ICI PRO GRO 25 SEED PROTECTANT

Main information

  • Trade name:
  • ICI PRO GRO 25 SEED PROTECTANT
  • Class:
  • AgChem
  • Medicine domain:
  • Plants
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ICI PRO GRO 25 SEED PROTECTANT
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BARLEY | OATS
  • Therapeutic area:
  • FUNGICIDE
  • Therapeutic indications:
  • COVERED STINKING SMUT | LOOSE SMUT - USTILAGO AVENAE | USTILAGO HORDEI | USTILAGO NUDA (TRITICI)

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Archived
  • Authorization number:
  • 30233
  • Last update:
  • 09-08-2016

22-1-2019

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-1-2019

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

Ruling by the French administrative court of Lyon: ANSES contests any error of assessment

ANSES has examined the ruling of 15 January 2019 by the French administrative court of Lyon overriding the marketing authorisation decision for Roundup Pro 360. It should be noted that, in order to protect human and environmental health, ANSES is responsible for implementing European regulations on the national level with regard to the marketing authorisation of regulated products (plant protection products, biocides and veterinary medicinal products). It also contributes to improving these regulations b...

France - Agence Nationale du Médicament Vétérinaire

18-1-2019

Updating of summaries of product characteristics due to changed ATC codes for 2019

Updating of summaries of product characteristics due to changed ATC codes for 2019

Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2019.

Danish Medicines Agency

14-1-2019


Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man

Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man

Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man

Europe - EMA - European Medicines Agency

14-1-2019


Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

Draft guideline on the evaluation of medicinal products indicated for treatment of bacterial infections - Revision 3

Europe - EMA - European Medicines Agency

19-12-2018


Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1

Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1

Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1

Europe - EMA - European Medicines Agency

18-12-2018


Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Europe - EMA - European Medicines Agency

18-12-2018


Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam)

Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam)

Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam)

Europe - EMA - European Medicines Agency

18-12-2018


eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Basel), DIA EMEA Office, Basel Switzerland, from 27/06/2019 to 28/06/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Basel), DIA EMEA Office, Basel Switzerland, from 27/06/2019 to 28/06/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Basel), DIA EMEA Office, Basel Switzerland, from 27/06/2019 to 28/06/2019

Europe - EMA - European Medicines Agency

18-12-2018


Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Basel)

Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Basel)

Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Basel)

Europe - EMA - European Medicines Agency

18-12-2018


eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid), Lexington - AZCA, Madrid, Spain, from 23/05/2019 to 24/05/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid), Lexington - AZCA, Madrid, Spain, from 23/05/2019 to 24/05/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid), Lexington - AZCA, Madrid, Spain, from 23/05/2019 to 24/05/2019

Europe - EMA - European Medicines Agency

18-12-2018


Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid)

Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid)

Agenda and registration form - eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Madrid)

Europe - EMA - European Medicines Agency

18-12-2018


eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

eXtended EudraVigilance Medicinal Product Dictionary face-to-face training course (Amsterdam), BCN Amsterdam Arena, Atlas Arena Complex Amsterdam, The Netherlands, from 14/02/2019 to 15/02/2019

Europe - EMA - European Medicines Agency

17-12-2018


Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Draft reflection paper on risk management requirements for elemental impurities in veterinary medicinal products

Europe - EMA - European Medicines Agency

17-12-2018

New format requirements for Marketing Authorization submissions from 1 January 2019

New format requirements for Marketing Authorization submissions from 1 January 2019

The NeeS submission format will be discontinued for all applications submitted under the national procedure (NP), i.e. applications for variations, renewals etc. This change is related to medicinal products for human use. Parallel import and parallel distribution are not affected by this change.

Danish Medicines Agency

14-12-2018


European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, from 03/12/2018 to 03/12/2018

Europe - EMA - European Medicines Agency

22-1-2019


Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201805

Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201805

Flunarizine: List of nationally authorised medicinal products - PSUSA/00001416/201805

Europe - EMA - European Medicines Agency

22-1-2019


Acemetacin: List of nationally authorised medicinal products - PSUSA/00000026/201805

Acemetacin: List of nationally authorised medicinal products - PSUSA/00000026/201805

Acemetacin: List of nationally authorised medicinal products - PSUSA/00000026/201805

Europe - EMA - European Medicines Agency

22-1-2019


Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201804

Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201804

Fenspiride: List of nationally authorised medicinal products - PSUSA/00001368/201804

Europe - EMA - European Medicines Agency

22-1-2019


Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Isotretinoin (oral formulations): List of nationally authorised medicinal products - PSUSA/00010488/201805

Europe - EMA - European Medicines Agency

21-1-2019


Nitrofurantoin, nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201802

Nitrofurantoin, nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201802

Nitrofurantoin, nifurtoinol: List of nationally authorised medicinal products - PSUSA/00002174/201802

Europe - EMA - European Medicines Agency

21-1-2019


Ciprofloxacin (systemic use):  List of nationally authorised medicinal products - PSUSA/00000775/201801

Ciprofloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00000775/201801

Ciprofloxacin (systemic use): List of nationally authorised medicinal products - PSUSA/00000775/201801

Europe - EMA - European Medicines Agency

18-1-2019


European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

European Medicines Agency practical guidance on the application form for centralised type IA and IB variations for veterinary medicinal products

Europe - EMA - European Medicines Agency

18-1-2019


Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Ivabradine / metoprolol: List of nationally authorised medicinal products - PSUSA/00010381/201804

Europe - EMA - European Medicines Agency

16-1-2019

Erleada (Janssen-Cilag International NV)

Erleada (Janssen-Cilag International NV)

Erleada (Active substance: apalutamide) - New authorisation - Commission Decision (2019)257 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4452

Europe -DG Health and Food Safety

16-1-2019

Product Quality Reviews (PQRs) for listed and complementary medicines

Product Quality Reviews (PQRs) for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

15-1-2019

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Aterna Zentaris GmbH)

Macimorelin Aeterna Zentaris (Active substance: macimorelin) - New authorisation - Commission Decision (2019)203 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4660

Europe -DG Health and Food Safety

14-1-2019

Paclitaxel Hetero and associated names

Paclitaxel Hetero and associated names

Paclitaxel Hetero and associated names (Active substance: paclitaxel) - Community Referrals - Art 29 - Commission Decision (2019)205 of Mon, 14 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H//A-29(4)/1466

Europe -DG Health and Food Safety

11-1-2019

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (LABORATORIOS SYVA, S.A.U.)

Syvazul BTV (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 3)) - New authorisation - Commission Decision (2019)135 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/V/C/4611

Europe -DG Health and Food Safety

11-1-2019

Isemid (Ceva SantE Animale)

Isemid (Ceva SantE Animale)

Isemid (Active substance: Torasemide) - New authorisation - Commission Decision (2019)134 of Fri, 11 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4345

Europe -DG Health and Food Safety

10-1-2019


BCG vaccine (freeze-dried): List of nationally authorised medicinal products - PSUSA/00000304/201803

BCG vaccine (freeze-dried): List of nationally authorised medicinal products - PSUSA/00000304/201803

BCG vaccine (freeze-dried): List of nationally authorised medicinal products - PSUSA/00000304/201803

Europe - EMA - European Medicines Agency

10-1-2019


Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/201801

Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/201801

Lorazepam: List of nationally authorised medicinal products - PSUSA/00001909/201801

Europe - EMA - European Medicines Agency

9-1-2019


Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Europe - EMA - European Medicines Agency

9-1-2019

Silodosin Recordati (Recordati Ireland Ltd)

Silodosin Recordati (Recordati Ireland Ltd)

Silodosin Recordati (Active substance: silodosin) - New authorisation - Commission Decision (2019)73 of Wed, 09 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4964

Europe -DG Health and Food Safety

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Europe - EMA - European Medicines Agency

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

19-12-2018


Enalapril: List of nationally authorised medicinal products - PSUSA/00001211/201803

Enalapril: List of nationally authorised medicinal products - PSUSA/00001211/201803

Enalapril: List of nationally authorised medicinal products - PSUSA/00001211/201803

Europe - EMA - European Medicines Agency

19-12-2018


Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3

Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3

Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3

Europe - EMA - European Medicines Agency

19-12-2018


Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Europe - EMA - European Medicines Agency

19-12-2018

Perlinring and associated names

Perlinring and associated names

Perlinring and associated names (Active substance: etonogestrel/ethinylestradiol) - Community Referrals - Art 29 - Commission Decision (2018)9141 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1473

Europe -DG Health and Food Safety

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


Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Mycophenolate mofetil, mycophenolic acid : List of nationally authorised medicinal products - PSUSA/00010550/201805

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured fibroblasts

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing prostate antigens

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Scientific recommendation on classification of advanced therapy medicinal products: Live-attenuated, double-deleted Listeria monocytogenes expressing human mesothelin

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Scientific recommendation on classification of advanced therapy medicinal products: Concentrate of autologous bone marrow-derived mononuclear cells (BM-MNC)

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro

Scientific recommendation on classification of advanced therapy medicinal products: Allogenic bone marrow derived mesenchymal stem cells expanded in vitro

Europe - EMA - European Medicines Agency

17-12-2018

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Active substance: obeticholic acid) - Centralised - Annual renewal - Commission Decision (2018)8909 of Mon, 17 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4093/R/9

Europe -DG Health and Food Safety

17-12-2018


Risk management requirements for elemental impurities in veterinary medicinal products

Risk management requirements for elemental impurities in veterinary medicinal products

Risk management requirements for elemental impurities in veterinary medicinal products

Europe - EMA - European Medicines Agency

14-12-2018


Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revsion 2

Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revsion 2

Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS) / limited market - Revsion 2

Europe - EMA - European Medicines Agency

14-12-2018

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8927 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2745/T/38

Europe -DG Health and Food Safety

14-12-2018

Valdoxan (Les Laboratoires Servier)

Valdoxan (Les Laboratoires Servier)

Valdoxan (Active substance: agomelatine) - Centralised - Renewal - Commission Decision (2018)8932 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/915/R/42

Europe -DG Health and Food Safety

14-12-2018

Ogivri (Mylan S.A.S.)

Ogivri (Mylan S.A.S.)

Ogivri (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)8913 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4916

Europe -DG Health and Food Safety