MED-TOX

Κύριές Πληροφορίες

  • Εμπορική ονομασία:
  • MED-TOX (0.5+12.5+100)MG/5ML SYR
  • Δοσολογία:
  • (0.5+12.5+100)MG/5ML
  • Φαρμακοτεχνική μορφή:
  • ΣΙΡΟΠΙ
  • Χρήση για:
  • Οι άνθρωποι
  • Τύπος φάρμακου:
  • αλλοπαθητική των ναρκωτικών

Έγγραφα

  • για το ευρύ κοινό:
  • Το ενημερωτικό φυλλάδιο για το προϊόν αυτό δεν είναι άμεσα διαθέσιμα, μπορείτε να στείλετε ένα αίτημα στην εξυπηρέτηση πελατών μας και εμείς θα σας ενημερώσουμε το συντομότερο είμαστε σε θέση να το αποκτήσει.


    Ζητήστε το ενημερωτικό φυλλάδιο για το ευρύ κοινό.

Εντοπισμός

  • Διατίθεται σε:
  • MED-TOX (0.5+12.5+100)MG/5ML SYR
    Ελλάδα
  • Γλώσσα:
  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική περιοχή:
  • ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ

Άλλες πληροφορίες

Κατάσταση

  • Πηγή:
  • Εθνικός Οργανισμός Φαρμάκων
  • τελευταία ενημέρωση:
  • 09-08-2016
  • Το ενημερωτικό φυλλάδιο για το προϊόν αυτό δεν είναι άμεσα διαθέσιμα, μπορείτε να στείλετε ένα αίτημα στην εξυπηρέτηση πελατών μας και εμείς θα σας ενημερώσουμε το συντομότερο είμαστε σε θέση να το αποκτήσει.

    Ζητήστε το ενημερωτικό φυλλάδιο για το ευρύ κοινό.

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

Stokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative benzalkonium chloride than is typical.

FDA - U.S. Food and Drug Administration

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. 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 triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

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

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

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. 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 glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of l‐valine produced using Corynebacterium glutamicum CGMCC 11675 for all animal species

Safety and efficacy of l‐valine produced using Corynebacterium glutamicum CGMCC 11675 for all animal species

Published on: Mon, 04 Mar 2019 The product subject of this assessment is l‐valine produced by fermentation with a strain of Corynebacterium glutamicum (CGMCC 11675). It is intended to be used in feed and water for drinking for all animal species and categories. Owing to the uncertainties regarding the possible genetic modification of the original production strain, the FEEDAP Panel cannot conclude on the safety of the additive l‐valine produced with C. glutamicum CGMCC 11675 for the target species, the ...

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

13-2-2019

Jurnista (hydromorphone hydrochloride) prolonged-release

Jurnista (hydromorphone hydrochloride) prolonged-release

Product defect correction - potentially damaged tablets

Therapeutic Goods Administration - Australia

5-2-2019

RH recalls Metal-Wrapped Coffee Tables

RH recalls Metal-Wrapped Coffee Tables

The plating beneath the surface coating may contain lead and may present a risk of lead exposure to children. Lead is toxic if ingested and can cause adverse health effects.

Health Canada

4-2-2019

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

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

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

FDA - U.S. Food and Drug Administration

1-2-2019

Safety and efficacy of l‐valine produced by fermentation using Corynebacterium glutamicum KCCM 11201P for all animal species

Safety and efficacy of l‐valine produced by fermentation using Corynebacterium glutamicum KCCM 11201P for all animal species

Published on: Thu, 31 Jan 2019 The product subject of this assessment is l‐valine produced by fermentation using a non‐genetically modified strain of Corynebacterium glutamicum (KCCM 11201P). It is intended to be used in feed and water for drinking for all animal species and categories. Species identity of the production organism was confirmed and the strain was sensitive to antibiotics at concentrations below thresholds specified by EFSA, thus C. glutamicum KCCM 11201P may be considered safe by the qua...

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

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Overview of available toxicity data for calystegines

Overview of available toxicity data for calystegines

Published on: Fri, 25 Jan 2019 Calystegines are polyhydroxylated nortropane alkaloids that have been found in various solanaceous foods, in particular in potatoes and aubergines. The biological activity and potential toxicity of calystegines are associated with their capacity to inhibit glycosidases and block carbohydrate metabolism inducing lysosomal storage toxicity. The present report summarises the retrieved information on the possible toxicity of calystegines. Only few in vivo short‐term toxicologi...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

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

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

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys f...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

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

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

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

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

3-12-2018

FDA Alerts Pet Owners about Potentially Toxic Levels of Vitamin D in Several Dry Pet Foods

FDA Alerts Pet Owners about Potentially Toxic Levels of Vitamin D in Several Dry Pet Foods

The FDA is investigating the presence of elevated, potentially toxic levels of vitamin D in several dry pet foodsVitamin D in very high amounts can cause serious health problems like kidney failure or death.

FDA - U.S. Food and Drug Administration

18-3-2019

Over 300 children in the United States are treated for poisoning each day. Keep your kids safe by keeping toxic products and medicines out of reach:  http://bit.ly/2Y7fVA2  #PPW2019 #MondayThoughtspic.twitter.com/wchq0dVW5r

Over 300 children in the United States are treated for poisoning each day. Keep your kids safe by keeping toxic products and medicines out of reach: http://bit.ly/2Y7fVA2  #PPW2019 #MondayThoughtspic.twitter.com/wchq0dVW5r

Over 300 children in the United States are treated for poisoning each day. Keep your kids safe by keeping toxic products and medicines out of reach: http://bit.ly/2Y7fVA2  #PPW2019 #MondayThoughts pic.twitter.com/wchq0dVW5r

FDA - U.S. Food and Drug Administration

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

6-3-2019

Fortekor and associated names

Fortekor and associated names

Fortekor and associated names (Active substance: Benazepril hydrochloride) - Corrigendum - Commission Decision (2012)772 of Wed, 06 Mar 2019

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/888 (DLRC Pharma Services Ltd)

EU/3/11/888 (DLRC Pharma Services Ltd)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1623 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003766

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/887 (DLRC Pharma Services Ltd)

EU/3/11/887 (DLRC Pharma Services Ltd)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1622 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003764

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/886 (DLRC Pharma Services Ltd)

EU/3/11/886 (DLRC Pharma Services Ltd)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1621 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003767

Europe -DG Health and Food Safety

25-2-2019

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Active substance: Chimeric monoclonal antibody to shiga-toxin 1 and 2) - Transfer of orphan designation - Commission Decision (2019)1636 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003835

Europe -DG Health and Food Safety

20-2-2019


Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Europe - EMA - European Medicines Agency

20-2-2019


Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Doxolipad,doxorubicin hydrochloride,  31/01/2019,  Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Europe - EMA - European Medicines Agency

29-1-2019


Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Europe - EMA - European Medicines Agency

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Active substance: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1))) - Orphan designation - Commission Decision (2018)9019 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/157/18

Europe -DG Health and Food Safety

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency