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mapa strony: Start. arrow Nowe rejestracje arrow 07.2013 - PL - nowe rejestracje.


 


07.2013 - PL - nowe rejestracje. Drukuj Email

NOWE REJESTRACJE - PL

LIPIEC 2013

 

W lipcu 2013 r. Prezes Urzędu Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych wydał 70 pozwoleń na dopuszczenie produktów leczniczych do obrotu w Polsce, w tym 69 pozwoleń dla nowych produktów leczniczych i 1 nowe pozwolenie dla leku już wcześniej zarejestrowanego (Implanon NXT - Organon), który został pominięty w niniejszym zestawieniu, obejmującym 38 jednostek klasyfikacyjnych 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 (http://bip.urpl.gov.pl/produkty-lecznicze ) – „Wykaz Produktów Leczniczych, które uzyskały pozwolenie na dopuszczenie do obrotu w lipcu 2013 r.” został opublikowany przez Urząd 13 sierpnia 2013.

 

A – Przewód pokarmowy i metabolizm

A01/A01A – Preparaty stomatologiczne; A01AD – Inne środki do stosowania miejscowego w jamie ustnej

Benzydaminum: Hascosept Forte (Hasco-Lek) aerozol 0,3% to rozszerzenie względem wprowadzonego wcześniej aerozolu i płynu Hascosept oraz zarejestrowanego aerozolu Hascosept Dental. Zarejestrowane są 4 marki benzydaminy. Na rynek wprowadzono 4 marki: Hascosept (Hasco-Lek), Septolux (ICN Polfa Rzeszów), Tantum (Angelini) i Uniben (Unia). W sprzedaży pojawiły się aerozole w dawce 0,15% Hascosept, Tantum Verde, od grudnia 2006 Septolux i od maja 2011 Uniben, aerozol w dawce 0,3% Tantum Verde Forte, płyny 0,15% Hascosept i Tantum Verde, a także pastylki do ssania Tantum Verde smak miętowy (wprowadzone na rynek pod wcześniejszą nazwą Tantum Verde P), tabl. do ssania Septolux, pastylki Tantum Verde smak cytrynowy (wprowadzone na rynek od grudnia 2008 pod nazwą Tantum Lemon) i od czerwca 2012 pastylki Tantum Verde smak miodowo-pomarańczowy. Preparaty z benzydaminą w postaci płynu 0,15% mają głównie wskazania stomatologiczne. Nie pojawiły się jeszcze na rynku preparaty: Hascosept Dental (Hasco-Lek) i Tantum Verde smak eukaliptusowy (Angelini).

Uwaga: preparaty benzydaminy w postaci aerozoli oraz pastylek/tabl. do ssania stosowane są zwykle w nieprzewidzianej przez WHO dla benzydaminy klasie: R02/R02A – Preparaty stosowane w chorobach gardła; R02AA – Antyseptyki.

A06/A06A – Środki przeczyszczające; A06AB – Środki przeczyszczające drażniące; A06AB58 – Pikosiarczan sodu w połączeniach

Natrii picosulfas+magnesii oxidum+acidum citricum: CitraFleet (Casen-Fleet) to 1. zarejestrowany lek o podanym składzie. Preparat jest wskazany do stosowania w celu oczyszczenia jelit przed przeprowadzeniem jakichkolwiek badań lub zabiegów diagnostycznych wymagających oczyszczonych jelit, np. kolonoskopia lub obrazowanie radiograficzne. Substancjami czynnymi są pikosiarczan sodu, środek przeczyszczający działający miejscowo w okrężnicy oraz cytrynian magnezu, który działa poprzez wywoływanie biegunki osmotycznej, zatrzymując wodę w okrężnicy. Działanie to wywiera silny ‘efekt wypłukujący’ połączony ze stymulacją ruchów perystaltycznych, co ma na celu oczyszczenie jelit przed badaniem radiograficznym, kolonoskopią lub zabiegami chirurgicznymi. Nie należy stosować produktu CitraFleet jako środka przeczyszczającego codziennego użycia.

C – Układ sercowo-naczyniowy

C01 – Leki stosowane w chorobach serca; C01A – Glikozydy nasercowe; C01AA – Glikozydy naparstnicy

Digoxinum: Digoxin Sopharma inj. to 3. zarejestrowana marka preparatów digoksyny. Do sprzedaży wprowadzono 2 marki: Digoxin Teva tabl. i Digoxin WZF tabl. i iniekcje (Polfa Warszawa).

C04/C04A – Leki rozszerzające naczynia obwodowe; C04AE – Alkaloidy sporyszu

Codergocrini mesilas = ergoloidi mesilas: DHX Filofarm to 1. rejestracja preparatu kodergokryny. Lek wskazany jest do stosowania w zaburzeniach sprawności mózgu związanych z wiekiem oraz niewydolnością krążenia mózgowego, a także w celu zapobiegania napadom migreny. Produkt leczniczy jest przeznaczony dla pacjentów w wieku powyżej 18 lat.

Kodergokryna jest mieszaniną trzech uwodornionych alkaloidów sporyszu, zawiera: od 30% do 35 % dihydroergokorniny, od 30% do 35% dihydroergokrystyny, od 20% do 25 % alfa-dihydroergokryptyny i od 10% do 13 % beta-dihydroergokryptyny. Kodergokryna działa rozszerzająco na większość naczyń mózgowych, poprawiając ukrwienie mózgowia i szybkość przepływu krwi przez mózgowie. Dihydroergokrystyna, jeden ze składników kodergokryny, posiada zarówno agonistyczną, jak i antagonistyczną komponentę w działaniu na receptory dopaminergiczne i adrenergiczne, jest również niekompetycyjnym antagonistą receptorów serotoninowych. Dihydroergokrystyna hamuje procesy beztlenowej glikolizy, zwiększa przepływ krwi przez naczynia mózgowe i zużycie tlenu przez mózg oraz poziom zredukowanego glutationu. Kodergokryna polepsza ukrwienie w niewydolności krążenia mózgowego, przez co zapobiega powikłaniom i występowaniu objawów niedokrwienia. W wyniku hamowania receptorów alfa-adrenergicznych, kodergokryna może łagodzić podrażnienie splotu współczulnego okołotętniczego lub nawet ucisk samej tętnicy kręgowej, co w konsekwencji może prowadzić do ustąpienia zaburzeń ukrwienia. Kodergokryna jest nieselektywnym antagonistą receptorów alfa-adrenergicznych, działa rozszerzająco na naczynia brzuszne i większość naczyń mózgowych oraz wykazuje słabe działanie rozkurczowe na obwodowe naczynia krwionośne, powoduje niewielkie obniżenie ciśnienia krwi i zwalnia częstość skurczów serca. Kodergokryna zmniejsza stężenie kwasu wanilino-migdałowego (HVA), nie ma wpływu na stężenie kwasu hydroksyindolooctowego (5-HIAA). Kliniczne działanie kodergokryny może być zależne od jej dopaminergicznej aktywności, związanej z hamowaniem metabolizmu dopaminy.

C05 – Leki ochraniające naczynia; C05C – Środki przywracające elastyczność naczyń włosowatych; C05CA – Bioflawonoidy

Diosminum: Diosminex Max (PharmaSwiss) w dawce 1000 mg to rozszerzenie w stosunku do wprowadzonego wcześniej preparatu Diosminex (Lekam) w dawce 500 mg. Zarejestrowano 9 marek produktów leczniczych z diosminą. Na rynek wprowadzono 8 marek: Diosminex (Lekam), Otrex (Stragen), Pelethrocin (Help), Phlebodia (Innothera), od czerwca 2009 Aflavic (Polfarmex), od lutego 2010 Dih (Hasco-Lek), od lipca 2010 Diohespan forte (Aflofarm) i Procto-Hemolan Control (Aflofarm), od marca 2011 Diohespan Max (Aflofarm) i od stycznia 2013 Dih Max (Aflofarm). Nie pojawił się jeszcze na rynku preparat Diosminum Aflofarm (wcześniejsza nazwa: Diohespan). Do obrotu wprowadzono także także suplementy diety zawierające diosminę: Dios (Espefa), Diosan (Sepharma), Diosmina Hasco (Hasco-Lek), Diosminal (Ethifarm), Diosmin Ethifarm, Diosmiven (Polfa-Łódź), ProDiosmin Optimal (Alpepharma).

C07 – Leki blokujące receptory b-adrenergiczne; C07A – Leki blokujące receptory b-adrenergiczne; C07AB – Selektywne leki blokujące receptory b‑adrenergiczne

Metoprololum: Metoprolol Aurobindo to 14. zarejestrowana marka preparatów metoprololu. Do sprzedaży wprowadzono 11 marek: Betaloc i Betaloc ZOK (AstraZeneca), Beto ZK (Sandoz), Metocard i Metocard ZK (Polpharma), MetoHexal ZK (1A Pharma), Metoprolol VP (ICN Polfa Rzeszów), od lutego 2011 Metostad (Stada), od października 2011 Metogen SC (Mylan), od października 2012 Metoprolol Biofarm ZK (Biofarm), od lutego 2013 Metoratio ZK (Ratiopharm) oraz od maja 2013 Iviprolol (Bioton; lek zarejestrowany pierwotnie pod nazwą Metoprolol succinate Farmaprojects) i Symlok SR (SymPhar). Nie pojawiły się jeszcze na rynku preparaty Mecorlong (Actavis) i Metoprolol tartrate Accord (Accord Healthcare). Skreślono z Rejestru: Metocard prolongatum (Polpharma), Metoprolol-1A Pharma, Metoprolol-Egis (zarejestrowany wcześniej jako Egilok) i Metoprolol PR-Ratiopharm.

C08 – Blokery kanału wapniowego; C08C – Selektywne blokery kanału wapniowego z głównym działaniem na naczynia krwionośne; C08CA – Pochodne dihydropirydyny

Lercanidipinum: Lercan (Recordati) to 4. zarejestrowana marka lerkanidypiny. Na rynek wprowadzono 3 leki: od sierpnia 2011 Karnidin (Orion), od lutego 2012 Primacor (Berlin-Chemie) i od listopada 2012 Lecalpin (Actavis). Skreślono z Rejestru: Lecramed (Medis), Lerpin (Torrent).

C09 – Leki działające na układ renina-angiotensyna; C09D – Antagoniści angiotensyny II, leki złożone; C09DA - Antagoniści angiotensyny II i leki moczopędne;

C09DA03 – Walsartan i leki moczopędne

Valsartanum+hydrochlorothiazidum: Valsartan HCT Fair-Med to 19. zarejestrowana marka preparatów o podanym składzie, zaś Valtap HCT (Zentiva) w 2 dawkach różniących się dawką hydrochlorotiazydu, a zawierający 320 mg walsartanu, to rozszerzenie względem wprowadzonych wcześniej zestawień dawek zawierających 160 mg walsartanu. 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 Mylan, 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).

C09DA07 – Telmisartan i leki moczopędne

Telmisartanum+hydrochlorothiazidum: Telmisartan/hydrochlorothiazide Egis to 6. zarejestrowana marka leków o podanym składzie, uwzględniając 5 wcześniejszych rejestracji w procedurze centralnej Unii Europejskiej. Do sprzedaży wprowadzono 3 marki: Micardis Plus (Boehringer Ingelheim), Pritor Plus (Bayer) i od lipca 2013 Tolucombi (Krka). Nie pojawiły się na rynku: Actelsar HCT (Actavis) i Kinzalkomb (Bayer).

 

D – Leki stosowane w dermatologii

D01 – Leki przeciwgrzybicze stosowane w dermatologii; D01A – Leki przeciwgrzybicze stosowane miejscowo; D01AE – Inne leki przeciwgrzybicze stosowane miejscowo

Amorolfinum: Funtrol (Chanelle Medical) to 5. zarejestrowany lek z amorolfiną. Do obrotu wprowadzono 3 marki: Loceryl (Galderma; lek oryginalny), od maja 2012 Myconolak (Axxon) i od sierpnia 2013 Amorolak (Sun-Pharm). Nie pojawił się jeszcze na rynku: Amorolfine Pierre Fabre (lek zarejestrowany pierwotnie pod nazwą Amorolfine Adoh).

D07 – Kortykosteroidy, preparaty dermatologiczne; D07A – Kortykosteroidy, leki proste; D07AC - Kortykosteroidy silnie działające (grupa III)

Mometasoni furoas: Ivoxel (Almirall Hermal) w postaci kremu i maści to rozszerzenie w stosunku do zarejestrowanego wcześniej roztworu na skórę. Aktualnie zarejestrowano w tej klasie 5 marek mometazonu. Do sprzedaży wprowadzono 3 marki: Elocom (Merck Sharp & Dohme; lek oryginalny), Elosone krem (ICN Polfa Rzeszów), Elosone maść (Jelfa; lek wprowadzony pierwotnie na rynek pod nazwą Momederm) i od sierpnia 2010 Momarid (Sanofi-Aventis; lek w postaci maści zarejestrowany pierwotnie przez firmę Glenmark pod nazwą Eztom). Nie pojawiły się jeszcze na rynku: Edelan (Polpharma), Ivoxel (Almirall Hermal) oraz Momederm (Jelfa) roztwór na skórę. Skreślono z Rejestru: Biometazon (Biomed Warszawa).

 

G – Układ moczowo-płciowy i hormony płciowe

G02 – Inne preparaty ginekologiczne; G02B – Środki antykoncepcyjne do stosowania miejscowego; G02BA – Wewnątrzmaciczne środki antykoncepcyjne

Levonorgestrelum: Levosert (Gedeon Richter Polska) to wkładka wewnątrzmaciczna z systemem dozującym lewonorgestrel. Do sprzedaży wprowadzono wkładkę Mirena (Bayer). Nie pojawiła się na rynku wkładka Jaydess (Bayer). Mirena i Levosert uwalniają 2 mcg lewonorgestrelu na dobę, a Jaydess od początkowo 14 mcg do 5 mcg lewonorgestrelu na dobę.

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

G03A - Hormonalne środki antykoncepcyjne działające ogólnie; G03AA – Progestageny i estrogeny, preparaty jednofazowe; G03AA12 – Drospirenon i estrogen

Drospirenonum+ethinylestradiolum: Mywy (Leon Farma) to 25. zarejestrowana marka środków antykoncepcyjnych o podanym składzie. Do sprzedaży wprowadzono 16 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), od listopada 2012 Naraya Plus (Temapharm), od czerwca 2013 Lesiplus (Teva; środek zarejestrowany pierwotnie pod nazwą Veyann), od lipca 2013 Sidretella (Zentiva; środek zarejestrowany pierwotnie przez Leon Farma pod nazwą Pirestrol) i od sierpnia 2013 Cortelle (Teva; preparat w dawkach 3 mg + 0,03 mg zarejestrowany wcześniej przez Leon Farma pod nazwą Dronin), Teenia (Gedeon Richter Polska), Varenelle (Teva; preparat w dawkach 3 mg + 0,02 mg zarejestrowany wcześniej przez Leon Farma pod nazwą Dronin) i Vixpo (Polpharma).

Nie ma jeszcze na rynku preparatów: Aliane (Bayer), Aneea (Gedeon Richter Polska), Belusha (Gedeon Richter Polska), Flexyess (Bayer), Linatera (Bayer; preparat zarejestrowany początkowo pod nazwą Ethinylestradiol/Drospirenon Bayer), Lulina (Ivowen), Palandra (Bayer).

Wszystkie środki zawierają 3 mg drospirenonu. Różnice dotyczą zawartości estrogenu oraz obecności tabletek placebo w zestawie. Dawkę 0,02 mg etynylestradiolu zawierają: Aliane, Aneea, Belusha (z placebo), Daylette (z placebo), Flexyess, Lesinelle, Lesiplus (z placebo), Linatera, Mywy (z placebo), Naraya, Naraya Plus (z placebo), Sidretella 20, Teenia, Varenelle (z placebo), Vibin Mini (z placebo), Vixpo (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.

G03DProgestageny; G03DA – Pochodne pregnenu-4

Progesteronum: Luteina (Adamed) tabl. dopochwowe 100 mg i 200 mg to rozszerzenie w stosunku do wprowadzonej wcześniej dawki 50 mg. Zarejestrowano 2 marki preparatów progesteronu. Na rynek wprowadzono preparaty Luteina (Adamed) i od czerwca 2011 Lutinus (Ferring). Skreślono z Rejestru Utrogestan (Besins).

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

Sildenafilum: Sildenafil Sandoz w nowej dla tej substancji czynnej postaci lamelek rozpadających się w jamie ustnej to rozszerzenie w stosunku do wprowadzonych wcześniej tabletek. Zarejestrowano 37 marek syldenafilu. Na rynek wprowadzono 17 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), od stycznia 2013 Sildenafil Ranbaxy i od września 2013 Rosytona (Actavis).

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

Skreślono z Rejestru: Sildenafil-1A Pharma, Sildenafil Arrow (Arrow Poland), Sildenafil Aspen, 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; J01M – Chinolony przeciwbakteryjne, J01MA – Fluorochinolony

Levofloxacinum: Levofloxacin Kabi (Fresenius Kabi) to 9. zarejestrowana marka lewofloksacyny, w tym 5. iniekcyjna. Na rynek wprowadzono 4 leki: Tavanic (Sanofi-Aventis; lek oryginalny), od czerwca 2011 Levoxa (Actavis), od marca 2012 Xyvelam (+Pharma) i od czerwca 2012 Oroflocina (Jelfa). Nie pojawiły się jeszcze w sprzedaży preparaty: Levofloxacinum B. Braun (Braun), Levofloxacin FP (Farmaprojects), Levofloxacin Macleods i Levofloxacin Sanovel (Sanovel Holding). Skreślono z Rejestru: Aflobax (Temapharm), Levofloxacin Teva.

J02/J02A – Leki przeciwgrzybicze działające ogólnie; J02AC – Pochodne triazolu

Voriconazolum: Voriconazole Tiefenbacher (Alfred E. Tiefenbacher) to 4. zarejestrowana marka worykonazolu. Do sprzedaży wprowadzono lek oryginalny Vfend (Pfizer). Nie pojawiły się jeszcze na rynku Voriconazole Accord (Accord Healthcare) i Voriconazol Polpharma.

J05 – Leki przeciwwirusowe działające ogólnie; J05A – Bezpośrednio działające leki przeciwwirusowe;

J05AE – Inhibitory proteazy

Ritonavirum: Ritonavir Mylan to 1. zarejestrowany lek generyczny. Do sprzedaży wprowadzono lek oryginalny Norvir (Abbvie).

J05AR – Leki przeciwwirusowe stosowane w leczeniu zakażeń wirusem HIV, preparaty złożone; J05AR04 – Zydowudyna, lamiwudyna i abakawir

Abacavirum+lamivudinum+zidovudinum: Abacavir/Lamivudine/Zidovudine Teva to 2. zarejestrowany lek o tym składzie. Na rynek wprowadzono Trizivir (Viiv Healthcare).

 

L – Leki przeciwnowotworowe i wpływające na układ odpornościowy

L01 – Leki przeciwnowotworowe;

L01B – Antymetabolity;

L01BB – Analogi puryny

Fludarabinum: Fludarabine Kabi inj. (Fresenius Kabi) to 5. zarejestrowana marka fludarabiny. Na rynek wprowadzono 4 leki: Fludara Oral (Genzyme), od maja 2008 Fludarabine Teva inj., od stycznia 2009 Fludarabin-Ebewe inj. i od listopada 2009 Fludalym inj. (Actavis). Skreślono z Rejestru: Fludara inj. (Genzyme; lek był obecny na rynku).

L01BC – Analogi pirymidyny

Capecitabinum: Actabi (Adamed) i Capecitalox (Mylan) to odpowiednio 21. i 22. zarejestrowana marka kapecytabiny. Na rynek wprowadzono lek oryginalny Xeloda (Roche). Nie pojawiły się jeszcze w sprzedaży: Binoda (GlaxoSmithKline), Capecitabine Accord, Capecitabine Actavis, Capecitabine Cipla, Capecitabine Fresenius Kabi, Capecitabine Glenmark, Capecitabine Intas, Capecitabine medac, Capecitabine Polpharma, Capecitabine Sandoz, Capecitabine Sun, Capecitabine Teva, Capecitabine Zentiva, Coloxet (Egis), Ecansya (Krka; lek zarejestrowany początkowo pod nazwą Capecitabine Krka), Lorpeda (PharOs Generics), Symloda (SymPhar), Vopecidex (PharmaSwiss) i Xalvobin (Alvogen).

L01X – Inne leki przeciwnowotworowe; L01XE – Inhibitory kinazy białkowej

Imatinibum: Imatinib Zentiva to 14. zarejestrowana marka imatynibu. Na rynek wprowadzono lek oryginalny Glivec (Novartis) i od czerwca 2013 Nibix (Adamed). Nie pojawiły się jeszcze w sprzedaży: Imakrebin (Alvogen), Imatenil (Biofarm), Imatinib Accord (Accord Healthcare), Imatinib Actavis, Imatinib Glenmark, Imatinib Nobilus Ent, Imatinib Teva, Kinacel (Celon), Leuzek (Nobilus Ent), Meaxin (Krka), Telux (Nobilus Ent).

 

M – Układ mięśniowo-szkieletowy

M01 – Leki przeciwzapalne i przeciwreumatyczne; M01A – Niesterydowe leki przeciwzapalne i przeciwreumatyczne; M01AE – Pochodne kwasu propionowego

Naproxenum: Nalgesin Mini (Krka) tabl. powlekane w dawce 220 mg to rozszerzenie względem wprowadzonych wcześniej wyższych dawek. Zarejestrowano 10 marek preparatów naproksenu. Na rynek wprowadzono 10 marek: Aleve (Bayer), Anapran i Anapran Neo (Polfa Pabianice), Naproxen Hasco doustny i czopki (Hasco-Lek), Naproxen Aflofarm, Naproxen Polfarmex, Natrax (Polfa Pabianice), Pabi-Naproxen tabl. i zawiesina (Polfa Pabianice), od kwietnia 2009 Apo-Napro (Apotex), od marca 2010 Naxii (US Pharmacia; preparat wprowadzony wcześniej pod nazwą Boloxen), od stycznia 2013 Nalgesin i Nalgesin forte (Krka) oraz od lipca 2013 Anapran EC (Adamed). Skreślono z Rejestru preparaty Apo-Naproxen (Apotex) i Naproxen czopki (GlaxoSmithKline, Poznań).

M02/M02A – Leki stosowane miejscowo w bólach stawów i mięśni; M02AA – Niesteroidowe leki przeciwzapalne do stosowania miejscowego

Diclofenacum: Diclodermex (Sophena) w postaci plastra leczniczego to 15. zarejestrowana marka preparatów diklofenaku do stosowania zewnętrznego. Na rynek wprowadzono 11 preparatów w postaci żeli 1%: Diclac Lipogel (Sandoz), Dicloratio Gel (Ratiopharm; wcześniejsza nazwa: Ratiogel), Dicloziaja (Ziaja), Diklonat P (Teva), Felogel Neo (Sopharma; preparat był wcześniej dostępny pod nazwą Felogel, a jeszcze wcześniej pod nazwą Feloran), Naklofen Top (Krka; lek wprowadzony wcześniej pod nazwą Naklofen Gel), Olfen (Mepha), Veral (Zentiva), Voltaren Emulgel (Novartis; lek oryginalny), od maja 2011 Diklofenak LGO (Laboratorium Galenowe Olsztyn) i od kwietnia 2013 Viklaren (ICN Polfa Rzeszów). W październiku 2008 na rynku pojawił się płyn do natryskiwania na skórę Diky 4% (Cyathus Exquirere Pharmaforschungs; poprzednia nazwa: Diklofenak MIKA Pharma 4%), a od lipca 2012 Voltaren Max (Novartis) w postaci żelu w dawce 2%.

Nie pojawiły się jeszcze w sprzedaży plastry lecznicze Flector Tissugel (IBSA) i Olfen Patch (Mepha) oraz 3% żel Solaraze (Almirall).

Skreślono z Rejestru: plastry lecznicze Dicloratio Plast (Ratiopharm), żel Voltenac (Sanofi-Aventis).

M03 – Środki zwiotczające mięśnie; M03A – Środki zwiotczające mięśnie działające obwodowo; M03AX – Inne środki zwiotczające mięśnie działające obwodowo

Toxinum botulinicum typum A: Dysport (Ipsen) w dawce 300 j. Speywood to rozszerzenie w stosunku do wprowadzonej wcześniej dawki 500 j. Speywood. Zarejestrowanych jest 6 preparatów zawierających toksynę botulinową typu A. Na rynek zostało wprowadzonych 5 leków: Botox (Allergan), Dysport (Ipsen), od maja 2009 Vistabel (Allergan), od maja 2010 Azzalure (Ipsen) i od stycznia 2013 Xeomin (Merz). Nie pojawił się jeszcze w sprzedaży preparat Bocouture (Merz).

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

Acidum zoledronicum: Fayton (Glenmark) w postaci roztworu do wlewów dożylnych to rozszerzenie względem wprowadzonego wcześniej koncentratu do przygotowania roztworu do wlewów dożylnych. Zarejestrowano 22 marki leków z kwasem zoledronowym. Na rynek wprowadzono 6 leków: Zometa (Novartis Europharm), od września 2012 Zomikos (Vipharm), od lutego 2013 Zoledronic acid Teva, od czerwca 2013 Fayton (Glenmark) i Zoledronic acid Actavis 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), Osporil (Egis), Symdronic (SymPhar), Zolacitor (Chiesi), Zolako (Vipharm), Zoledronic acid Fresenius Kabi, Zoledronic acid Hospira, Zoledronic acid Medac, Zoledronic acid Mylan, Zoledronic acid Polpharma, Zoledronic acid Sandoz, Zoledronic acid Strides (Strides Arcolab), 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

N01 – Środki znieczulające; N01A – Środki znieczulające działające ogólnie; N01AX – Inne środki znieczulające działające ogólnie

Propofolum: Propofol MCT/LCT Fresenius (Fresenius Kabi) w 2 dawkach w postaci ampułkostrzykawek to rozszerzenie względem wprowadzonych wcześniej ampułek i fiolek. Zarejestrowano 8 marek preparatów propofolu. Na rynek wprowadzono 6 leków: Diprivan (AstraZeneca), Plofed (Polfa Warszawa), Propofol Fresenius (Fresenius Kabi), od marca 2007 Propofol MCT/LCT Fresenius (Fresenius Kabi), od września 2009 Propofol-Lipuro (Braun) i od czerwca 2011 Provive (Claris Lifesciences). Nie pojawiły się jeszcze w sprzedaży Nylosed (Polfa Warszawa) i Propofol Norameda. Skreślono z Rejestru: Curtega (Pfizer), Propofol Pfizer.

N02 – Leki przeciwbólowe;

N02A – Opioidy;

N02AB – Pochodne fenylopiperydyny

Fentanylum: Vellofent (Angelini) tabl. podjęzykowe w 6 dawkach to aktualnie 11. zarejestrowana marka fentanylu, w tym w 4 nowych dawkach: 67 mcg, 133 mcg, 267 mcg i 533 mcg. Do sprzedaży wprowadzono 9 leków: Durogesic (Janssen), od sierpnia 2007 Matrifen (Takeda), od października 2007 Fentanyl Actavis, od sierpnia 2008 Fenta MX (Sandoz) i od lipca 2009 Dolforin (Gedeon Richter) w postaci systemów transdermalnych oraz Fentanyl WZF inj. (Polfa Warszawa), od marca 2009 Effentora (Teva) w postaci tabletek podpoliczkowych, które musują w wilgotnym środowisku ulegając rozpadowi i uwalniając substancję czynną, od września 2011 Instanyl (Takeda) w postaci aerozolu do nosa i od października 2012 PecFent (Archimedes Development) w postaci aerozolu do nosa.

Nie został jeszcze wprowadzony na rynek Breakyl (Meda) w postaci lamelek podpoliczkowych.

Skreślono z Rejestru: Algogesic (Renantos), Fentagesic (Teva; preparat wprowadzony na rynek od września 2007), Fentanyl Chesi inj. (wprowadzony pierwotnie pod nazwą Fentanyl Torrex), Fentanyl MX Sandoz, Fentanyl Novosis (Acino), Fentanyl Orion, Fentanyl-Ratiopharm (lek był obecny na rynku od kwietnia 2007), Fentanyl Stada, system transdermalny jontoforetyczny Ionsys (Janssen; zarejestrowany centralnie w UE w styczniu 2006, zalecany do stosowania wyłącznie w warunkach szpitalnych - Komisja Europejska 16 stycznia 2009 zawiesiła pozwolenie na dopuszczenie do obrotu tego preparatu; podmiot odpowiedzialny nie zgłosił wniosku o przedłużenie rejestracji), Lunaldin (Gedeon Richter; lek był obecny na rynku od października 2010; preparat zarejestrowany wcześniej pod nazwą Rapinyl przez firmę ProStrakan).

N02AX – Inne opioidy; N02AX52 – Tramadol, preparaty złożone

Tramadolum+paracetamolum: Symtram (SymPhar) i Strenduo (Abbott) to odpowiednio 19. i 20. zarejestrowana marka preparatów o podanym składzie. Do sprzedaży wprowadzono 12 leków: Zaldiar i Zaldiar Effervescent (Stada), od stycznia 2010 Doreta (Krka), od maja 2010 Acutral (Stada; lek zarejestrowany wcześniej pod nazwą Primiza), od marca 2011 Poltram Combo (Polpharma), od kwietnia 2011 Padolten (Teva), od lutego 2012 Delparan (Sandoz; lek zarejestrowany wcześniej pod nazwą Tramadol/Paracetamol Sandoz), od czerwca 2012 Tramapar (Polfarmex), od października 2012 Exbol (ICN Polfa Rzeszów) i Parcotram (Glenmark), od lutego 2013 Curidol (Gedeon Richter Polska), od kwietnia 2013 ApoPatram (Apotex) i od czerwca 2013 Paratram (Mylan; lek zarejestrowany pierwotnie przez firmę Substipharm pod nazwą Calone). Nie pojawiły się jeszcze na rynku: Acutral Effervescent (Stada), Azemdol (Labopharm), Bacizol (Substipharm), Sedoloris (Actavis), Tracemol (Substipharm), Traparac (Disphar) i Zaldiar Retard (Labopharm). Skreślono z Rejestru: Tramaparastad (Stada).

N02B – Inne leki przeciwbólowe i przeciwgorączkowe; N02BE – Anilidy

Paracetamolum: Panadol Novum (GlaxoSmithKline) tabl. powlekane to rozszerzenie względem wprowadzonych wcześniej postaci i dawek marki Panadol. Zarejestrowano 41 marek paracetamolu. Na rynek wprowadzono 29 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, od lutego 2013 Paracetamol Actavis tabl. powlekane i od lipca 2013 Paramax Rapid (Vitabalans).

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 Polpharma inj., Paracetamol Rockspring, Paracetamol Sandoz inj., Paracetamol Teva inj., Paralen Sus (Zentiva), 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).

N06 – Psychoanaleptyki; N06D – Leki przeciw demencji;

N06DA – Antycholinoesterazy

Rivastigminum: Rivastigmine Acino i Werendi (Acino) to odpowiednio 30. i 31. zarejestrowana marka rywastygminy. Do sprzedaży wprowadzono 14 leków: Exelon (Novartis Europharm), od sierpnia 2009 Nimvastid (Krka), od maja 2010 Prometax (Novartis Europharm), od sierpnia 2010 Ristidic (ICN Polfa Rzeszów), od stycznia 2011 Rivastigmin Orion i Rivaxon (Biogened), od marca 2011 Symelon (SymPhar; lek zarejestrowany początkowo pod nazwą Rivaller), od czerwca 2011 Rivaldo (Polfa Pabianice; lek zarejestrowany początkowo pod nazwą Velastina), Rivastigmine Teva i od lipca 2011 Rivastigmine Teva Pharma, od sierpnia 2011 Rivastigmin Stada (lek zarejestrowany początkowo pod nazwą Niddastig), od września 2011 Rivastigmine Mylan, od stycznia 2012 Signelon (Synteza) i od lutego 2012 Rivastigmine Actavis.

Nie pojawiły się jeszcze na rynku: Ivagalmin (Genepharm), Kerstipon (Pharmathen), Loristiven (Blau Farma Group), Permente (Alvogen), Rivaldo TDS (Adamed), Rivalong (Farma-Projekt), Rivastigmin Cipla, Rivastigmine 1A Pharma, Rivastigmine Hexal, Rivastigmine Sandoz, Rivastigmin Welding, Rivastin (Polpharma), Rivoder (Welding), Rywastygmina-Neuraxpharm.

Skreślono z Rejestru: Evertas (Zentiva), Resymtia (Abbott), Rivastigmine Genthon, Rivastigmine Pol-Nil, Rivastigmine-Ratiopharm, Rivastigmine Synthon, Rivastigmine Synthon Hispania, Rivastigmine Teva (lek był dostępny na rynku od grudnia 2009), Rivastigmine Tiefenbacher (Alfred E. Tiefenbacher), Rivastigmine Torrent, Rivastinorm (+Pharma), Riveka (Unia; lek był obecny na rynku od stycznia 2011), Rywastygmina Apotex.

N06DX - Inne leki przeciw otępieniu starczemu

Memantinum: Memantine Orion to 10. zarejestrowana marka memantyny. Na rynek wprowadzono 4 leki: Axura (Merz), Ebixa (Lundbeck), od listopada 2012 Biomentin (Biofarm) i od sierpnia 2013 Nemdatine (Actavis). Nie pojawiły się jeszcze w sprzedaży preparaty: Marixino (Consilient Health; lek zarejestrowany pierwotnie przez firmę Krka pod nazwą Maruxa), Memantine Lek (Pharmathen), Memantine Merz, Memantine Mylan (Generics), Memantine Ratiopharm.

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

Nicotinum: Nicotine Perrigo (Wrafton) tabl. do ssania to 7. zarejestrowana marka preparatów z nikotyną. Na rynku pojawiły się następujące produkty lecznicze:

- 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) oraz od lipca 2013 aerozolu do stosowania w jamie ustnej Nicorette Spray;

- 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: Exmo (Actavis) system transdermalny, Exmo Fruit i Exmo Mint (Actavis) w postaci gumy do żucia, Nico Fruit i Nico Mint (Apotex) w postaci gumy do żucia, 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 i Niquitin Mini smak wiśniowy (McNeil) w postaci tabletek do ssania.

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).

 

R – Układ oddechowy

R03 – Leki stosowane w obturacyjnych chorobach dróg oddechowych; R03D - Inne leki działające ogólnie stosowane w obturacyjnych chorobach dróg oddechowych; R03DC – Antagoniści receptorów leukotrienowych

Montelukastum: Asmenol Mini (Polpharma) w postaci jednodawkowego granulatu to rozszerzenie w stosunku do wprowadzonych wcześniej tabletek i tabletek do rozgryzania i żucia Asmenol. Zarejestrowano 44 marki montelukastu. Do sprzedaży wprowadzono 23 leki: Singulair (Merck Sharp & Dohme; lek oryginalny), od października 2008 Drimon (Teva), od stycznia 2009 Astmirex (Temapharm), Hardic (Teva) i Monkasta (Krka), od lutego 2009 Montest (Genexo), od kwietnia 2009 Milukante (Adamed) i Promonta (ICN Polfa Rzeszów), od maja 2009 Asmenol (Polpharma), od października 2009 Eonic (Gedeon Richter) i Montelak (Medreg), od grudnia 2009 Montessan (Apotex; preparat zarejestrowany wcześniej pod nazwą Montekast), od czerwca 2010 Montespir (Biofarm) i Vizendo (GlaxoSmithKline; preparat zarejestrowany wcześniej przez Synthon pod nazwą MontSyn), od listopada 2010 Montenorm (+Pharma) i Symlukast (SymPhar), od marca 2011 Montelukast Sandoz i Spirokast (Zentiva), od października 2011 Montelukast Stada, od lutego 2012 Astmodil (Polfarmex), od czerwca 2012 Orilukast (Orion), od sierpnia 2012 Montelukast Bluefish (lek zarejestrowany wcześniej przez firmę Helm pod nazwą Montelukast Helm), od lutego 2013 Montelukast Arrow (Arrow Poland) i od lipca 2013 Romilast (Ranbaxy; lek zarejestrowany pierwotnie pod nazwą Teleact).

Nie pojawiły się jeszcze na rynku preparaty: Alvokast (Alvogen; lek zarejestrowany pierwotnie przez firmę Arti Farma pod nazwą Montekast), ApoMontessan (Apotex; lek zarejestrowany pierwotnie pod nazwą Montelukast Apotex), Asmenol PPH (Polpharma; lek zarejestrowany pierwotnie pod nazwą Montelukast Polpharma), Astmontex (Farma-Projekt), Elukan (Specifar), Lamoten (Polfa Pabianice), Miralust (Adamed), Montak (Glenmark), Montelukast-1A Pharma, Montelukast Accord (Accord Healthcare), Montelukast Aurobindo, Montelukast MSD (Merck Sharp & Dohme), Montelukast Pharmathen, Montelukast PharOS, Montelukastum Accord (Accord Healthcare), Montelukastum Synthon, Montetrinas (Sigillata), Montexal (ICN Polfa Rzeszów), Sigilukad (Sigillata), Sitemortak (Sigillata) i Telumyl (Generics).

Skreślono z Rejestru: Actamone (Actavis), Airuno (Blubit), Brogalast (Galex d.d.), Monteflow (Sun-Farm; lek zarejestrowany początkowo pod nazwą Montelukast Sunfarm), Montelukast Invent Farma, Montelukast Miklich, Montelukast Pfizer, Montelukast-Ratiopharm, Montulind (Sigillata), Polmonte (Merck Sharp & Dohme; lek zarejestrowany wcześniej pod nazwą Airathon), Telumantes (Sigillata).

R05 – Leki stosowane w kaszlu i przeziębieniach;

R05C – Leki wykrztuśne, z wyłączeniem preparatów złożonych zawierających leki przeciwkaszlowe; R05CB – Leki mukolityczne

Acetylcysteinum: ACC Mini (Sandoz) w nowej postaci roztworu doustnego to rozszerzenie względem wprowadzonych wcześniej postaci marki ACC. Zarejestrowano 4 marki acetylocysteiny. Do sprzedaży wprowadzono 4 marki w różnych wersjach i dawkach: ACC, ACC Hot, ACC Max, ACC Mini, ACC Optima (Sandoz), Acetylcysteine Sandoz inj., Fluimucil, Fluimucil Muko, Fluimucil Muko Junior (Zambon), Tussicom (Sanofi-Aventis).

