BECEZE 100 INHALER

Main information

  • Trade name:
  • BECEZE 100 INHALER
  • Available from:
  • Norton
  • Medicine type:
  • Human

Localization

  • Available in:
  • South Africa
  • Language:
  • English

Therapeutic information

Status

  • Source:
  • Sounth African Electronic Package Inserts

Documents

4-7-2015

Scientific Opinion on the safety of UV-treated bread as a novel food EFSA Panel on Dietetic Products, Nutrition and Allergies

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 Panel) was asked to carry out the additional assessment for UV-treated bread as a novel food (NF) in the context of Regulation (EC) No 258/97, taking into account the comments and objections of a scientific nature raised by Member States. The NF is bread to which a treatment with UV radiation is applied after baking in o...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2015

Scientific and technical assistance on the evaluation of the temperature to be applied to pre-packed fishery products at retail level

European Food Safety Authority Relevant hazards associated with pre-packed fresh fishery products were identified through a literature search. The main temperature-dependent hazards identified are histamine formation, Listeria monocytogenes, Clostridium botulinum, and Yersinia enterocolitica. To assess bacterial growth and histamine production during storage and transport at retail level and to evaluate different storage scenarios, published predictive microbiology growth models were used assuming ...

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

16-6-2015

Hempola brand "100% Hemp Powder, Protein & Fibre Powder" recalled due to undeclared gluten

The recalling firm is Hempola Valley Farms.This product has been distributed in Retail.

Canada - Health Canada

10-6-2015

Dear Healthcare Professional Letter on complaints on the product due to particles of a solid material to be present on the needle surface of Kineret 100 mg solution for injection in pre-filled syringe (anakinra)

Swedish Orphan Biovitrum (Sobi) has in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines Agency (EMA) sent a letter to healthcare professionals on complaints on the product due to particles of a solid material to be present on the needle surface of Kineret 100 mg solution for injection in pre-filled syringe (anakinra). Further information and the Dear Healthcare Professional Letter is accessible under the link below.

Croatia - HALMED - Medicines Agency of Croatia

29-5-2015

Scientific Opinion on the safety evaluation of the process ‘Evertis Iberica’, based on EREMA MPR technology, used to recycle post-consumer PET into 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 assessment of the recycling process Evertis Iberica (EU register number RECYC0123), which is based on the EREMA Multi-Purpose Reactor (MPR) technology. The input to this process is washed and dried polyethylene terephthalate (PET) flakes originating from collected post-consume...

Europe - EFSA - European Food Safety Authority EFSA Journal

29-5-2015

Scientific Opinion on the safety assessment of the process “Terrachim” based on VACUREMA Prime® technology used to recycle post-consumer PET into food contact materials

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) Erratum in: This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the recycling process Terrachim (EU register number RECYC122), which is based on the VACUREMA Prime® technology. The input of the process is hot caustic washed and dried PET flakes originating from collected post-consumer PET containers and con...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-5-2015

Notice on temporary discontinuation of supply chain and use of batches 15HK11F2 and 15HL218F1 of Ciprofloxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofloxacin Kabi 200 mg/100 ml solution for infusion.

Fresenius Kabi d.o.o., the marketing authorisation holder for Ciprofloxacin Kabi 400 mg/200 ml solution for infusion, Fresenius Kabi d.o.o., has initiated upon request of the Agency for Medicinal Products and Medical Devices (HALMED) a procedure of temporary disruption of distribution and use of the batches: 15IB515P2 of Ciprofoxacin Kabi 400 mg/200 ml solution for infusion and batches 15IB15P2 of Ciprofoxacin Kabi 200 mg/100 ml solution for infusion in the Republic of Croatia. The procedure of disconti...

Croatia - HALMED - Medicines Agency of Croatia

20-5-2015

Scientific Opinion on the safety and efficacy of AGal-Pro BL/BL-L (alpha-galactosidase and endo-1,4-beta-glucanase) as a feed additive for laying hens and minor poultry species for laying

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) The additive AGal-Pro BL/BL-L is a preparation of alpha-galactosidase produced by a genetically modified strain of Saccharomyces cerevisiae and of endo-1,4-beta-glucanase produced by a non-genetically modified strain of Aspergillus niger. The additive is intended for use in laying hens and minor poultry species for laying (e.g. ducks, goose, quail, turkey, etc.). This product is currently authorised for use in chickens for ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-5-2015

Scientific Opinion on the safety and efficacy of Rovabio® Spiky (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) as a feed additive for turkeys and minor poultry species for fattening or reared for laying or breeding

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Rovabio® Spiky is an enzyme preparation, available in solid and liquid forms, of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The enzymes present in the additive are produced by two strains of Penicillium funiculosum, one of which is genetically modified. The additive is intended to be used as a feed additive for turkeys for fattening and minor poultry species for fattening or reared for laying or breedi...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-5-2015

Extension of use of extracts of rosemary (E 392) in fat-based spreads

EFSA Panel on Food Additives and Nutrient Sources added to food (ANS) Following a request from the European Commission, a refined exposure assessment was carried out based on the maximum permitted levels (MPLs) authorised in Annex II of Regulation (EC) No 1333/2008 for extracts of rosemary (E 392) and the extension of its use in fat-based spreads at the levels proposed by the applicant of 30 mg/kg and 100 mg/kg. This was not covered by the previous re-evaluation of the safety of extracts of rosemary (...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-5-2015

Kamado Joe Company recalls Kamado Joe 100% Natural Charcoal

Health Canada's sampling and evaluation program has revealed that the Kamado Joe 100% Natural Charcoal Charcoal does not meet the bilingual warning label requirements under Canadian Law.

Canada - Health Canada

14-4-2015

Scientific Opinion on the safety evaluation of the following processes based on EREMA Basic technology used to recycle post-consumer PET into food contact materials ‘Coveris’ and ‘Envaplaster'

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 deals with the safety assessment of the recycling processes Coveris and Envaplaster (RECYC0117 and RECYC0120, respectively), which are based on the same EREMA Basic technology. The input to these processes is washed and dried polyethylene terephthalate (PET) flakes originating from col...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-4-2015

Recall of one batch of RAN-Gabapentin 100 mg capsules due to cross-contamination with Etodolac

Ranbaxy Pharmaceuticals Canada Inc., in consultation with Health Canada, is recalling one batch of RAN-Gabapentin, a medication used to treat epilepsy, due to cross-contamination during the manufacturing process with Etodolac, a non-steroidal anti-inflammatory drug.

Canada - Health Canada

9-3-2015

Dextrose 5% INJ 5 g /100 mL USP (2015-03-04)

Canada - Health Canada

26-2-2015

Scientific Opinion on the safety of refined Buglossoides oil as a novel food ingredient

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 a scientific opinion on refined Buglossoides oil as a novel food ingredient (NFI) in the context of Regulation (EC) No 258/97. The NFI is produced from the seeds of Buglossoides arvensis (L.) I. M. Johnst, using processes conventionally used for edible oil production. The main fatty acids (FAs)...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2015

Scientific Opinion on the safety and efficacy of Cygro(R) 10G (maduramicin ammonium-α) for turkeys

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Cygro® 10G is a coccidiostat for turkeys for fattening containing 10 g of the polyether ionophore maduramicin ammonium-α (Maα)/kg additive. The maximum proposed dose (5 mg Maα/kg) is considered safe for turkeys with a margin of safety of 2.5. It is unlikely that there will be any measurable adverse effects of Maα on the overall gut flora. Maα is absorbed and excrete...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-2-2015

Scientific Opinion on the safety and efficacy of XTRACT(R) Evolution-B, Code X60-6930 (carvacrol, cinnamaldehyde and capsicum oleoresin), as a feed additive for chickens for fattening

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) The additive XTRACT® Evolution-B, Code X60-6930, is a preparation of carvacrol, cinnamaldehyde and capsicum oleoresin and is intended to be used as a zootechnical feed additive for chickens for fattening. Based on a tolerance study in which chickens for fattening tolerated a 10-fold overdose of the additive, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) conc...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2015

Scientific Opinion on the safety and efficacy of Biomin®C3 (Bifidobacterium animalis ssp. animalis, Lactobacillus salivarius ssp. salivarius and Enterococcus faecium) as feed additive for chickens for fattening, chickens reared for laying and minor avian

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Biomin®C3 is a preparation of strains of Enterococcus faecium, Bifidobacterium animalis and Lactobacillus salivarius. It is currently authorised in the European Union for use in feed for chickens for fattening. Application now has been made for an extension of use to chickens reared for laying and minor avian species other than laying species, for use in water for drinking and for the removal of a maximum dose. A tolera...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2015

Scientific Opinion on the safety evaluation of the following processes based on Starlinger Decon technology used to recycle post-consumer PET into food contact materials: "Baltija Eco PET", "Eurocast", "Fernholz", "Formas y Envases" and "Klöckner Pentapla

