VALS 320 mg 28 comprimidos

Informació principal

  • Denominació comercial:
  • VALS 320 mg 28 comprimidos recubiertos
  • formulario farmacéutico:
  • Comprimidos
  • Vía de administración:
  • Oral
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • VALS 320 mg 28 comprimidos recubiertos
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 660013
  • última actualització:
  • 09-06-2018

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

VALS 320 mg 28 comprimidos recubiertos

valsart

n

Indicacions

Medicament que dilata els vasos sanguinis i normalitza la pressi

sangu

nia (ANTIHIPERTENSIU).

Consideracions

Prengui els comprimits empassant-los amb ajuda d'un got d'aigua.

Pot prendre aquest medicament amb o sense aliments; si t

sties d'est

mac, prengui'l amb

algun aliment.

S'aconsella que prengui aquest medicament sempre en les mateixes condicions per tal d'augmentar la seva

efic

cia.

Segueixi estrictament la pauta indicada pel seu metge pel que fa a dosi i freq

眉猫

ncia d'administraci

Tot i trobar-se millor, NO deixi de prendre aquest medicament durant el temps indicat pel seu metge.

Si fa molt temps que pren aquest medicament, NO deixi de prendre-ho de forma brusca sense consultar-

ho abans amb el seu metge.

Avisi el seu metge si pateix diabetis.

Avisi el seu metge si pateix o ha patit problemes de fetge, problemes de rony

o problemes de cor.

Aquest medicament modifica l'acci

d'altres f

rmacs, NO prengui altres medicaments sense consultar

abans al seu metge o farmac

utic.

s possible que el seu metge li recomani una dieta especial, que conv

seguir per augmentar l'efic

cia d'aquest medicament.

Procuri NO fumar, NO abusar de begudes alcoh

liques NI de begudes amb cafe

na (caf

, te,

refrescs de cola) NI prendre salses picants NI menjars irritants i seguir la dieta especial que el seu metge

li recomani, per augmentar l'efic

cia d'aquest medicament.

NO utilitzi substituts de la sal de taula ni suplements de potassi sense coneixement del seu metge.

Aquest medicament pot modificar el resultat d'algunes an

lisis de sang.

Informi immediatament el seu metge si est

embarassada o creu que pot estar-ho, aix

com si qued

s embarassada durant el tractament.

Avisi al seu metge si t

algun fill a qui estigui alletant.

Efectes adversos

Avisi el seu metge si durant el tractament apareix dificultat per respirar.

Aquest medicament pot produir mol

sties gastrointestinals (n

usees, v

mits, etc.), mal de cap,

sensaci

de cansament i s

mptomes de grip.

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.

VIA ORAL.

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

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 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

15-3-2019

An international scientific conference to provide an update on genomics for food safety

An international scientific conference to provide an update on genomics for food safety

ANSES, the German Federal Institute for Risk Assessment (BfR), the National Food Institute of the Technical University of Denmark (DTU) and the Republic of Korea's National Institute of Food and Drug Safety Evaluation (NIFDS) are holding an international conference on the theme "Foodborne Pathogens & Whole Genome Sequencing: Impact on Public Health Protection", from Tuesday 26 to Thursday 28 March 2019 in Paris.

France - Agence Nationale du Médicament Vétérinaire

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

Modification of the existing maximum residue level for fluopyram in broccoli

Published on: Thu, 14 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance fluopyram in broccoli. The data submitted in support of the request were found to be sufficient to derive MRL proposals for broccoli. Adequate analytical methods for enforcement are available to control the residues of fluopyram on the commodit...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

Published on: Wed, 13 Mar 2019 The Scientific Panel on Food Additives and Flavouring (FAF) provides a scientific opinion on the safety evaluation of annatto E and an exposure assessment of the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive, taking into account new proposed uses and use levels. In 2016, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of annatto extracts (E 160b) as a food additive....

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the 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 Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

1-3-2019

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species

Safety and efficacy of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.248 for all animal species

Published on: Thu, 28 Feb 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐tryptophan produced by fermentation with a genetically modified strain of Escherichia coli CGMCC 7.248 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain E. coli CGMCC 7.248 and its recombinant DNA were not detected in the f...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Aleurocanthus spiniferus and Aleurocanthus woglumi

Pest survey card on Aleurocanthus spiniferus and Aleurocanthus woglumi

Published on: Thu, 28 Feb 2019 Abstract This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its hos...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Clavibacter michiganensis subsp. sepedonicus

Pest survey card on Clavibacter michiganensis subsp. sepedonicus

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Tecia solanivora

Pest survey card on Tecia solanivora

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species

Safety and efficacy of l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ for all animal species

Published on: Thu, 28 Feb 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐threonine produced by fermentation with Corynebacterium glutamicum ■■■■■ when used as a nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l‐threonine produced by fermentation with a ■■■■■ strain of C. glutamicum (■■■■■). l‐Threo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Safety and efficacy of Bonvital (Enterococcus faecium, DSM 7134) as an additive in water for drinking for sows

Safety and efficacy of Bonvital (Enterococcus faecium, DSM 7134) as an additive in water for drinking for sows

Published on: Thu, 28 Feb 2019 The additive Bonvital is a preparation of Enterococcus faecium authorised in feed for piglets and pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. The current authorisation in sows does not include the use of the additive in water for drinking. The additive is intended for use in water for drinking for sows at a minimum level of 2.5 × 108 colony forming unit (CFU)/L. This level is half of that minimum authorised in com...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on potato brown rot, Ralstonia solanacearum

Pest survey card on potato brown rot, Ralstonia solanacearum

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Scirtothrips aurantii, Scirtothrips citri and Scirtothrips dorsalis

Pest survey card on Scirtothrips aurantii, Scirtothrips citri and Scirtothrips dorsalis

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA-Q2017-00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk-based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, i...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Epitrix cucumeris, Epitrix papa, Epitrix subcrinita and Epitrix tuberis

Pest survey card on Epitrix cucumeris, Epitrix papa, Epitrix subcrinita and Epitrix tuberis

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Ceratitis rosa and Ceratitis quilicii

Pest survey card on Ceratitis rosa and Ceratitis quilicii

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Meloidogyne chitwoodi and Meloidogyne fallax

Pest survey card on Meloidogyne chitwoodi and Meloidogyne fallax

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Toxoptera citricida

Pest survey card on Toxoptera citricida

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest categorisation of Thrips palmi

Pest categorisation of Thrips palmi

Published on: Thu, 28 Feb 2019 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Thrips palmi(Thysanoptera: Thripidae), for the EU. T. palmi is listed in Annex IAI of 2000/29 EC. Using molecular methods, cryptic speciation has been shown although no new species from the group have been formally described. Here, we consider T. palmi sensu lato as a defined species native to southern Asia, which has spread to tropical and subtropical countries in Asia, the Pacific, North, Central and...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Modification of the terms of the authorisation of Natuphos® E as a feed additive for chickens for fattening or reared for laying/breeding

Modification of the terms of the authorisation of Natuphos® E as a feed additive for chickens for fattening or reared for laying/breeding

Published on: Thu, 28 Feb 2019 The additive Natuphos® E presents 6‐phytase produced by a genetically modified strain of Aspergillus niger. The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets. The authorisation for chickens for ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest survey card on Globodera rostochiensis and Globodera pallida

Pest survey card on Globodera rostochiensis and Globodera pallida

Published on: Thu, 28 Feb 2019 This pest survey card was prepared in the context of the mandate on plant pest surveillance (EFSA‐Q‐2017‐00831), upon request by the European Commission. The purpose of this document is to assist the Member States in planning annual survey activities of quarantine organisms using a statistically sound and risk‐based pest survey approach, in line with the current international standards. The data requirements for such activity include the pest distribution, its host range, ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

18-3-2019


Orphan designation: Triheptanoin, Treatment of carnitine palmitoyltransferase II deficiency, 28/07/2015, Positive

Orphan designation: Triheptanoin, Treatment of carnitine palmitoyltransferase II deficiency, 28/07/2015, Positive

Orphan designation: Triheptanoin, Treatment of carnitine palmitoyltransferase II deficiency, 28/07/2015, Positive

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


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

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

28-2-2019

EU/3/19/2135 (Enzyvant Therapeutics Ireland Limited)

EU/3/19/2135 (Enzyvant Therapeutics Ireland Limited)

EU/3/19/2135 (Active substance: Allogeneic cultured postnatal thymus-derived tissue) - Orphan designation - Commission Decision (2019)1727 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002975

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2134 (FGK Representative Service GmbH)

EU/3/19/2134 (FGK Representative Service GmbH)

EU/3/19/2134 (Active substance: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester) - Orphan designation - Commission Decision (2019)1726 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002279

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1750 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004372

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1749 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004369

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1748 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004343

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2145 (Roche Registration GmbH)

EU/3/19/2145 (Roche Registration GmbH)

EU/3/19/2145 (Active substance: Risdiplam) - Orphan designation - Commission Decision (2019)1737 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001899

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2143 (Pharma Mar S.A.)

EU/3/19/2143 (Pharma Mar S.A.)

EU/3/19/2143 (Active substance: Lurbinectedin) - Orphan designation - Commission Decision (2019)1735 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001317

Europe -DG Health and Food Safety

28-2-2019

EU/3/14/1250 (Akcea Therapeutics Ireland Limited)

EU/3/14/1250 (Akcea Therapeutics Ireland Limited)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2019)1739 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004311

Europe -DG Health and Food Safety

28-2-2019

EU/3/16/1696 (Clinical Network Services (NL) B.V.)

EU/3/16/1696 (Clinical Network Services (NL) B.V.)

EU/3/16/1696 (Active substance: Autologous Epstein-Barr virus specific T-cells derived from peripheral blood mononuclear cells, expanded ex vivo) - Transfer of orphan designation - Commission Decision (2019)1747 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004066

Europe -DG Health and Food Safety

28-2-2019

EU/3/16/1695 (Clinical Network Services (NL) B.V.)

EU/3/16/1695 (Clinical Network Services (NL) B.V.)

EU/3/16/1695 (Active substance: Autologous Epstein-Barr virus specific T-cells derived from peripheral blood mononuclear cells, expanded ex vivo) - Transfer of orphan designation - Commission Decision (2019)1746 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004064

Europe -DG Health and Food Safety

28-2-2019

EU/3/13/1227 (Clinical Network Services (NL) B.V.)

EU/3/13/1227 (Clinical Network Services (NL) B.V.)

EU/3/13/1227 (Active substance: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo) - Transfer of orphan designation - Commission Decision (2019)1745 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004039

Europe -DG Health and Food Safety

28-2-2019

EU/3/09/635 (Unither Therapeutik GmbH)

EU/3/09/635 (Unither Therapeutik GmbH)

EU/3/09/635 (Active substance: Treprostinil diethanolamine) - Transfer of orphan designation - Commission Decision (2019)1743 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004224

Europe -DG Health and Food Safety

28-2-2019

EU/3/05/310 (Unither Therapeutik GmbH)

EU/3/05/310 (Unither Therapeutik GmbH)

EU/3/05/310 (Active substance: Treprostinil diethanolamine (oral use)) - Transfer of orphan designation - Commission Decision (2019)1742 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004331

Europe -DG Health and Food Safety

28-2-2019

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Active substance: Treprostinil sodium (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)1741 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004330

Europe -DG Health and Food Safety