TRUBIN L-

Main information

  • Trade name:
  • TRUBIN L-50 GROWTH PROMOTANT FOR PIGS
  • Pharmaceutical form:
  • ORAL POWDER, PRE-MIX
  • Units in package:
  • 20kg
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • COUNTRY VET

Documents

Localization

  • Available in:
  • TRUBIN L-50 GROWTH PROMOTANT FOR PIGS
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • PIGS | BOAR | GILT | PIGLET | SOW | SWINE
  • Therapeutic area:
  • antibiotic
  • Therapeutic indications:
  • PROMOTE ANIMAL GROWTH | FEED CONVERSION | FINISHING | GROWTH PROMOTION | GROWTH RATE | LIVEWEIGHT GAIN
  • Product summary:
  • For improved growth rate of pigs up to 35 kg liveweight.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 35806/53433
  • Authorization date:
  • 30-04-2012
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Front Panel

Issue Date: 17/4/2012

Page: 1 of 2

Version 2

The information above this line is not included in the label

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

TRUBIN

L-50

Growth Promotant For Pigs

ACTIVE CONSTITUENT:

31.0 mg/g KITASAMYCIN

(pig logo)

For improved growth rate of pigs up to 35 kg liveweight

20 kg NET

RLP

APPROVED

Infopest

Verified

Back Panel

Issue Date: 17/4/2012

Page: 2 of 2

Version 2

The information above this line is not included in the label

PRODUCT DESCRIPTION:

The active constituent of Trubin L-50 is kitasamycin, a macrolide

antibiotic. It improves average daily liveweight gains of pigs raised under a variety of management

systems and states of health. Trubin L-50 is composed of kitasamycin base and calcium carbonate.

DIRECTIONS FOR USE

Trubin L-50 should be included in the ration at the rate of 2 kg / tonne of feed for pigs up to 35 kg

liveweight. Twenty (20) kg of Trubin L-50 is sufficient to medicate 10 tonnes of complete feed.

2 kg OF TRUBIN L-50 IS REQUIRED FOR ONE TONNE OF FEED

This product will not treat disease irrespective of the quantity used. During the period of use of

Trubin L-50 do not allow pigs access to non-medicated feeds.

WITHHOLDING PERIOD: MEAT NIL

TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): This product does not have

an ESI established. For advice on the ESI, contact the manufacturer on 1800 678 368 before

using this product.

FIRST AID:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia

13 11 26.

DISPOSAL:

Thoroughly shake and empty contents in to medicated feed. Do not dispose of

undiluted chemicals on site. Shred and bury empty bag in a local authority landfill. If no landfill is

available, bury the bag below 500 mm in a disposal pit specifically marked and set up for this

purpose clear of waterways, vegetation and roots. Empty bag and product should not be burned.

Limitation of Liability

Failure to use the product strictly as directed may be illegal, prove dangerous or render the product

ineffective. Notwithstanding anything else contained on this label, and subject to any rights you

have under the Australian Consumer Law and any other applicable law, Bayer Australia Limited’s

liability is limited to replacing this product or supplying equivalent product or paying the cost of

replacing this product, at its discretion.

Trubin

is a registered trademark of Bayer AG, Leverkusen, Germany. ©Copyright Bayer Australia Ltd 2010

Store below 30

C (Room Temperature)

APVMA Approval No 35806/53433

Batch

Expiry

Bayer

Bayer Australia Ltd

875 Pacific Highway

PYMBLE NSW 2073

ACN 000 138 714

20-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales

The FDA provides update on Essure postmarket review study as company prepares to halt sales of the device on December 31.

FDA - U.S. Food and Drug Administration

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

October 31, 2018: Fullerton Man Arrested on Federal Charges Alleging Illegal Importation and Sale of Male Sexual Enhancement Drugs

FDA - U.S. Food and Drug Administration

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

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Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

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Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. 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 glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. 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 glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Conotrachelus nenuphar

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Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

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Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

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Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. 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 starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Enforcement Report for the Week of October 31, 2018

Enforcement Report for the Week of October 31, 2018

Recently Updated Records for the Week of October 31, 2018 Last Modified Date: Monday, October 29, 2018

FDA - U.S. Food and Drug Administration

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

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Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

6-9-2018

August 31, 2018: Former Home Health Nurse Pleads Guilty to Tampering with Patients' Drugs

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FDA - U.S. Food and Drug Administration

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

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Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

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Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Spodoptera frugiperda partial risk assessment

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Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Danish Medicines Agency launches new concept for National Scientific Advice

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Danish Medicines Agency

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

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Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

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Europe - EFSA - European Food Safety Authority Publications

16-8-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on significant public health value and cost savings resulting from the agency’s youth smoking prevention campaign

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FDA - U.S. Food and Drug Administration

1-8-2018

July 31, 2018: Three Canadians and their Company Sentenced for Wholesale Distribution of Misbranded Prescription Drugs and Money Laundering

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FDA - U.S. Food and Drug Administration

31-7-2018

Enforcement Report for the Week of December 28, 2016

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Recently Updated Records for the Week of December 28, 2016 Last Modified Date: Tuesday, July 31, 2018

FDA - U.S. Food and Drug Administration

6-6-2018

May 31, 2018: Two Suburban Chicago Residents Charged with Illegally Selling Narcotics Over the Internet; Law Enforcement Seizes Websites

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FDA - U.S. Food and Drug Administration

1-6-2018

FDA Adverse Event Reporting System (FAERS) Public Dashboard

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Four FAERS summary statistics reports updated with data through December 31, 2013.

FDA - U.S. Food and Drug Administration

1-6-2018

Pending EC decision:  Nityr, nitisinone, Opinion date: 31-May-2018

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Europe - EMA - European Medicines Agency

1-6-2018

Pending EC decision:  Aimovig, erenumab, Opinion date: 31-May-2018

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1-6-2018

Pending EC decision:  Rxulti, brexpiprazole, Opinion date: 31-May-2018

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1-6-2018

Pending EC decision:  Myalepta, metreleptin, Opinion date: 31-May-2018

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1-6-2018

Pending EC decision:  Hyrimoz, adalimumab, Opinion date: 31-May-2018

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1-6-2018

Pending EC decision:  Hefiya, adalimumab, Opinion date: 31-May-2018

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1-6-2018

Pending EC decision:  Xeljanz, tofacitinib, Opinion date: 31-May-2018

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Europe - EMA - European Medicines Agency

18-12-2018

Alkyl nitrites - public meetings

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Therapeutic Goods Administration - Australia

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

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Europe - EMA - European Medicines Agency

22-11-2018


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Europe - EMA - European Medicines Agency

20-11-2018

Memorandum of Understanding between Philips Electronics Australia and the Therapeutic Goods Administration

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Therapeutic Goods Administration - Australia

31-10-2018

Therapeutic goods advertising: Update 31 October 2018

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The 2018 Code No.2 made today replaces the code that was made on 29 June 2018, and will take effect on 1 January 2019

Therapeutic Goods Administration - Australia

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

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Europe -DG Health and Food Safety

31-10-2018

AMGEVITA (Amgen Europe B.V.)

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Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Eporatio (ratiopharm GmbH)

Eporatio (ratiopharm GmbH)

Eporatio (Active substance: epoetin theta) - Centralised - Yearly update - Commission Decision (2018)7336 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Viramune (Boehringer Ingelheim International GmbH)

Viramune (Boehringer Ingelheim International GmbH)

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Europe -DG Health and Food Safety

11-9-2018

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Europe - EMA - European Medicines Agency

11-9-2018

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30-8-2018

Consultation: Referral of proposed amendment to the current Poisons Standard to the meeting of the ACMS, March 2019

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Advisory Committee on Medicines Scheduling to consider upscheduling of modified release paracetamol to 'Pharmacist Only'. Closing date 31 October 2018

Therapeutic Goods Administration - Australia

29-8-2018

Lojuxta (Amryt Pharmaceuticals DAC)

Lojuxta (Amryt Pharmaceuticals DAC)

Lojuxta (Active substance: Lomitapide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5762 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2578/T/31

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Consultation: Boxed Warning guidance

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The TGA is seeking comments on the proposed guidance for the use of Boxed Warnings for prescription medicines. Closing date: 31 August 2018

Therapeutic Goods Administration - Australia

30-7-2018

 Minutes of the CHMP meeting 28-31 May 2018

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Europe - EMA - European Medicines Agency

27-7-2018

Scientific guideline:  Reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation, draft: consultation open

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Established veterinary antibiotics are not always used at the authorised dose, and the dose may need to be reviewed in order to maintain their effectiveness whilst limiting the risks of antimicrobial resistance. Before a new dose is introduced, the company would typically have to conduct new studies to ensure it does not negatively affect the safety of the target animal, the consumer of animal produce, or the environment. This may reduce product availability, which could have a negative impact on antimic...

Europe - EMA - European Medicines Agency

22-7-2018

On Friday, Bayer said the permanent birth control device Essure would no longer be sold or distributed in the US for commercial reasons after 12/31/18. This came after FDA’s patient safety action in April restricting sale and distribution of the device an

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FDA - U.S. Food and Drug Administration

4-7-2018

ACM meeting statement, Meeting 9, 31 May - 1 June 2018

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Advisory Committee on Medicines

Therapeutic Goods Administration - Australia

3-7-2018

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Otsuka Pharmaceutical Europe Ltd)

Samsca (Active substance: tolvaptan) - Centralised - 2-Monthly update - Commission Decision (2018) 4250 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/980/II/31

Europe -DG Health and Food Safety

2-7-2018

Statutory advisory committee vacancies

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We are seeking expressions of interest for vacancies on the Statutory advisory committees. Closing date: 31 July 2018

Therapeutic Goods Administration - Australia

25-6-2018

Targretin (Eisai Limited)

Targretin (Eisai Limited)

Targretin (Active substance: bexarotene) - Referral - Commission Decision (2018)4021 of Mon, 25 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1446/C/326/43

Europe -DG Health and Food Safety

25-6-2018

Panretin (Eisai Limited)

Panretin (Eisai Limited)

Panretin (Active substance: alitretinoin) - Referral - Commission Decision (2018)4025 of Mon, 25 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1446/C/279/37

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety