Peyona (previously Nymusa)

RSS

caffeine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Peyona. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Peyona.

This EPAR was last updated on 25/10/2017

Authorisation details

Product details
Name
Peyona (previously Nymusa)
Agency product number
EMEA/H/C/001014
Active substance
Caffeine citrate
International non-proprietary name (INN) or common name
caffeine
Therapeutic area (MeSH)
Apnea
Anatomical therapeutic chemical (ATC) code
N06BC01
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Chiesi Farmaceutici SpA
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
02/07/2009
Contact address
Via Palermo 26/A
IT-43100 Parma
Italy

Product information

21/09/2017 Peyona (previously Nymusa) - EMEA/H/C/001014 - IAIN/0019

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Psychoanaleptics

Therapeutic indication

Treatment of primary apnoea of premature newborns.

Assessment history

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