited Taplow Maidenhead Berkshire SL6 0PH TAZOCIN 4g/0.5g 4.5g Piperacillin 4g and 500mg both present as sodium salts. 10