Պրեդնիզոլոն

main_info

  • trade_name:
  • Պրեդնիզոլոն
  • dosage:
  • 5մգ/գ10գ ալյումինե պարկուճ
  • pharmaceutical_form:
  • քսուք արտաքին կիրառման
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Պրեդնիզոլոն
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

18-4-2019

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP

FDA - U.S. Food and Drug Administration

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

Mondelēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US

Mondelēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US

Mondelēz Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received.

FDA - U.S. Food and Drug Administration

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

16-4-2019

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Mon, 15 Apr 2019 Following an application from H.J. Heinz Supply Chain Europe B.V. submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respirator...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-4-2019

Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels

Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels

Published on: Thu, 11 Apr 2019 In 2016, the EFSA Panel on Contaminants in the Food Chain (CONTAM) published a scientific opinion on the acute health risks related to the presence of cyanogenic glycosides (CNGs) in raw apricot kernels in which an acute reference dose (ARfD) of 20 μg/kg body weight (bw) was established for cyanide (CN). In the present opinion, the CONTAM Panel concluded that this ARfD is applicable for acute effects of CN regardless the dietary source. To account for differences in cyanid...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-4-2019

Monitoring drinking water quality and protecting human health: ANSES proposes a method for identifying relevant pesticide metabolites

Monitoring drinking water quality and protecting human health: ANSES proposes a method for identifying relevant pesticide metabolites

Pesticides disperse into the natural environment where they can transform into one or more other compounds called "metabolites". These chemical metabolites can potentially contaminate water resources and even water supplied to consumers. Water quality controls are increasingly detecting situations where regulatory quality limits are exceeded, meaning that management measures are needed before distribution.

France - Agence Nationale du Médicament Vétérinaire

4-4-2019

Conagra Brands Announces Recall of a Limited Amount of Hunt’s Tomato Paste Cans Due to Potential Presence of Mold

Conagra Brands Announces Recall of a Limited Amount of Hunt’s Tomato Paste Cans Due to Potential Presence of Mold

Conagra Brands, Inc. (NYSE: CAG) is voluntarily recalling a limited amount of Hunt’s Tomato Paste No Salt Added six ounce cans. After the canning process, the final product could have been damaged, creating the potential for mold. Conagra Brands became aware of the issue after receiving calls from consumers.

FDA - U.S. Food and Drug Administration

2-4-2019

CTG Kool Charmz Chains with Various Charms recalled due to lead in excess of allowable limits

CTG Kool Charmz Chains with Various Charms recalled due to lead in excess of allowable limits

Health Canada's sampling and evaluation program has determined that the recalled jewellery contains lead in excess of allowable limits.

Health Canada

2-4-2019

NadaMoo! Voluntarily Recalls Select Pints of Strawberry Cheesecake Due to Undeclared Almond

NadaMoo! Voluntarily Recalls Select Pints of Strawberry Cheesecake Due to Undeclared Almond

Little Red Rooster Ice Cream Company, d/b/a NadaMoo! (“NadaMoo!”) announced a limited voluntary recall of approximately 26,000 pints of its Strawberry Cheesecake Non-Dairy Frozen Dessert because they contain an undeclared almond ingredient. People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume the recalled products.

FDA - U.S. Food and Drug Administration

30-3-2019

Nestle Purina PetCare Company Voluntarily Recalls a Limited Amount of Muse Wet Cat Food Natural Chicken Recipe in Gravy in Three-ounce Cans due to the Potential Presence of Rubber Pieces

Nestle Purina PetCare Company Voluntarily Recalls a Limited Amount of Muse Wet Cat Food Natural Chicken Recipe in Gravy in Three-ounce Cans due to the Potential Presence of Rubber Pieces

Out of an abundance of caution, Nestle Purina PetCare Company is voluntarily recalling a limited amount of Muse wet cat food Natural Chicken Recipe in Gravy in three-ounce cans. The product could contain rubber pieces that are translucent yellow with a blue backing, which may present a potential choking hazard.

FDA - U.S. Food and Drug Administration

29-3-2019

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Published on: Thu, 28 Mar 2019 This study applied a procedure for the identification of potential emerging chemical risks in the food chain to substances registered under the REACH Regulation that was previously developed and tested in an EFSA‐sponsored pilot study. The selection was limited to substances that (a) were registered with a full registration, (b) met eligibility criteria (e.g. availability of a CAS number and a SMILES notation) and (c) were considered to be inside the applicability domain o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Lumpy skin disease III. Data collection and analysis

Lumpy skin disease III. Data collection and analysis

Published on: Thu, 21 Mar 2019 In 2018, no lumpy skin disease (LSD) outbreaks were reported in the Balkan region, after the decline reported in 2017 (385) compared to 2016 (7,483). This confirms the effectiveness of the vaccination campaign based on the LSD homologous vaccine strain which continued throughout 2018 with over 2.5 million animals vaccinated, keeping the mean vaccination coverage above 70%. In 2018, LSD outbreaks were reported in Russia, Turkey and Georgia. In Russia, the LSD epidemics expa...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Air King Limited Canada recalls Wall Anchors supplied with Air King Valencia Range Hoods

Air King Limited Canada recalls Wall Anchors supplied with Air King Valencia Range Hoods

If installed using the supplied wall anchors, andnot secured to a wall stud, the range hood may pull away from the wall, posing an injury hazard.

Health Canada

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus”  Because of Possible Health Risk

Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk

Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have...

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

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

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

24-4-2019

Chanhold (Chanelle Pharmaceuticals Manufacturing Limited)

Chanhold (Chanelle Pharmaceuticals Manufacturing Limited)

Chanhold (Active substance: selamectin) - Centralised - Authorisation - Commission Decision (2019)3137 of Wed, 24 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4824

Europe -DG Health and Food Safety

15-4-2019

Neparvis (Novartis Europharm Limited)

Neparvis (Novartis Europharm Limited)

Neparvis (Active substance: sacubitril / valsartan) - Referral - Commission Decision (2019)2979 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1471/C/4343/20

Europe -DG Health and Food Safety

15-4-2019

EU/3/14/1270 (Mundipharma Corporation (Ireland) Limited)

EU/3/14/1270 (Mundipharma Corporation (Ireland) Limited)

EU/3/14/1270 (Active substance: (5R,5aR,8aR,9S)-9-[[4,6-O-[(R)-Ethylidene]-beta-D-glucopyranosyl]-oxy]-5-(4-({[(2,2-dimethyl-1,3-dioxolan-4-yl)methoxy]carbonyl}oxy)-3,5-dimethoxyphenyl)-5,8,8a,9-tetrahydroisobenzofuro[5,6-f][1,3]benzodioxol-6(5aH)-one) - Transfer of orphan designation - Commission Decision (2019)2968 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005740

Europe -DG Health and Food Safety

15-4-2019

EU/3/15/1491 (Cochamo Pharma Limited)

EU/3/15/1491 (Cochamo Pharma Limited)

EU/3/15/1491 (Active substance: Adeno-associated viral vector serotype 9 containing the human HGSNAT gene) - Transfer of orphan designation - Commission Decision (2019)2970 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004475

Europe -DG Health and Food Safety

15-4-2019

EU/3/10/780 (Mundipharma Corporation (Ireland) Limited)

EU/3/10/780 (Mundipharma Corporation (Ireland) Limited)

EU/3/10/780 (Active substance: Forodesine) - Transfer of orphan designation - Commission Decision (2019)2967 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004896

Europe -DG Health and Food Safety

15-4-2019

EU/3/06/428 (Mundipharma Corporation (Ireland) Limited)

EU/3/06/428 (Mundipharma Corporation (Ireland) Limited)

EU/3/06/428 (Active substance: Forodesine hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2966 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004893

Europe -DG Health and Food Safety

15-4-2019

EU/3/06/421 (Mundipharma Corporation (Ireland) Limited)

EU/3/06/421 (Mundipharma Corporation (Ireland) Limited)

EU/3/06/421 (Active substance: Forodesine hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2965 of Mon, 15 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005745

Europe -DG Health and Food Safety

12-4-2019

EU/3/12/1093 (Regulis Consulting Europe Limited)

EU/3/12/1093 (Regulis Consulting Europe Limited)

EU/3/12/1093 (Active substance: 1,2:5,6-Dianhydrogalactitol) - Transfer of orphan designation - Commission Decision (2019)2919 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005923

Europe -DG Health and Food Safety

12-4-2019

EU/3/15/1588 (Regulis Consulting Europe Limited)

EU/3/15/1588 (Regulis Consulting Europe Limited)

EU/3/15/1588 (Active substance: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea) - Transfer of orphan designation - Commission Decision (2019)2917 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005712

Europe -DG Health and Food Safety

12-4-2019

EU/3/07/452 (Regulis Consulting Europe Limited)

EU/3/07/452 (Regulis Consulting Europe Limited)

EU/3/07/452 (Active substance: R-1-[2,3-dihydro-2-oxo-1-pivaloylmethyl-5-(2-pyridyl)-1 H -1,4-benzodiazepin-3-yl]-3-(3-methylaminophenyl)urea) - Transfer of orphan designation - Commission Decision (2019)2916 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005708

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Active substance: Codon-optimised human cystic fibrosis transmembrane conductance regulator messenger ribonucleic acid complexed with lipid-based nanoparticles) - Orphan designation - Commission Decision (2019)2666 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002333

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2146 (Taiho Pharma Europe Limited)

EU/3/19/2146 (Taiho Pharma Europe Limited)

EU/3/19/2146 (Active substance: 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one) - Orphan designation - Commission Decision (2019)2662 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002457

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/16/1628 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2673 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003473

Europe -DG Health and Food Safety

3-4-2019

EU/3/14/1378 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/14/1378 (New B Innovation Biopharmaceutical (Ireland) Limited)

EU/3/14/1378 (Active substance: Diaspirin cross-linked haemoglobin) - Transfer of orphan designation - Commission Decision (2019)2672 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003420

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1721 (Araim Pharmaceuticals Europe Limited)

EU/3/16/1721 (Araim Pharmaceuticals Europe Limited)

EU/3/16/1721 (Active substance: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser) - Transfer of orphan designation - Commission Decision (2019)2676 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005497

Europe -DG Health and Food Safety

3-4-2019

EU/3/13/1191 (Araim Pharmaceuticals Europe Limited)

EU/3/13/1191 (Araim Pharmaceuticals Europe Limited)

EU/3/13/1191 (Active substance: L-Pyr-L-Glu-L-Gln-L-Leu-L-Glu-L-Arg-L-Ala-L-Leu-L-Asn-L-Ser-L-Ser) - Transfer of orphan designation - Commission Decision (2019)2675 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004909

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Active substance: Human/murine chimeric monoclonal antibody against endoglin) - Transfer of orphan designation - Commission Decision (2019)2677 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004633

Europe -DG Health and Food Safety

2-4-2019

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Therakind (Europe) Limited)

Jylamvo (Active substance: methotrexate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2624 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3756/T/7

Europe -DG Health and Food Safety

2-4-2019

EU/3/06/374 (Therakos Europe Limited)

EU/3/06/374 (Therakos Europe Limited)

EU/3/06/374 (Active substance: Methoxsalen) - Transfer of orphan designation - Commission Decision (2019)2420 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004676

Europe -DG Health and Food Safety

2-4-2019

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Regulis Consulting Europe Limited)

EU/3/18/2036 (Active substance: L-cystine bis(N'-methylpiperazide)) - Transfer of orphan designation - Commission Decision (2019)2411 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004889

Europe -DG Health and Food Safety

1-4-2019

Sialanar (Proveca Pharma Limited)

Sialanar (Proveca Pharma Limited)

Sialanar (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2593 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3883/T/09

Europe -DG Health and Food Safety

1-4-2019

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Transfer of orphan designation - Commission Decision (2019)2423 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004425

Europe -DG Health and Food Safety

1-4-2019

EU/3/13/1232 (Amicus Therapeutics Europe Limited)

EU/3/13/1232 (Amicus Therapeutics Europe Limited)

EU/3/13/1232 (Active substance: Allantoin) - Transfer of orphan designation - Commission Decision (2019)2422 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004625

Europe -DG Health and Food Safety

1-4-2019

EU/3/06/368 (Amicus Therapeutics Europe Limited)

EU/3/06/368 (Amicus Therapeutics Europe Limited)

EU/3/06/368 (Active substance: 1-deoxygalactonojirimycin hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2421 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004426

Europe -DG Health and Food Safety

1-4-2019

EU/3/14/1379 (Maxia Strategies-Europe Limited)

EU/3/14/1379 (Maxia Strategies-Europe Limited)

EU/3/14/1379 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2410 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004589

Europe -DG Health and Food Safety

1-4-2019

Galafold (Amicus Therapeutics Europe Limited)

Galafold (Amicus Therapeutics Europe Limited)

Galafold (Active substance: migalastat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2580 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004059/T/0020

Europe -DG Health and Food Safety

1-4-2019

VPRIV (Shire Pharmaceuticals Ireland Limited)

VPRIV (Shire Pharmaceuticals Ireland Limited)

VPRIV (Active substance: Velaglucerase alfa) - Centralised - Yearly update - Commission Decision (2019)2575 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

29-3-2019

EU/3/14/1280 (Orchard Therapeutics (Europe) Limited)

EU/3/14/1280 (Orchard Therapeutics (Europe) Limited)

EU/3/14/1280 (Active substance: Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene) - Transfer of orphan designation - Commission Decision (2019)2432 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003985

Europe -DG Health and Food Safety

27-3-2019

EU/3/14/1409 (Polaris Pharmaceuticals Ireland Limited)

EU/3/14/1409 (Polaris Pharmaceuticals Ireland Limited)

EU/3/14/1409 (Active substance: Pegylated recombinant arginine deiminase) - Transfer of orphan designation - Commission Decision (2019)2380 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004587

Europe -DG Health and Food Safety

27-3-2019

EU/3/16/1689 (Boyd Consultants Limited)

EU/3/16/1689 (Boyd Consultants Limited)

EU/3/16/1689 (Active substance: Teriparatide) - Transfer of orphan designation - Commission Decision (2019)2384 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004935

Europe -DG Health and Food Safety

27-3-2019

EU/3/14/1428 (Boyd Consultants Limited)

EU/3/14/1428 (Boyd Consultants Limited)

EU/3/14/1428 (Active substance: Sodium valproate) - Transfer of orphan designation - Commission Decision (2019)2382 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: MA/OD/0000004995

Europe -DG Health and Food Safety

27-3-2019

EU/3/16/1664 (Boyd Consultants Limited)

EU/3/16/1664 (Boyd Consultants Limited)

EU/3/16/1664 (Active substance: Polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase) - Transfer of orphan designation - Commission Decision (2019)2383 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004883

Europe -DG Health and Food Safety

27-3-2019

Omidria (Omeros Ireland Limited)

Omidria (Omeros Ireland Limited)

Omidria (Active substance: phenylephrine / ketorolac) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2379 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3702/T/10

Europe -DG Health and Food Safety

27-3-2019

EU/3/16/1711 (Akcea Therapeutics Ireland Limited)

EU/3/16/1711 (Akcea Therapeutics Ireland Limited)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2019)2381 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004196

Europe -DG Health and Food Safety

27-3-2019

EU/3/10/753 (Intercept Pharma International Limited)

EU/3/10/753 (Intercept Pharma International Limited)

EU/3/10/753 (Active substance: 6alpha-ethyl-chenodeoxycholic acid) - Transfer of orphan designation - Commission Decision (2019)2408 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002873

Europe -DG Health and Food Safety

22-3-2019

SCENESSE (Clinuvel Europe Limited)

SCENESSE (Clinuvel Europe Limited)

SCENESSE (Active substance: afamelanotide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2303 of Fri, 22 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2548/T/24

Europe -DG Health and Food Safety

19-3-2019

Loxicom (Norbrook Laboratories (Ireland) Limited)

Loxicom (Norbrook Laboratories (Ireland) Limited)

Loxicom (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2179 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/141/T/32

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2155 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004764

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2154 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004730

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2153 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004734

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)2156 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004770

Europe -DG Health and Food Safety

15-3-2019

EU/3/14/1249 (Akcea Therapeutics Ireland Limited)

EU/3/14/1249 (Akcea Therapeutics Ireland Limited)

EU/3/14/1249 (Active substance: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III) - Transfer of orphan designation - Commission Decision (2019)2104 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004954

Europe -DG Health and Food Safety

15-3-2019

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Active substance: Apomorphine hydrochloride (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)2115 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004495

Europe -DG Health and Food Safety