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23.9.2003 Official Journal of the European Union 23.9.2003EN Official Journal of the European Union 763 Appendix A referred to in Chapter 1, points 4 and 5 of Annex XII (*) List as provided by Poland in one language of pharmaceutical products for which a marketing authorisation issued under Polish law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or until 31 December 2008, whichever is the earlier. Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing authorisation in compliance with the acquis. Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date 1 0,9 % Sodium Chloride- Natrii chloridum Solution for infusion 9 mg/ml B. Braun Melsungen AG 26/04/06 BRAUN 2 10 % Dekstran 40 000 Dextranum Solution for infusion 100 mg/ml Baxter Terpol Sp. z o.o. 31/12/08 3 26 RANUNCULUS-Dago-med. DAGOMED-Pharma Sp. zo.o., 31/12/06 opryszczka wargowa Warszawa 4 27 ABROTANUM-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 tra˛dzik róz˙owaty Warszawa 5 28 SULFUR-Dagomed tra˛dzik DAGOMED-Pharma Sp. zo.o., 31/12/06 pospolity Warszawa 6 29 HYDROCOTYLE-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 zmiany łuszczycowe Warszawa 93TC Lamivudinum Film-coated tablets 150 mg Glaxo Wellcome Group 31/12/08 Glaxo Wellcome House 10 3 TC Lamivudinum Film-coated tablets 150 mg GlaxoSmithKline 31/12/08 Pharmaceuticals S.A. 73TC Lamivudinum Syrup 10 mg/ml Glaxo Wellcome Group 31/12/08 Glaxo Wellcome House 83TC Lamivudinum Syrup 10 mg/ml GlaxoSmithKline 31/12/08 Pharmaceuticals S.A. 11 30 MEZEREUM-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 nerwobóle, półpasiec Warszawa 12 31 THUJA-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 brodawki, kurzajki Warszawa 13 32 BELLADONNA-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 wysypki w chorobach Warszawa zakaz´nych u dzieci 14 324 pojedyncze DHU-Arzneimittel GmbH 31/03/06 prep.homeopatyczne wg listy & Co.KG 15 33 SECALE-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 miaz˙dz˙yca naczyn´ obwodo- Warszawa wych 16 34 BARIUM-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 zaburzenia pamie˛ci Warszawa 17 35 MAGNESIUM-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 kolki jelitowe Warszawa 18 36 RUTA-Dagomed urazy DAGOMED-Pharma Sp. zo.o., 31/12/06 s´cie˛gien i mie˛s´ni Warszawa 19 37 BRYONIA-Dagomed bóle DAGOMED-Pharma Sp. zo.o., 31/12/06 barkowe i szyjne Warszawa (*) For the text of Annex XII see OJ L 236, 23.9.2003, p. 875. 764EN Official Journal of the European Union 23.9.2003 Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date 20 38 COLOCYNTHIS-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 rwa kulszowa, lumbago Warszawa 21 39 PASSIFLORA-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 nadpobudliwos´c´, bezsennos´c´ Warszawa 22 40 LUFFA-Dagomed katar DAGOMED-Pharma Sp. zo.o., 31/12/06 sienny Warszawa 23 41 MERCURIUS-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 anginy ropne Warszawa 24 42 CONIUM-Dagomed stany DAGOMED-Pharma Sp. zo.o., 31/12/06 zapalne migdałków Warszawa podniebiennych 25 43 BORAX-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 zapalenia i grzybice jamu Warszawa ustnej 26 44 CHAMOMILLA-Dago-med. DAGOMED-Pharma Sp. zo.o., 31/12/06 bolesne za˛bkowanie Warszawa 27 45 ACIDUM NITRICUM- DAGOMED-Pharma Sp. zo.o., 31/12/06 Dagomed stany zapalne Warszawa s´luzówki 28 46 ECHINACEA-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 nawracaja˛ce infekcje Warszawa 29 47 THALLIUM-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 wypadanie włosów, łysienie Warszawa 30 48 KREOZOTUM-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 upławy Warszawa 31 49 VIBURNUM-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 bolesne miesia˛czki Warszawa 32 4XLA Kwas mlekowy, Liquid for veterinary Alcide Corporation USA 31/12/08 chloryn sodu use 33 5- Fluorouracyl Fluorouracilum Solution for injection 50 mg/ml PLIVA Kraków Zakłady 31/12/08 Farmaceutyczne S.A. 34 50 TABACUM-Dagomed DAGOMED-Pharma Sp. zo.o., 31/12/06 uzalez˙nienie nikotynowe Warszawa 35 51 Cr-EDTA do wstrzykiwan´ Preparat Solution for injection Polatom Os´rodek Badawczo- 31/12/08 radiodiagnostyczny Rozwojowy Izotopów 36 5-Ala Methyl aminolevulinate Cream 6 % Przedsie˛biorstwo 31/12/08 hydrochloride Farmaceutyczne JELFA S.A 37 5-Fluorouracil-Ebewe, 5- Fluorouracilum Solution for injection, 50 mg/ml EBEWE Arzneimittel GmbH 30/11/04 Fluorouracyl-Knoll intravenous and intraarterial infusion 38 6 % Dekstran 70 000 Dextranum Solution for infusion 60 mg/ml Baxter Terpol Sp. z o.o. 31/12/08 39 A 20 Acidum Powder for veterinary Vetos-Farma 31/12/08 acetylsalicylicum use 42 Abaktal Pefloxacinum Film-coated tablets 0.4 g Lek Pharmaceuticals d.d. 30/04/04 43 Abaktal Pefloxacinum Film-coated tablets 0.4 g Lek Polska Sp. z o.o. 30/10/05 40 Abaktal Pefloxacinum Solution for 80 mg/ml Lek Pharmaceuticals d.d. 30/04/04 intravenous infusion 23.9.2003EN Official Journal of the European Union 765 Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date 41 Abaktal Pefloxacinum Solution for 80 mg/ml Lek Polska Sp. z o.o. 30/10/05 intravenous infusion 44 Abamitel L.A inj. Abamectinum Solution for veterinary KRKA 31/12/08 use 45 Abamitel Plus Abamectinum + Paste for veterinary KRKA 31/12/08 Praziquantelum use 46 Abbocurium Atracurii besilas Solution for injection 10 mg/ml Abbott Laboratoires 31/05/05 and intravenous infusion 47 Abbofol 1 % Propofolum Emulsion for injection 10 mg/ml Abbott Laboratories 30/06/04 and intravenous infusion 48 ABBOTAXIM 1 g Cefotaximum Powder for solution 1 g Abbott Laboratories Poland 31/12/08 for intramuscular and Sp. z o.o. intravenous injection and infusion 49 ABBOTAXIM 2 g Cefotaximum Powder for solution 2 g Abbott Laboratories Poland 31/12/08 for intramuscular and Sp. z o.o. intravenous injection and infusion 50 ABBOTAXIM 500 mg Cefotaximum Powder for solution 500 mg Abbott Laboratories Poland 31/12/08 for intramuscular and Sp. z o.o. intravenous injection and infusion 51 ABBOTRIAXON 1 g Ceftriaxonum Powder for solution 1 g Abbott Laboratories Poland 31/12/08 for intramuscular and Sp. z o.o. intravenous injection and infusion 52 ABBOTRIAXON 2 g Ceftriaxonum Powder for solution 2 g Abbott Laboratories Poland 31/12/08 for intramuscular and Sp. z o.o. intravenous injection and infusion 53 ABBOTRIAXON 500 mg Ceftriaxonum Powder for solution 500 mg Abbott Laboratories Poland 31/12/08 for intramuscular and Sp. z o.o. intravenous injection and infusion 54 Abbovancomycin Vancomycinum Powder for solution 500 mg Abbott France S.A. 31/12/08 for infusion 55 Abbovancomycin Vancomycinum Powder for solution 1 g Abbott France S.A. 31/12/08 for infusion 56 Abbovir Aciclovirum Powder for solution 250 mg Abbott Laboratories 11/10/06 for infusion 57 Abbovir Aciclovirum Powder for solution 500 mg Abbott Laboratories 11/10/06 for infusion 58 ABC-Salbe Ointment Beiersdorf AG 31/12/08 59 Abdomilon Oral solution Julius Redel CESRA — 30/04/04 Arzneimittelfabrik GmbH 60 ABE — płyn do usuwania Coutanous liquid Inco-Veritas S.A. Oddział w 30/10/05 odcisków Pruszkowie; Celia Zakład Produkcji Kosmetyczno- Farmaceutycznej 61 Abelcet Amphotericinum B Suspension for 5 mg/ml ELAN PHARMA 30/09/07 intravenous infusion INTERNATIONAL Ltd. 766EN Official Journal of the European Union 23.9.2003 Lp. Commercial name Chemical constitution Pharmaceutical form Strength Marketing authorisation holder Date 62 Abropernol Tablets Heel GmbH 31/12/08 63 Abutol Acebutololum Film-coated tablets 200 mg Schwarz Pharma Sp. z o.o. 31/12/04 64 Abutol Long 400 Acebutololum Gastro-resistant, 400 mg Schwarz Pharma Sp. z o.o. 12/10/05 prolonged release tablets 65 Acard Acidum acetylsalicylicum Film-coated tablets 75 mg Warszawskie Zakłady 13/06/06 Farmaceutyczne POLFA 66 Acatar Oxymetazolini Nasal spray, solution 0.05 % US Pharmacia International 31/10/05 hydrochloridum Inc. 67 ACC Acetylcysteinum Granules for oral 20 mg/ml Hexal AG 30/09/05 solution 68 ACC Acetylcysteinum Solution for 300 mg/3 ml Hexal AG 31/12/08 intravenous injection or for respiratory system 71 ACC 100 Acetylcysteinum Effervescent tablets 100 mg Hexal AG 31/01/05 69 ACC 100 Acetylcysteinum Granules for oral 100 mg Hexal AG 31/01/05 solution 70 ACC 100 Acetylcysteinum Tablets 100 mg Hexal AG 15/11/06 73 ACC 200 Acetylcysteinum Capsules 200 mg Hexal AG 31/01/05 75 ACC 200 Acetylcysteinum Effervescent tablets 200 mg Hexal AG 31/01/05 72 ACC 200 Acetylcysteinum Granules for oral 200 mg Hexal AG 31/01/05 solution 74 ACC 200 Acetylcysteinum Tablets 200 mg Hexal AG 15/11/06 76 ACC 200 Hot Acetylcysteinum Granules for oral 200 mg/3 g Hexal AG 5/07/06 solution 77 Acc 300 Acetylcysteinum Tablets 300 mg HEXAL AG 31/12/08 78 ACC 600 Acetylcysteinum Effervescent tablets 600 mg Hexal AG 6/12/06 79 Acc 600 Acetylcysteinum Tablets 600 mg HEXAL AG 6/12/06 80 ACC 600 Hot Acetylcysteinum Granules for oral 600 mg/3g Hexal AG 5/07/06 solution 81 Acceptin Tianeptinum Tablets 12,5 mg Zakłady Farmaceutyczne 31/12/08 POLFA — ŁÓDZ´ S.A. 82 Accolate Zafirlukastum Film-coated tablets 10 mg Astra Zeneca UK Ltd. 29/11/06 83 Accolate Zafirlukastum Film-coated tablets 20 mg AstraZeneca UK Ltd. 31/12/08 84 Accupro 10 Quinaprilum Film-coated tablets 10 mg Gödecke AG 30/06/07 85 Accupro 20 Quinaprilum Film-coated tablets 20 mg Gödecke AG 30/06/07 86 Accupro 40 Quinaprilum Film-coated tablets 40 mg Gödecke GmbH 31/12/08 87 Accupro 5 Quinaprilum Film-coated tablets 5 mg Gödecke AG 30/06/07 88 Accuzide Hydrochlorothiazidum + Film-coated tablets 12,5mg + Parke-Davis GmbH — 12/10/05 Quinaprilum 10mg Freiburg 23.9.2003EN Official Journal of the European Union 767 Lp.
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