Օմեպ-20

main_info

  • trade_name:
  • Օմեպ-20
  • dosage:
  • 20մգ(100/10x10/) ստրիպում, (30/3x10/) բլիստերում
  • pharmaceutical_form:
  • դեղապատիճներ աղելույծ
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Օմեպ-20
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

17-4-2019


Committee for Advanced Therapies (CAT): 20-22 March 2019, European Medicines Agency, from 20/03/2019 to 22/03/2019

Committee for Advanced Therapies (CAT): 20-22 March 2019, European Medicines Agency, from 20/03/2019 to 22/03/2019

Committee for Advanced Therapies (CAT): 20-22 March 2019, European Medicines Agency, from 20/03/2019 to 22/03/2019

Europe - EMA - European Medicines Agency

16-4-2019

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with <em>Salmonella</em>

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with <em>Salmonella</em>

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella. The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272.

FDA - U.S. Food and Drug Administration

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

27-3-2019

Enforcement Report for the Week of March 27, 2019

Enforcement Report for the Week of March 27, 2019

Recently Updated Records for the Week of March 27, 2019 Last Modified Date: Wednesday, March 20, 2019

FDA - U.S. Food and Drug Administration

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

21-3-2019

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Published on: Wed, 20 Mar 2019 The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be establ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Enforcement Report for the Week of March 20, 2019

Enforcement Report for the Week of March 20, 2019

Recently Updated Records for the Week of March 20, 2019 Last Modified Date: Monday, March 18, 2019

FDA - U.S. Food and Drug Administration

13-3-2019

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk

Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted.

FDA - U.S. Food and Drug Administration

12-3-2019


Agenda - CAT agenda of the 20-22 February 2019 meeting

Agenda - CAT agenda of the 20-22 February 2019 meeting

Agenda - CAT agenda of the 20-22 February 2019 meeting

Europe - EMA - European Medicines Agency

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Pest categorisation of Thrips palmi

Pest categorisation of Thrips palmi

Published on: Thu, 28 Feb 2019 The EFSA Panel on Plant Health (PLH) performed a pest categorisation of Thrips palmi(Thysanoptera: Thripidae), for the EU. T. palmi is listed in Annex IAI of 2000/29 EC. Using molecular methods, cryptic speciation has been shown although no new species from the group have been formally described. Here, we consider T. palmi sensu lato as a defined species native to southern Asia, which has spread to tropical and subtropical countries in Asia, the Pacific, North, Central and...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-2-2019

Enforcement Report for the Week of February 27, 2019

Enforcement Report for the Week of February 27, 2019

Recently Updated Records for the Week of February 27, 2019 Last Modified Date: Wednesday, February 20, 2019

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-2-2019

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

February 20, 2019: Home Health Nurse Sentenced to Federal Prison for Tampering with Patients' Medication

FDA - U.S. Food and Drug Administration

22-2-2019

Enforcement Report for the Week of February 20, 2019

Enforcement Report for the Week of February 20, 2019

Recently Updated Records for the Week of February 20, 2019 Last Modified Date: Friday, February 22, 2019

FDA - U.S. Food and Drug Administration

21-2-2019

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Annual report of the EFSA Scientific Network for Risk Assessment of GMOs for 2018

Published on: Wed, 20 Feb 2019 The EFSA Scientific Network for Risk Assessment of GMOs (the GMO Network) was established in accordance with EFSA's strategy for cooperation and networking with Member States. The goals of the GMO Network are to improve dialogue among members, build mutual understanding of risk assessment principles, enhance knowledge and confidence in the scientific assessment carried out in the EU, and increase the transparency of the process among Member States and EFSA. The annual repo...

Europe - EFSA - European Food Safety Authority EFSA Journal

24-1-2019

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills Recalls Five Pound Bags of Gold Medal Unbleached Flour

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached Flour with a better if used by date of April 20, 2020. The recall is being issued for the potential presence of Salmonella which was discovered during sampling of the five-pound bag product.

FDA - U.S. Food and Drug Administration

21-1-2019

John Deere recalls some Attachment Kits for Snow Blowers and 52 Inch Brooms that were sold without manuals

John Deere recalls some Attachment Kits for Snow Blowers and 52 Inch Brooms that were sold without manuals

Some of the attachment kits are missing the operator's manual.The operator's manual describes how to attach and safely operate the snow blowers and 52 inch brooms.Not following the operator's manual can result in important safety information being missed, posing an injury hazard.

Health Canada

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 Following a request from the European Commission, the EFSA 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

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

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

21-12-2018

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

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

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-4-2019


Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of epidermolysis bullosa, 20/06/2017, Positive

Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of epidermolysis bullosa, 20/06/2017, Positive

Orphan designation: Asp-Arg-Val-Tyr-Ile-His-Pro (Angiotensin 1-7), Treatment of epidermolysis bullosa, 20/06/2017, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Cannabidiol, Treatment of Lennox-Gastaut syndrome, 20/03/2017, Positive

Orphan designation: Cannabidiol, Treatment of Lennox-Gastaut syndrome, 20/03/2017, Positive

Orphan designation: Cannabidiol, Treatment of Lennox-Gastaut syndrome, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

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

12-4-2019


Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Orphan designation: 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1, Treatment of Huntington's disease, 20/06/2005, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Referral: Lemtrada,  alemtuzumab, Article 20 procedures, Procedure started

Referral: Lemtrada,  alemtuzumab, Article 20 procedures, Procedure started

Referral: Lemtrada,  alemtuzumab, Article 20 procedures, Procedure started

Europe - EMA - European Medicines Agency

8-4-2019


Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine, Treatment of fragile X syndrome, 20/04/2017, Positive

Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine, Treatment of fragile X syndrome, 20/04/2017, Positive

Orphan designation: N-[(1R)-1-phenylethyl]-6-{1H-pyrazolo[3,4-d]pyrimidin-4-yl}quinazolin-2-amine, Treatment of fragile X syndrome, 20/04/2017, Positive

Europe - EMA - European Medicines Agency

3-4-2019

Submissions received: Fees and charges proposal 2019-20

Submissions received: Fees and charges proposal 2019-20

We thank those individuals and organisations who lodged submissions for their valuable contribution

Therapeutic Goods Administration - Australia

28-3-2019


20 years of sampling and testing of centrally authorised products: 1998 – 2017

20 years of sampling and testing of centrally authorised products: 1998 – 2017

20 years of sampling and testing of centrally authorised products: 1998 – 2017

Europe - EMA - European Medicines Agency

28-3-2019


20 years of sampling and testing programme for medicines authorised for the EU

20 years of sampling and testing programme for medicines authorised for the EU

20 years of sampling and testing programme for medicines authorised for the EU

Europe - EMA - European Medicines Agency

20-3-2019

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2145 of Wed, 20 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003817

Europe -DG Health and Food Safety

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Active substance: isavuconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2069 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2734/T/20

Europe -DG Health and Food Safety

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

6-3-2019


Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Orphan designation: Avacopan, Treatment of C3 glomerulopathy, 20/06/2017, Positive

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Europe - EMA - European Medicines Agency

20-2-2019

Rizmoic (Shionogi B.V.)

Rizmoic (Shionogi B.V.)

Rizmoic (Active substance: naldemedine) - Centralised - Authorisation - Commission Decision (2019)1520 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4256

Europe -DG Health and Food Safety

20-2-2019

Tobramycin PARI (PARI Pharma GmbH)

Tobramycin PARI (PARI Pharma GmbH)

Tobramycin PARI (Active substance: tobramycin) - Centralised - Authorisation - Commission Decision (2019)1504 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/5086

Europe -DG Health and Food Safety

20-2-2019

Miglustat Dipharma (Dipharma B.V.)

Miglustat Dipharma (Dipharma B.V.)

Miglustat Dipharma (Active substance: miglustat) - Centralised - Authorisation - Commission Decision (2019)1512 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004904/0000

Europe -DG Health and Food Safety

20-2-2019

Advagraf (Astellas Pharma Europe B.V.)

Advagraf (Astellas Pharma Europe B.V.)

Advagraf (Active substance: Tacrolimus) - PSUSA - Modification - Commission Decision (2019)1513 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00002839/201803

Europe -DG Health and Food Safety

20-2-2019

Vantobra (PARI Pharma GmbH)

Vantobra (PARI Pharma GmbH)

Vantobra (Active substance: Tobramycin) - Centralised - Withdrawal - Commission Decision (2019)1511 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Silgard (Merck Sharp and Dohme Limited)

Silgard (Merck Sharp and Dohme Limited)

Silgard (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Withdrawal - Commission Decision (2019)1516 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Lusutrombopag Shionogi (Shionogi B.V.)

Lusutrombopag Shionogi (Shionogi B.V.)

Lusutrombopag Shionogi (Active substance: lusutrombopag) - Centralised - Authorisation - Commission Decision (2019)1507 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4720

Europe -DG Health and Food Safety

20-2-2019

ATryn (Laboratoire franCais du Fractionnement et des Biotechnologies)

ATryn (Laboratoire franCais du Fractionnement et des Biotechnologies)

ATryn (Active substance: antithrombin alfa) - Centralised - Annual reassessment - Commission Decision (2019)1509 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/587/S/35

Europe -DG Health and Food Safety

20-2-2019

Zelboraf (Roche Registration GmbH)

Zelboraf (Roche Registration GmbH)

Zelboraf (Active substance: vemurafenib) - Centralised - Yearly update - Commission Decision (2019)1506 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019

Pixuvri (CTI Life Sciences Deutschland GmbH)

Pixuvri (CTI Life Sciences Deutschland GmbH)

Pixuvri (Active substance: pixantrone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1510 of Wed, 20 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002055/T/0045

Europe -DG Health and Food Safety

20-2-2019

Zyprexa (Eli Lilly Nederland B.V.)

Zyprexa (Eli Lilly Nederland B.V.)

Zyprexa (Active substance: Olanzapine) - Centralised - Yearly update - Commission Decision (2019)1515 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Orphan designation: Adeno-associated viral vector serotype LK03 encoding human ornithine transcarbamylase, Treatment of ornithine transcarbamylase deficiency, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

4-2-2019

Feraccru (Norgine B.V.)

Feraccru (Norgine B.V.)

Feraccru (Active substance: ferric maltol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)857 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2733/T/20

Europe -DG Health and Food Safety

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

1-2-2019


Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Withdrawn application: Cavoley, pegfilgrastim, Date of withdrawal: 20/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Withdrawn application: Efgratin, pegfilgrastim, Date of withdrawal: 20/12/2019, Initial authorisation

Europe - EMA - European Medicines Agency

1-2-2019


Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Referral: Lartruvo, olaratumab, Article 20 procedures, 31/01/2019

Europe - EMA - European Medicines Agency

23-1-2019


Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem cell transplantation, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione, Treatment of Duchenne muscular dystrophy, 22/08/2014, Positive

Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione, Treatment of Duchenne muscular dystrophy, 22/08/2014, Positive

Orphan designation: 17α,21-Dihydroxy-16α-methyl-pregna-1,4,9(11)-triene-3,20-dione, Treatment of Duchenne muscular dystrophy, 22/08/2014, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/14/1309 (Pharma Gateway AB)

EU/3/14/1309 (Pharma Gateway AB)

EU/3/14/1309 (Active substance: 17a,21-dihydroxy-16a-methyl-pregna-1,4,9(11)-triene-3,20-dione) - Transfer of orphan designation - Commission Decision (2019)232 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002736

Europe -DG Health and Food Safety

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety