Reporting adverse event or adverse drug reaction

Reporting adverse event or adverse drug reaction
The following information, appearing in Polish, refers to the reporting adverse event of adverse drug reaction only on territory of Poland. For more information in English please contact us: +48 22 56 62 630

Komtur Polska Sp. z o.o. makes a kind request to report all information on suspected adverse event or adverse drug reaction after the following medicinal products:

Marketing Authorisation Holder: Janssen Cilag

  • Veletri 0,5mg; powder for solution for infusion
  • Veletri 1,5mg; powder for solution for infusion

Marketing Authorisation Holder: Riemser Pharma GmbH

  • Aldactone (Kalii canrenoas) 20 mg/ml, solution for injection

Marketing Authorisation Holder: Cheplapharm Arzneimittel GmbH

  • Atacand (Candesartanum) 8 mg; 16 mg; tablets
  • Biosotal 40; Biosotal 80; (Sotalolum) 40 mg; 80 mg; tablets
  • Cymevene (Ganciclovirum) 500 mg, powder for solution for injection
  • Dilatrend (Carvedilolum) 6,25 mg; 12 mg; 25 mg; tablets
  • Ditropan (Oxybutyninum) 5 mg, tablets
  • Dormicum (Midazolamum) 7,5 mg; 15 mg, film-coated tablets
  • Duomox (Amoxicillin) 250 mg; 375 mg; 500 mg; 750 mg; 1000 mg; tablets
  • Ebrantil 25 (Urapidili hydrochloridum) 5 mg/ml, solution for injection
  • Exacyl (Acidum tranexamicum) 500 mg; film-coated tablets
  • Exacyl (Acidum tranexamicum) 100 mg/ml; solution for injection
  • Exacyl (Acidum tranexamicum) 100 mg/ml; oral solution
  • Fungizone (Amphotericinum B) 50 mg, powder for solution for injection
  • Gutron (Midodrini hydrochloridum) 2,5 mg, tablets
  • Heminevrin (Clomethiazolum) 300 mg, capsules hard
  • Inhibace (Cilazaprilum) 1 mg; 2,5 mg; 5 mg; film-coated tablets
  • Inhibace Plus (Cilazaprilum + Hydrochlorothiazidum) 5 mg + 12,5 mg; film-coated tablets
  • Lexotan (Bromazepamum) 3 mg; 6 mg, tablets
  • Locoid (Hydrocortisoni butyras) 1 mg/ml, solution for use on the skin
  • Locoid (Hydrocortisoni butyras) 1 mg/g, cream
  • Locoid Crelo (Hydrocortisoni butyras) 1 mg/ml, emulsion
  • Locoid Lipocream (Hydrocortisoni butyras) 1 mg/g, cream
  • Lokren 20 (Betaxololi hydrochloridum) 20 mg; film-coated tablets
  • Losec (Omeprazolum) 20 mg, capsules
  • Pimafucin (Natamycinum) 100 mg, vaginal globules
  • Pimafucin (Natamycinum) 20 mg/g, cream
  • Ubretid (Distigmini bromidum) 5 mg, tablets
  • Unidox Solutab (Doxycycline) 100 mg; tablets for oral suspension
  • Vesanoid (Tretinoinum) 10 mg, capsules soft
  • Visudyne (Verteporfinum) 15 mg, powder for solution for infusion
  • Xenical (Orlistatum) 120 mg, capsules hard

Marketing Authorisation Holder: Zambon S.p.A.

  • Fluimucil Forte (Acetylocysteinum) 600 mg; effervescent tablets
  • Fluimucil Muko (Acetylocysteinum) 200 mg; granules for oral solution
  • Fluimucil Muko Junior (Acetylocysteinum) 100 mg; granules for oral solution

Marketing authorisation holder: ALK-Abelló A/S

  • Acarizax (Standardised allergen extract from the house dust mites), oral lyophilisate
  • Alutard SQ (Allergen from animal sources (Canis Familiaris and Felis Domesticus)), suspension for injection
  • Alutard SQ (Allergen from honey bee and wasp venom), suspension for injection
  • Grazax (Standardised allergen extract of grass pollen from Timothy (Phleum pratense)), oral lyophilisate
  • Jext® (Adrenaline) 150 mcg; 300 mcg, solution for injection
  • Pharmalgen Hymenoptera venoms (Allergen from honey bee and wasp venom), powder and solvent for solution for injection
  • Itulazax (Standardised allergen extract of pollen from white birch (Betula verrucosa)), oral lyophilisate

Marketing authorisation holder: NTC Srl

  • Cusi Erythromycin 0,5% (Erythromycinum) 5 mg/g, ophthalmic ointment

Marketing authorisation holder: Advanz Pharma Corp Ltd

  • Brinavess (Vernakalanti hydrochloridum) 20 mg/ml, concentrate for solution for infusion

Marketing authorisation holder: Piramal Critical Care B.V.

  • Desfluran Piramal (Desfluranum) 100% v/v, inhalation vapour liquid
  • Hypnomidate (Etomidatum) 2 mg/ml, solution for injection
  • Sojourn (Sevofluranum) 100%, solution for inhalation