FELIBEN 70 mcg/h (en 72 h) 5 parches 40 mg

Informació principal

  • Denominació comercial:
  • FELIBEN 70 mcg/h (en 72 h) 5 parches 40 mg
  • formulario farmacéutico:
  • Parche
  • Vía de administración:
  • Transdérmica
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

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  • Disponible en:
  • FELIBEN  70 mcg/h (en 72 h) 5 parches 40 mg
    Andorra
  • Idioma:
  • català

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Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 662948
  • última actualització:
  • 09-06-2018

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

FELIBEN 70 mcg/h (en 72 h) 5 parches 40 mg

buprenorfina

Indicacions

Medicament que alleuja el dolor (ANALG

SIC).

Consideracions

Renti's les mans abans i despr

s de cada aplicaci

Netegi i assequi b

la zona a tractar abans de cada aplicaci

Apliqui's el pegat sobre la pell seca, no irradiada, no irritada, sense ferides i sense borrissol (el borrissol

pot tallar-ho amb tisores per

no afaitar), preferentment al tronc o a la part superior del bra

Si ha d'aplicar un nou pegat, canvi

el lloc d'aplicaci

, per a qu

la pell no s'irriti.

No talli ni utilitzi pegats perforats o deteriorats.

Ha de guardar els pegats en un lloc sec, i evitar la calor i la llum solar directa.

Pot banyar-se, dutxar-se o practicar nataci

amb el pegat, per

eviti exposar-ho a una calor excessiva.

Si el pegat cau, intenti tornar a col

locar-ho. Si no

s possible, tiri-ho i apliqui un de nou.

Ha de canviar el pegat cada 4 dies, alternant el lloc d'aplicaci

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

眉猫

ncia d'administraci

Si vost

nota que disminueix l'efic

cia del medicament, NO augmenti la dosi sense consultar-ho

abans amb el seu metge.

Aquest medicament triga algun temps a fer efecte, NO deixi d'aplicar-se'l encara que al principi no noti

millora.

Avisi el seu metge si pateix asma.

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

Aquest medicament modifica l'acci

d'altres f

rmacs, NO prengui altres medicaments sense consultar

abans al seu metge o farmac

utic.

Mentre duri el tractament NO begui alcohol NI prengui altres medicaments per a dormir, per al refredat,

per a les al

rgies, tranquil

litzants o relaxants musculars sense consultar abans al seu metge, ja

que poden augmentar els efectes adversos.

Aquest medicament pot causar somnol

ncia i disminuir els seus reflexos, per aix

s'aconsella que

vagi amb compte en conduir o en manipular maquin

ria perillosa.

Aquest medicament pot donar un resultat positiu en els controls de dopatge.

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

En tractaments llargs pot apar

ixer depend

ncia f

sica i ps

quica.

Aquest medicament pot produir envermelliment o mol

sties al punt d'aplicaci

, mol

sties

gastrointestinals (n

usees, v

mits, etc.), atordiment o confusi

, mal de cap i augment de la sudoraci

Si apareix restrenyiment,

s aconsellable que segueixi una dieta rica en fibra i begui molta aigua.

Si not

s qualsevol altre s

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

seu metge.

Posologia

Ha de canviar el pegat cada 4 dies, tot rotant el lloc d'aplicaci

VIA TRANSD

RMICA.

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Safety and efficacy of Biomin®DC‐C as a zootechnical feed additive for weaned piglets

Safety and efficacy of Biomin®DC‐C as a zootechnical feed additive for weaned piglets

Published on: Tue, 16 Apr 2019 The additive (trade name Biomin® DC‐C) is a blend of essential oils from oregano (Origanum vulgare L.) and from caraway seed (Carum carvi L.) and three individual compounds (carvacrol, methyl salicylate and l‐menthol) encapsulated with a hydrogenated vegetable oil. The additive is intended for use in feed for weaned piglets at a minimum concentration of 75 mg/kg complete feed and a recommended maximum level of 125 mg/kg complete feed. A tolerance test in which piglets were...

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Published on: Tue, 09 Apr 2019 In 2018, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that whey basic protein isolate obtained by ion exchange chromatography from skimmed cow's milk is safe for human consumption under the proposed conditions of use as infant and follow on formula, meal replacement beverages, foods for special medical purposes and food supplements. Following a request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion ...

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Published on: Fri, 05 Apr 2019 In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the a...

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Theo Chocolate of Seattle, WA is voluntarily recalling 3oz Sea Salt 70% Dark Chocolate bars (UPC 8 74492 00325 8) because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.

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Fact or Fiction: What to Know About Smoking Cessation and Medications

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Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent of current smokers report wanting to quit smoking, but quitting can be hard and often takes multiple attempts. A variety of FDA-approved medications are available to help people successfully quit smoking.

FDA - U.S. Food and Drug Administration

28-3-2019

Safety and efficacy of sorbitan monolaurate as a feed additive for all animal species

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Published on: Wed, 27 Mar 2019 The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. It is intended to be used as a technological additive, functional group: emulsifier, in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that sorbitan monolaurate is safe for all animal species at the proposed ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Lumpy skin disease III. Data collection and analysis

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Published on: Thu, 21 Mar 2019 In 2018, no lumpy skin disease (LSD) outbreaks were reported in the Balkan region, after the decline reported in 2017 (385) compared to 2016 (7,483). This confirms the effectiveness of the vaccination campaign based on the LSD homologous vaccine strain which continued throughout 2018 with over 2.5 million animals vaccinated, keeping the mean vaccination coverage above 70%. In 2018, LSD outbreaks were reported in Russia, Turkey and Georgia. In Russia, the LSD epidemics expa...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

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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

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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

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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

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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

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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...

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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

Modification of the existing maximum residue level for fluopyram in broccoli

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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

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Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

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13-3-2019

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13-3-2019

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

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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)

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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

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Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


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

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7-3-2019

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

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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

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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

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Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

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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

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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

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

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

B&G Foods Voluntarily Recalls a Limited Number of Jars of Victoria® Marinara Sauce Due to Possible Undeclared Cashew

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B&G Foods announced today it is voluntarily recalling 1,280 cases of a single date code of 40 oz. Victoria Marinara Sauce, with a “best by” date of 03/06/2022, after learning that the product may contain cashew allergens that are not declared on the product’s ingredient statement. People who have an allergy or severe sensitivity to cashew run the risk of serious or life-threatening allergic reaction if they consume this product. There is no health risk associated with this product for individuals without...

FDA - U.S. Food and Drug Administration

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. 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 lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 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 trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2019

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

These tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. 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. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Pest categorisation of Cronartium spp. (non‐EU)

Pest categorisation of Cronartium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium spp. (non‐EU), a well‐defined and distinguishable group of fungal pathogens of the family Cronartiaceae. There are at least 40 species described within the Cronartium genus, of which two are considered native to the EU (C. gentianeum and C. pini) and one has been introduced in the 19th century (C. ribicola) and is now widespread in the EU – these t...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

18-2-2019

Jardiance (Boehringer Ingelheim International GmbH)

Jardiance (Boehringer Ingelheim International GmbH)

Jardiance (Active substance: Empagliflozin) - Centralised - Renewal - Commission Decision (2019)1427 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2677/R/40

Europe -DG Health and Food Safety

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

23-1-2019

Eladynos (Radius International Ltd)

Eladynos (Radius International Ltd)

Eladynos (Active substance: abaloparatide) - Refusal of authorisation - Commission Decision (2019)70 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4157

Europe -DG Health and Food Safety

9-1-2019

Thymanax (Servier (Ireland) Industries Limited)

Thymanax (Servier (Ireland) Industries Limited)

Thymanax (Active substance: agomelatine) - Centralised - Renewal - Commission Decision (2019)71 of Wed, 09 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/916/R/40

Europe -DG Health and Food Safety

9-1-2019

Ivabradine Anpharm (ANPHARM Przedsiebiorstwo Farmaceutyczne S.A.)

Ivabradine Anpharm (ANPHARM Przedsiebiorstwo Farmaceutyczne S.A.)

Ivabradine Anpharm (Active substance: ivabradine) - PASS - Modification - Commission Decision (2019)72 of Wed, 09 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4187/PSR/S/19

Europe -DG Health and Food Safety

19-12-2018

Zubsolv (Mundipharma Corporation (Ireland) Limited)

Zubsolv (Mundipharma Corporation (Ireland) Limited)

Zubsolv (Active substance: buprenorphine / naloxone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9063 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004407/T/0003

Europe -DG Health and Food Safety

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency