Pączki Sosny

Główne informacje

  • Nazwa własna:
  • Pączki Sosny zioła do zaparzania
  • Forma farmaceutyczna:
  • zioła do zaparzania
  • Używać do:
  • Ludzie
  • Typ medycyny:
  • alopatycznych narkotyków

Dokumenty

Lokalizacja

  • Dostępne w:
  • Pączki Sosny zioła do zaparzania
    Polska
  • Język:
  • polski

Informacje terapeutyczne

  • Podsumowanie produktu:
  • 1 op. 25 g, 5909990468317, OTC; 1 op. 50 g, 5909990468324, OTC

Inne informacje

Status

  • Źródło:
  • Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
  • Numer pozwolenia:
  • 04683
  • Ostatnia aktualizacja:
  • 17-03-2018

Charakterystyka produktu leczniczego: interakcje, dawkowanie, skutki uboczne

Charakterystyka Produktu Leczniczego

1. NAZWA WŁASNA PRODUKTU LECZNICZEGO PĄCZKI SOSNY (Pini gemmae) 2. SKŁAD JAKOŚCIOWY i ILOŚCIOWY SUBSTANCJI CZYNNYCH Skład produktu w przeliczeniu na 100g: Pączki sosny (Pini gemmae) - 100g 3. POSTAĆ FARMACEUTYCZNA Zioła do zaparzania 4. SZCZEGÓŁOWE DANE KLINICZNE 4.1 Wskazania do stosowania Środek tradycyjnie stosowany pomocniczo w schorzeniach górnych dróg oddechowych, jako słaby środek wykrztuśny. Produkt jest tradycyjnym produktem leczniczym roślinnym do stosowania w określonych wskazaniach, wynikających wyłącznie z jego długotrwałego stosowania. 4.2 Dawkowanie i sposób podawania Do stosowania doustnie w postaci naparu: 1 łyżkę stołową produktu (ok. 3g) zalać 1 szklanką wrzącej wody, naparzać pod przykryciem przez 15 minut. Przecedzić i pić 3 razy dziennie w ten sposób przygotowany napar pamiętając aby był on zawsze świeży i ciepły. Jeśli objawy nie ustąpią po 1 tygodniu stosowania produktu należy skonsultować się z lekarzem.
4.3 Przeciwwskazania Dotychczas nie stwierdzono. 4.4 Specjalne ostrzeżenia i środki ostrożności dotyczące stosowania Jeśli objawy nie ustąpią po 1 tygodniu stosowania produktu lub wystąpią nie wymienione w oznakowaniu opakowania działania niepożądane, należy skonsultować się z lekarzem. 4.5 Interakcje z innymi lekami i inne rodzaje interakcji Dotychczas nie stwierdzono. 4.6 Ciąża lub laktacja Ze względu na brak danych nie stosować podczas ciąży i karmienia piersią. 4.7 Wpływ na zdolność prowadzenia pojazdów mechanicznych i obsługiwania urządzeń mechanicznych w ruchu Brak danych. 4.8 Działania niepożądane Dotychczas nie stwierdzono. W przypadku wystąpienia objawów niepożądanych należy poinformować o nich lekarza lub farmaceutę. 4.9 Przedawkowanie Brak danych. 5. WŁAŚCIWOŚCI FARMAKOLOGICZNE 5.1 Właściwości farmakodynamiczne Brak danych. 5.2 Właściwości farmakokinetyczne Brak danych. 5.3 Przedkliniczne dane o bezpieczeństwie Brak danych. 6. DANE FARMACEUTYCZNE 6.1 Wykaz substancji pomocniczych Nie dotyczy 6.2 Niezgodności farmaceutyczne Nie dotyczy 6.3 Okres ważności 1 rok 6.4 Specjalne środki ostrożności przy przechowywaniu Przechowywać w zamkniętych opakowaniach, w temperaturze nie wyższej niż 25°C. Chronić od światła, wilgoci i wpływu obcych zapachów. Przechowywać w miejscu niedostępnym i niewidocznym dla dzieci. 6.5 Rodzaj i zawartość opakowania Torebka papierowa powlekana PE i PVDC zawierająca 25g lub 50g wysuszonych pączków sosny. 6.6 Instrukcja dotycząca przygotowania produktu leczniczego do stosowania i usuwania jego pozostałości Sposób przygotowania produktu leczniczego do stosowania – patrz punkt 4.2. 7. PODMIOT ODPOWIEDZIALNY POSIADAJĄCY POZWOLENIE NA DOPUSZCZENIE DO OBROTU Zakład Konfekcjonowania Ziół FLOS Elżbieta i Jan Głąb 98-345 Mokrsko 118 8. NUMER(-Y) POZWOLENIA NA DOPUSZCZENIE DO OBROTU 4683 9. DATA WYDANIA PIERWSZEGO POZWOLENIA NA DOPUSZCZENIE DO OBROTU / DATA PRZEDŁUŻENIA POZWOLENIA 17.09.1999 r. / 04.03.2005 r./ 10.02.2006 r./ 13.08.2008 r.
10. DATA ZATWIERDZENIA LUB CZĘŚCIOWEJ ZMIANY TEKSTU CHARAKTERYSTYKI PRODUKTU LECZNICZEGO.



16-2-2019

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Published on: Fri, 15 Feb 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 (AfB1) binder for all animal species; the additive is composed of bentonite feed grade and algae belonging to Ulva spp. The European Commission request follows an opinion of the FEEDAP Panel published in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-2-2019

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Pesticide active substances that do not require a review of the existing maximum residue levels under Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 12 Feb 2019 According to Article 12(1) of Regulation (EC) No 396/2005, EFSA shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance. Among the active substances that need to be reviewed under Article 12(1) of Regulation (EC) No 396/2005, EFSA identified 13 active substances for which a review of MRLs i...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for flutolanil

Evaluation of confirmatory data following the Article 12 MRL review for flutolanil

Published on: Mon, 04 Feb 2019 The applicant Nihon Nohyaku Co. Ltd. submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flutolanil in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to new residue trials for globe artichokes and beans with pods and for storage stability data in products of animal origin were addressed. Further risk mana...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for imazamox

Evaluation of confirmatory data following the Article 12 MRL review for imazamox

Published on: Fri, 01 Feb 2019 The applicant BASF SE submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for imazamox in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, the applicant submitted new residue trials on rice. Since the number of trials was not sufficient, the data gap was considered only partially addressed. The remaining dat...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

Opinion/decision on a Paediatric investigation plan (PIP): Otezla,apremilast, decision type: , therapeutic area: , PIP number: P/0398/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,ivacaftor, decision type: , therapeutic area: , PIP number: P/0353/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,ivacaftor, decision type: , therapeutic area: , PIP number: P/0353/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco,ivacaftor, decision type: , therapeutic area: , PIP number: P/0353/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa,Dabigatran etexilate mesilate, decision type: , therapeutic area: , PIP number: P/0399/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa,Dabigatran etexilate mesilate, decision type: , therapeutic area: , PIP number: P/0399/2018

Opinion/decision on a Paediatric investigation plan (PIP): Pradaxa,Dabigatran etexilate mesilate, decision type: , therapeutic area: , PIP number: P/0399/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,Edoxaban (tosylate), decision type: , therapeutic area: , PIP number: P/0368/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,Edoxaban (tosylate), decision type: , therapeutic area: , PIP number: P/0368/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lixiana,Edoxaban (tosylate), decision type: , therapeutic area: , PIP number: P/0368/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx,Secukinumab, decision type: , therapeutic area: , PIP number: P/0372/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx,Secukinumab, decision type: , therapeutic area: , PIP number: P/0372/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx,Secukinumab, decision type: , therapeutic area: , PIP number: P/0372/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cialis,tadalafil, decision type: , therapeutic area: , PIP number: P/0395/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cialis,tadalafil, decision type: , therapeutic area: , PIP number: P/0395/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cialis,tadalafil, decision type: , therapeutic area: , PIP number: P/0395/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Votrient,pazopanib, decision type: , therapeutic area: , PIP number: P/0405/2018

Opinion/decision on a Paediatric investigation plan (PIP): Votrient,pazopanib, decision type: , therapeutic area: , PIP number: P/0405/2018

Opinion/decision on a Paediatric investigation plan (PIP): Votrient,pazopanib, decision type: , therapeutic area: , PIP number: P/0405/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab, decision type: , therapeutic area: , PIP number: P/0404/2018

Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab, decision type: , therapeutic area: , PIP number: P/0404/2018

Opinion/decision on a Paediatric investigation plan (PIP): Evinacumab, decision type: , therapeutic area: , PIP number: P/0404/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Evobrutinib, decision type: , therapeutic area: , PIP number: P/0393/2018

Opinion/decision on a Paediatric investigation plan (PIP): Evobrutinib, decision type: , therapeutic area: , PIP number: P/0393/2018

Opinion/decision on a Paediatric investigation plan (PIP): Evobrutinib, decision type: , therapeutic area: , PIP number: P/0393/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): brigatinib, decision type: , therapeutic area: , PIP number: P/0350/2018

Opinion/decision on a Paediatric investigation plan (PIP): brigatinib, decision type: , therapeutic area: , PIP number: P/0350/2018

Opinion/decision on a Paediatric investigation plan (PIP): brigatinib, decision type: , therapeutic area: , PIP number: P/0350/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Janus Kinase-1 inhibitor (PF-04965842), decision type: , therapeutic area: , PIP number: P/0391/2018

Opinion/decision on a Paediatric investigation plan (PIP): Janus Kinase-1 inhibitor (PF-04965842), decision type: , therapeutic area: , PIP number: P/0391/2018

Opinion/decision on a Paediatric investigation plan (PIP): Janus Kinase-1 inhibitor (PF-04965842), decision type: , therapeutic area: , PIP number: P/0391/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated), decision type: , therapeutic area: , PIP number: P/0390/2018

Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated), decision type: , therapeutic area: , PIP number: P/0390/2018

Opinion/decision on a Paediatric investigation plan (PIP): SER-109 (Eubacterial Spores, Purified Suspension, Encapsulated), decision type: , therapeutic area: , PIP number: P/0390/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): pemigatinib, decision type: , therapeutic area: , PIP number: P/0386/2018

Opinion/decision on a Paediatric investigation plan (PIP): pemigatinib, decision type: , therapeutic area: , PIP number: P/0386/2018

Opinion/decision on a Paediatric investigation plan (PIP): pemigatinib, decision type: , therapeutic area: , PIP number: P/0386/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc, decision type: , therapeutic area: , PIP number: P/0392/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc, decision type: , therapeutic area: , PIP number: P/0392/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cenicriviroc, decision type: , therapeutic area: , PIP number: P/0392/2018

Europe - EMA - European Medicines Agency

14-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Calcifediol, decision type: , therapeutic area: , PIP number: P/0339/2018

Opinion/decision on a Paediatric investigation plan (PIP): Calcifediol, decision type: , therapeutic area: , PIP number: P/0339/2018

Opinion/decision on a Paediatric investigation plan (PIP): Calcifediol, decision type: , therapeutic area: , PIP number: P/0339/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Alecensa,Alectinib, decision type: , therapeutic area: , PIP number: P/0359/2018

Opinion/decision on a Paediatric investigation plan (PIP): Alecensa,Alectinib, decision type: , therapeutic area: , PIP number: P/0359/2018

Opinion/decision on a Paediatric investigation plan (PIP): Alecensa,Alectinib, decision type: , therapeutic area: , PIP number: P/0359/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Flurpiridaz F18, decision type: , therapeutic area: , PIP number: P/0396/2018

Opinion/decision on a Paediatric investigation plan (PIP): Flurpiridaz F18, decision type: , therapeutic area: , PIP number: P/0396/2018

Opinion/decision on a Paediatric investigation plan (PIP): Flurpiridaz F18, decision type: , therapeutic area: , PIP number: P/0396/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin,Ezetimibe, decision type: , therapeutic area: , PIP number: P/0374/2018

Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin,Ezetimibe, decision type: , therapeutic area: , PIP number: P/0374/2018

Opinion/decision on a Paediatric investigation plan (PIP): Atorvastatin,Ezetimibe, decision type: , therapeutic area: , PIP number: P/0374/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ipatasertib, decision type: , therapeutic area: , PIP number: P/0383/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ipatasertib, decision type: , therapeutic area: , PIP number: P/0383/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ipatasertib, decision type: , therapeutic area: , PIP number: P/0383/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Molibresib, decision type: , therapeutic area: , PIP number: P/0375/2018

Opinion/decision on a Paediatric investigation plan (PIP): Molibresib, decision type: , therapeutic area: , PIP number: P/0375/2018

Opinion/decision on a Paediatric investigation plan (PIP): Molibresib, decision type: , therapeutic area: , PIP number: P/0375/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Avadomide, decision type: , therapeutic area: , PIP number: P/0379/2018

Opinion/decision on a Paediatric investigation plan (PIP): Avadomide, decision type: , therapeutic area: , PIP number: P/0379/2018

Opinion/decision on a Paediatric investigation plan (PIP): Avadomide, decision type: , therapeutic area: , PIP number: P/0379/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, decision type: , therapeutic area: , PIP number: P/0382/2018

Europe - EMA - European Medicines Agency

13-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Selinexor, decision type: , therapeutic area: , PIP number: P/0384/2018

Opinion/decision on a Paediatric investigation plan (PIP): Selinexor, decision type: , therapeutic area: , PIP number: P/0384/2018

Opinion/decision on a Paediatric investigation plan (PIP): Selinexor, decision type: , therapeutic area: , PIP number: P/0384/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Indacaterol (acetate),mometasone (furoate), decision type: , therapeutic area: , PIP number: P/0292/2018

Opinion/decision on a Paediatric investigation plan (PIP): Indacaterol (acetate),mometasone (furoate), decision type: , therapeutic area: , PIP number: P/0292/2018

Opinion/decision on a Paediatric investigation plan (PIP): Indacaterol (acetate),mometasone (furoate), decision type: , therapeutic area: , PIP number: P/0292/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Fasenra,benralizumab, decision type: , therapeutic area: , PIP number: P/0244/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fasenra,benralizumab, decision type: , therapeutic area: , PIP number: P/0244/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fasenra,benralizumab, decision type: , therapeutic area: , PIP number: P/0244/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Iclusig,ponatinib, decision type: , therapeutic area: , PIP number: P/0293/2018

Opinion/decision on a Paediatric investigation plan (PIP): Iclusig,ponatinib, decision type: , therapeutic area: , PIP number: P/0293/2018

Opinion/decision on a Paediatric investigation plan (PIP): Iclusig,ponatinib, decision type: , therapeutic area: , PIP number: P/0293/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Caplacizumab, decision type: , therapeutic area: , PIP number: P/0294/2018

Opinion/decision on a Paediatric investigation plan (PIP): Caplacizumab, decision type: , therapeutic area: , PIP number: P/0294/2018

Opinion/decision on a Paediatric investigation plan (PIP): Caplacizumab, decision type: , therapeutic area: , PIP number: P/0294/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): brexpiprazole, decision type: , therapeutic area: , PIP number: P/0316/2018

Opinion/decision on a Paediatric investigation plan (PIP): brexpiprazole, decision type: , therapeutic area: , PIP number: P/0316/2018

Opinion/decision on a Paediatric investigation plan (PIP): brexpiprazole, decision type: , therapeutic area: , PIP number: P/0316/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Forxiga,Dapagliflozin, decision type: , therapeutic area: , PIP number: P/0307/2018

Opinion/decision on a Paediatric investigation plan (PIP): Forxiga,Dapagliflozin, decision type: , therapeutic area: , PIP number: P/0307/2018

Opinion/decision on a Paediatric investigation plan (PIP): Forxiga,Dapagliflozin, decision type: , therapeutic area: , PIP number: P/0307/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Romosozumab, decision type: , therapeutic area: , PIP number: P/0247/2018

Opinion/decision on a Paediatric investigation plan (PIP): Romosozumab, decision type: , therapeutic area: , PIP number: P/0247/2018

Opinion/decision on a Paediatric investigation plan (PIP): Romosozumab, decision type: , therapeutic area: , PIP number: P/0247/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Alprolix,eftrenonacog alfa, decision type: , therapeutic area: , PIP number: P/0296/2018

Opinion/decision on a Paediatric investigation plan (PIP): Alprolix,eftrenonacog alfa, decision type: , therapeutic area: , PIP number: P/0296/2018

Opinion/decision on a Paediatric investigation plan (PIP): Alprolix,eftrenonacog alfa, decision type: , therapeutic area: , PIP number: P/0296/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Adasuve,loxapine, decision type: , therapeutic area: , PIP number: P/0295/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adasuve,loxapine, decision type: , therapeutic area: , PIP number: P/0295/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adasuve,loxapine, decision type: , therapeutic area: , PIP number: P/0295/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Bydureon,exenatide, decision type: , therapeutic area: , PIP number: P/0297/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bydureon,exenatide, decision type: , therapeutic area: , PIP number: P/0297/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bydureon,exenatide, decision type: , therapeutic area: , PIP number: P/0297/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lanthanum carbonate hydrate, decision type: , therapeutic area: , PIP number: P/0303/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lanthanum carbonate hydrate, decision type: , therapeutic area: , PIP number: P/0303/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lanthanum carbonate hydrate, decision type: , therapeutic area: , PIP number: P/0303/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Olysio,simeprevir, decision type: , therapeutic area: , PIP number: P/0325/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olysio,simeprevir, decision type: , therapeutic area: , PIP number: P/0325/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olysio,simeprevir, decision type: , therapeutic area: , PIP number: P/0325/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Omadacycline, decision type: , therapeutic area: , PIP number: P/0269/2018

Opinion/decision on a Paediatric investigation plan (PIP): Omadacycline, decision type: , therapeutic area: , PIP number: P/0269/2018

Opinion/decision on a Paediatric investigation plan (PIP): Omadacycline, decision type: , therapeutic area: , PIP number: P/0269/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz,Tofacitinib, decision type: , therapeutic area: , PIP number: P/0275/2018

Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz,Tofacitinib, decision type: , therapeutic area: , PIP number: P/0275/2018

Opinion/decision on a Paediatric investigation plan (PIP): Xeljanz,Tofacitinib, decision type: , therapeutic area: , PIP number: P/0275/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1), decision type: , therapeutic area: , PIP number: P/0249/2018

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1), decision type: , therapeutic area: , PIP number: P/0249/2018

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens - A/turkey/Turkey/1/05 (H5N1), decision type: , therapeutic area: , PIP number: P/0249/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Benlysta,belimumab, decision type: , therapeutic area: , PIP number: P/0313/2018

Opinion/decision on a Paediatric investigation plan (PIP): Benlysta,belimumab, decision type: , therapeutic area: , PIP number: P/0313/2018

Opinion/decision on a Paediatric investigation plan (PIP): Benlysta,belimumab, decision type: , therapeutic area: , PIP number: P/0313/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga,Eliglustat (tartrate), decision type: , therapeutic area: , PIP number: P/0298/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga,Eliglustat (tartrate), decision type: , therapeutic area: , PIP number: P/0298/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cerdelga,Eliglustat (tartrate), decision type: , therapeutic area: , PIP number: P/0298/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Fycompa,perampanel, decision type: , therapeutic area: , PIP number: P/0308/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fycompa,perampanel, decision type: , therapeutic area: , PIP number: P/0308/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fycompa,perampanel, decision type: , therapeutic area: , PIP number: P/0308/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu,Oseltamivir (phosphate), decision type: , therapeutic area: , PIP number: P/0251/2018

Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu,Oseltamivir (phosphate), decision type: , therapeutic area: , PIP number: P/0251/2018

Opinion/decision on a Paediatric investigation plan (PIP): Tamiflu,Oseltamivir (phosphate), decision type: , therapeutic area: , PIP number: P/0251/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Brintellix,Vortioxetine, decision type: , therapeutic area: , PIP number: P/0234/2018

Opinion/decision on a Paediatric investigation plan (PIP): Brintellix,Vortioxetine, decision type: , therapeutic area: , PIP number: P/0234/2018

Opinion/decision on a Paediatric investigation plan (PIP): Brintellix,Vortioxetine, decision type: , therapeutic area: , PIP number: P/0234/2018

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Keytruda,pembrolizumab,  31/01/2019,  Positive

Summary of opinion: Keytruda,pembrolizumab, 31/01/2019, Positive

Summary of opinion: Keytruda,pembrolizumab, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Ajovy,fremanezumab,  01/02/2019,  Positive

Summary of opinion: Ajovy,fremanezumab, 01/02/2019, Positive

Summary of opinion: Ajovy,fremanezumab, 01/02/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Tecentriq,atezolizumab,  31/01/2019,  Positive

Summary of opinion: Tecentriq,atezolizumab, 31/01/2019, Positive

Summary of opinion: Tecentriq,atezolizumab, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Doxolipad,doxorubicin hydrochloride,  31/01/2019,  Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Edistride,dapagliflozin,  31/01/2019,  Positive

Summary of opinion: Edistride,dapagliflozin, 31/01/2019, Positive

Summary of opinion: Edistride,dapagliflozin, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Idacio,adalimumab,  31/01/2019,  Positive

Summary of opinion: Idacio,adalimumab, 31/01/2019, Positive

Summary of opinion: Idacio,adalimumab, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Forxiga,dapagliflozin,  31/01/2019,  Positive

Summary of opinion: Forxiga,dapagliflozin, 31/01/2019, Positive

Summary of opinion: Forxiga,dapagliflozin, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: MabThera,rituximab,  31/01/2019,  Positive

Summary of opinion: MabThera,rituximab, 31/01/2019, Positive

Summary of opinion: MabThera,rituximab, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Praluent,alirocumab,  31/01/2019,  Positive

Summary of opinion: Praluent,alirocumab, 31/01/2019, Positive

Summary of opinion: Praluent,alirocumab, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Atazanavir Krka,atazanavir,  31/01/2019,  Positive

Summary of opinion: Atazanavir Krka,atazanavir, 31/01/2019, Positive

Summary of opinion: Atazanavir Krka,atazanavir, 31/01/2019, Positive

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Kromeya,adalimumab,  31/01/2019,  Positive

Summary of opinion: Kromeya,adalimumab, 31/01/2019, Positive

Summary of opinion: Kromeya,adalimumab, 31/01/2019, Positive

Europe - EMA - European Medicines Agency