TYLEX 30 MG/500 MG EFFERVESCENT TABLETS

Main information

  • Trade name:
  • TYLEX 30 MG/500 MG EFFERVESCENT TABLETS
  • Available from:
  • UCB (Pharma) Ireland Limited
  • Dosage:
  • 30/500 Milligram
  • Pharmaceutical form:
  • Tablets Effervescent
  • Medicine type:
  • Human

Localization

  • Available in:
  • Ireland
  • Language:
  • English

Therapeutic information

Status

  • Source:
  • IMB
  • Authorization date:
  • 2010-09-03

Documents

21-7-2015

Safety of 2'-<i>O</i>-fucosyllactose as a novel food ingredient pursuant to Regulation (EC) No 258/97

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 2'-O-fucosyllactose as a novel food ingredient (NFI) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 2'-O-fucosyllactose (2'-FL) is a synthetic tr...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-7-2015

Safety of lacto-<i>N</i>-neotetraose as a novel food ingredient pursuant to Regulation (EC) No 258/97

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on lacto-N-neotetraose as a novel food ingredient (NFI) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. Lacto-N-neotetraose (LNnT) is a synthetic ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-7-2015

Modification of the existing maximum residue level for thiacloprid in Jerusalem artichokes

European Food Safety Authority In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Belgium, compiled an application to modify the existing maximum residue level (MRL) for the active substance thiacloprid in Jerusalem artichokes. In order to accommodate for the intended use of thiacloprid Belgium proposed to raise the value of the existing MRL from the limit of quantification (LOQ) of 0.02 mg/kg to 0.05 mg/kg. Belgium drafted an evaluation repo...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-7-2015

Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbita

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) The Panel on Food Additives and Nutrient Sources added to Food (ANS) re-evaluated the safety of polysorbate 20 (E 432), polysorbate 80 (E 433), polysorbate 40 (E 434), polysorbate 60 (E 435) and polysorbate 65 (E 436) as food additives. The Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) derived an Acceptable...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2015

Modification of the existing maximum residue level for metalaxyl-M in gooseberries

European Food Safety Authority In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), the United Kingdom, received an application from the UK Agriculture and Horticulture Development Board to modify the existing maximum residue level (MRL) for the active substance metalaxyl-M in gooseberries. In order to accommodate for the intended use of metalaxyl-M, the United Kingdom proposed to raise the existing MRL from the limit of quantification to 0.3 mg/kg. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2015

Reasoned opinion on the setting of maximum residue levels for tefluthrin in various crops

European Food Safety Authority In accordance with Article 6 of Regulation (EC) No 396/2005, France, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Agro S.A.S. to modify the existing maximum residue levels (MRLs) for the active substance tefluthrin in beetroots, celeriacs, radishes, swedes, turnips, garlic, onions, shallots, herbal infusions from roots, root and rhizome spices, sugar beet and chicory roots. In order to accommodate for the intende...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-7-2015

ACUSON DIAGNOSTIC ULTRASOUND SYSTEMS (2015-06-30)

Canada - Health Canada

15-7-2015

Scientific Opinion on the safety assessment of the substance perfluoromethyl perfluorovinylether, CAS No 1187-93-5, for use in food contact materials

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety re-evaluation of perfluoromethyl perfluorovinylether, CAS No 1187-93-5 and FCM No 391, as a co-monomer for fluoro- and perfluoropolymers. The polymers are intended to be used for the production of O-rings, gaskets and seals for repeated u...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-7-2015

African swine fever

EFSA Panel on Animal Health and Welfare (AHAW) Since entering the eastern EU at the start of 2014, African swine fever (ASF) has spread locally in the wild boar population, independently of outbreaks in domestic pigs. No correlation between the density of the wild boar population and the case notification in an area has been observed. The source of virus introduction appeared to be the low biosecurity level in backyard farms; yet, direct contact between pigs and wild boar ...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-7-2015

Scientific Opinion on the safety of use of dimethyl ether as an extraction solvent under the intended conditions of use and the proposed maximum residual limits

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Dimethyl ether was previously evaluated by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) and considered to give rise to no safety concerns under the conditions of use and the maximum residual limits proposed by the applicant. The present scientific opinion of the EFSA CEF Panel deals with the re-evaluation of the safety of dimethyl ether as...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-7-2015

Setting of an import tolerance for chlorothalonil in cranberries

European Food Safety Authority In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), the Netherlands, received an application from the Cranberry Marketing Committee USA to set an import tolerance for the active substance chlorothalonil in cranberries from import country USA at the proposed level of 10 mg/kg. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitte...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-7-2015

Scientific Opinion on Dietary Reference Values for vitamin E as α-tocopherol

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) derived Dietary Reference Values (DRVs) for vitamin E. In this Opinion, the Panel considers vitamin E as α-tocopherol only. The Panel considers that Average Requirements (ARs) and Population Reference Intakes (PRIs) for vitamin E (as α-tocopherol) cannot be derived for adults, infants...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-7-2015

Phil & teds USA recalls the Cushy Ride Seat Liner

Health Canada's sampling and evaluation program has revealed that this product made, in whole or in part, of polyurethane foam (PUF) contains tris (2-chlorethyl) phosphate (TCEP) and can pose a chemical hazard to young children.

Canada - Health Canada

8-7-2015

Scientific Opinion on the safety and efficacy of VevoVitall® (benzoic acid) as a feed additive for pigs for reproduction (gestating and lactating sows, boars and gilts)

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) VevoVitall® consists of 99.9 % benzoic acid. It is already authorised in the European Union as a zootechnical additive for weaned piglets and pigs for fattening. VevoVitall® is intended to be used in pigs for reproduction to reduce the pH of their urine. The applicant initially linked this effect to the reduction of the ammonia emission from the target animal’s manure and the...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-7-2015

Scientific Opinion on the safety and efficacy of lignosulphonate as a feed additive for all animal species

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Lignosulphonates are amorphous branched polymers of lignin, containing sulphonated covalently linked phenyl propane monomers, produced from the sulphite pulping of lignocellulosic biomasses. The calcium lignosulphonate, sodium lignosulphonate and magnesium lignosulphonate under assessment are considered together under the term lignosulphonate. Lignosulphonate is safe for chickens for fattening,...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-7-2015

Scientific Opinion on the safety and efficacy of ENZY PHOSTAR® (6-phytase) as a feed additive for avian and porcine species

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) ENZY PHOSTAR® is a preparation of 6-phytase produced by a genetically modified strain of Komagataella pastoris to be used as a zootechnical additive in avian and porcine species. Neither the production strain nor its recombinant DNA was detected in the final products. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-7-2015

Ketorolac Tromethamine Injection, USP (2015-06-30)

Canada - Health Canada

7-7-2015

Zenhale Product Recall (2015-06-30)

Canada - Health Canada

4-7-2015

Updating risk management recommendations to limit exposure of non-target Lepidoptera of conservation concern in protected habitats to Bt-maize pollen

EFSA Panel on Genetically Modified Organisms (GMO) Using mathematical modelling, the EFSA GMO Panel has previously quantified the risk to non-target (NT) Lepidoptera of conservation concern, potentially occurring within protected habitats, associated with the ingestion of Bt-maize pollen deposited on their host plants. To reduce the estimated larval mortality to a negligible level, an isolation distance of 20 and 30 m was recommended between protected habitats and the nearest fields of m...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2015

Scientific Opinion on the re-evaluation of oxidised polyethylene wax (E 914) as a food additive

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) The EFSA ANS Panel delivered a scientific opinion re-evaluating the safety of oxidised polyethylene wax (OPEW) (E 914) as a food additive. E 914 is authorised at quantum satis only for the surface treatment of some fruits. The Scientific Committee on Food (SCF) evaluated the use of OPEW as a food additive but could not allocate an ADI and as an additive in food contact materials. The EFSA Panel on Food Contact Mat...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-7-2015

Reasoned opinion on the modification of the existing MRLs for ametoctradin in sage and basil

European Food Safety Authority In accordance with Article 6 of Regulation (EC) No 396/2005, Belgium, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing maximum residue levels (MRLs) for the active substance ametoctradin in sage and basil. In order to accommodate for the intended uses of ametoctradin, Belgium proposed to raise the existing MRLs from the limit of quantification (LOQ) 0.01* mg/kg to 60 mg/kg. Belgium drafted an evaluation report in a...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-7-2015

Scientific opinion on the safety of the extension of use of steviol glycosides (E 960) as a food additive

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Following a request from the European Commission, EFSA carried out an exposure assessment of steviol glycosides (E 960) arising from their use as a food additive, taking into account the proposed extension of uses. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of steviol glycosides (E 960) and established an Acceptable Daily Intake (ADI) o...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-7-2015

Scientific Opinion on the re-evaluation of sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) as food additives

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating sorbic acid (E 200), potassium sorbate (E 202) and calcium sorbate (E 203) when used as food additives. Sorbic acid is absorbed and mainly excreted as expired carbon dioxide. The Panel noted that there was no evidence of genotoxic activity for sorbic acid or potassium sorbate. Sub-acu...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-7-2015

Etopophos 100 mg, Lyophilisat zur Herstellung einer Infusionslösung

Out-of-Stock – befristetes Inverkehrbringen in ausländischer Aufmachung.

Swissmedic - Swiss Agency for Therapeutic Products

20-7-2015

VELTIN (Clindamycin Phosphate And Tretinoin) Gel [Stiefel Laboratories Inc]

Updated Date: Jul 20, 2015 EST

US - DailyMed

17-7-2015

CODEINUM (Codeine) Pellet [Remedy Makers]

Updated Date: Jul 17, 2015 EST

US - DailyMed

17-7-2015

DEXAMETHASONE SODIUM PHOSPHATE Injection, Solution [REMEDYREPACK INC. ]

Updated Date: Jul 17, 2015 EST

US - DailyMed

13-7-2015

VIRTUSSIN A/C (Codeine Phosphate And Guaifenesin) Liquid [Virtus Pharmaceuticals]

Updated Date: Jul 13, 2015 EST

US - DailyMed

13-7-2015

CLINDESSE (Clindamycin Phosphate) Cream [Perrigo New York Inc]

Updated Date: Jul 13, 2015 EST

US - DailyMed

6-7-2015

DEXAMETHASONE SODIUM PHOSPHATE Injection [General Injectables And Vaccines, Inc.]

Updated Date: Jul 6, 2015 EST

US - DailyMed

1-7-2015

ACETAMINOPHEN AND CODEINE PHOSPHATE Tablet [Direct RX]

Updated Date: Jul 1, 2015 EST

US - DailyMed

30-6-2015

CORTIFOAM (Hydrocortisone Acetate) Aerosol, Foam [Meda Pharmaceuticals]

Updated Date: Jun 30, 2015 EST

US - DailyMed

30-6-2015

UDDERGOLD 5-STAR BASE (Sodium Chlorite) Liquid [IBA]

Updated Date: Jun 30, 2015 EST

US - DailyMed

30-6-2015

HYDROCORTISONE WITH ALOE (Hydrocortisone) Cream [Proficient Rx LP]

Updated Date: Jun 30, 2015 EST

US - DailyMed

30-6-2015

OCELLA (Drospirenone And Ethinyl Estradiol) Kit [BARR LABORATORIES, INC.]

Updated Date: Jun 30, 2015 EST

US - DailyMed

30-6-2015

HEMORRHOIDAL (Mineral Oil, Petrolatum, Phenylephrine Hcl) Ointment [Proficient Rx LP]

Updated Date: Jun 30, 2015 EST

US - DailyMed

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