List of nationally authorised medicinal products

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1 30 March 2016 EMA/319353/2016 Procedure Management and Committees Support Active substance: paracetamol / tramadol Procedure no.: PSUSA/ / Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 Tramadol/Paracetamol Teva 75 mg/ 650 mg comprimidos recubiertos con película Zaldiar 37,5 mg/325 mg filmsko obložene tablete Zaldiar 37,5 mg/325 mg filmsko obložene tablete ZALDIAR 37,5 mg/325 mg, filmuhúðaðar töflur ZALDIAR 37,5 mg/325 mg comprimidos recubiertos con película ZALDIAR 37,5 mg/325 mg, filmomhulde tabletten Zaldiar 37,5 mg/325 mg Filmtabletten ZALDIAR 37,5 mg / 325 mg, comprimés pelliculés ZALDIAR 37,5 mg/325 mg Filmtabletten ZALDIAR 37,5 mg/325 mg, bruistabletten ZALDIAR 37,5 mg/325 mg, bruistabletten Zaldiar Bruis, 37,5 mg/325 mg, bruistabletten National Number TEVA PHARMA S.L.U /H/0212/ I-638/13 STADA /H/0212/ I-639/13 STADA /H/0212/E GRÜNENTHAL S.A. PT /H/0212/E GRÜNENTHAL S.A. PT /H/0212/E GRÜNENTHAL S.A. PT /H/0212/001 IS/1/02/038/01 GRÜNENTHAL IS /H/0212/E GRÜNENTHAL S.A. PT /H/0212/E GRÜNENTHAL S.A. PT /H/0212/E GRÜNENTHAL S.A. PT /H/0212/ GRÜNENTHAL PHARMA S.A. /H/0212/001 RVG GRÜNENTHAL B.V. NL /H/0212/ GRÜNENTHAL GES. M.B.H. AT /H/0212/001 BE SA GRÜNENTHAL BE /H/0212/ GRÜNENTHAL DE /H/0212/002/DC BE SA GRÜNENTHAL BE /H/0212/002/DC BE SA GRÜNENTHAL BE /H/0212/002/DC RVG GRÜNENTHAL B.V. NL ES ES EMA/319353/2016 Page 2/9

3 National Number Diliban Retard 75 mg IS/H/0168/001/DC IS/1/10/092/01 Gebro Pharma IS GmbH Fieberbrunn Austria Diliban Retard 75 mg IS/H/0168/001/DC Paladin Labs ES Eudrope Limited (Endo) Dublin Ireland Diliban Retard 75 mg IS/H/0168/001/DC , Jaba recordati, S.A PT Porto Salvo Portugal Tramadol+Paracetamol Bluepharma , Bluepharma PT Genericos - Comercio de Medicamentos, S.A. Zaldiar 65/107/11-C, 65/237/02-C STADA CS Zaldiar 37.5 mg/325 mg filmcoated STADA EE tablets Zaldiar 37.5 mg/ 325mg STADA LV filmtabletta Zaldiar effervescent STADA PL Zaldiar STADA PL Zaldiar 37.5 mg 5186/2005/01-12 STADA Zaldiar effevescens 65/080/11-S STADA SK Zaldiar 65/0152/04-S STADA SK Pontalistic /H/0211/002 BE332796, BE SA GRÜNENTHAL BE Pontalistic /H/0211/001 BE SA GRÜNENTHAL BE IXPRIM /H/0211/002 NL35216 LABORATOIRES EMA/319353/2016 Page 3/9

4 National Number GRÜNENTHAL S.A.S. IXPRIM /H/0211/001 NL25970 LABORATOIRES GRÜNENTHAL S.A.S. Zaldiar /H/0212/002 NL35215 LABORATOIRES GRÜNENTHAL S.A.S. Zaldiar /H/0212/001 NL25971 LABORATOIRES GRÜNENTHAL S.A.S. DOLEVAR /H/0211/ GRÜNENTHAL DE Zaldiar /H/0212/ GRÜNENTHAL DE Zaldiar /H/0212/ / GRÜNENTHAL GR Zaldiar /H/0212/001 OGYI-T-20557/01-06 STADA Zaldiar /H/0212/002 OGYI-T-20557/07-10 STADA Ixprim /H/0212/001 PA 1189/5/1 Grunenthal Ltd IR Ixprim effervescent /H/0212/002 PA1189/005/002 Grunenthal Ltd IR ZALDIAR 37,5 mg / 325 mg, /H/0212/ / SA GRÜNENTHAL LU comprimés effervescents ZALDIAR 37,5 mg / 325 mg, /H/0212/ /03/01/0017 SA GRÜNENTHAL LU comprimés pelliculés Zaldiar EFE /H/0212/ , , Gruhnenthal, S.A. PT Zaldiar /H/0212/ I-641/13, 5363-I-642/13 STADA Zaldiar 37,5 mg/325 mg filmsko /H/0212/ I-640/13 STADA obložene tablete Pontalsic /H/0211/ Zambon S.A.U. ES Zaldiar /H/0212/ GRÜNENTHAL PHARMA S.A. ES EMA/319353/2016 Page 4/9

5 National Number Tramacet /H/0211/001 PL 21727/0039 Grunenthal Ltd UK Tramacet /H/0211/002 PL 21727/0040 Grunenthal Ltd UK Tramadol/Paracetamol Krka /H/0190/002/E/ KRKA, d.d., Novo Дорета /H/0190/002/E/ KRKA, d.d., Novo Doreta /H/0190/002 65/185/12-C KRKA, d.d., Novo Doreta /H/0190/002/E/ KRKA, d.d., Novo Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramadol/Paracetamol Krka /H/0190/002/E/002 NL 42263, CIS: KRKA, d.d., Novo ( ) Tramabian /H/0190/002/E/ KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/12 KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/13 KRKA, d.d., Novo AT BG CS EE DE EMA/319353/2016 Page 5/9

6 National Number Doreta /H/0190/002/E/002 OGYI-21059/14 KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/15 KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/16 KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/17 KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/18 KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/19 KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/20 KRKA, d.d., Novo Doreta /H/0190/002/E/002 OGYI-21059/21 KRKA, d.d., Novo Doreta /H/0190/002/E/ KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/012 KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/013 KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/014 KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/015 KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/016 KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/017 KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/018 KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/019 KRKA, d.d., Novo Doreta /H/0190/002/E/002 /1/09/1638/020 KRKA, d.d., Novo LV EMA/319353/2016 Page 6/9

7 National Number Doreta /H/0190/002/E/002 /1/09/1638/021 KRKA, d.d., Novo Doreta /H/0190/002/E/ KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/01 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/02 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/03 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/04 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/05 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/06 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/07 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/08 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/09 KRKA, d.d., Novo Doreta /H/0190/002/E/ /2014/10 KRKA, d.d., Novo Doreta /H/0190/002/E/002 65/0742/11-S KRKA, d.d., Novo Doreta /H/0190/002/E/002 H/09/00506/012 KRKA, d.d., Novo Doreta /H/0190/002/E/002 H/09/00506/013 KRKA, d.d., Novo Doreta /H/0190/002/E/002 H/09/00506/014 KRKA, d.d., Novo Doreta /H/0190/002/E/002 H/09/00506/015 KRKA, d.d., Novo Doreta /H/0190/002/E/002 H/09/00506/037 KRKA, d.d., Novo PL SK EMA/319353/2016 Page 7/9

8 National Number Doreta /H/0190/002/E/002 H/09/00506/040 KRKA, d.d., Novo Doreta /H/0190/002/E/002 H/09/00506/043 KRKA, d.d., Novo Doreta /H/0190/002/E/002 H/09/00506/044 KRKA, d.d., Novo Tramadol/Paracetamol Krka /H/0190/002/E/ KRKA, d.d., Novo ES Diliban Laboratorios Gebro ES Pharma, S.A. Pazital Laboratorios Gebro ES Pharma, S.A. Tramadol/Paracetamol ratiopharm ratiopharm Espana ES SA Zilpen , Tecnimede, PT Sociedade Tecnico-Medicinal, S.A. Tramadol+Paracetamol tolife PT/H/ /01-02/DC , tolife - productos Farmaceuticos, S.A. PT Kolibri , , Alfa Wassermann IT , , S.p.A , , , Kolibri , , Alfa Wassermann IT , , S.p.A Patrol , , Alfa Wassermann IT , , S.p.A , , Patrol , , Alfa Wassermann IT , , S.p.A PALGOTAL IS/H/0220/001/DC 7424/2015/01-03 ZENTIVA, k.s., EMA/319353/2016 Page 8/9

9 National Number Tramadol/Pracetamol Tarbis Tarbis Farma, S.L. ES Palgotal IS/H/0220/001 65/252/14-C Zentiva, k.s. CS Palgotal IS/H/0220/001/DC Zentiva, k.s. PL Tramadol+Paracetamol Litexil PT/H919/002/MR , , , , , , , , , , , PTR Pharma Consulting, Lda PT EMA/319353/2016 Page 9/9

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