181 results
-
List item
Human medicine European public assessment report (EPAR): Protopic
tacrolimus, Dermatitis, Atopic
Date of authorisation: 27/02/2002, Revision: 26, Authorised, Last updated: 11/01/2023Protopic Congenital, Hereditary … assessment report (EPAR) for Protopic. It explains how the The committee … the conditions of use for Protopic. What is Protopic? Protopic is an ointment that contains … -
List item
Human medicine European public assessment report (EPAR): Protopy
tacrolimus, Dermatitis, Atopic
Date of authorisation: 28/02/2002, Revision: 10, Withdrawn, Last updated: 29/10/2008Protopy Dermatitis, Atopic … marketing authorisation for Protopy has been withdrawn at the … holder. Summary documents Protopy : EPAR - Summary for the … -
List item
Press release: European Medicines Agency recommends cautious use of protopic/protopy and elidel
Last updated: 27/03/2006recommends cautious use of protopic/protopy and elidel … Finalising its safety review of Protopic/Protopy (tacrolimus) and Elidel (pimecrolimus … possible. Patients who are using Protopic/Protopy or Elidel should not stop … -
List item
Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,
, 
, 
, Revision: 9, Authorised, Last updated: 04/11/2022
Diseases Metabolic Diseases Porphyrias Protoporphyria, Erythropoietic … patients with erythropoietic protoporphyria (EPP), a rare disease that … levels of a substance called protoporphyrin IX in the body Protoporphyrin IX is phototoxic and, when … -
List item
Referral: Elidel
pimecrolimus, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/03/2006, Last updated: 29/08/2006allergy). These medicines are: Protopic/Protopy: a medicine containing tacrolimus … marketed in the EU, the use of Protopic/Protopy and Elidel is being continuously … potential link between the use of Protopic/Protopy or Elidel and the skin cancers … -
List item
Orphan designation: [Nle4, D-Phe7]-alfa-melanocyte stimulating hormone (afamelanotide) for: Treatment of erythropoietic protoporphyria
Date of designation: 08/05/2008, Positive, Last updated: 11/04/2016treatment of erythropoietic protoporphyria … treatment of erythropoietic protoporphyria First publication 29 July … treatment of erythropoietic protoporphyria. What is erythropoietic protoporphyria? Porphyrias are a group … -
List item
Orphan designation: 5-aminolevulinic acid hydrochloride for: Intra-operative photodynamic diagnosis of residual glioma
Date of designation: 14/11/2002, Expired, Last updated: 03/10/2017transformed into a substance called protoporphyrin. Under blue light protoporphyrin becomes fluorescent, and … fluorescence depends on the protoporphyrin concentration. The chemical … into a substance called protoporphyrin. Under blue light protoporphyrin becomes fluorescent, and … -
List item
Human medicine European public assessment report (EPAR): Gliolan
5-aminolevulinic acid hydrochloride, Glioma
Date of authorisation: 07/09/2007, Revision: 8, Authorised, Last updated: 28/04/2023fluorescent chemicals, particularly protoporphyrin IX (PPIX). Since glioma cells … chemicals, particularly protoporphyrin IX (PPIX). Since glioma cells … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Dersimelagon
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-002850-PIP02-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate dosage form, Film-coated tablet
Decision date: 10/06/2022, Last updated: 13/06/2023, Compliance check: XTreatment of erythropoietic protoporphyria Treatment of X-linked protoporphyria Oral use Mitsubishi Tanabe … Treatment of erythropoietic protoporphyria Treatment of X-linked protoporphyria Pharmaceutical form(s … Treatment of erythropoietic protoporphyria The waiver applies to … -
List item
Orphan designation: Dersimelagon for: Treatment of erythropoietic protoporphyria
Date of designation: 16/03/2022, Positive, Last updated: 21/07/2023treatment of erythropoietic protoporphyria in the European Union on … -
List item
News: Rare Disease Day 2015
Last updated: 26/02/2015treatment for erythropoietic protoporphyria, a rare genetic disease which … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): afamelanotide
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-000737-PIP02-11, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Age-appropriate dosage form, other, Implant
Decision date: 02/12/2011, Last updated: 19/01/2012, Compliance check: XTreatment of erythropoietic protoporphyria Subcutaneous use Clinuvel … Treatment of erythropoietic protoporphyria Pharmaceutical form(s … treatment of erythropoietic protoporphyria The waiver applies to … -
List item
National expert: Ingrid Wang, Norwegian Medicines Agency (updated)
- Declaration of interests - 40.95 KB | PDF
- Curriculum Vitae - 30.12 KB | PDF
aminolaevulinic acid_induced protoporphyrin IX sensitisation in experimental … 5_aminolevulinic acid_induced protoporphyrin IX accumulation in tumours … aminolaevulinic acid_induced protoporphyrin IX accumulation in basal … -
List item
Orphan designation: 5-aminolevulinic acid for: Treatment of glioma
Date of designation: 12/01/2017, Positive, Last updated: 10/03/2023converted by enzymes into protoporphyrin IX (PPIX), a photosensitising … converted by enzymes into protoporphyrin IX (PPIX), a photosensitising … -
List item
Press release: Record number of medicines for rare diseases recommended for approval in 2014
Last updated: 09/01/2015treatment for erythropoietic protoporphyria, a rare genetic disease which … treatment for erythropoietic protoporphyria, a rare genetic disease which … -
List item
News: Involving patients in discussions on benefits and risks of medicines
Last updated: 08/05/2017treatment of erythropoietic protoporphyria (EPP) (September 2014 … treatment of erythropoietic protoporphyria (EPP) 2. June 2015 - Intuniv … -
List item
Press release: Scenesse recommended for rare disease that causes intolerance to sunlight
CHMP, Last updated: 24/10/2014adults with erythropoietic protoporphyria (EPP), a rare genetic disease … adults with erythropoietic protoporphyria (EPP), a rare genetic disease … -
List item
Press release: Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use
Last updated: 26/09/2014treatment of erythropoietic protoporphyria (EPP), a rare genetic blood … treatment of erythropoietic protoporphyria (EPP), a rare genetic blood … -
List item
National expert: Andreea Barbu, Medical Products Agency (updated)
- Declaration of interests - 39.21 KB | PDF
- Curriculum Vitae - 30.96 KB | PDF
-
List item
National expert: Carla Marcella Caramella, Italian Medicines Agency (updated)
- Declaration of interests - 39.88 KB | PDF
- Curriculum Vitae - 48.59 KB | PDF
Il caso di Betabioptal unguento oftalmico, Minerva Oftalmologica … -
List item
Human medicine European public assessment report (EPAR): Envarsus
tacrolimus, Graft Rejection
Date of authorisation: 18/07/2014, Revision: 12, Authorised, Last updated: 23/01/2023 -
List item
Human medicine European public assessment report (EPAR): Ameluz
5-aminolevulinic acid hydrochloride, Keratosis, Actinic; Carcinoma, Basal Cell
Date of authorisation: 13/12/2011, Revision: 19, Authorised, Last updated: 23/03/2022 -
List item
Human medicine European public assessment report (EPAR): Briviact (in Italy: Nubriveo)
Brivaracetam, Epilepsy
Date of authorisation: 13/01/2016, Revision: 21, Authorised, Last updated: 04/04/2023 -
List item
Human medicine European public assessment report (EPAR): Advate
octocog alfa, Hemophilia A
Date of authorisation: 02/03/2004, Revision: 31, Authorised, Last updated: 24/08/2023 -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 October 2014
CHMP, Last updated: 24/10/2014treatment of erythropoietic protoporphyria (EPP), a rare genetic disease …