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 deals with the safety evaluation of the recycling processes "Baltija Eco PET", "Eurocast", "Fernholz", "Formas y Envases", and "Klöckner Pentaplast" (EU register numbers RECYC0118, RECYC0111, RECYC0113, RECYC0115 and RECYC0121 respectively), which are all ...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-12-2014

Notice on the occurrence of suspected falsified batches of MabThera 100 mg concentrate for solution for infusion and MabThera 500 mg concentrate for solution for infusion

Via the Rapid Alert System from the German competent authority, the Agency for Medicinal Products and Medical Devices (HALMED) has received a notice on the suspected counterfeit batches of MabThera 100 mg concentrate for solution for infusion (batch: H0156B09, shelf-life: 05/2016) and MabThera 500 mg concentrate for solution for infusion (batch: H0721B04, shelf-life: 04/2016). These batches reported as a suspected counterfeit have never been placed on the Croatian market. More information is accessible...

Croatia - HALMED - Medicines Agency of Croatia

4-12-2014

Overview of the Workshop "OTC medicines: the role of good classification practices in promoting medication safety and accessibility in Europe"

An expert workshop "OTC medicines: the role of good classification in promoting medication safety and accessibility in Europe" organised by the Council of Europe’s European Directorate for the Quality of Medicines and Healthcare (EDQM) and the Agency for Medicinal Products and Medical Devices (HALMED) was held from 20 to 21 November 2014 in Zagreb. Nearly 100 participants from 19 countries in Europe, representing national and European competent drug authorities, ministries of health, heal...

Croatia - HALMED - Medicines Agency of Croatia

28-11-2014

Naming of medicinal products

In future, we will comment on medicinal product names applied for (names of human medicines applied for under the mutual recognition (MRP) and decentralised procedures (DCP)) on Day 50 for MRP and on Day 100 for DCP with Denmark as concerned member state, and on Day 70 with Denmark as reference member state. This takes place at request from the pharmaceutical industry. Subject to approval of name However, this procedure is subject to the final approval of a name, because in the period until a marketing ...

Danish Medicines Agency

6-11-2014

Beware if your heart flutters

The combination of low-dose aspirins and anticoagulant medicines can cause severe bleeding. Consequently, we have published new material describing the risk of this combination to patients with heart flutters and doctors. About 100,000 Danes suffer from heart flutters, and every year between 15,000 and 20,000 new patients are diagnosed with heart flutters. Heart flutters can be dangerous, because there is an increased risk of blood clots. One out of five blood clots in the brain is caused by heart flut...

Danish Medicines Agency

11-9-2014

Kaletra 100/25, Filmtabletten

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

Swissmedic - Swiss Agency for Therapeutic Products

9-11-2006

NAM continues to campaign for the safe and correct use of analgesics

NAM continues to campaign for the safe and correct use of analgesicsNational Agency for Medicines continues its public campaign called "Enough is enough - also in medicines" to promote the safe and correct use of analgesics. The aim is to decrease the customary use of analgesics and to raise awareness on their differences and adverse effects. It has been estimated that 100-200 people in Finland die each year of the bleeding of digestive track.A study carried out at the University of Kuopio on the ...

Finland - Fimea News

18-6-2015

PENNOX 100 HI-FLO (Oxytetracycline) Powder [Pharmgate Animal Health]

Updated Date: Jun 18, 2015 EST

US - DailyMed

2-6-2015

PENNOX 100-MR (Oxytetracycline Hydrochloride) Powder [Pharmgate Animal Health]

Updated Date: Jun 2, 2015 EST

US - DailyMed

12-5-2015

WAC 100 IODINE-HYDRIODIC ACID COMPLEX (Iodine) Solution, Concentrate [WestAgro, Inc.]

Updated Date: May 12, 2015 EST

US - DailyMed

17-2-2015

PENNCHLOR 100 HI-FLO (Chlortetracycline Calcium) Powder [Pharmgate Animal Health]

Updated Date: Feb 17, 2015 EST

US - DailyMed

6-1-2015

CLTC 100 MR (Chlortetracycline Hydrochloride) Powder [Phibro Animal Health]

Updated Date: Jan 6, 2015 EST

US - DailyMed

24-12-2014

STOOL SOFTENER (Docusate Sodium 100 Mg) Capsule [Allegiant Health]

Updated Date: Dec 24, 2014 EST

US - DailyMed

15-12-2014

TERRAMYCIN 100 MR (Oxytetracycline) Powder [Phibro Animal Health]

Updated Date: Dec 15, 2014 EST

US - DailyMed

9-12-2014

TERRAMYCIN 100 (Oxytetracycline) Powder [Phibro Animal Health]

Updated Date: Dec 9, 2014 EST

US - DailyMed

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