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page title: AMIS - Öffentlicher Teil (Public Part)
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AMIS - Öffentlicher Teil (Public Part) (AJ29)
PharmNet.Bund-Drug Information System

AMIS - Öffentlicher Teil (AMIS-Public Part) contains parts of the comprehensive drug information system BfArM- AMIS , managed and updated by the German drug regulatory authorities BfArM, BVL, and PEI.

The contents of the Drug Information System of PharmNet.Bund and AMIS-Öffentlicher Teil are identical. This database description applies for both databases.

AMIS - Öffentlicher Teil / PharmNet.Bund-Drug Information System consists of two parts. The database "Drugs" contains documents to medicinal products and the variation notifications to each product, and in an increasing number of drugs additionally the summary of product characteristics and the package insert. The database "Substances" containing documents concerning active and other substances.

At the moment, the database "Drugs" contains documents for German drugs with approved or expired marketing authorisation (since 30.04.1990) as well as the variation notifications referring to these documents. The information available is mainly administrative, for example trade name, marketing authorisation number or date of approval. The database "Substances" contains documents of active and other substances, for example adjuvants, impurities or not-marketable or controlled substances and includes further informations.

 

 

Database Content

Subject Coverage

Drugs, Pharmacy

TypeFact database
LanguageGerman
Search Accessexclusively accessible via DIMDI SmartSearch
Superbases

There are predefined databases groups (superbase) for several subjects.

The database AMIS - Öffentlicher Teil (Public Part) is part of the following superbases:
XAMIS_OFF .

Database Resources

File Size175,150 (Status 11/2012)
File Data

Database "Drugs":

approximately 120,000 documents (drugs with approved or expired marketing authorisation)

approximately 560,000 documents (variation notifications)

Database "Substances":

approximately 36,000 documents of active and other substances

 

You will find the number of database records in the current update status.

Update CycleDaily

Query

Special Notes

The database "Drugs" contains mainly administrative information, for example trade name, marketing authorisation number, date of approval, date of latest marketing authorisation notification, type of marketing authorisation procedure, information concerning marketability, addresses of the pharmaceutical companies, composition, dosage form, route of application, and indications: Anatomical-Therapeutic-Chemical Code of the WHO (ATC-Code).

The database "Substances" contains documents of active and other substances, for example adjuvants, impurities, not-marketable or controlled substances and includes information such as preferred name, synonyms, CAS number, Arzneistoffkatalog (ASK)-number, molecular formula, molecular weight, and possible impurities.

Access ist permitted either by

  1. signing a contract with DIMDI which makes customers benefit from exclusive advantages such as reduced document prices and additional functions
  2. or within the Pay-Per-View (PPV) procedure. If customers want to call up documents without the contractual obligation, payments can be made by credit card via a shopping basket function (minimum order value of 5 € per order transaction).

Basically, the following information in the application are free of charge:

  • Medicinal Product Name
  • Dosage Form
  • Marketing Authorisation Holder
  • Licence Number
  • Marketability
  • Patient Information Leaflets
  • Summary of Product Characteristics (SPC)
  • Public Assessment Reports

The database is only available via the DIMDI SmartSearch. Standing orders (SDI) are possible for Premium customers.

For further information see the German version.

 

Sample Search(es)
Sample Record(s)

2/1 von 1  DIMDI: AMIS-Öffentlicher Teil (AJ29) © BfArM

Amadol Kapseln; Hartkapsel; TAD Pharma GmbH

Allgemeine Angaben

Eingangsnummer: 2132283
Arzneimittelname: Amadol Kapseln Darreichungsform-Text : HartkapselZielgruppe-Text: Mensch

Anwendungsgebiete

Anwendungsgebiete: Maessig starke bis starke Schmerzen. /
Indikation/ATC: N02AX02  NERVENSYSTEM - ANALGETIKUM - OPIOIDE - Andere Opioide - Tramadol

Administrative Daten

Antragsteller: 3044021   TAD Pharma GmbHZuständigkeit: BfArM
Satzart-Text: Zulassung nach §21/§25 AMG
Bescheiddatum der Zulassung: 12.10.1995
PZU-Datum der Zulassung: 18.10.1995
Letzte Bescheidart: POS-VLG   Dem Verlaengerungsantrag wurde zugestimmtVerkehrsfähig: jaZulassungs-/Reg-Nr.(AMG76): 32283.00.00
letztes Bescheiddatum: 18.10.2000
letztes PZU-Datum: 05.06.2003
letztes Bundesanzeigerdatum: 13.11.2003
letzte Änderungsanzeige(AJ30): 12.12.2007
letzte Bekanntmachungsnummer: 290

Pharmazeutische Unternehmer

Antragsteller

3044021  TAD Pharma GmbHHeinz-Lohmann-Str. 5
D -27472  Cuxhaven
Niedersachsen

Hersteller/Endfreigabe

3044021   TAD Pharma GmbHHeinz-Lohmann-Str. 5
D -27472  Cuxhaven
Niedersachsen

Zusammensetzung

Anzahl Wirkstoffe: 01
Anwendungsart:   zum EinnehmenBezugsmenge:   1 Stück

Arzneilich wirksame Bestandteile

ASK-Nr. Stoffname Stoffmenge
08720 Tramadolhydrochlorid 50.mg

Hilfsstoffe

ASK-Nr. Stoffname Ort
13376 Calciumhydrogenphosphat -
15598 Magnesiumstearat (Ph.Eur.) -
15657 Hochdisperses Siliciumdioxid -
00131 Gelatine Kapsel
00785 Titandioxid Kapsel
01457 Eisen(III)-hydroxid-oxid x H<2>O Kapsel
01459 Indigocarmin Kapsel

Packungsgrößen-Gruppe/ Verkaufsabgrenzung

Verkaufsabgrenzung für alle Packungsgrößen-Text: verschreibungspflichtiges Arzneimittel nach § 48 (1), (2)2 AMG
Dauer der Haltbarkeit für alle Packungsgrößen: 4 J

Packungsgröße

Verkaufsabgrenzung Dauer/Haltbarkeit
OP10 verschreibungspflichtiges Arzneimittel nach § 48(1),(2)2 AMG 4 J
OP30 verschreibungspflichtiges Arzneimittel nach § 48(1),(2)2 AMG 4 J
OP50 verschreibungspflichtiges Arzneimittel nach § 48(1),(2)2 AMG 4 J
UM10 verschreibungspflichtiges Arzneimittel nach § 48(1),(2)2 AMG 4 J
AP100 verschreibungspflichtiges Arzneimittel nach § 48(1),(2)2 AMG 4 J
AP5000 verschreibungspflichtiges Arzneimittel nach § 48(1),(2)2 AMG 4 J

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Appendix

Appendix

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