Մոնոնայն

main_info

  • trade_name:
  • Մոնոնայն 500
  • dosage:
  • 500ՄՄI փաթեթ (ապակե սրվակ փոշով և 5մլ ապակե սրվակ լուծչով), II փաթեթ
  • pharmaceutical_form:
  • դեղափոշի և լուծիչ ներարկման կամ կաթիլաներարկման լուծույթի
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Մոնոնայն 500
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

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

4-4-2019

FDA expands approved use of metastatic breast cancer treatment to include male patients

FDA expands approved use of metastatic breast cancer treatment to include male patients

The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

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

20-2-2019

Salmonella control in poultry flocks and its public health impact

Salmonella control in poultry flocks and its public health impact

Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Literature review in support of adjuvanticity/immunogenicity assessment of proteins

Published on: Fri, 25 Jan 2019 Based on the risk assessment of genetically modified plants, according to Implementing Regulation (EU) No 503/201321 “In cases when known functional aspects of the newly expressed protein or structural similarity to known strong adjuvants may indicate possible adjuvant activity, the applicant shall assess the possible role of these proteins as adjuvants”. To further investigate the topic, an EFSA procurement was launched requesting a comprehensive literature review and cri...

Europe - EFSA - European Food Safety Authority EFSA Journal

30-11-2018


Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Europe - EMA - European Medicines Agency

30-11-2018


Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2

Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2

Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2

Europe - EMA - European Medicines Agency

30-11-2018

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Published on: Thu, 29 Nov 2018 This update on the African swine fever (ASF) outbreaks in the EU demonstrated that out of all tested wild boar found dead, the proportion of positive samples peaked in winter and summer. For domestic pigs only, a summer peak was evident. Despite the existence of several plausible factors that could result in the observed seasonality, there is no evidence to prove causality. Wild boar density was the most influential risk factor for the occurrence of ASF in wild boar. In th...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

9-4-2019


Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

29-3-2019

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (Active substance: human coagulation factor X) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2577 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/T/14

Europe -DG Health and Food Safety

26-3-2019


Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Europe - EMA - European Medicines Agency

18-3-2019

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2148 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003801

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2147 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003809

Europe -DG Health and Food Safety

18-3-2019

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (Active substance: Human coagulation factor X) - Transfer of orphan designation - Commission Decision (2019)2158 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004129

Europe -DG Health and Food Safety

11-3-2019


Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

1-3-2019


First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban

First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban

First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/19/2141 (Fondazione Telethon)

EU/3/19/2141 (Fondazione Telethon)

EU/3/19/2141 (Active substance: Lentiviral vector encoding human coagulation factor IX) - Orphan designation - Commission Decision (2019)1733 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002293

Europe -DG Health and Food Safety

22-2-2019

EU/3/17/1874 (TxCell S.A.)

EU/3/17/1874 (TxCell S.A.)

EU/3/17/1874 (Active substance: Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII) - Transfer of orphan designation - Commission Decision (2019)1369 of Fri, 22 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003577

Europe -DG Health and Food Safety

20-2-2019


Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription fac

Opinion/decision on a Paediatric investigation plan (PIP): Human donor haematopoietic stem and progenitor cells (HSPC) that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor (TBX-1400), decision type: , therapeutic area: , PIP number: P/0284/2018

Europe - EMA - European Medicines Agency

28-1-2019


Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Orphan designation: Pegylated B-domain-deleted sequence-modified recombinant human factor VIII (damoctocog alfa pegol), Treatment of haemophilia A, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

22-1-2019

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (Active substance: Chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2) - Transfer of orphan designation - Commission Decision (2019)575 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003313

Europe -DG Health and Food Safety

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9010 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002648

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9011 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002649

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9012 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002650

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2112 (Merck Europe B.V.)

EU/3/18/2112 (Merck Europe B.V.)

EU/3/18/2112 (Active substance: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1) - Orphan designation - Commission Decision (2018)9027 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/154/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Rigenerand S.r.l.)

EU/3/18/2085 (Active substance: Autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand) - Orphan designation - Commission Decision (2018)7794 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/18

Europe -DG Health and Food Safety

21-11-2018

EU/3/16/1752 (Pfizer Europe MA EEIG)

EU/3/16/1752 (Pfizer Europe MA EEIG)

EU/3/16/1752 (Active substance: Human monoclonal IgG1 antibody against tissue factor pathway inhibitor) - Transfer of orphan designation - Commission Decision (2018)7838 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/093/16/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

29-8-2018

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Bio Products Laboratory Ltd)

Coagadex (Active substance: human coagulation factor X) - Centralised - 2-Monthly update - Commission Decision (2018)5772 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/II/07

Europe -DG Health and Food Safety

23-8-2018

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Bayer AG)

EU/3/18/1979 (Active substance: Human monoclonal IgG2 antibody against tissue factor pathway inhibitor) - Corrigendum - Commission Decision (2018)1246 of Thu, 23 Aug 2018

Europe -DG Health and Food Safety

2-8-2018

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Kyowa Kirin Holdings B.V.)

EU/3/14/1351 (Active substance: Recombinant human monoclonal IgG1 antibody for fibroblast growth factor 23) - Transfer of orphan designation - Commission Decision (2018)5289 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/133/14/T/02

Europe -DG Health and Food Safety

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2040 (IQVIA RDS Ireland Limited)

EU/3/18/2040 (IQVIA RDS Ireland Limited)

EU/3/18/2040 (Active substance: Recombinant human placental growth factor) - Orphan designation - Commission Decision (2018)4185 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/035/18

Europe -DG Health and Food Safety

27-6-2018

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

EU/3/17/1874 (Sangamo Therapeutics UK LTD)

EU/3/17/1874 (Active substance: Recombinant adeno-associated viral vector serotype 6 encoding the B-domain-deleted human factor VIII) - Transfer of orphan designation - Commission Decision (2018)4099 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/17/T/01

Europe -DG Health and Food Safety

2-6-2018

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Active substance: Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor) - Transfer of orphan designation - Commission Decision (2018)3630 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Baxalta Innovations GmbH)

EU/3/18/2015 (Active substance: Adeno-associated viral vector serotype 8 containing a functional copy of the codon-optimised F8 cDNA encoding the B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)3382 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/18

Europe -DG Health and Food Safety

18-5-2018

EU/3/16/1817 (IQVIA RDS Ireland Limited)

EU/3/16/1817 (IQVIA RDS Ireland Limited)

EU/3/16/1817 (Active substance: Human donor haematopoietic stem and progenitor cells that have been treated ex vivo with the protein transduction domain of the HIV-1 transactivation protein fused to MYC transcription factor) - Transfer of orphan designation - Commission Decision (2018)3143 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/191/16/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety