EMTOR

Main information

  • Trade name:
  • EMTOR 10 TAB
  • Dosage:
  • 1MG
  • Pharmaceutical form:
  • TAB
  • Composition:
  • 10
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EMTOR 10 TAB
    India
  • Language:
  • English

Other information

Status

  • Source:
  • Central Drugs Standard Control Organization
  • Last update:
  • 09-08-2016

14-3-2018

Orphan designation:  Sirolimus,  for the: Treatment of sickle cell disease

Orphan designation: Sirolimus, for the: Treatment of sickle cell disease

Europe - EMA - European Medicines Agency

7-3-2018

Opinion/decision on a Paediatric investigation plan (PIP):    -, Sirolimus, Therapeutic area: Other

Opinion/decision on a Paediatric investigation plan (PIP): -, Sirolimus, Therapeutic area: Other

Europe - EFSA - European Food Safety Authority EFSA Journal

14-8-2017

Orphan designation:  sirolimus,  for the: Treatment of pachyonychia congenita

Orphan designation: sirolimus, for the: Treatment of pachyonychia congenita

Europe - EMA - European Medicines Agency

17-7-2017

Orphan designation:  Sirolimus,  for the: Treatment of tuberous sclerosis

Orphan designation: Sirolimus, for the: Treatment of tuberous sclerosis

Europe - EMA - European Medicines Agency

20-4-2017

Opinion/decision on a Paediatric investigation plan (PIP):    -, Sirolimus, Therapeutic area: Ophthalmology

Opinion/decision on a Paediatric investigation plan (PIP): -, Sirolimus, Therapeutic area: Ophthalmology

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2018

EU/3/17/1970 (Rare Partners srl Impresa Sociale)

EU/3/17/1970 (Rare Partners srl Impresa Sociale)

EU/3/17/1970 (Active substance: Sirolimus) - Orphan designation - Commission Decision (2018)392 of Fri, 19 Jan 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/17

Europe -DG Health and Food Safety

20-12-2017

SIROLIMUS Tablet, Film Coated [Cadila Healthcare Limited]

SIROLIMUS Tablet, Film Coated [Cadila Healthcare Limited]

Updated Date: Dec 20, 2017 EST

US - DailyMed

20-12-2017

SIROLIMUS Tablet, Film Coated [Zydus Pharmaceuticals (USA) Inc.]

SIROLIMUS Tablet, Film Coated [Zydus Pharmaceuticals (USA) Inc.]

Updated Date: Dec 20, 2017 EST

US - DailyMed

1-12-2017

SIROLIMUS Tablet [American Health Packaging]

SIROLIMUS Tablet [American Health Packaging]

Updated Date: Dec 1, 2017 EST

US - DailyMed

22-11-2017

SIROLIMUS Tablet, Film Coated [American Health Packaging]

SIROLIMUS Tablet, Film Coated [American Health Packaging]

Updated Date: Nov 22, 2017 EST

US - DailyMed

30-10-2017

SIROLIMUS Tablet [Dr. Reddy'S Laboratories Limited]

SIROLIMUS Tablet [Dr. Reddy'S Laboratories Limited]

Updated Date: Oct 30, 2017 EST

US - DailyMed

25-8-2017

EU/3/17/1910 (Best Regulatory Consulting Ltd)

EU/3/17/1910 (Best Regulatory Consulting Ltd)

EU/3/17/1910 (Active substance: Sirolimus) - Orphan designation - Commission Decision (2017)5919 of Fri, 25 Aug 2017 European Medicines Agency (EMA) procedure number: EMA/OD/047/17

Europe -DG Health and Food Safety

19-7-2017

EU/3/17/1896 (Raremoon Consulting Ltd)

EU/3/17/1896 (Raremoon Consulting Ltd)

EU/3/17/1896 (Active substance: Sirolimus) - Orphan designation - Commission Decision (2017)5160 of Wed, 19 Jul 2017 European Medicines Agency (EMA) procedure number: EMA/OD/025/17

Europe -DG Health and Food Safety

27-6-2017

Rapamune (Pfizer Limited)

Rapamune (Pfizer Limited)

Rapamune (Active substance: sirolimus) - Centralised - Yearly update - Commission Decision (2017)4480 of Tue, 27 Jun 2017

Europe -DG Health and Food Safety

22-6-2017

EU/3/17/1886 (Vale Pharmaceuticals Limited)

EU/3/17/1886 (Vale Pharmaceuticals Limited)

EU/3/17/1886 (Active substance: Sirolimus) - Orphan designation - Commission Decision (2017)4372 of Thu, 22 Jun 2017 European Medicines Agency (EMA) procedure number: EMA/OD/007/17

Europe -DG Health and Food Safety