R05X – Różne preparaty na przeziębienie

Acidum ascorbicum+paracetamolum+phenylephrinum: Coldrex Menthol Active (GlaxoSmithKline) to rozszerzenie względem wprowadzonych wcześniej innych preparatów marki Coldrex o tym składzie. Zarejestrowano 5 marek preparatów o podanym składzie. Na rynku pojawiło się 5 marek w różnych wersjach: Coldrex o smaku cytrynowym i Coldrex o smaku czarnej porzeczki (GlaxoSmithKline; preparaty wprowadzone pierwotnie pod nazwą Coldrex HotRem), Coldrex MaxGrip o smaku cytrynowym (GlaxoSmithKline), Febrisan (Takeda), Gripex HotActiv (US Pharmacia) i Gripex HotActiv Forte (US Pharmacia; preparat zarejestrowany pod nazwą Apap przeziębienie Hot Rem, następnie wprowadzony w kwietniu 2010 pod nazwą Gripex Max HotActiv), od kwietnia 2010 Actiflu Extra C (US Pharmacia; zmiana nazwy na Apap Przeziębienie Hot, ale lek pod nową nazwą jeszcze nie pojawił się na rynku), od listopada 2011 Choligrip (GlaxoSmithKline; lek wprowadzony na rynek w sierpniu 2010 pod nazwą Coldrex o smaku miodowo-cytrynowym, następnie zmiana nazwy na Choligrip Hot, a potem na Choligrip) i od grudnia 2012 Choligrip Max (GlaxoSmithKline; lek zarejestrowany pierwotnie pod nazwą Coldrex MaxGrip o smaku owoców leśnych i mentolu). Nie wprowadzono dotychczas do sprzedaży preparatu Coldrex Junior C (GlaxoSmithKline).

R06/R06A – Leki przeciwhistaminowe działające ogólnie; R06AE – Pochodne piperazyny

Levocetirizinum: Medtax (Synthon) to 16. zarejestrowana marka lewocetyryzyny. Zastosowanie aktywnego izomeru cetyryzyny umożliwia zmniejszenie o połowę stosowanych dawek, a tym samym działań niepożądanych. Na rynek wprowadzono 8 leków: Xyzal (Vedim; lek oryginalny), od stycznia 2010 Cezera (Krka), od sierpnia 2010 Zenaro (Zentiva), od września 2010 Lirra (Glenmark) oraz Zyx (Biofarm), od lutego 2012 Contrahist (Adamed), od stycznia 2013 Lirra Gem (Glenmark), od lutego 2013 Lecetax (Axxon), od marca 2013 Zyx Bio (Biofarm; lek zarejestrowany pierwotnie pod nazwą Levocetirizine-Biofarm) i od maja 2013 Votrezin (Sandoz). Nie pojawiły się jeszcze w sprzedaży: Ahist (Generics), L-Cetirinax (Actavis), Levocetirizine Bristol Laboratories, Levocetirizine dihydrochloride Zentiva, Lewocetyryzyna Glenmark Generics, Nossin (Apotex), Zilola (Gedeon Richter Polska).

Uwaga: wprowadzonemu onegdaj na rynek preparatowi Zyx 7 (Biofarm) zawierającemu racemiczną cetyryzynę w lipcu 2008 zmieniono nazwę na Amertil Bio. Obecne aktualnie na rynku preparaty Zyx i Zyx Bio zawierają lewocetyryzynę.

 

S – Narządy zmysłów

S01 – Leki okulistyczne; S01C – Połączenia leków przeciwzapalnych z przeciwinfekcyjnymi; S01CA – Połączenia kortykosteroidów z lekami przeciwinfekcyjnymi

Dexamethasonum+tobramycinum: Tobrasone (Polpharma) to 3. zarejestrowana marka leku o podanym składzie. Do sprzedaży wprowadzono Tobradex (Alcon). Nie pojawił się jeszcze na rynku Tobrosopt-DEX (Polfa Warszawa).

 

Opracowanie: dr n. farm. Jarosław Filipek

Kierownik Działu Informacji o Produktach

Administrator Farmaceutycznej Bazy Danych BAZYL

IMS Health

2013-10-22

Krajowa Baza Produktów Ochrony Zdrowia (KBPOZ)

Źródła:

- klasyfikacja ATC na podstawie opracowania WHO Collaborating Centre for Drug Statistics Methodology (“Guidelines for ATC Classification and DDD assignment 2013”, Oslo 2012; “ATC Index with DDDs 2013”, Oslo 2012), ze zmianami i uzupełnieniami mającymi zastosowanie od stycznia 2013 – tłumaczenie własne;

- nomenklatura nazw substancji czynnych: “Urzędowy Wykaz Produktów Leczniczych Dopuszczonych do Obrotu na Terytorium Rzeczypospolitej Polskiej”; „Farmakopea Polska Wydanie IX”;

- informacje rejestracyjne: “Urzędowy Wykaz Produktów Leczniczych Dopuszczonych do Obrotu na Terytorium Rzeczypospolitej Polskiej”; miesięczne wykazy zarejestrowanych produktów leczniczych publikowane w Biuletynie Informacji Publicznej Urzędu Rejestracji PLWMiPB; pozwolenia i decyzje porejestracyjne nadsyłane przez podmioty odpowiedzialne; wykazy produktów leczniczych, którym skrócono okres ważności pozwolenia;

- informacje o wprowadzeniu produktu na rynek w Polsce: dane IMS Health;

- opisy wskazań i mechanizmów działania: Charakterystyki Produktów Leczniczych;

- pozostałe opinie i komentarze: autorskie.

 

 
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