This document is an excerpt from the EUR-Lex website
Document 52013XC1228(03)
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)
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)
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)
OJ C 380, 28.12.2013, p. 11–14
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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 |
|
DIDANOSINE AUROBINDO 200 mg, gélule gastro-résistante |
200 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
France |
|
DIDANOSINE AUROBINDO 250 mg, gélule gastro-résistante |
250 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
France |
|
DIDANOSINE AUROBINDO 400 mg, gélule gastro-résistante |
400 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Germany |
|
Didanosin Aurobindo 200 mg magensaftresistente Hartkapseln |
200 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Germany |
|
Didanosin Aurobindo 250 mg magensaftresistente Hartkapseln |
250 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Germany |
|
Didanosin Aurobindo 400 mg magensaftresistente Hartkapseln |
400 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Italy |
|
Didanosina Aurobindo 200 mg capsule rigide gastroresistenti |
200 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Italy |
|
Didanosina Aurobindo 250 mg capsule rigide gastroresistenti |
250 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Italy |
|
Didanosina Aurobindo 400 mg capsule rigide gastroresistenti |
400 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Netherlands |
|
Didanosine Aurobindo 250 mg maagsapresistente capsules, hard |
250 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Netherlands |
|
Didanosine Aurobindo 400 mg maagsapresistente capsules, hard |
400 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Portugal |
|
Didanosina Aurobindo |
250 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Portugal |
|
Didanosina Aurobindo |
400 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Romania |
|
Didanosine Aurobindo 250 mg capsule gastrorezistente |
250 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Romania |
|
Didanosine Aurobindo 400 mg capsule gastrorezistente |
400 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Spain |
|
DIDANOSINA AUROBINDO 250 mg cápsulas duras gastrorresistentes |
250 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
Spain |
|
DIDANOSINA AUROBINDO 400 mg cápsulas duras gastrorresistentes |
400 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
United Kingdom |
|
Didanosine 200 mg gastro-resistant capsules, hard |
200 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
United Kingdom |
|
Didanosine 250 mg gastro-resistant capsules, hard |
250 mg |
Gastro-resistant capsule, hard |
Oral use |
|||||
|
United Kingdom |
|
Didanosine 400 mg gastro-resistant capsules, hard |
400 mg |
Gastro-resistant capsule, hard |
Oral use |