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02.2013 - PL - nowe rejestracje. Drukuj Email

LUTY 2013


W lutym 2013 r. Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych wydał 85 pozwoleń na dopuszczenie produktów leczniczych do obrotu w Polsce, obejmujących 34 jednostki klasyfikacyjne na 5. poziomie klasyfikacji ATC (substancja czynna/skład). Produkty omówiono na tle wcześniejszych rejestracji i produktów obecnych już na rynku, w ramach poszczególnych klas ATC/WHO oraz substancji czynnej lub składu preparatu, pomijając szczegóły (postaci, dawki, opakowania, kategorie dostępności, numery pozwoleń, urzędowe kody kreskowe), które można znaleźć w internetowym Biuletynie Informacji Publicznej Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych ( ) – Wykaz Produktów Leczniczych, które uzyskały pozwolenie na dopuszczenie do obrotu w lutym 2013, został opublikowany przez Urząd 10 maja 2013.


A – Przewód pokarmowy i metabolizm

A02 – Preparaty stosowane w zaburzeniach związanych z nadkwaśnością;

A02A – Środki zobojętniające kwasy żołądkowe; A02AX – Środki zobojętniające kwasy żołądkowe w innych połączeniach

Calcii carbonas+natrii alginas+natrii hydrogenocarbonas: Gaviscon Duo (Reckitt Benckiser) w postaci zawiesiny jednodawkowej to rozszerzenie w stosunku do wprowadzonych wcześniej preparatów Gaviscon o smaku mięty (Reckitt Benckiser) w postaci zawiesiny jedno- i wielodawkowej oraz Gaviscon o smaku mięty TAB (Reckitt Benckiser) w postaci tabl. do rozgryzania i żucia.

A02B – Leki stosowane w chorobie wrzodowej i refluksie żołądkowo-przełykowym; A02BA – Antagoniści receptora H2

Ranitidinum: Ranitidine Accord Healthcare to 12. zarejestrowana marka ranitydyny, zaś Ranitidine Accord (Accord Healthcare) w postaci tabletek powlekanych to rozszerzenie w stosunku do zarejestrowanych wcześniej tabletek musujących. Na rynek wprowadzono 9 marek: Gastranin Zdrovit (NP Pharma), Raniberl (Berlin-Chemie), Ranic (Sandoz), Ranigast, Ranigast Fast, Ranigast Max i Ranigast Pro (Polpharma), Ranisan (Pro.Med.CS), Ranitydyna Sanofi (Sanofi-Aventis), Riflux (Polfarmex), Solvertyl (ICN Polfa Rzeszów), Zantac (GlaxoSmithKline). Nie pojawiły się jeszcze w sprzedaży preparaty: Ranimax (Teva; preparat zarejestrowany wcześniej pod nazwą Riflux), Ranitidine Accord (Accord Healthcare). Skreślono z Rejestru: Apo-Ranitidine (Apotex), Histac (Ranbaxy), Ranigast forte (Polpharma), Ranitidinum Pliva (Teva Kraków; lek zarejestrowany wcześniej pod nazwą Ranimax), Ranitydyna (Teva Kraków), Ulran (Krka).

A04/A04A – Leki przeciw wymiotom i nudnościom; A04AA – Antagoniści serotoniny (5HT3)

Ondansetronum: Ondatran (Polfa Tarchomin) to 10. zarejestrowany doustny preparat ondansetronu. Do obrotu wprowadzono 6 marek leków doustnych: Atossa (Egis), Emetron (Gedeon Richter), Setronon (Teva), Zofran i Zofran Zydis (GlaxoSmithKline; lek oryginalny), od lutego 2007 OndaLek (Sandoz) i od stycznia 2012 Ondansetron Bluefish (Bluefish Pharmaceuticals). Nie pojawiły się jeszcze na rynku preparaty: Ondansetron-1A Pharma, Ondansetron Arrow (Arrow Poland) i Ondansetron Pfizer (tabl. powlekane zarejestrowano pierwotnie pod nazwą Ondansetron Aurobindo). Ponadto na rynek wprowadzono 7 marek leków dożylnych: Atossa (ICN Polfa Rzeszów), Setronon (Teva Kraków), Zofran (GlaxoSmithKline; lek oryginalny), od sierpnia 2008 Ondansetron Kabi (Fresenius Kabi), od kwietnia 2012 Ondansetron B.Braun (Braun), od września 2012 Ondansetron Claris (Claris Lifesciences) i od lutego 2013 Ondansetron Accord (Accord Healthcare). Do sprzedaży wprowadzono także Zofran w postaci czopków doodbytniczych. Skreślono z Rejestru: Ebesetron (Ebewe; lek zarejestrowany pierwotnie pod nazwą Ondansetron Ebewe, był obecny na rynku od września 2009), Emeset (Cipla), Emetron inj. (Gedeon Richter; lek był obecny na rynku), Ondagen (Generics), OndaLek inj. (Sandoz), OndaHexal (Hexal), Ondansetron-1A (1A Pharma) i Ondansetron Ranbaxy.


C – Układ sercowo-naczyniowy

C09 – Leki działające na układ renina-angiotensyna;

C09A/C09AA – Inhibitory ACE, leki proste

Perindoprilum: Perindopril Teva to 19. zarejestrowana marka peryndoprylu. Na rynek wprowadzono 8 leków: Prestarium (Servier), Prenessa (Krka Polska), od lutego 2009 Vidotin (Gedeon Richter), od marca 2009 Apo-Perindox (Apotex; zarejestrowany wcześniej jako Perindox) w dawkach 4 mg i 8 mg, od kwietnia 2009 Lextril (Glenmark) i Stopress (Polpharma), od kwietnia 2010 Cardipen (Lekam; zarejestrowany wcześniej pod nazwą Presdopril) i od czerwca 2012 Perindopril Pfizer.

Nie pojawiły się jeszcze w sprzedaży: ApoPerindox (Apotex) w dawkach 5 mg i 10 mg, Coverex (Egis), Erbugen (Jenson Pharmaceutical Services), Ikarium i Ikarium forte (Polfarmex), Perindopril Aurobindo, Perindopril Krka, Perindopril Arrow (Arrow Generics), Perindopril Medana (Medana Pharma), Presomyl (Generics), Tensinor (Generics).

Peryndopryl w dawkach 2 mg, 4 mg i 8 mg dostępny jest w połączeniu z tert-butyloaminą, zaś w dawkach 2,5 mg, 5 mg i 10 mg w połączeniu z argininą lub jako tosylan peryndoprylu, przy czym rejestrowane dawki dotyczą tych połączeń, a nie zawartości samego peryndoprylu. Większość zarejestrowanych marek peryndoprylu zawiera jego połączenie z tert-butyloaminą. Połączenie z argininą zawierają 4 marki: ApoPerindox, Presomyl, Prestarium i Prestarium Oro (w dawkach 2,5 mg, 5 mg i 10 mg), Tensinor. Tosylan peryndoprylu jest zawarty w preparacie Perindopril Teva.

Skreślono z Rejestru: Abapter (Pol-Nil), Irpax (Anpharm; lek wprowadzony wcześniej na rynek pod nazwą Peryndopryl Anpharm), Percarnil (Actavis), Perilan (Sandoz), Perindopril BMM Pharma, Perindopril-Ratiopharm (dawka 8 mg zarejestrowana wcześniej przez Krka Polska pod nazwą Perotens), Perindoran (Ranbaxy; lek był obecny na rynku od października 2009), Peryl (ICN Polfa Rzeszów), Prestarium forte (Servier), Pritnox (Galex d.d.) i Rindolex (Galex d.d.).

Ramiprilum: Ramipril Pfizer w dawkach 1,25 mg i 2,5 mg to rozszerzenie względem wprowadzonych wcześniej wyższych dawek tego leku. Zarejestrowano 19 marek ramiprylu. Do obrotu wprowadzono 14 preparatów: Mitrip (123ratio), Piramil (Sandoz), Ramicor (Ranbaxy), Tritace (Sanofi-Aventis; lek oryginalny), od grudnia 2006 Axtil (Adamed), od lutego 2007 Vivace (Actavis), od kwietnia 2007 Polpril (Polpharma), od października 2007 Ramve (Farma-Projekt), od grudnia 2007 Ramistad (Stada), od listopada 2008 Apo-Rami (Apotex), od marca 2009 Ampril (Krka), od października 2010 Ramipril Actavis, od lutego 2012 Ramipril Pfizer i od czerwca 2012 Rami-A (Arrow Poland).

Nie pojawiły się jeszcze w sprzedaży preparaty: Ramigamma (Woerwag), Ramipril +Pharma, Ramipril Aurobindo, Ramipril-Lupin, Ramipril Teva. Skreślono z Rejestru: Ramipril Ozone (Labormed) i Ramipril-Ratiopharm (zarejestrowany pierwotnie przez Galex d.d. jako Ramilex; lek był obecny na rynku od czerwca 2008).

Trandolaprilum: Trandolapril Pizo to 6. zarejestrowana marka trandolaprylu. Do sprzedaży wprowadzono 3 leki: Gopten (Abbott; lek oryginalny), od stycznia 2009 Trandolapril Arrow (Arrow Poland) i od maja 2010 TrandoGen (Generics). Nie pojawiły się jeszcze na rynku preparaty Fezzor (Labormed) i Trandolapril Galex (Galex d.d.). Skreślono z Rejestru: Tensotrand (Actavis; zarejestrowany wcześniej jako Trandolapril Actavis; lek był obecny na rynku od maja 2009), Trandolapril-Ratiopharm (lek był obecny na rynku od października 2007) i Trandox (Apotex).

C09B - Inhibitory ACE, leki złożone; C09BA – Inhibitory ACE i leki moczopędne; C09BA04 – Peryndopryl i leki moczopędne

Perindoprilum+indapamidum: Indix Combi (Teva; zawiera tosylan peryndoprylu) w 2 dawkach (2,5 mg+0,625 mg i 5 mg+1,25 mg) to 15. zarejestrowana marka preparatów o podanym składzie.

Na rynek wprowadzono 4 preparaty zawierające peryndopryl w połączeniu z argininą i indapamid (zastąpiły wcześniejsze preparaty zawierające peryndopryl w połączeniu z erbuminą i indapamid): Noliprel forte (Anpharm) i Tertensif Kombi (Servier), zawierające 5 mg peryndoprylu i 1,25 mg indapamidu oraz Noliprel Bi-Forte (Servier; lek zarejestrowany początkowo pod nazwą Peryndopryl arginine + Indapamid Servier) i Tertensif Bi-Kombi (Anpharm; lek zarejestrowany wcześniej pod nazwą Peryndopryl arginine + Indapamid Anpharm), zawierające 10 mg peryndoprylu i 2,5 mg indapamidu. Od czerwca 2008 wprowadzono także 1 lek zawierający peryndopryl w połączeniu z erbuminą i indapamid: Co-Prenessa (Krka Polska) w 3 dawkach: 2 mg + 0,625 mg, 4 mg + 1,25 mg oraz 8 mg +2,5 mg.

Zarejestrowanych jest także 10 marek leków dotychczas nie wprowadzonych do obrotu: Co-Presomyl (2,5 mg+0,625 mg) i Co-Presomyl Forte (5 mg+1,25 mg; Generics), Co-Tensinor (2,5 mg+0,625 mg) i Co-Tensinor Forte (5 mg+1,25 mg; Generics), Lextril Combo (Glenmark; 2 dawki: 2 mg+0,625 mg i 4 mg+1,25 mg), Noliprel (Servier; 2,5 mg+0,625 mg), Noliterax (Servier; 8 mg+2,5 mg), Panoprist (Sandoz; 2 dawki: 2 mg+0,625 mg i 4 mg+1,25 mg), Perindopril Indapamide Arrow (Arrow Poland; 2 dawki: 2 mg+0,625 mg i 4 mg+1,25 mg), Prenix N (Anpharm; 2,5 mg+0,625 mg), Romapal (Galex d.d.; 2 dawki: 2 mg+0,625 mg i 4 mg+1,25 mg).

Skreślono z Rejestru lub wygasły pozwolenia: Arifon Kombi (Anpharm; 4 mg+1,25 mg), Davapamid (Gedeon Richter Polska; 2 dawki: 2 mg+0,625 mg i 4 mg+1,25 mg), Indix Combi (Ratiopharm; 2 dawki: 2 mg+0,625 mg i 4 mg+1,25 mg; lek zarejestrowany pierwotnie pod nazwą Ratiotensin), Perilexin (Galex d.d.; 2 dawki: 2 mg+0,625 mg i 4 mg+1,25 mg), Peryl Combi (ICN Polfa Rzeszów; 2 dawki: 2 mg+0,625 mg i 4 mg+1,25 mg), Peryndopryl+Indapamid Servier (2 mg+0,625 mg), Prenix (Anpharm; 2 mg+0,625 mg), Prestarium Plus (Servier; 4 mg+1,25 mg), Teraxans (Anpharm; 8 mg+2,5 mg).

C09D – Antagoniści angiotensyny II, leki złożone; C09DA - Antagoniści angiotensyny II i leki moczopędne; C09DA03 – Walsartan i leki moczopędne

Valsartanum+hydrochlorothiazidum: Valsartan HCT Mylan to aktualnie 18. zarejestrowana marka preparatów o podanym składzie. Na rynek wprowadzono 11 leków: Co-Diovan (Novartis), od września 2009 Tensart HCT (Egis), od stycznia 2010 Co-Valsacor (Krka), od maja 2010 Co-Bespres (Teva; wcześniejsza nazwa preparatu: Bespresco), od lipca 2010 Zelvartancombo (Galex d.d.), od sierpnia 2010 Co-Nortivan (Gedeon Richter Polska), od listopada 2010 Valtap HCT (Zentiva), od maja 2011 Axudan HCT (Sandoz), od grudnia 2011 Valsotens HCT (Actavis), od stycznia 2012 Vanatex HCT (Polpharma) i od maja 2012 Valsartan + HCT Arrow (Arrow Poland).

Nie zostały jeszcze wprowadzone do sprzedaży: ApoValsart HCT (Apotex), Valsartan HCT-1A Pharma, Valsartan HCT Bluepharma (Polfarmex), Valsartan HCT Ranbaxy, Valsartan + Hydrochlorothiazide Krka i Valsavil HCT (Stada).

Skreślono z Rejestru: Anartan HCT (Ratiopharm; lek był obecny na rynku od grudnia 2009), Co-Diomef (Mepha), Valsanorm HCT (+Pharma), Valsartan HCT Genericon, Valsartan HCT-Ratiopharm, Valsartan Hydrochlorothiazide Pliva (Teva).

C10 – Leki wpływające na stężenie lipidów; C10A - Leki wpływające na stężenie lipidów, leki proste; C10AA – Inhibitory reduktazy HMG CoA

Atorvastatinum: Calipra (Alkaloid-Int) i Atorvastatin Ranbaxy to odpowiednio 39. i 40. zarejestrowana marka preparatów atorwastatyny, zaś Atorvasterol (Polpharma) w dawce 80 mg to rozszerzenie w stosunku do wprowadzonych wcześniej niższych dawek tego leku. W obrocie pojawiły się 22 leki: Atoris (Krka), Sortis (Pfizer; lek oryginalny), Tulip (Sandoz), od czerwca 2006 Torvacard (Zentiva), od października 2006 Atorvox (Teva), od lutego 2007 Atrox (Biofarm), od stycznia 2008 Torvalipin (Actavis), od marca 2008 Atorvasterol (Polpharma; zarejestrowany wcześniej przez Medis jako Atorvin), od kwietnia 2008 Atractin (PharmaSwiss; zarejestrowany wcześniej przez Medis jako Copastatin), od listopada 2008 Corator (Lekam), od grudnia 2008 Larus (Gedeon Richter Polska; zarejestrowany wcześniej przez Medis jako Atorpharm), od maja 2009 Atorvastatinum Farmacom, od czerwca 2009 Torvazin (Egis), od lipca 2010 Storvas (Ranbaxy), od września 2010 Apo-Atorva (Apotex), od października 2011 Atorgamma (Wörwag), od lutego 2012 Lambrinex (S-Lab), od czerwca 2012 Atorvastatinum 123ratio (lek zarejestrowany pierwotnie pod nazwą Atorvastatin Teva Pharma), od lipca 2012 Atorvastatin Arrow (Arrow Poland), od marca 2013 Ivistatyna (Bioton; lek zarejestrowany pierwotnie pod nazwą Atorvastatin Olinka) i Pharmastatin (Stada) oraz od kwietnia 2013 Atorvastatin Bluefish.

Nie zostały jeszcze wprowadzone preparaty: Actozora (Actavis), Atolinka (Olinka), Atorlip (Sun-Farm), Atorock (Rockspring Healthcare), Atorvagen (Generics), Atorvanorm (+Pharma), Atorvastatin-1A Pharma, Atorvastatin Billev, Atorvastatin Egis, Atorvastatin Stada, Liporion (Orion), Mephator (Mepha), Olinkator (Olinka), Orztiza (Actavis), Statorva (Krka) i Xistatin (Biokanol).

Skreślono z Rejestru: Atorvastatin Miklich, Atorvastatin Pfizer, Atorvastatin-Ratiopharm, Atosener (Sandoz), Euroclast (Sandoz), Gletor (Glenmark), Haepcard (Sandoz), Voredanin (Labormed; lek był obecny na rynku od czerwca 2011), Xavitor (Tabuk Poland; lek zarejestrowany wcześniej przez firmę Medis pod nazwą Copator, był obecny na rynku od grudnia 2009).


G – Układ moczowo-płciowy i hormony płciowe

G03 – Hormony płciowe i środki wpływające na czynność układu płciowego;

G03A - Hormonalne środki antykoncepcyjne działające ogólnie;

G03AA – Progestageny i estrogeny, preparaty jednofazowe;

G03AA09 – Dezogestrel i estrogen

Desogestrelum+ethinylestradiolum: Estmar (Zentiva) to 7. zarejestrowana w tej klasie marka środków o podanym składzie. Do sprzedaży wprowadzono 5 marek: Marvelon (Organon), Mercilon (Organon), Novynette (Gedeon Richter), Regulon (Gedeon Richter) oraz od marca 2012 Ovulastan i Ovulastan forte (Polfa Pabianice). Nie pojawiły się jeszcze na rynku preparaty Dessette i Dessette forte (Sun-Farm). Wszystkie środki zawierają 0,15 mg dezogestrelu, a różnią się dawką etynylestradiolu: 0,02 mg zawierają Dessette, Estmar, Mercilon, Novynette i Ovulastan, a 0,03 mg zawierają Dessette forte, Estmar, Marvelon, Ovulastan forte i Regulon.

G03AA12 – Drospirenon i estrogen

Drospirenonum+ethinylestradiolum: Flexyess (Bayer) to 23. zarejestrowana marka środków antykoncepcyjnych o podanym składzie. Do sprzedaży wprowadzono 10 marek tych środków: Yasmin (Bayer), od stycznia 2007 Yasminelle (Bayer), od grudnia 2008 Yaz (Bayer), od lipca 2010 Asubtela (Temapharm), Midiana (Gedeon Richter Polska) i Naraya (Temapharm), od lutego 2011 Lesine (Teva; preparat w dawkach 3 mg + 0,03 mg zarejestrowany wcześniej przez Leon Farma pod nazwą Drosiol) i Lesinelle (Teva; preparat w dawkach 3 mg + 0,02 mg zarejestrowany wcześniej przez Leon Farma pod nazwą Drosiol), od listopada 2011 Daylette (Gedeon Richter Polska), od sierpnia 2012 Vibin (Polpharma; preparat zarejestrowany początkowo pod nazwą Subtelineight, a następnie Subteliv) i Vibin Mini (Polpharma; preparat zarejestrowany początkowo pod nazwą Narayeight, a następnie Naravela) oraz od listopada 2012 Naraya Plus (Temapharm).

Nie ma jeszcze na rynku preparatów: Aliane (Bayer), Aneea (Gedeon Richter Polska), Belusha (Gedeon Richter Polska), Cortelle (Teva; preparat w dawkach 3 mg + 0,03 mg zarejestrowany wcześniej przez Leon Farma pod nazwą Dronin), Linatera (Bayer; preparat zarejestrowany początkowo pod nazwą Ethinylestradiol/Drospirenon Bayer), Lulina (Ivowen), Palandra (Bayer), Sidretella (Zentiva; środek zarejestrowany pierwotnie przez Leon Farma pod nazwą Pirestrol), Teenia (Gedeon Richter Polska), Varenelle (Teva; preparat w dawkach 3 mg + 0,02 mg zarejestrowany wcześniej przez Leon Farma pod nazwą Dronin), Veyann (Teva).

Wszystkie środki zawierają 3 mg drospirenonu. Różnice dotyczą zawartości estrogenu. Dawkę 0,02 mg etynylestradiolu zawierają: Aliane, Aneea, Belusha (z placebo), Daylette (z placebo), Flexyess, Lesinelle, Linatera, Naraya, Naraya Plus (z placebo), Sidretella 20, Teenia, Varenelle (z placebo), Veyann (z placebo), Vibin Mini (z placebo), Yasminelle i Yaz (z placebo). Dawkę 0,03 mg etynylestradiolu zawierają: Asubtela, Cortelle, Lesine, Lulina, Midiana, Palandra, Sidretella 30, Vibin (z placebo) i Yasmin.

G03F – Progestageny i estrogeny, leki złożone; G03FA - Progestageny i estrogeny, preparaty zawierające stałe dawki; G03FA01 – Noretisteron i estrogen

Norethisteronum+estradiolum: Gynaika (Zentiva) tabl. powlekane 0,5 mg + 1 mg to 6. zarejestrowana marka preparatów o podanym składzie, w tym 4. marka doustna. W sprzedaży dostępne są 3 marki preparatów doustnych - w dawce 0,5 mg noretisteronu i 1 mg estradiolu: Activelle (Novo Nordisk) i od sierpnia 2008 Cliovelle (Dr. Kade); w dawce 1 mg noretisteronu i 2 mg estradiolu: Kliogest (Novo Nordisk). Ponadto dostępne są 3 systemy transdermalne uwalniające 50 mcg estradiolu/24 godz., lecz różniące się dawkami uwalnianego noretisteronu: Estalis 50/140 (Novartis), Systen Conti (Janssen-Cilag) i Estalis 50/250 (Novartis) uwalniają odpowiednio 140 mcg, 170 mcg i 250 mcg noretisteronu/24 godz..

G04 – Leki urologiczne; G04B – Inne leki urologiczne, w tym przeciwskurczowe; G04BE – Leki stosowane w zaburzeniach erekcji

Sildenafilum: Sildenafil Teva w postaci tabletek do rozgryzania i żucia to rozszerzenie względem wprowadzonych wcześniej tabletek powlekanych. Zarejestrowano 34 marki syldenafilu. Na rynek wprowadzono 16 preparatów z opisanym wyżej zastosowaniem: Maxigra (Polpharma), Viagra (Pfizer), od października 2009 Vizarsin (Krka), od lipca 2010 Sildenafil Actavis, od września 2010 Sildenafil Sandoz, od grudnia 2010 Sildenafil Medana (Medana Pharma), od stycznia 2011 Sildenafil Teva, od marca 2011 Falsigra (Polfarmex), od czerwca 2011 Sildenafil Ratiopharm i Vigrande (Zentiva), od sierpnia 2011 Ecriten (Jelfa), od października 2011 Silfeldrem (+Pharma), od grudnia 2011 Sildenafil Apotex, od czerwca 2012 Sildenafil SymPhar (lek zarejestrowany pierwotnie pod nazwą Sildenafil Tecnimede), od października 2012 Lekap (Lekam; lek zarejestrowany pierwotnie pod nazwą Syldenafil Jubilant) i od stycznia 2013 Sildenafil Ranbaxy.

Nie pojawiły się jeszcze w sprzedaży preparaty: Amfidor (Egis), Erasilton (Actavis; lek zarejestrowany pierwotnie przez firmę Sigillata pod nazwą Vilgendra), Fildlata (Sigillata), Rosytona (Actavis), Sildeagil (Sun-Farm), Sildenafil Accord (Accord Healthcare), Sildenafil Ajanta Pharma, Sildenafil Aspen, Sildenafil Axxon, Sildenafil Bluefish, Sildenafil Hasco (Hasco-Lek), Sildenafil Macleods, Sildenafil Mylan, Sildenafil Pfizer, Sildenafil Stada, Sildenafilum Farmacom, Yextor (Tactica Pharmaceuticals).

Skreślono z Rejestru: Sildenafil-1A Pharma, Sildenafil Arrow (Arrow Poland), Sildenafil BMM Pharma.

Do sprzedaży wprowadzono także preparat Revatio (Pfizer). Lek zawiera sildenafil umieszczony przez WHO w klasie G04BE – Leki stosowane w zaburzeniach erekcji, choć według wskazań dla tego preparatu (leczenie pacjentów z nadciśnieniem płucnym sklasyfikowanym według WHO jako klasa II i III - lek stosuje się w celu poprawy zdolności wysiłkowej; wykazano skuteczność działania leku w pierwotnych postaciach nadciśnienia płucnego oraz wtórnych związanych z chorobami tkanki łącznej) bardziej pasowałaby klasa C01EB – Inne leki nasercowe.


J – Leki przeciwzakaźne działające ogólnie

J01 – Leki przeciwbakteryjne działające ogólnie;

J01A/J01AA – Tetracykliny

Lymecyclinum: Damelium (Actavis) to 1. zarejestrowany lek generyczny. Na rynek wprowadzono lek oryginalny Tetralysal (Galderma).

J01C – Beta-laktamowe leki przeciwbakteryjne – penicyliny; J01CR – Złożone preparaty penicylin, w tym z inhibitorami beta-laktamaz;

J01CR02 – Amoksycylina i inhibitor enzymatyczny

Amoxicillinum+acidum clavulanicum: Ramoclav (Ranbaxy) w dawkach 875 mg + 125 mg to rozszerzenie względem niższych dawek tego leku. Zarejestrowano 10 marek leków o podanym składzie. Do sprzedaży wprowadzono 8 preparatów: Amoksiklav (Sandoz), Augmentin (GlaxoSmithKline; lek oryginalny), Curam (1A Pharma), Forcid (Yamanouchi), Ramoclav (Ranbaxy), Taromentin (Polfa Tarchomin), od sierpnia 2007 Amoclan (Hikma Farmaceutica) i od lutego 2013 Recute (Pfizer). Nie pojawiły się jeszcze na rynku: Amoclan BID (Hikma Farmaceutica), Amoxicillin/Clavulanic acid Aurobindo i Co-amoxiclav Bluefish (Bluefish Pharmaceuticals). Skreślono z Rejestru: Claviratio (Ratiopharm), Klavocin (Teva Kraków).

J01CR05 – Piperacylina i inhibitor enzymatyczny

Piperacillinum+tazobactamum: Piperacillin/Tazobactam Noridem to 10. zarejestrowana marka preparatów o podanym składzie. Na rynek wprowadzono 5 leków: Tazocin (Pfizer), od października 2009 Tazacylin (Axxon), od grudnia 2010 Piperacillin/Tazobactam Kabi (Fresenius Kabi) oraz od czerwca 2011 Piperacillin/Tazobactam Actavis i Piperacillin/Tazobactam Teva. Nie pojawiły się jeszcze w sprzedaży preparaty: Piperacillin + Tazobactam Mylan, Piperacillin/Tazobactam Aurobindo, Piperacillin/Tazobactam Milpharm, Piperacillin/Tazobactam Sandoz. Skreślono z Rejestru: Piperato (Midas Pharma), Tazabax (Ranbaxy), Tazopiperatio (Ratiopharm).


L – Leki przeciwnowotworowe i wpływające na układ odpornościowy

L01 – Leki przeciwnowotworowe

L01A – Leki alkilujące; L01AX – Inne leki alkilujące

Imatinibum: Imakrebin (Alvogen), Kinacel (Celon), Imatinib Glenmark, Imatenil (Biofarm) i Nibix (Adamed) to odpowiednio 3., 4., 5., 6. i 7. zarejestrowana marka imatynibu. Na rynek wprowadzono lek oryginalny Glivec (Novartis). Nie pojawił się jeszcze w sprzedaży Imatinib Teva.

L01B – Antymetabolity; L01BC – Analogi pirymidyny

Capecitabinum: Binoda (GlaxoSmithKline), Capecitabine Cipla i Capecitabine Fresenius Kabi to odpowiednio 14., 15. i 16. zarejestrowana marka kapecytabiny. Na rynek wprowadzono lek oryginalny Xeloda (Roche). Nie pojawiły się jeszcze w sprzedaży: Capecitabine Accord, Capecitabine Actavis, Capecitabine Glenmark, Capecitabine Intas, Capecitabine Krka, Capecitabine medac, Capecitabine Polpharma, Capecitabine Teva, Coloxet (Egis), Symloda (SymPhar), Vopecidex (PharmaSwiss) i Xalvobin (Alvogen).


M – Układ mięśniowo-szkieletowy

M01 – Leki przeciwzapalne i przeciwreumatyczne; M01A – Niesterydowe leki przeciwzapalne i przeciwreumatyczne;

M01AE – Pochodne kwasu propionowego

Ibuprofenum: Ibuprofen Fair-Med (Fair-Med Healthcare) to 28. zarejestrowana marka preparatów ibuprofenu, zaś Brufen Forte (Abbott) zawiesina doustna 4% to rozszerzenie względem wprowadzonych wcześniej zawiesiny 2% i tabletek powlekanych.

Z postaci 1‑dawkowych na rynek zostały wprowadzone: Ibum i Ibum Forte (Hasco-Lek), Ibupar i Ibupar Forte (Polfa Pabianice), Ibuprofen-Pabi (Polfa Pabianice), Ibuprofen AFL (Aflofarm), Ibuprofen Polfarmex, Ibufen Total (Polpharma), Ibuprom, Ibuprom Duo i Ibuprom Max (US Pharmacia), Nurofen, Nurofen Express, Nurofen Forte, Nurofen Ultra (zarejestrowany początkowo jako Nurofen Express KAP), Nurofen Ultra Forte, Nurofen Ultrafast i Nurofen dla dzieci czopki (Reckitt Benckiser) oraz wprowadzone od maja 2006 Ibuprom Sprint Caps (US Pharmacia, Wrocław), od lipca 2006 Nurofen Ultra Forte (Reckitt Benckiser), od lutego 2008 Ibuprofen Aflofarm (następnie zmiana nazwy preparatu na Opokan Express, po czym w lutym 2012 zmiana powrotna na Ibuprofen Aflofarm), od października 2008 Ibalgin (Zentiva), Ibalgin Maxi (Zentiva) oraz Nurofen Forte Express (Reckitt Benckiser), od września 2009 Aprofen i Aprofen forte (Polfarmex), od października 2009 Iburion (Orion), od listopada 2009 MIG (Berlin-Chemie), od stycznia 2010 Nurofen Express Tab (Reckitt Benckiser; preparat został wprowadzony we wrześniu 2007 pod nazwą Nurofen Migrenol Forte i w listopadzie 2008 pod nazwą Nurofen Migrenol), od maja 2010 Nurofen na ból pleców (Reckitt Benckiser; preparat został wprowadzony wcześniej pod nazwą Nurofen Menstrual), od grudnia 2010 Spedifen (Zambon), od stycznia 2011 Ibalgin Fast (Zentiva), od marca 2011 Ibufen Junior (Polpharma), od maja 2011 Ibumax (Vitabalans) oraz Ifenin forte (Actavis; lek zarejestrowany wcześniej pod nazwą Ibunin forte), od czerwca 2011 Ibumax forte (Vitabalans), od lipca 2011 Ibuprofen Hasco (Hasco-Lek), od sierpnia 2011 Brufen (Abbott), od lutego 2012 Ibufen Baby czopki (Polpharma), od lipca 2012 Ibuprofen LGO (Laboratorium Galenowe Olsztyn), od listopada 2012 Ifenin (Actavis; lek zarejestrowany wcześniej pod nazwą Ibunin), od grudnia 2012 Kidofen czopki (Aflofarm) i od stycznia 2013 czopki Ibum dla dzieci (Hasco-Lek).

Z postaci wielodawkowych do sprzedaży wprowadzono 9 marek: Ibufen i Ibufen D (Medana Pharma), Ibum o smaku malinowym (Hasco-Lek), Nurofen dla dzieci zawiesina 2% (o smaku pomarańczowym i truskawkowym; Reckitt Benckiser), od marca 2009 Kidofen (Aflofarm), od sierpnia 2009 Bufenik 2% i 4% (Ratiopharm; preparat zarejestrowany wcześniej jako Ibusir), od maja 2010 Ibalgin Baby (Zentiva), od lipca 2010 Nurofen dla dzieci Forte zawiesina 4% (Reckitt Benckiser), od czerwca 2011 Ibufen dla dzieci forte zawiesina 4% (Polpharma), od sierpnia 2011 Nurofen dla dzieci Junior pomarańczowy (Reckitt Benckiser; wcześniejsza nazwa: Nurofen dla dzieci 4% pomarańczowy) i Nurofen dla dzieci Junior truskawkowy (Reckitt Benckiser; wcześniejsza nazwa: Nurofen dla dzieci 4% truskawkowy), od października 2011 Milifen (Pinewood), od lutego 2012 Ibum zawiesina o smaku bananowym (Hasco-Lek), od marca 2012 MIG dla dzieci zawiesina (Berlin-Chemie), od sierpnia 2012 Brufen zawiesina 2% (Abbott) i od września 2012 Ibum forte zawiesina (Hasco-Lek).

Nie zostały jeszcze wprowadzone na rynek: Brufen retard (Abbott), Buscofem (Boehringer Ingelheim), Ibuprofen Actavis (Actavis; lek zarejestrowany wcześniej pod nazwą Ibuprofen Alchemia), Ibuprofen Banner, Ibuprofen Forte Hasco (Hasco-Lek), Ibuprofen Lysine Perrigo (Wrafton), Irfen (Mepha), Nurofen Ultra Forte do rozpuszczania i Nurofen Ultra Forte rozpuszczalny (oba: Reckitt Benckiser).

Skreślono z Rejestru: Ibuprofen Banner Pharmacaps, Nurofen Topss (Reckitt Benckiser), Pabi-Ibuprofen tabl. powl. 400 mg (Polfa Pabianice) i Solpaflex (GlaxoSmithKline).

M01AX – Inne niesterydowe leki przeciwzapalne i przeciwreumatyczne

Glucosaminum: Proenzi (Walmark) to aktualnie 7. zarejestrowany doustny lek zawierający glukozaminę. W sprzedaży pojawiły się 4 produkty lecznicze: Arthryl (Rottapharm), od września 2006 Glukozamina Pharma Nord, od maja 2009 Flexove (Expanscience; lek zarejestrowany wcześniej przez firmę Navamedic pod nazwą Glucomed) i od kwietnia 2010 Actistav (Biofarm; preparat zarejestrowany wcześniej jako Biozamina), natomiast nie zostały jeszcze wprowadzone: Chondrostad (Stada) i Slideflex (Blue Bio Pharmaceuticals; preparat zarejestrowany początkowo pod nazwą Dolenio). Z Rejestru skreślono: Gool (Medagro; preparat zarejestrowany wcześniej pod nazwą Artraxin), Stavaktiv Elastik (US Pharmacia), Voltaflex Glucosamine (Novartis).

Na rynku znalazło się także co najmniej 40 preparatów z glukozaminą w różnych (nieraz wysokich) dawkach (i drugie tyle preparatów złożonych zawierających glukozaminę), wprowadzonych jako produkty spożywcze – suplementy diety: ActivePharm Glukozamina Ochrona Stawów (Active Pharm), Apteczka Domowa Giętkie Stawy Glukozamina (Bio Medica), Arthro Balans (Vitabalans), Arthron Flex (Unipharm), Arthrostop Classic (Walmark), Arthrozamina Polfa-Łódź, Artresan 1 a Day (ASA), Artretcaps Glukozamina (Herbapol Kraków), Artreum (Puritan’s Pride), Artro-Vital Jedyny (Olfarm), Bio-Active Glukozamina (Bio-Active), Bio-Glukozamina (Pharma Nord), Eld Glukozamina (Tech-Food), Flexodon (Medicom), Glucosamin i Glucosamin Forte (Vitalas), Glucosamine ‘1000’ i Glucosamine Sulfate (Now Foods), Glucosamine Sulfate (Biotech), Glukozamina (Apteka Medyczna), Glukozamina (Chemman), Glukozamina (Domowa Apteczka), Glukozamina 500 Farm (Invent Farm), Glukozamina 500 mg (Ozone), Glukozamina 1000mg (Power Health), Glukozamina 1000 mg (Solgar), Glukozamina Complex (Kabco), Glukozamina Gal, Glukozamina Ozone, Glukozamina Redflex (Avec), Na Stawy (Kwiaty Polskie Marketing), Ortholan (ICMC), Pharma Zdrowia Glukozamina 900 (Pharm Service), Reumatrix (Scanomedica), Royal Plus Glukozamina (Danfarma), Stavomax (GlaxoSmithKline, Poznań), Stawolux (ICN Polfa Rzeszów), SupHerb Glucosamine (SupHerb), Vita Care Glukozamina (Jemo-Pharm), Vitana Artromax (Vitapol-Farm), Zdrovit Glukozamina (NP Pharma).

M05 – Leki stosowane w chorobach kości; M05B – Leki wpływające na strukturę i mineralizację kości; M05BA - Bifosfoniany

Acidum zoledronicum: Zoledronic acid Zentiva to 21. zarejestrowany lek z kwasem zoledronowym. Na rynek wprowadzono 4 leki: Zometa (Novartis Europharm), od września 2012 Zomikos (Vipharm) i od lutego 2013 Zoledronic acid Teva wskazane w zapobieganiu powikłaniom kostnym oraz w leczeniu hiperkalcemii wywołanej chorobą nowotworową, a także Aclasta (Novartis Europharm) stosowany w osteoporozie.

Nie pojawiły się jeszcze na rynku preparaty: Desinobon (Alvogen), Fayton (Glenmark), Osporil (Egis), Symdronic (SymPhar), Zolacitor (Chiesi), Zolako (Vipharm), Zoledronic acid Actavis, Zoledronic acid Fresenius Kabi, Zoledronic acid Hospira, Zoledronic acid Medac, Zoledronic acid Mylan, Zoledronic acid Polpharma, Zoledronic acid Sandoz, Zoledronic acid Zentiva, Zoledronic Fair-Med o wskazaniach odpowiadających lekowi Zometa oraz Symblasta (SymPhar), Zoledronic acid Hospira, Zoledronic acid Sandoz, Zoledronic acid Teva Pharma i Zoledronic acid Zentiva o wskazaniach odpowiadających lekowi Aclasta.


N – Układ nerwowy

N02 – Leki przeciwbólowe;

N02A – Opioidy; N02AX – Inne opioidy

Tramadolum: Tramadol Aurobindo kaps. to aktualnie 9. zarejestrowana marka preparatów tramadolu.

Spośród zarejestrowanych doustnych preparatów jednodawkowych o standardowym uwalnianiu na rynek wprowadzono 3 leki: Poltram (Polpharma), Tramadol Synteza i Tramal (Grünenthal), natomiast nie wprowadzono jeszcze preparatów Noax (CSC Pharmaceuticals Handels) w postaci tabletek ulegających rozpadowi w jamie ustnej i Tramadol Vitabalans tabl..

Do sprzedaży wprowadzono 5 leków o przedłużonym uwalnianiu: Poltram Retard (Polpharma), Tramal Retard (Grünenthal), Tramundin (Norpharma), od czerwca 2007 Adamon SR (Meda) i Noax Uno (CSC Pharmaceuticals Handels) oraz od grudnia 2008 Oratram (Molteni).

Spośród zarejestrowanych doustnych preparatów wielodawkowych (krople) na rynek wprowadzono 3 leki: Poltram (Polpharma), Tramadol Synteza i Tramal (Grünenthal).

Spośród zarejestrowanych preparatów doodbytniczych (czopki) na rynek wprowadzono 1 lek: Tramal (Grünenthal).

Spośród zarejestrowanych preparatów iniekcyjnych na rynek wprowadzono 2 leki: Poltram (Polpharma) i Tramal (Grünenthal).

Skreślono z Rejestru: Ethypharm Tramadol (Ethypharm), Poltram Rapid (Polpharma), Tralgit (Zentiva), TramaLek (1A Pharma), Tramadol czopki (GlaxoSmithKline, Poznań), Tramadol kaps. (Gedeon Richter Polska), Tramadol kaps. (Teva Kutno), Tramadol inj. (Teva Kraków), Tramadol-1A Pharma (wprowadzony wcześniej na rynek przez Sandoz pod nazwą TramaHexal ID), Tramadol HCl P.S.S. Pharma retard (P.S.S. Pharma), Tramadol Retard (Lannacher), Tramadol-Stada, TramaHexal tabl. musujące i iniekcje (Sandoz; lek był obecny na rynku), TramaHexal krople (1A Pharma; w grudniu 2007 zmiana nazwy na Tramadol-1A Pharma), Tramal PR (Grünenthal; lek zarejestrowany pierwotnie pod nazwą Tramium), Tramcod (Polfa Warszawa), Travictol (Actavis; lek obecny na rynku od lutego 2008).

N02B – Inne leki przeciwbólowe i przeciwgorączkowe;

N02BE – Anilidy

Paracetamolum: Paracetamol Polpharma w postaci iniekcyjnej to 40. zarejestrowana marka paracetamolu. Na rynek wprowadzono 28 marek o różnych drogach podania (doustnie, doodbytniczo i w iniekcjach), jednodawkowych i wielodawkowych: Acenol i Acenol forte (Galena), Apap oraz od sierpnia 2012 Apap Direct i Apap Junior (US Pharmacia), Calpol (McNeil), Codipar (Medagro), Efferalgan i Efferalgan forte (Bristol-Myers Squibb), Etoran (Polpharma), Gemipar (Gemi), Grippostad (Stada), Paracetamol Aflofarm czopki (lek wprowadzony wcześniej jako Paracetamol przez firmę Farmjug, następnie jako Paracetamol Aflofarm, potem Malupar, a obecnie znów jako Paracetamol Aflofarm), tabletki i zawiesina, Panadol, Panadol dla dzieci, Panadol Max (lek wprowadzony na rynek od kwietnia 2010 pod wcześniejszą nazwą Panadol Strong) i Panadol Rapid (GlaxoSmithKline), Paracetamol Rubital (Gemi), Perfalgan inj. (Bristol-Myers Squibb), preparaty o nazwie międzynarodowej Paracetamol wytwarzane przez wielu producentów (Biofarm, Farmina, Filofarm, Galena, Hasco-Lek, Herbapol Wrocław, Marcmed, Polfa-Łódź, Polfarmex) oraz od czerwca 2011 Pedicetamol (Sequoia; preparat zarejestrowany wcześniej przez firmę Ionfarma pod nazwą Apiredol), od października 2011 Paracetamol Actavis (iniekcje), od stycznia 2012 Paracetamol Kabi (Fresenius Kabi) roztwór do infuzji, od marca 2012 Paracetamol LGO (Laboratorium Galenowe Olsztyn) tabletki i Paracetamol Panpharma (Panmedica) roztwór do infuzji, od sierpnia 2012 Paracetamol 123ratio, od stycznia 2013 iniekcje do wlewów Paracetamol B. Braun i od lutego 2013 Paracetamol Actavis tabl. powlekane.

Nie pojawiły się dotychczas w sprzedaży: Apap Direct Max (US Pharmacia), Bolopax (NP Pharma), Panadol Menthol Active (GlaxoSmithKline), Paracetamol Accord (Accord Healthcare) tabletki musujące, Paracetamol Actavis tabl. (lek zarejestrowany pierwotnie pod nazwą Paracetamol Sigillata), Paracetamol APC (APC Instytut), Paracetamol Hospira inj. (lek zarejestrowany pierwotnie przez firmę Combino Pharm pod nazwą Paracetamol Vancombex), Paracetamol Life (Galpharm Healthcare; lek zarejestrowany pierwotnie pod nazwą Galpamol), Paracetamol Sandoz inj., Paracetamol Teva inj., Paralen Sus (Zentiva), Paramax Rapid (Vitabalans), Tespamol (Galpharm Healthcare), Theraflu Grip Owoce Leśne i Theraflu Grip Miód i Cytryna (Novartis).

Skreślono z Rejestru syropy Paracetamol o smaku malinowym i o smaku truskawkowym (Unia), Apap zawiesina (US Pharmacia, Wrocław), Plicet syrop (Teva Kraków), Amipar (Amilek), Benuron (Bene), Efferalgan Odis (Bristol-Myers Squibb), Hascopar (Hasco-Lek), Paracetamol (Ozone), Paracetamol (Polpharma), Paracetamol Accord (Accord Healthcare), Tazamol (Polfa Tarchomin).

N02BE51 – Paracetamol, preparaty złożone z wyłączeniem leków psychotropowych

Paracetamolum+phenylephrinum: APAP Przeziębienie Caps (US Pharmacia) to 3. zarejestrowana marka leku o podanym składzie. Do sprzedaży wprowadzono Theraflu Zatoki (Novartis). Nie pojawił się jeszcze na rynku preparat GeloPromt (Pohl-Boskamp).

N03/N03A – Leki przeciwpadaczkowe; N03AX – Inne leki przeciwpadaczkowe

Levetiracetamum: Levetiracetam Sanovel to 46. zarejestrowana marka lewetyracetamu. Na rynek wprowadzono 13 marek: Keppra (UCB; lek oryginalny), od października 2011 Levetiracetam Teva, od marca 2012 Levetiracetam Actavis, od kwietnia 2012 Vetira (Adamed), od maja 2012 Trund (Glenmark), od czerwca 2012 Levetiracetam GSK (GlaxoSmithKline), od sierpnia 2012 Cezarius (Hasco-Lek), od listopada 2012 Eliptus (Biofarm), Levetiracetam Actavis Group (Actavis) i Levetiracetam Apotex, od stycznia 2013 Symetra (SymPhar), od lutego 2013 Levetiracetam Zdrovit (Natur Produkt Zdrovit) i od kwietnia 2013 Levetiracetam PharmaSwiss.

Nie pojawiły się jeszcze w sprzedaży preparaty: Altein (+Pharma), Dretacen (Sandoz), Epiletam (Egis), Eprilexan (Pharmaselect), Etibral (Polfa Warszawa), Kapidokor (Vipharm), Levebon (G.L. Pharma), Levelanz (Abbott), Levelept (Sun-Farm), Levetiracetam Accord (Accord Healthcare), Levetiracetam Arrow, Levetiracetam Astron (Astron Research), Levetiracetam Aurobindo, Levetiracetam Bluefish, Levetiracetam FGX (FirstGenerixInternational), Levetiracetam Lupin (Generics), Levetiracetam Mylan, Levetiracetam Orion, Levetiracetam Pfizer, Levetiracetam Ranbaxy, Levetiracetam Ratiopharm, Levetiracetam Stada, Levetiracetam Sun inj. (Sun Pharmaceuticals Industries Europe), Levetiragamma (Wörwag), Lewetyracetam Ewopharma (Pro.Med.CS), Lewetyracetam-Neuraxpharm, Matever (Pharmathen), Noepix (Actavis), Normeg (Zentiva), Polkepral (Polfa Tarchomin), Pterocyn (SVUS Pharma) i Zelta (Axxon).

N04 – Leki przeciw chorobie Parkinsona; N04B – Leki dopaminergiczne; N04BC – Agoniści dopaminy

Ropinirolum: Ceurolex SR (Orion) to 21. zarejestrowana marka ropinirolu. Na rynek wprowadzono 10 marek: lek oryginalny Requip i Requip-Modutab o przedłużonym uwalnianiu (GlaxoSmithKline), od czerwca 2008 Adartrel (GlaxoSmithKline), od stycznia 2010 Aropilo (Vipharm), od sierpnia 2010 Parnirol (Glenmark), od listopada 2010 Aropix (Temapharm) i Ceuronex (Orion), od sierpnia 2011 Rolpryna SR (Krka), od stycznia 2013 Nironovo SR (Adamed) i Repirol SR (PharmaSwiss) oraz od kwietnia 2013 Ropodrin (Egis). Nie pojawiły się jeszcze w sprzedaży preparaty: Aparxon PR (Teva), Elozrol (Vipharm), Nironovo (Blau Farma Group), Polpix SR (Polpharma), Raponer (Actavis), Ropinirole Accord (Accord Healthcare), Ropinirole Aurobindo, Ropinstad (Stada), Skonnerop (Sigillata), Valzorol (Sigillata). Skreślono z Rejestru: Aparxon (Teva), Contexine (Ranbaxy), Lirona (Teva), Ropinir (Axxon), Ropinirole Arrow (Arrow Poland), Ropitor (Torrent Pharma).

N05 – Leki psychotropowe; N05C – Leki nasenne i uspokajające; N05CD – Pochodne benzodiazepiny

Midazolamum: Midazolam Sandoz w 2 dawkach iniekcyjnych to aktualnie 6. zarejestrowany preparat do wstrzyknięć z midazolamem. Na rynku pojawiły się 4 leki: Midanium (Polfa Warszawa), Midazolam Chiesi (lek wprowadzony początkowo pod nazwą Midazolam Torrex), Sopodorm (ICN Polfa Rzeszów) i od listopada 2010 Midazolam Accord (Accord Healthcare). Lek oryginalny Dormicum (Roche) dostępny jest w postaci doustnej. Nie został jeszcze wprowadzony do sprzedaży Midazolam Accord (Accord Healthcare). Skreślono z Rejestru: Dormicum inj. (Roche), Fulsed (Ranbaxy), Midazolam-MIP (MIP Pharma Polska).

N06 – Psychoanaleptyki; N06A – Leki przeciwdepresyjne;

N06AB – Selektywne inhibitory zwrotnego wychwytu serotoniny

Sertralinum: Sertraline Bluefish to aktualnie 16. zarejestrowana marka sertraliny. Na rynek wprowadzono 13 leków: Asentra (Krka), Asertin (Biofarm), Sertralinum 123ratio (rejestracja V 2007 jako SerTeva, III 2008 zmiana nazwy na Apresia, XII 2008 wprowadzenie na rynek; IX 2009 zmiana nazwy na Luxeta; XI 2011 zmiana nazwy na Sertralinum 123ratio), Stimuloton (Egis), Zoloft (Pfizer; lek oryginalny), Zotral (Polpharma), od lipca 2006 Setaloft (Actavis), od października 2007 Sertagen (Generics), od września 2008 Sertraline Arrow (Arrow Poland), od marca 2009 Sertraline Aurobindo, od października 2010 Sertranorm (+Pharma; lek zarejestrowany wcześniej przez firmę Actavis jako Sertralin Actavis), od kwietnia 2011 Miravil (Orion) i od marca 2013 Sertralina Krka. Nie zostały jeszcze wprowadzone do sprzedaży: Restaline (Farmalider) i Zortral Pro (J&P Pharma).

Skreślono z Rejestru: Antideprimal (Jelfa), Exazol (Expharm), Sertiva (Sandoz), Sertraline-1A Pharma (1A Pharma; preparat wprowadzony uprzednio na rynek pod nazwą SertaHexal), Sertraline Pliva (Teva Kraków; preparat wprowadzony wcześniej na rynek pod nazwą Luxeta), Setaratio (Ratiopharm; lek był obecny na rynku od lipca 2006) i Tralix (Sanofi-Synthelabo, Rzeszów).

N06AX – Inne leki przeciwdepresyjne

Venlafaxinum: Venlafaxine Mylan to 25. zarejestrowana marka wenlafaksyny. Do obrotu wprowadzono 14 marek: Efectin ER (Pfizer), Velafax i od września 2007 Velafax XL (Farmacom), od grudnia 2006 Venlectine kaps. o przedłużonym uwalnianiu (ICN Polfa Rzeszów), od października 2007 Alventa (Krka), od listopada 2007 Velaxin ER (Egis), od października 2008 Axyven (Axxon; po zmianie nazwy i podmiotu odpowiedzialnego z Venlafaxine Liconsa), od maja 2009 Lafactin (Apotex), od września 2009 Prefaxine (Polpharma), od listopada 2009 Faxolet ER (Polfa Pabianice), od grudnia 2009 Faxigen XL (Generics), od lutego 2010 Venlabax MR (Ranbaxy), od kwietnia 2010 Efevelon SR (Actavis), od lutego 2011 Venlafaxine Bluefish XL (Bluefish Pharmaceuticals) i od kwietnia 2011 Oriven (Orion).

Nie pojawiły się jeszcze na rynku preparaty: Afaxine (PharOS), Depretaxer (Sopharma), Efexiva (Sandoz; lek zarejestrowany wcześniej pod nazwą Venlafaxin Sandoz), Jarvis (Gedeon Richter), Paxifar ER (Biofarm), Tavex (Krka), Tifaxin PR (Stada), Tonpular PR (Wockhardt), Venlagamma (Wörwag) i Zaredrop (ITF Pharma).

Skreślono z Rejestru: Lanvexin (G.L. Pharma; lek zarejestrowany wcześniej pod nazwą Venlafaxine Gerot), Nopekar (Labormed; wcześniejsza nazwa: Estaq), Symfaxin ER (SymPhar; lek był na rynku od sierpnia 2007), Velahibin (Actavis), Velaxiran MR (Ranbaxy), Venlafaxine Arrow (Arrow Poland), Venlafaxin-Ratiopharm PR, Venlafaxinum XL Farmacom, Venlax XL (Celon Pharma), Venlectine tabl. o standardowym uwalnianiu (ICN Polfa Rzeszów), Xaveksin ER (Tabuk Poland).

N07 – Inne leki działające na układ nerwowy; N07B – Leki stosowane w uzależnieniach; N07BA – Leki stosowane w uzależnieniu od nikotyny

Nicotinum: Nico Fruit i Nico Mint (Apotex) w postaci gumy do żucia to 5. zarejestrowana marka preparatów z nikotyną. Na rynek wprowadzono następujące produkty:

- Nicorette (McNeil) w postaci gumy do żucia (4 smaki: Classic, FreshFruit, FreshMint i Icy White), tabletek do ssania Nicorette Freshdrops i od września 2012 Nicorette Coolmint, systemu transdermalnego (od września 2009 Nicorette Invisipatch – preparat był dostępny od grudnia 2008 pod nazwą Nicorette Semi Transparent Patch; zmiana nazwy nastąpiła w lutym 2009) i inhalatora (Nicorette Inhaler);

- Niquitin (GlaxoSmithKline) w postaci pastylek do ssania, systemu transdermalnego (Niquitin i Niquitin Przezroczysty) oraz tabletek do ssania Niquitin Mini;

- Nicopass (Pierre Fabre Medicament) w postaci pastylek do ssania 1,5 mg o 2 smakach.

Nie zostały jeszcze wprowadzone preparaty: Nico-Loz (Actavis) w postaci miękkich pastylek w 2 dawkach i 3 smakach (Citrus, Spearmint i Toffee), Nicopass (Pierre Fabre Medicament) w postaci pastylek do ssania 2,5 mg o 2 smakach oraz Niquitin miętowe listki (GlaxoSmithKline) w postaci lamelek rozpadających się w jamie ustnej.

Skreślono z Rejestru: Nicorette Microtab Lemon (McNeil) w postaci tabl. podjęzykowych, Nicotinell (Novartis) w postaci gumy do żucia i systemu transdermalnego (Nicotinell TTS) oraz system transdermalny Nicopatch (Pierre Fabre Medicament).

Ponadto na rynek wprowadzono kosmetyk Nicofix w postaci żelu do wcierania do rąk dla palaczy, zawierający wyciągi z liścia tytoniu szlachetnego i liścia aloesu.


R – Układ oddechowy

R01 – Preparaty stosowane w chorobach nosa; R01A – Środki udrażniające nos i inne preparaty stosowane miejscowo do nosa;

R01AD - Kortykosteroidy

Mometasoni furoas: Mometazonu furoinian Cipla to 3. zarejestrowana w tej klasie marka mometazonu. Do sprzedaży wprowadzono Nasonex (Merck Sharp & Dohme) i od lutego 2013 Nasometin (Sandoz).

R05 – Leki stosowane w kaszlu i przeziębieniach; R05X – Różne preparaty na przeziębienie

Guaifenesinum+paracetamolum+phenylephrinum: Gripex Pro (US Pharmacia) to 5. zarejestrowana marka preparatów o podanym składzie. Na rynek wprowadzono od czerwca 2012 Vicks SymptoMed Complete cytrynowy (Wick). Nie pojawiły się jeszcze w sprzedaży: Coldrex Pocket (GlaxoSmithKline), Paracetamol + Guaifenesin + Phenylephrine Hydrochloride Perrigo (Wrafton) i Vicks TriActin Complete cytrynowy (Wick).


V – Preparaty różne

V03/V03A – Inne środki stosowane w lecznictwie; V03AE – Leki stosowane w hiperkalemii i hiperfosfatemii

Lanthanum carbonicum: Fosrenol (Shire) w postaci proszku doustnego to rozszerzenie względem wprowadzonych wcześniej tabletek do żucia. Fosrenol to jedyny zarejestrowany lek z węglanem lantanu, dostępny na rynku od października 2006. Na rynku znajdują się także inne leki z tej samej klasy ATC, ale o innym składzie: Calcium Resonium (Sanofi-Synthelabo) i Resonium A (Sanofi-Synthelabo) zawierają siarczan polistyrenu, a substancją czynną preparatów Renagel (Genzyme) i Renvela (Genzyme) jest sewelamer.

V09Radiofarmaceutyki diagnostyczne; V09E – Układ oddechowy; V09EBPreparaty do wstrzyknięć zawierające technet (99mTc)

Technetium [99mTc] macrosalb: Technescan LyoMAA to 2. zarejestrowany zestaw do sporządzania radiofarmaceutyku zawierający makroagregaty ludzkiej albuminy. Wcześniej zarejestrowano Maasol (GE Healthcare).




Opracowanie: dr n. farm. Jarosław Filipek

Kierownik Działu Informacji o Produktach

Administrator Farmaceutycznej Bazy Danych BAZYL

IMS Poland


Krajowa Baza Produktów Ochrony Zdrowia (KBPOZ)



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