YAZ 0,02/3

Informació principal

  • Denominació comercial:
  • YAZ 0,02/3 mg 3x28 comprimidos recubiertos
  • formulario farmacéutico:
  • Comprimidos
  • Vía de administración:
  • Oral
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • YAZ 0,02/3 mg 3x28 comprimidos recubiertos
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 661541
  • última actualització:
  • 09-06-2018

Prospecte: composició, indicacions, interacció, posologia, embaràs, lactància, reaccions adverses

YAZ 0,02/3 mg 3x28 comprimidos recubiertos

etinilestradiol+drospirenona

Indicacions

Medicament utilitzat per evitar quedar embarassada (ANTICONCEPTIU).

Consideracions

Prengui els comprimits sencers, sense partir ni mastegar, empassant-los amb ajuda d'un got d'aigua.

Prengui aquest medicament sempre a la mateixa hora.

L'efic

cia anticonceptiva del preparat es pot veure redu

da si oblida la presa d'alguna de les dosis.

Si s'adona de l'oblit de la presa dins de les 12 hores seg

ents a l'hora habitual de la presa, ha de prendre

el comprimit immediatament i continuar el tractament normalment, prenent el seg

ent comprimit a

l'hora habitual. .

Si s'adona de l'oblit de la presa despr

s de les 12 hores seg

ents a l'hora habitual de la presa, ja no es

pot assegurar la protecci

anticonceptiva. Ha de prendre l'

ltim comprimit oblidat immediatament i

continuar el tractament fins a acabar l'env

s juntament amb altres m

todes de control de l'embar

fins a comen

ar el seg

ent env

Aquest medicament modifica l'acci

d'altres f

rmacs, NO prengui altres medicaments sense consultar

abans al seu metge o farmac

utic.

Efectes adversos

Interrompi immediatament el tractament i AVISI al seu metge si durant el tractament apareix mal de cap

fort i duratiu, visi

borrosa, augment de la tensi

arterial o sagnats irregulars.

Aquest medicament pot produir mol

sties gastrointestinals (n

usees, v

mits, etc.), dolor

abdominal i p

rdua de gana.

Si not

s qualsevol altre s

mptoma que creu que pot ser causat per aquest medicament, digui-li-ho al

seu metge.

Posologia

Prengui 1 comprimit a l'esmorzar.

Prengui aquest medicament durant 28 dies al mes, sense cap dia de descans.

VIA ORAL.

3-4-2019


Paediatric Committee (PDCO): 26 February-1 March 2019, European Medicines Agency, from 26/02/2019 to 01/03/2019

Paediatric Committee (PDCO): 26 February-1 March 2019, European Medicines Agency, from 26/02/2019 to 01/03/2019

Paediatric Committee (PDCO): 26 February-1 March 2019, European Medicines Agency, from 26/02/2019 to 01/03/2019

Europe - EMA - European Medicines Agency

3-4-2019

Assessment of the application for renewal of the authorisation of Natuphos (3‐phytase) as a feed additive for poultry and pigs

Assessment of the application for renewal of the authorisation of Natuphos (3‐phytase) as a feed additive for poultry and pigs

Published on: Tue, 02 Apr 2019 Natuphos® is a feed additive that contains 3‐phytase which is produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, piglets (weaned) and pigs for fattening, laying hens and turkeys for fattening, ducks, sows, all minor avian species other than ducks and ornamental birds. This scientific opinion concerns the renewal of the authorisation of this additive for those species. The application also included chickens reared for la...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-4-2019


Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS, European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019

Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS, European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019

Online training: How to submit a 'safety update and update of the status' for parallel distribution via IRIS, European Medicines Agency, Amsterdam, the Netherlands, from 15/02/2019 to 15/02/2019

Europe - EMA - European Medicines Agency

23-3-2019

Baxter recalls two lots of Extraneal peritoneal dialysis solution because of high levels of sodium hypochlorite, which may pose serious health risks

Baxter recalls two lots of Extraneal peritoneal dialysis solution because of high levels of sodium hypochlorite, which may pose serious health risks

Affected products Product DIN Product Code Lot Expiry Extraneal 2L/2L Twinbag 02240806 JB9912 W9B28T0 02/29/2020 Extraneal 7.5% 2.5L SYSII 02240806 JB9923LP W9C05T1 03/31/2020

Health Canada

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-3-2019

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass.

FDA - U.S. Food and Drug Administration

4-3-2019

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.

FDA - U.S. Food and Drug Administration

28-2-2019

Ratio-Nystatin (2019-02-28)

Ratio-Nystatin (2019-02-28)

Health Canada

20-2-2019


Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 February 2019, European Medicines Agency, from 19/02/2019 to 21/02/2019

Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 February 2019, European Medicines Agency, from 19/02/2019 to 21/02/2019

Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 February 2019, European Medicines Agency, from 19/02/2019 to 21/02/2019

Europe - EMA - European Medicines Agency

9-2-2019

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

BIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-1-2019

Software for Benchmark Dose Modelling

Software for Benchmark Dose Modelling

Published on: Mon, 14 Jan 2019 In specific contract No 7 issued under the framework agreement OC/EFSA/AMU/2015/02, EFSA requested Open Analytics to extend the Web application for Benchmark Dose Modelling built under specific contracts No 3 and No 4. The Web application is further developed in R with focus on creating a graphical module to evaluate model fit and to modify specific plot settings, as specified in the Technical Annex to Specific Contract No 7. The web application includes the latest develop...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-4-2019


Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

17-4-2019


Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease,

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease,

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease, Date of authorisation: 02/04/2019, Status: Authorised

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Venetoclax, Treatment of acute myeloid leukaemia, 17/02/2016, Withdrawn

Orphan designation: Venetoclax, Treatment of acute myeloid leukaemia, 17/02/2016, Withdrawn

Orphan designation: Venetoclax, Treatment of acute myeloid leukaemia, 17/02/2016, Withdrawn

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of severe combined immunodeficiency due to FOXN1 deficiency, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of CHARGE syndrome, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of CHARGE syndrome, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of CHARGE syndrome, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of DiGeorge syndrome, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of DiGeorge syndrome, 26/02/2019, Positive

Orphan designation: Allogeneic cultured postnatal thymus-derived tissue, Treatment of DiGeorge syndrome, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: losartan, Treatment of epidermolysis bullosa, 26/02/2019, Positive

Orphan designation: losartan, Treatment of epidermolysis bullosa, 26/02/2019, Positive

Orphan designation: losartan, Treatment of epidermolysis bullosa, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, Treatment of infantile neuroaxonal dystrophy, 26/02/2019, Positive

Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, Treatment of infantile neuroaxonal dystrophy, 26/02/2019, Positive

Orphan designation: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, Treatment of infantile neuroaxonal dystrophy, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Risdiplam, Treatment of spinal muscular atrophy, 26/02/2019, Positive

Orphan designation: Risdiplam, Treatment of spinal muscular atrophy, 26/02/2019, Positive

Orphan designation: Risdiplam, Treatment of spinal muscular atrophy, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Orphan designation: Autologous adult live cultured osteoblasts, Treatment of non-traumatic osteonecrosis, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

5-4-2019


Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Europe - EMA - European Medicines Agency

3-4-2019

EU/3/19/2147 (Gilead Sciences Ireland UC)

EU/3/19/2147 (Gilead Sciences Ireland UC)

EU/3/19/2147 (Active substance: 2-[3-(2-chloro-4-{[5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-yl]methoxy}phenyl)-3-hydroxyazetidin-1-yl]pyridine-4-carboxylic acid-2-amino-2-(hydroxymethyl)propane-1,3-diol (1/1)) - Orphan designation - Commission Decision (2019)2663 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002498

Europe -DG Health and Food Safety

2-4-2019

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Active substance: methotrexate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2624 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3756/T/7

Europe -DG Health and Food Safety

2-4-2019

EU/3/06/374 (Therakos Europe Limited)

EU/3/06/374 (Therakos Europe Limited)

EU/3/06/374 (Active substance: Methoxsalen) - Transfer of orphan designation - Commission Decision (2019)2420 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004676

Europe -DG Health and Food Safety

2-4-2019

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Transfer of orphan designation - Commission Decision (2019)2411 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004889

Europe -DG Health and Food Safety

2-4-2019

Arti-Cell Forte (Global Stem cell Technology (G.S.T.) NV)

Arti-Cell Forte (Global Stem cell Technology (G.S.T.) NV)

Arti-Cell Forte (Active substance: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells) - Centralised - Authorisation - Commission Decision (2019)2625 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4727

Europe -DG Health and Food Safety

2-4-2019

EU/3/17/1868 (Diamond ROC EOOD)

EU/3/17/1868 (Diamond ROC EOOD)

EU/3/17/1868 (Active substance: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine) - Transfer of orphan designation - Commission Decision (2019)2407 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004677

Europe -DG Health and Food Safety

14-3-2019


Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

7-3-2019

Granpidam (Accord Healthcare S.L.U.)

Granpidam (Accord Healthcare S.L.U.)

Granpidam (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1914 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4289/T/02

Europe -DG Health and Food Safety

5-3-2019

Lacosamide Accord (Accord Healthcare S.L.U.)

Lacosamide Accord (Accord Healthcare S.L.U.)

Lacosamide Accord (Active substance: lacosamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1831 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4443/T/02

Europe -DG Health and Food Safety

1-3-2019


Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019


Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019


Summary of opinion: Skyrizi,risankizumab,  28/02/2019,  Positive

Summary of opinion: Skyrizi,risankizumab, 28/02/2019, Positive

Summary of opinion: Skyrizi,risankizumab, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Summary of opinion: Trydonis,beclometasone / formoterol / glycopyrronium bromide,  28/02/2019,  Positive

Summary of opinion: Trydonis,beclometasone / formoterol / glycopyrronium bromide, 28/02/2019, Positive

Summary of opinion: Trydonis,beclometasone / formoterol / glycopyrronium bromide, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Summary of opinion: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.),beclometasone / formoterol / glycopyrronium bromide,  28/02/2019,  Positive

Summary of opinion: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.),beclometasone / formoterol / glycopyrronium bromide, 28/02/2019, Positive

Summary of opinion: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.),beclometasone / formoterol / glycopyrronium bromide, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Summary of opinion: Dectova,Zanamivir,  28/02/2019,  Positive

Summary of opinion: Dectova,Zanamivir, 28/02/2019, Positive

Summary of opinion: Dectova,Zanamivir, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Summary of opinion: Palynziq,pegvaliase,  28/02/2019,  Positive

Summary of opinion: Palynziq,pegvaliase, 28/02/2019, Positive

Summary of opinion: Palynziq,pegvaliase, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Withdrawn application: Epjevy, pacritinib, Date of withdrawal: 07/02/2019, Initial authorisation

Withdrawn application: Epjevy, pacritinib, Date of withdrawal: 07/02/2019, Initial authorisation

Withdrawn application: Epjevy, pacritinib, Date of withdrawal: 07/02/2019, Initial authorisation

Europe - EMA - European Medicines Agency

1-3-2019


Summary of opinion: Viread,tenofovir disoproxil,  28/02/2019,  Positive

Summary of opinion: Viread,tenofovir disoproxil, 28/02/2019, Positive

Summary of opinion: Viread,tenofovir disoproxil, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Summary of opinion: Ondexxya,andexanet alfa,  28/02/2019,  Positive

Summary of opinion: Ondexxya,andexanet alfa, 28/02/2019, Positive

Summary of opinion: Ondexxya,andexanet alfa, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Summary of opinion: Waylivra,volanesorsen,  28/02/2019,  Positive

Summary of opinion: Waylivra,volanesorsen, 28/02/2019, Positive

Summary of opinion: Waylivra,volanesorsen, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Europe - EMA - European Medicines Agency

1-3-2019


Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

28-2-2019


Summary of opinion: Zynquista,sotagliflozin,  28/02/2019,  Positive

Summary of opinion: Zynquista,sotagliflozin, 28/02/2019, Positive

Summary of opinion: Zynquista,sotagliflozin, 28/02/2019, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Summary of opinion: ReproCyc ParvoFLEX,porcine parvovirosis vaccine (inactivated),  21/02/2019,  Positive

Summary of opinion: ReproCyc ParvoFLEX,porcine parvovirosis vaccine (inactivated), 21/02/2019, Positive

Summary of opinion: ReproCyc ParvoFLEX,porcine parvovirosis vaccine (inactivated), 21/02/2019, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Summary of opinion: Chanhold,selamectin,  22/02/2019,  Positive

Summary of opinion: Chanhold,selamectin, 22/02/2019, Positive

Summary of opinion: Chanhold,selamectin, 22/02/2019, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Summary of opinion: Felisecto Plus,selamectin / sarolaner,  22/02/2019,  Positive

Summary of opinion: Felisecto Plus,selamectin / sarolaner, 22/02/2019, Positive

Summary of opinion: Felisecto Plus,selamectin / sarolaner, 22/02/2019, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Summary of opinion: Forceris,toltrazuril,gleptoferron,  21/02/2019,  Positive

Summary of opinion: Forceris,toltrazuril,gleptoferron, 21/02/2019, Positive

Summary of opinion: Forceris,toltrazuril,gleptoferron, 21/02/2019, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Summary of opinion: HorStem,equine umbilical cord mesenchymal stem cells,  21/02/2019,  Positive

Summary of opinion: HorStem,equine umbilical cord mesenchymal stem cells, 21/02/2019, Positive

Summary of opinion: HorStem,equine umbilical cord mesenchymal stem cells, 21/02/2019, Positive

Europe - EMA - European Medicines Agency

20-2-2019


Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201807

Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201807

Levonorgestrel / ethinylestradiol, ethinylestradiol (combination pack): List of nationally authorised medicinal products - PSUSA/00010442/201807

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Orphan designation: miglustat, Treatment of Niemann-Pick disease, type C, 16/02/2006, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: azacitidine, Treatment of myelodysplastic syndromes, 06/02/2002, Expired

Orphan designation: azacitidine, Treatment of myelodysplastic syndromes, 06/02/2002, Expired

Orphan designation: azacitidine, Treatment of myelodysplastic syndromes, 06/02/2002, Expired

Europe - EMA - European Medicines Agency

6-2-2019

Zycortal (Dechra Regulatory B.V.)

Zycortal (Dechra Regulatory B.V.)

Zycortal (Active substance: desoxycortone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)914 of Wed, 06 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3782/T/02

Europe -DG Health and Food Safety

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: Febuxostat Krka,febuxostat,  01/02/2019,  Positive

Summary of opinion: Febuxostat Krka,febuxostat, 01/02/2019, Positive

Summary of opinion: Febuxostat Krka,febuxostat, 01/02/2019, Positive

Europe - EMA - European Medicines Agency

28-1-2019


Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

25-1-2019

Trimbow (Chiesi Farmaceutici S.p.A.)

Trimbow (Chiesi Farmaceutici S.p.A.)

Trimbow (Active substance: beclometasone / formoterol / glycopyrronium bromide) - Centralised - 2-Monthly update - Commission Decision (2019)686 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4257/II/02

Europe -DG Health and Food Safety

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency