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Etibi

Hauptinformation

  • Handelsname:
  • Etibi 500 mg - Tabletten
  • Einheiten im Paket:
  • 100 Stueck, Laufzeit: 60 Monate
  • Verschreibungstyp:
  • Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge
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Dokumenten

Lokalisierung

  • Erhältlich in:
  • Etibi 500 mg - Tabletten
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Ethambutol
  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 15213
  • Berechtigungsdatum:
  • 16-01-1973
  • Letzte Änderung:
  • 09-08-2017

Packungsbeilage


KE - Etibi 500 mg - Tabletten

zugelassen: 16.01.1973 Seite 1 (2)

geändert: 02.08.2013

ANGABEN AUF DER ÄUSSEREN UMHÜLLUNG UND AUF DEM BEHÄLTNIS

Umkarton und Flaschenetikette

1. BEZEICHNUNG DES ARZNEIMITTELS

Etibi 500 mg - Tabletten

Wirkstoff: Ethambutol-Dihydrochlorid

2. WIRKSTOFF(E)

1 Tablette enthält 500 mg Ethambutol-Dihydrochlorid

3. SONSTIGE BESTANDTEILE

sowie Lactose-Monohydrat.

4. DARREICHUNGSFORM UND INHALT

100 Tabletten

5. HINWEISE ZUR UND ART(EN) DER ANWENDUNG

Packungsbeilage beachten.

Zum Einnehmen.

6. WARNHINWEIS, DASS DAS ARZNEIMITTEL FÜR KINDER UNERREICHBAR UND 

NICHT SICHTBAR AUFZUBEWAHREN IST

Arzneimittel für Kinder unzugänglich aufbewahren.

7. WEITERE WARNHINWEISE, FALLS ERFORDERLICH

 Achtung: Dieses Arzneimittel kann die Reaktionsfähigkeit und Verkehrstüchtigkeit 

beeinträchtigen.

KE - Etibi 500 mg - Tabletten

zugelassen: 16.01.1973 Seite 2 (2)

geändert: 02.08.2013

8. VERFALLDATUM

verwendbar bis:

9. BESONDERE VORSICHTSMASSNAHMEN FÜR DIE AUFBEWAHRUNG 

Nicht über 25°C lagern. In der Originalverpackung aufbewahren, um den Inhalt vor Licht zu 

schützen.

10. GEGEBENENFALLS BESONDERE VORSICHTSMASSNAHMEN FÜR DIE 

BESEITIGUNG VON NICHT VERWENDETEM ARZNEIMITTEL ODER DAVON 

STAMMENDEN ABFALLMATERIALIEN

11. NAME UND ANSCHRIFT DES PHARMAZEUTISCHEN UNTERNEHMERS

Pharmazeutischer Unternehmer: G.L. Pharma GmbH, 8502 Lannach

12. ZULASSUNGSNUMMER(N) 

Z.Nr.: 15.213

13. CHARGENBEZEICHNUNG 

Ch.Nr.:

14. VERKAUFSABGRENZUNG

Rezept- und apothekenpflichtig.

15. HINWEISE FÜR DEN GEBRAUCH

16. ANGABEN IN BLINDENSCHRIFT  (nur Faltkarton!)

Etibi 500 mg - Tabletten

Document Outline

29-1-2018

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [PD-Rx Pharmaceuticals, Inc.]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [PD-Rx Pharmaceuticals, Inc.]

Updated Date: Jan 29, 2018 EST

US - DailyMed

19-1-2018

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [A-S Medication Solutions]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [A-S Medication Solutions]

Updated Date: Jan 19, 2018 EST

US - DailyMed

12-1-2018

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [REMEDYREPACK INC.]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [REMEDYREPACK INC.]

Updated Date: Jan 12, 2018 EST

US - DailyMed

2-1-2018

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet, Film Coated [Bryant Ranch Prepack]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet, Film Coated [Bryant Ranch Prepack]

Updated Date: Jan 2, 2018 EST

US - DailyMed

20-12-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Solution [Perrigo New York Inc]

LEVOCETIRIZINE DIHYDROCHLORIDE Solution [Perrigo New York Inc]

Updated Date: Dec 20, 2017 EST

US - DailyMed

18-12-2017

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [Alembic Pharmaceuticals Limited]

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [Alembic Pharmaceuticals Limited]

Updated Date: Dec 18, 2017 EST

US - DailyMed

12-12-2017

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2017) 8618 of Tue, 12 Dec 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/T/33

Europe -DG Health and Food Safety

12-12-2017

EU/3/05/272 (Noventia Pharma Srl)

EU/3/05/272 (Noventia Pharma Srl)

EU/3/05/272 (Active substance: Histamine dihydrochloride) - Transfer of orphan designation - Commission Decision (2017)8597 of Tue, 12 Dec 2017 European Medicines Agency (EMA) procedure number: EMEA/OD/094/04/T/03

Europe -DG Health and Food Safety

6-12-2017

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [A-S Medication Solutions]

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [A-S Medication Solutions]

Updated Date: Dec 6, 2017 EST

US - DailyMed

1-12-2017

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [American Health Packaging]

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [American Health Packaging]

Updated Date: Dec 1, 2017 EST

US - DailyMed

16-11-2017

IMMITICIDE (Melarsomine Dihydrochloride And Water) Kit [Merial, Inc.]

IMMITICIDE (Melarsomine Dihydrochloride And Water) Kit [Merial, Inc.]

Updated Date: Nov 16, 2017 EST

US - DailyMed

14-11-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Proficient Rx LP]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Proficient Rx LP]

Updated Date: Nov 14, 2017 EST

US - DailyMed

8-11-2017

Zyrtec vs. Xyzal

Zyrtec vs. Xyzal

Zyrtec (cetirizine hydrochloride) and Xyzal (levocetirizine dihydrochloride) antihistamines that treat symptoms such as itching, runny nose, watery eyes, and sneezing from hay fever (allergic rhinitis) and other allergies, such as allergies to molds and dust mites. Both Zyrtec and Xyzal are available over-the-counter (OTC).

US - RxList

31-10-2017

Xyzal vs. Allegra

Xyzal vs. Allegra

Xyzal (levocetirizine dihydrochloride) and Allegra (fexofenadine hydrochloride) are antihistamines used to treat allergic symptoms of seasonal allergic rhinitis (sneezing, runny nose, itchy or watery eyes), and hives.

US - RxList

30-10-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Solution [Taro Pharmaceuticals U.S.A., Inc.]

LEVOCETIRIZINE DIHYDROCHLORIDE Solution [Taro Pharmaceuticals U.S.A., Inc.]

Updated Date: Oct 30, 2017 EST

US - DailyMed

26-10-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Solution [Apotex Corp.]

LEVOCETIRIZINE DIHYDROCHLORIDE Solution [Apotex Corp.]

Updated Date: Oct 26, 2017 EST

US - DailyMed

25-10-2017

ETHAMBUTOL HYDROCHLORIDE Tablet [American Health Packaging]

ETHAMBUTOL HYDROCHLORIDE Tablet [American Health Packaging]

Updated Date: Oct 25, 2017 EST

US - DailyMed

16-10-2017

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [Golden State Medical Supply, Inc]

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [Golden State Medical Supply, Inc]

Updated Date: Oct 16, 2017 EST

US - DailyMed

11-10-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet, Film Coated [PD-Rx Pharmaceuticals, Inc.]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet, Film Coated [PD-Rx Pharmaceuticals, Inc.]

Updated Date: Oct 11, 2017 EST

US - DailyMed

29-9-2017

ETHAMBUTOL HYDROCHLORIDE Tablet, Film Coated [REMEDYREPACK INC.]

ETHAMBUTOL HYDROCHLORIDE Tablet, Film Coated [REMEDYREPACK INC.]

Updated Date: Sep 29, 2017 EST

US - DailyMed

21-9-2017

Designation notices

Designation notices

Added orphan drug designation: sapropterin Dihydrochloride (KUVAN)

Therapeutic Goods Administration - Australia

14-9-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [American Health Packaging]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [American Health Packaging]

Updated Date: Sep 14, 2017 EST

US - DailyMed

23-8-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet, Film Coated [Sun Pharma Global FZE]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet, Film Coated [Sun Pharma Global FZE]

Updated Date: Aug 23, 2017 EST

US - DailyMed

14-8-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet, Film Coated [Teva Pharmaceuticals USA, Inc.]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet, Film Coated [Teva Pharmaceuticals USA, Inc.]

Updated Date: Aug 14, 2017 EST

US - DailyMed

28-7-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Apotex Corp.]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Apotex Corp.]

Updated Date: Jul 28, 2017 EST

US - DailyMed

26-7-2017

ALLOPAX (Levocetirizine Dihydrochloride 5%, Loratadine 5%) Kit [PharmaGenetico LLC]

ALLOPAX (Levocetirizine Dihydrochloride 5%, Loratadine 5%) Kit [PharmaGenetico LLC]

Updated Date: Jul 26, 2017 EST

US - DailyMed

24-7-2017

ETHAMBUTOL HYDROCHLORIDE Tablet, Film Coated [STI Pharma LLC]

ETHAMBUTOL HYDROCHLORIDE Tablet, Film Coated [STI Pharma LLC]

Updated Date: Jul 24, 2017 EST

US - DailyMed

6-7-2017

ETHAMBUTOL HYDROCHLORIDE Tablet [Carilion Materials Management]

ETHAMBUTOL HYDROCHLORIDE Tablet [Carilion Materials Management]

Updated Date: Jul 6, 2017 EST

US - DailyMed

3-7-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Vensun Pharmaceuticals, Inc.]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Vensun Pharmaceuticals, Inc.]

Updated Date: Jul 3, 2017 EST

US - DailyMed

16-6-2017

LEVOCETIRIZINE DIHYDROCHLORIDE (Levocetirizine Dihydrochloride) Tablet [AvKARE, Inc.]

LEVOCETIRIZINE DIHYDROCHLORIDE (Levocetirizine Dihydrochloride) Tablet [AvKARE, Inc.]

Updated Date: Jun 16, 2017 EST

US - DailyMed

8-6-2017

HISTAMINUM HYDROCHLORICUM (Histamine Dihydrochloride) Pellet [BrandStorm HBC]

HISTAMINUM HYDROCHLORICUM (Histamine Dihydrochloride) Pellet [BrandStorm HBC]

Updated Date: Jun 8, 2017 EST

US - DailyMed

7-6-2017

PAIN RELIEVING ARTHRITIS (Histamine Dihydrochloride) Cream [Yash Pharmceuticals]

PAIN RELIEVING ARTHRITIS (Histamine Dihydrochloride) Cream [Yash Pharmceuticals]

Updated Date: Jun 7, 2017 EST

US - DailyMed

7-6-2017

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [Strides Shasun Limited]

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [Strides Shasun Limited]

Updated Date: Jun 7, 2017 EST

US - DailyMed

26-5-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Glenmark Pharmaceuticals Inc., USA]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Glenmark Pharmaceuticals Inc., USA]

Updated Date: May 26, 2017 EST

US - DailyMed

23-5-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Bryant Ranch Prepack]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [Bryant Ranch Prepack]

Updated Date: May 23, 2017 EST

US - DailyMed

23-5-2017

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [Bryant Ranch Prepack]

PRAMIPEXOLE DIHYDROCHLORIDE Tablet [Bryant Ranch Prepack]

Updated Date: May 23, 2017 EST

US - DailyMed

29-3-2017

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [YILING PHARMACEUTICAL, INC.]

LEVOCETIRIZINE DIHYDROCHLORIDE Tablet [YILING PHARMACEUTICAL, INC.]

Updated Date: Mar 29, 2017 EST

US - DailyMed

14-3-2017

XYZAL ALLERGY 24HR (Levocetirizine Dihydrochloride) Tablet [Chattem, Inc.]

XYZAL ALLERGY 24HR (Levocetirizine Dihydrochloride) Tablet [Chattem, Inc.]

Updated Date: Mar 14, 2017 EST

US - DailyMed

2-3-2017

PAIN RELIEVING ARTHRITIS (Histamine Dihydrochloride) Cream [Velocity Pharma LLC]

PAIN RELIEVING ARTHRITIS (Histamine Dihydrochloride) Cream [Velocity Pharma LLC]

Updated Date: Mar 2, 2017 EST

US - DailyMed

27-2-2017

DIROBAN (Melarsomine Dihydrochloride And Water) Kit [Zoetis Inc.]

DIROBAN (Melarsomine Dihydrochloride And Water) Kit [Zoetis Inc.]

Updated Date: Feb 27, 2017 EST

US - DailyMed

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