Ստիմոլ

main_info

  • trade_name:
  • Ստիմոլ
  • dosage:
  • 100մգ/մլ(18) փաթեթիկներ 10մլ
  • pharmaceutical_form:
  • լուծույթ ներքին ընդունման
  • prescription_type:
  • Առանց դեղատոմսի
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Ստիմոլ
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

  • source:
  • Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում - Armenia
  • last_update:
  • 31-05-2018

24-4-2019

Efficacy of Saccharomyces cerevisiae NBRC 0203, Lactobacillus plantarum NBRC 3070 and Lactobacillus casei NBRC 3425 as a technological additive (silage additive) for all animal species

Efficacy of Saccharomyces cerevisiae NBRC 0203, Lactobacillus plantarum NBRC 3070 and Lactobacillus casei NBRC 3425 as a technological additive (silage additive) for all animal species

Published on: Tue, 23 Apr 2019 The product under assessment is a preparation containing single strains of Saccharomyces cerevisiae, Lactobacillus plantarum and Lactobacillus casei to be used as a technological additive to improve the ensiling process. EFSA has been previously requested by the European Commission to evaluate this product. The safety of the additive for consumers, users, the environment and target animals was established at that time. There was, evidence for improved aerobic stability in ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-4-2019

Safety of chia seeds (Salvia hispanica L.) as a novel food for extended uses pursuant to Regulation (EU) 2015/2283

Safety of chia seeds (Salvia hispanica L.) as a novel food for extended uses pursuant to Regulation (EU) 2015/2283

Published on: Wed, 17 Apr 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel foods and Food Allergens (NDA) was asked to deliver an opinion on overall safety assessment for chia seeds (Salvia hispanica L.) as a novel food (NF) pursuant to Regulation (EU) 2015/2283 in the light of the increasing dietary intake from the growing number of authorised uses in recent years. The safety assessment of this NF is based on data supplied in seven applications, previous safety ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-4-2019

2019 seasonal influenza vaccines

2019 seasonal influenza vaccines

Information for consumers and health professionals

Therapeutic Goods Administration - Australia

16-4-2019

Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint

Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint

Unilever is voluntarily recalling a limited quantity of Ben & Jerry’s Coconut Seven Layer Bar bulk and Ben & Jerry’s Chunky Monkey pints, which may inadvertently contain tree nuts including almonds, Brazil nuts, and hazelnuts that are not declared in the ingredient list or allergy information list. Both affected products include a “Contains Walnuts” and a “May contain other tree nuts” label on the back of the pack. Persons who have an allergy or severe sensitivity to these undeclared tree nuts run the ri...

FDA - U.S. Food and Drug Administration

15-4-2019

Food additive E171: ANSES reiterates its recommendations for consumer safety

Food additive E171: ANSES reiterates its recommendations for consumer safety

The food additive E171, which consists of titanium dioxide (TiO2) particles, mainly in nanoparticle form, is used in many different food products. Following the expert appraisal work it conducted in 2017, ANSES was asked in February 2019 to review the most recent studies on the oral toxicology of E171 and to update its recommendations. On completion of this expert appraisal, the Agency concluded that it had not obtained any new information to resolve the uncertainties regarding the safety of the additive...

France - Agence Nationale du Médicament Vétérinaire

12-4-2019

EFSA Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment

EFSA Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment

Published on: Thu, 11 Apr 2019 The European Union (EU) pesticides Regulation established that in vitro comparative metabolism studies shall be performed. At present an Organisation for Economic Co‐operation and Development (OECD) test guideline for this kind of studies is not available. The European Food Safety Authority (EFSA) Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment discussed the use of these studies to identify human metabolites and to support the as...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-4-2019

FDA orders important safety labeling changes for Addyi

FDA orders important safety labeling changes for Addyi

FDA has issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi requiring the company to revise important safety information.

FDA - U.S. Food and Drug Administration

9-4-2019

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who

Statement by Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA’s Center for Drug Evaluation and Research, on new opioid analgesic labeling changes to give providers better information for how to properly taper patients who

Agency issued a drug safety communication to make doctors and patients aware of the labeling changes and the need for careful tapering to avoid side effects

FDA - U.S. Food and Drug Administration

5-4-2019

Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market

Explanatory note on literature searching conducted in the context of GMO applications for (renewed) market authorisation and annual post‐market environmental monitoring reports on GMOs authorised in the EU market

Published on: Thu, 04 Apr 2019 Guidance of the Panel on Genetically Modified Organisms (GMOs) of the European Food Safety Authority (EFSA) assists applicants in the preparation and presentation of their market registration applications by describing elements and information/data requirements for the risk assessment and monitoring of GMOs. This explanatory note to the guidance: (1) clarifies the scope and methodology for literature searching performed in the context of applications for market authorisati...

Europe - EFSA - European Food Safety Authority EFSA Journal

3-4-2019

Assessment of the application for renewal of the authorisation of Natuphos (3‐phytase) as a feed additive for poultry and pigs

Assessment of the application for renewal of the authorisation of Natuphos (3‐phytase) as a feed additive for poultry and pigs

Published on: Tue, 02 Apr 2019 Natuphos® is a feed additive that contains 3‐phytase which is produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, piglets (weaned) and pigs for fattening, laying hens and turkeys for fattening, ducks, sows, all minor avian species other than ducks and ornamental birds. This scientific opinion concerns the renewal of the authorisation of this additive for those species. The application also included chickens reared for la...

Europe - EFSA - European Food Safety Authority EFSA Journal

29-3-2019

Natugrain®Wheat TS/TS L

Natugrain®Wheat TS/TS L

Published on: Thu, 28 Mar 2019 Natugrain® Wheat TS is the trade name for a feed additive that contains endo‐1,4‐beta‐xylanase produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, turkeys for fattening or reared for breeding, ducks, ornamental birds and minor avian species (except ducks and laying birds). This scientific opinion concerns the renewal of the authorisation of this additive for those species. The applicant provided evidence that the additiv...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-3-2019

Scientific advice on the Testbiotech's request for internal review of Commission Implementing Decision (EU) No 2018/2046 on maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations (application EFSA‐GMO‐BE‐2013‐118)

Scientific advice on the Testbiotech's request for internal review of Commission Implementing Decision (EU) No 2018/2046 on maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and subcombinations (application EFSA‐GMO‐BE‐2013‐118)

Published on: Tue, 26 Mar 2019 Abstract Following a request of the European Commission, the European Food Safety Authority (EFSA) reviewed the scientific arguments raised by Testbiotech against the Commission Implementing Decision (EU) 2018/2046 authorising the placing on the market of products containing, consisting of, or produced from maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122 and its subcombinations (application EFSA‐GMO‐BE‐2013‐118). Testbiotech argued that the risk assessment of maize ...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-3-2019

EU Insights Chemical mixtures awareness, understanding and risk perceptions

EU Insights Chemical mixtures awareness, understanding and risk perceptions

Published on: Mon, 25 Mar 2019 EFSA defines ‘chemical mixtures’ as ‘several substances which may have combined effects on the body from their combined exposures’. There are already some methodologies for assessing risks from combined exposure to groups of chemicals, and EFSA together with European partners is developing methodologies to assess the risk from exposure to combinations of chemicals in food. However, consumers' understanding and views on this topic have not been documented. This poses signif...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Assessment of the application for renewal of authorisation of Levucell SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for lambs and horses

Assessment of the application for renewal of authorisation of Levucell SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for lambs and horses

Published on: Thu, 21 Mar 2019 Levucell® SC is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae. The product is currently authorised for use in feed for horses, lambs, dairy sheep and dairy goats, dairy cows and cattle for fattening. This opinion concerns the renewal of the authorisation of Levucell® SC as a zootechnical additive for lambs and horses. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Resources for Animal Food Producers in Flooded Central & Southern Plains of U.S.

Resources for Animal Food Producers in Flooded Central & Southern Plains of U.S.

FDA’s Center for Veterinary Medicine reminds animal food producers who may be affected by extreme weather and flooding in the Central and Southern Plains of the United States and who may be harvesting, mixing, storing or distributing grains and other foods for animals about information resources available.

FDA - U.S. Food and Drug Administration

18-3-2019

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

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

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

FDA - U.S. Food and Drug Administration

15-3-2019

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass.

FDA - U.S. Food and Drug Administration

15-3-2019

Peer review of the pesticide risk assessment of the active substance thiacloprid

Peer review of the pesticide risk assessment of the active substance thiacloprid

Published on: Thu, 14 Mar 2019 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiaclopr...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

Multi-country outbreak of Salmonella Poona infections linked to consumption of infant formula

Published on: Tue, 12 Mar 2019 An outbreak of 32 Salmonella enterica serotype Poona cases in infants and young children has recently been identified in France (30 cases), Belgium (one case) and Luxembourg (one case). All 32 patients were infected with the same bacterial strain based on core genome multilocus sequence typing analysis. All patients had onset of symptoms between August 2018 and February 2019. Information from interviews was available for 30 patients. All consumed one of three rice-based in...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019

Data sources on animal diseases:Country Card of Denmark

Data sources on animal diseases:Country Card of Denmark

Published on: Thu, 07 Mar 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

4-3-2019

CVB Incorporated recalls LUCID Folding Mattress

CVB Incorporated recalls LUCID Folding Mattress

The mattress does not meet the Mattress Regulations of the Canada Consumer Product Safety Act posing a fire hazard.

Health Canada

19-2-2019

Data sources on animal diseases: Country Card of Sweden

Data sources on animal diseases: Country Card of Sweden

Published on: Mon, 18 Feb 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Slovakia

Data sources on animal diseases: Country Card of Slovakia

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspo...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Finland

Data sources on animal diseases: Country Card of Finland

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Czech Republic

Data sources on animal diseases: Country Card of Czech Republic

Published on: Mon, 18 Feb 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-2-2019

Data sources on animal diseases: Country Card of Italy

Data sources on animal diseases: Country Card of Italy

Published on: Mon, 18 Feb 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspon...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-2-2019

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Published on: Fri, 15 Feb 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 (AfB1) binder for all animal species; the additive is composed of bentonite feed grade and algae belonging to Ulva spp. The European Commission request follows an opinion of the FEEDAP Panel published in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-2-2019

Food allergies: improve information to prevent risks

Food allergies: improve information to prevent risks

With the constant changes in eating habits and the marketing of novel foods, food allergies continue to be a public health concern.  As a result of its expert assessment work, ANSES found that there was a lack of data on the prevalence of food allergies in France. The Agency therefore delivers a series of recommendations to ensure better monitoring of food allergies, and recommends providing better information to doctors as well as to consumers subject to food allergies.

France - Agence Nationale du Médicament Vétérinaire

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for spinosad

Evaluation of confirmatory data following the Article 12 MRL review for spinosad

Published on: Mon, 04 Feb 2019 The applicant Dow AgroSciences Ltd submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified for spinosad in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gaps related to residue trials on globe artichokes, flowering brassica and the nature of residues in processed commodities were satisfactorily addressed. A new feedi...

Europe - EFSA - European Food Safety Authority EFSA Journal

2-2-2019

Evaluation of confirmatory data following the Article 12 MRL review for imazamox

Evaluation of confirmatory data following the Article 12 MRL review for imazamox

Published on: Fri, 01 Feb 2019 The applicant BASF SE submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified for imazamox in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, the applicant submitted new residue trials on rice. Since the number of trials was not sufficient, the data gap was considered only partially addressed. The remaining dat...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Review of the existing maximum residue levels for imidacloprid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for imidacloprid according to Article 12 of Regulation (EC) No 396/2005

Published on: Thu, 31 Jan 2019 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 imidacloprid. To assess the occurrence of imidacloprid 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 as the import to...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Review of the existing maximum residue levels for hexythiazox according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for hexythiazox according to Article 12 of Regulation (EC) No 396/2005

Published on: Thu, 31 Jan 2019 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 hexythiazox. To assess the occurrence of hexythiazox residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Commission as well a...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-4-2019


Paracetamol (IV formulation): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002311/201805

Paracetamol (IV formulation): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002311/201805

Paracetamol (IV formulation): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00002311/201805

Europe - EMA - European Medicines Agency

23-4-2019

Labelling changes: information for health professionals

Labelling changes: information for health professionals

Medicine labels are improving, the active ingredient will be easier to locate

Therapeutic Goods Administration - Australia

15-4-2019


Cefuroxime sodium (for intracameral use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010206/201805

Cefuroxime sodium (for intracameral use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010206/201805

Cefuroxime sodium (for intracameral use): CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010206/201805

Europe - EMA - European Medicines Agency

15-4-2019


Ceftriaxone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation -  PSUSA/00000613/201805

Ceftriaxone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000613/201805

Ceftriaxone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00000613/201805

Europe - EMA - European Medicines Agency

12-4-2019


Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010667/201806

Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010667/201806

Pseudoephedrine, acetylsalicylic acid / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010667/201806

Europe - EMA - European Medicines Agency

12-4-2019


Tianeptine: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002943/201806

Tianeptine: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002943/201806

Tianeptine: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002943/201806

Europe - EMA - European Medicines Agency

10-4-2019


Paracetamol / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002307/201806

Paracetamol / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002307/201806

Paracetamol / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002307/201806

Europe - EMA - European Medicines Agency

10-4-2019


Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001711/201807

Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001711/201807

Ibuprofen / pseudoephedrine: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00001711/201807

Europe - EMA - European Medicines Agency

5-4-2019


Metyrapone: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002046/201806

Metyrapone: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002046/201806

Metyrapone: CMDh scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002046/201806

Europe - EMA - European Medicines Agency

27-3-2019

The new proposed rule on mammography will require, for the first time under federal rules, that women receive information about breast density to better inform their healthcare decisions https://www.nytimes.com/2019/03/27/health/mammogram-dense-breast-can

The new proposed rule on mammography will require, for the first time under federal rules, that women receive information about breast density to better inform their healthcare decisions https://www.nytimes.com/2019/03/27/health/mammogram-dense-breast-can

The new proposed rule on mammography will require, for the first time under federal rules, that women receive information about breast density to better inform their healthcare decisions https://www.nytimes.com/2019/03/27/health/mammogram-dense-breast-cancer.html …

FDA - U.S. Food and Drug Administration

20-3-2019

Today is #KickButtsDay. Take some time today to learn facts about the harms of smoking. 
#FACT Tobacco use causes more than 480,000 deaths each year in the United States. Find out more information to quit tobacco:  https://go.usa.gov/xEWdT  via @FDATobacc

Today is #KickButtsDay. Take some time today to learn facts about the harms of smoking. #FACT Tobacco use causes more than 480,000 deaths each year in the United States. Find out more information to quit tobacco: https://go.usa.gov/xEWdT  via @FDATobacc

Today is #KickButtsDay. Take some time today to learn facts about the harms of smoking. #FACT Tobacco use causes more than 480,000 deaths each year in the United States. Find out more information to quit tobacco: https://go.usa.gov/xEWdT  via @FDATobacco pic.twitter.com/vOvAFo6jO1

FDA - U.S. Food and Drug Administration

19-3-2019


Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804

Fentanyl (transdermal patches, solution for injection - nationally authorised product only): CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - PSUSA/00001370/201804

Europe - EMA - European Medicines Agency

19-3-2019

Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence

Suspending, revoking and TGA initiated variation of conditions of a manufacturing licence

As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS

Therapeutic Goods Administration - Australia

19-3-2019

Requesting variations to your manufacturing licence

Requesting variations to your manufacturing licence

As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS

Therapeutic Goods Administration - Australia

19-3-2019

Australian manufacturing licences and overseas GMP certification

Australian manufacturing licences and overseas GMP certification

As part of the revised GMP fees and charges, this information has been updated to reflect changes in TBS

Therapeutic Goods Administration - Australia

15-3-2019

We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee.  https://go.usa.gov/xE6WG 

We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. https://go.usa.gov/xE6WG 

We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. https://go.usa.gov/xE6WG 

FDA - U.S. Food and Drug Administration

14-3-2019


Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00010572/201806

Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00010572/201806

Nitrous oxide, nitrous oxide / oxygen: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00010572/201806

Europe - EMA - European Medicines Agency

14-3-2019


Milnacipran: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002063/201804

Milnacipran: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002063/201804

Milnacipran: CMDh Scientific conclusions, amendments to product information and implementation timetable - PSUSA/00002063/201804

Europe - EMA - European Medicines Agency

13-3-2019


Loperamide, loperamide / simeticone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/201805

Loperamide, loperamide / simeticone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/201805

Loperamide, loperamide / simeticone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010665/201805

Europe - EMA - European Medicines Agency

8-3-2019

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to the ACMS #25, ACCS #23 and Joint ACMS-ACCS #20 meetings held in November 2018

Public submissions on scheduling matters referred to ACMS/ACCS meetings held in November 2018

Therapeutic Goods Administration - Australia

1-3-2019


Regulatory information – adjusted fees for applications to EMA from 1 April 2019

Regulatory information – adjusted fees for applications to EMA from 1 April 2019

Regulatory information – adjusted fees for applications to EMA from 1 April 2019

Europe - EMA - European Medicines Agency

25-2-2019

Update to the advertising complaints and investigation information database improves search features

Update to the advertising complaints and investigation information database improves search features

This update implements feedback from stakeholders to make the database more user-friendly

Therapeutic Goods Administration - Australia

21-2-2019


EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

Europe - EMA - European Medicines Agency

19-2-2019


Oxycodone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/201804

Oxycodone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/201804

Oxycodone: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00002254/201804

Europe - EMA - European Medicines Agency

18-2-2019


Nortriptyline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00002192/201803

Nortriptyline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00002192/201803

Nortriptyline: CMDh Scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementatio - PSUSA/00002192/201803

Europe - EMA - European Medicines Agency

8-2-2019


Information required for early identification of a need for pre-authorisation GCP inspections

Information required for early identification of a need for pre-authorisation GCP inspections

Information required for early identification of a need for pre-authorisation GCP inspections

Europe - EMA - European Medicines Agency