Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2013 to 30 November 2013 (decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2013-12-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013380EN.01001101.xml










28.12.2013   


EN


Official Journal of the European Union


C 380/11





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2013 to 30 November 2013

(decisions taken pursuant to Article 34 of Directive 2001/83/EC
 (1)
or Article 38 of Directive 2001/82/EC
 (2)
)

2013/C 380/02
—   Issuing, maintenance or modification of a national marketing authorization










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorization


Member State concerned


Date of notification




20.11.2013


Didanosine Art 29


See Annex I


See Annex I


22.11.2013






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) IN THE MEMBER STATES











Member State EU/EEA


Applicant company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




France







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






DIDANOSINE AUROBINDO 200 mg, gélule gastro-résistante


200 mg


Gastro-resistant capsule, hard


Oral use




France







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






DIDANOSINE AUROBINDO 250 mg, gélule gastro-résistante


250 mg


Gastro-resistant capsule, hard


Oral use




France







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






DIDANOSINE AUROBINDO 400 mg, gélule gastro-résistante


400 mg


Gastro-resistant capsule, hard


Oral use




Germany







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosin Aurobindo 200 mg magensaftresistente Hartkapseln


200 mg


Gastro-resistant capsule, hard


Oral use




Germany







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosin Aurobindo 250 mg magensaftresistente Hartkapseln


250 mg


Gastro-resistant capsule, hard


Oral use




Germany







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosin Aurobindo 400 mg magensaftresistente Hartkapseln


400 mg


Gastro-resistant capsule, hard


Oral use




Italy







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosina Aurobindo 200 mg capsule rigide gastroresistenti


200 mg


Gastro-resistant capsule, hard


Oral use




Italy







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosina Aurobindo 250 mg capsule rigide gastroresistenti


250 mg


Gastro-resistant capsule, hard


Oral use




Italy







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosina Aurobindo 400 mg capsule rigide gastroresistenti


400 mg


Gastro-resistant capsule, hard


Oral use




Netherlands







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosine Aurobindo 250 mg maagsapresistente capsules, hard


250 mg


Gastro-resistant capsule, hard


Oral use




Netherlands







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosine Aurobindo 400 mg maagsapresistente capsules, hard


400 mg


Gastro-resistant capsule, hard


Oral use




Portugal







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosina Aurobindo


250 mg


Gastro-resistant capsule, hard


Oral use




Portugal







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosina Aurobindo


400 mg


Gastro-resistant capsule, hard


Oral use




Romania







Aurobindo Pharma (Malta) Limited




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913




Malta






Didanosine Aurobindo 250 mg capsule gastrorezistente


250 mg


Gastro-resistant capsule, hard


Oral use




Romania







Aurobindo Pharma (Malta) Limited




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913




Malta






Didanosine Aurobindo 400 mg capsule gastrorezistente


400 mg


Gastro-resistant capsule, hard


Oral use




Spain







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






DIDANOSINA AUROBINDO 250 mg cápsulas duras gastrorresistentes


250 mg


Gastro-resistant capsule, hard


Oral use




Spain







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






DIDANOSINA AUROBINDO 400 mg cápsulas duras gastrorresistentes


400 mg


Gastro-resistant capsule, hard


Oral use




United Kingdom







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosine 200 mg gastro-resistant capsules, hard


200 mg


Gastro-resistant capsule, hard


Oral use




United Kingdom







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosine 250 mg gastro-resistant capsules, hard


250 mg


Gastro-resistant capsule, hard


Oral use




United Kingdom







Aurobindo Pharma (Malta) Limited,




Vault 14, Level 2,




Valletta Waterfront,




Floriana FRN 1913,




Malta






Didanosine 400 mg gastro-resistant capsules, hard


400 mg


Gastro-resistant capsule, hard


Oral use