FEMBESOL

Main information

  • Trade name:
  • FEMBESOL 10G CRM
  • Dosage:
  • 0.05%W/W(17)
  • Pharmaceutical form:
  • CRM
  • Composition:
  • 10G
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FEMBESOL 10G CRM
    India
  • Language:
  • English

Other information

Status

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

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Horizon Pharma Ireland Limited)

Ravicti (Active substance: Glycerol phenylbutyrate) - Centralised - 2-Monthly update - Commission Decision (2018)9126 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3822/II/19

Europe -DG Health and Food Safety

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Ravicti,Glycerol phenylbutyrate, decision type: , therapeutic area: , PIP number: P/0191/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ravicti,Glycerol phenylbutyrate, decision type: , therapeutic area: , PIP number: P/0191/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ravicti,Glycerol phenylbutyrate, decision type: , therapeutic area: , PIP number: P/0191/2018

Europe - EMA - European Medicines Agency

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety