Norvipren
Primær information
- Handelsnavn:
- Norvipren 200 mikrogram resoribletter, sublinguale
- Aktiv bestanddel:
- BUPRENORPHINHYDROCHLORID
- Tilgængelig fra:
- Orifarm A/S
- ATC-kode:
- N02AE01
- INN (International Name):
- buprenorphine
- Dosering:
- 200 mikrogram
- Lægemiddelform:
- resoribletter, sublinguale
- Brugt til:
- Mennesker
- Medicin typen:
- Allopatiske stof
Dokumenter
- for den brede offentlighed:
- Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.
Anmode informationsbrochure for offentligheden.
- for sundhedspersonale:
- Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.
Anmode informationsbrochure for sundhedspersonale.
Lokation
- Fås i:
-
Danmark
- Sprog:
- dansk
Andre oplysninger
Status
- Kilde:
- Lægemiddelstyrelsen - Danish Medicines Agency
- Autorisationsnummer:
- 56169
- Sidste ændring:
- 22-02-2018
- Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.
Anmode informationsbrochure for offentligheden.
- Adgang til dette dokument er kun tilgængelig for registrerede brugere.
Tilmeld dig nu for fuld adgang
6-3-2018

Human medicines European public assessment report (EPAR): Zubsolv, buprenorphine / naloxone, Revision: 1, Authorised
Europe - EMA - European Medicines Agency
12-1-2018

Human medicines European public assessment report (EPAR): Zubsolv, buprenorphine / naloxone, Revision: 0, Authorised
Europe - EMA - European Medicines Agency
1-12-2017

Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments
Statement from FDA Commissioner Scott Gottlieb, M.D., on the approval of a new formulation of buprenorphine and FDA’s efforts to promote more widespread innovation and access to opioid addiction treatments
FDA - U.S. Food and Drug Administration
1-12-2017

FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder
FDA - U.S. Food and Drug Administration
20-9-2017

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
Based on our additional review, the U.S. Food and Drug Administration (FDA) is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS). The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction usually outweighs these risks. Careful medication management by health care professionals can reduce...
FDA - U.S. Food and Drug Administration
20-9-2017

Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants: Drug Safety Communication - Careful Medication Management Can Reduce Risks
Health care professionals should develop a treatment plan when buprenorphine or methadone is used in combination with benzodiazepines or other CNS depressants.
FDA - U.S. Food and Drug Administration
15-9-2017

Pending EC decision: Zubsolv, buprenorphine / naloxone, Opinion date: 14-Sep-2017
Europe - EMA - European Medicines Agency
24-7-2017

Opinion/decision on a Paediatric investigation plan (PIP): -, Buprenorphine (hydrochloride), Therapeutic area: Psychiatry
Europe - EFSA - European Food Safety Authority EFSA Journal
3-4-2018
![BUPRENORPHINE AND NALOXONE Tablet [Actavis Pharma, Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE AND NALOXONE Tablet [Actavis Pharma, Inc.]
Updated Date: Apr 3, 2018 EST
US - DailyMed
7-3-2018
![BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [Amneal Pharmaceuticals LLC]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [Amneal Pharmaceuticals LLC]
Updated Date: Mar 7, 2018 EST
US - DailyMed
5-3-2018
![BUNAVAIL (Buprenorphine And Naloxone) Film [BioDelivery Sciences International, Inc.]](/web/assets/global/img/flags/us.png)
BUNAVAIL (Buprenorphine And Naloxone) Film [BioDelivery Sciences International, Inc.]
Updated Date: Mar 5, 2018 EST
US - DailyMed
28-2-2018
![BUPRENEX (Buprenorphine Hydrochloride) Injection [Reckitt Benckiser Pharmaceuticals Inc
]](/web/assets/global/img/flags/us.png)
BUPRENEX (Buprenorphine Hydrochloride) Injection [Reckitt Benckiser Pharmaceuticals Inc ]
Updated Date: Feb 28, 2018 EST
US - DailyMed
26-2-2018
![SUBLOCADE (Buprenorphine) Solution [Indivior Inc.]](/web/assets/global/img/flags/us.png)
SUBLOCADE (Buprenorphine) Solution [Indivior Inc.]
Updated Date: Feb 26, 2018 EST
US - DailyMed
14-2-2018
![BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [REMEDYREPACK INC.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [REMEDYREPACK INC.]
Updated Date: Feb 14, 2018 EST
US - DailyMed
14-2-2018
![SIMBADOL (Buprenorphine) Injection [Zoetis Inc.]](/web/assets/global/img/flags/us.png)
SIMBADOL (Buprenorphine) Injection [Zoetis Inc.]
Updated Date: Feb 14, 2018 EST
US - DailyMed
13-2-2018
![BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [AvPAK]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [AvPAK]
Updated Date: Feb 13, 2018 EST
US - DailyMed
12-2-2018
![SUBOXONE (Buprenorphine Hydrochloride, Naloxone Hydrochloride) Film, Soluble [Indivior Inc.]](/web/assets/global/img/flags/us.png)
SUBOXONE (Buprenorphine Hydrochloride, Naloxone Hydrochloride) Film, Soluble [Indivior Inc.]
Updated Date: Feb 12, 2018 EST
US - DailyMed
6-2-2018
![BUTRANS (Buprenorphine) Patch, Extended Release [Purdue Pharma LP]](/web/assets/global/img/flags/us.png)
BUTRANS (Buprenorphine) Patch, Extended Release [Purdue Pharma LP]
Updated Date: Feb 6, 2018 EST
US - DailyMed
2-2-2018
![BUPRENORPHINE HCL Tablet [West-Ward Pharmaceuticals Corp.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HCL Tablet [West-Ward Pharmaceuticals Corp.]
Updated Date: Feb 2, 2018 EST
US - DailyMed
2-2-2018
![BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Tablet [West-Ward Pharmaceuticals Corp]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Tablet [West-Ward Pharmaceuticals Corp]
Updated Date: Feb 2, 2018 EST
US - DailyMed
30-1-2018
![BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Golden State Medical Supply, Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Golden State Medical Supply, Inc.]
Updated Date: Jan 30, 2018 EST
US - DailyMed
19-1-2018
![BUPRENORPHINE Patch [Lake Erie Medical DBA Quality Care Products LLC]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE Patch [Lake Erie Medical DBA Quality Care Products LLC]
Updated Date: Jan 19, 2018 EST
US - DailyMed
19-1-2018
![BUPRENORPHINE HYDROCHLORIDE Tablet [REMEDYREPACK INC.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE Tablet [REMEDYREPACK INC.]
Updated Date: Jan 19, 2018 EST
US - DailyMed
19-1-2018
![BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [AvKARE, Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [AvKARE, Inc.]
Updated Date: Jan 19, 2018 EST
US - DailyMed
19-1-2018
![BUPRENORPHINE AND NALOXONE Tablet [Sun Pharmaceutical Industries Limited ]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE AND NALOXONE Tablet [Sun Pharmaceutical Industries Limited ]
Updated Date: Jan 19, 2018 EST
US - DailyMed
8-1-2018
![BUPRENORPHINE HYDROCHLORIDE Injection, Solution [American Regent, Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE Injection, Solution [American Regent, Inc.]
Updated Date: Jan 8, 2018 EST
US - DailyMed
8-1-2018
![BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Bryant Ranch Prepack]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Bryant Ranch Prepack]
Updated Date: Jan 8, 2018 EST
US - DailyMed
26-12-2017
![BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Hi-Tech Pharmacal Co. Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride And Naloxone Hydrochloride) Tablet [Hi-Tech Pharmacal Co. Inc.]
Updated Date: Dec 26, 2017 EST
US - DailyMed
22-12-2017
![BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Tablet [SpecGx LLC]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE Tablet [SpecGx LLC]
Updated Date: Dec 22, 2017 EST
US - DailyMed
21-12-2017
![BUPRENORPHINE HYDROCHLORIDE Tablet [A-S Medication Solutions]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE Tablet [A-S Medication Solutions]
Updated Date: Dec 21, 2017 EST
US - DailyMed
20-12-2017
![BUPRENORPHINE HYDROCHLORIDE Tablet [Hi-Tech Pharmacal Co., Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE Tablet [Hi-Tech Pharmacal Co., Inc.]
Updated Date: Dec 20, 2017 EST
US - DailyMed
19-12-2017
![BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride Naloxone Hydrochloride Dihydrate) Tablet [Gemini Laboratories, LLC]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE AND NALOXONE (Buprenorphine Hydrochloride Naloxone Hydrochloride Dihydrate) Tablet [Gemini Laboratories, LLC]
Updated Date: Dec 19, 2017 EST
US - DailyMed
18-12-2017
![BUPRENORPHINE Patch, Extended Release [Lake Erie Medical DBA Quality Care Products LLC]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE Patch, Extended Release [Lake Erie Medical DBA Quality Care Products LLC]
Updated Date: Dec 18, 2017 EST
US - DailyMed
15-12-2017
![BELBUCA (Buprenorphine Hydrochloride) Film [Endo Pharmaceuticals, Inc.]](/web/assets/global/img/flags/us.png)
BELBUCA (Buprenorphine Hydrochloride) Film [Endo Pharmaceuticals, Inc.]
Updated Date: Dec 15, 2017 EST
US - DailyMed
14-11-2017

Zubsolv (Mundipharma Corporation Limited)
Zubsolv (Active substance: buprenorphine / naloxone) - Centralised - Authorisation - Commission Decision (2017)7640 of Tue, 14 Nov 2017 European Medicines Agency (EMA) procedure number: EMEA/H/C/4407
Europe -DG Health and Food Safety
24-10-2017
![PROBUPHINE (Buprenorphine Hydrochloride) Implant [Braeburn Pharmaceuticals]](/web/assets/global/img/flags/us.png)
PROBUPHINE (Buprenorphine Hydrochloride) Implant [Braeburn Pharmaceuticals]
Updated Date: Oct 24, 2017 EST
US - DailyMed
24-10-2017
![BUPRENORPHINE AND NALOXONE Tablet [Lannett Company, Inc..]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE AND NALOXONE Tablet [Lannett Company, Inc..]
Updated Date: Oct 24, 2017 EST
US - DailyMed
23-10-2017
![BUPRENORPHINE HYDROCHLORIDE Tablet [PD-Rx Pharmaceuticals, Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE Tablet [PD-Rx Pharmaceuticals, Inc.]
Updated Date: Oct 23, 2017 EST
US - DailyMed
18-10-2017
![BUPRENORPHINE AND NALOXONE Tablet [Teva Pharmaceuticals USA, Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE AND NALOXONE Tablet [Teva Pharmaceuticals USA, Inc.]
Updated Date: Oct 18, 2017 EST
US - DailyMed
10-10-2017
![BUPRENORPHINE Tablet [Sun Pharmaceutical Industries Limited ]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE Tablet [Sun Pharmaceutical Industries Limited ]
Updated Date: Oct 10, 2017 EST
US - DailyMed
4-10-2017
![BUPRENORPHINE (Buprenorphine Hydrochloride) Tablet [REMEDYREPACK INC.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE (Buprenorphine Hydrochloride) Tablet [REMEDYREPACK INC.]
Updated Date: Oct 4, 2017 EST
US - DailyMed
2-10-2017
![BELBUCA (Buprenorphine Hydrochloride) Film, Soluble [BioDelivery Sciences International Inc]](/web/assets/global/img/flags/us.png)
BELBUCA (Buprenorphine Hydrochloride) Film, Soluble [BioDelivery Sciences International Inc]
Updated Date: Oct 2, 2017 EST
US - DailyMed
15-9-2017
![BUPRENORPHINE Tablet [Contract Pharmacy Services-PA]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE Tablet [Contract Pharmacy Services-PA]
Updated Date: Sep 15, 2017 EST
US - DailyMed
15-9-2017
![BUPRENORPHINE HYDROCHLORIDE Tablet [Contract Pharmacy Services-PA]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE Tablet [Contract Pharmacy Services-PA]
Updated Date: Sep 15, 2017 EST
US - DailyMed
15-9-2017
![BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL Tablet [Contract Pharmacy Services-PA]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL Tablet [Contract Pharmacy Services-PA]
Updated Date: Sep 15, 2017 EST
US - DailyMed
15-9-2017
![BUPRENORPHINE HCL Tablet [Contract Pharmacy Services-PA]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HCL Tablet [Contract Pharmacy Services-PA]
Updated Date: Sep 15, 2017 EST
US - DailyMed
14-9-2017

Withdrawn application: Somnena, buprenorphine, Initial authorisation
Europe - EMA - European Medicines Agency
14-9-2017
![BUPRENORPHINE (Buprenorphine Hydrochloride) Tablet [Contract Pharmacy Services-PA]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE (Buprenorphine Hydrochloride) Tablet [Contract Pharmacy Services-PA]
Updated Date: Sep 14, 2017 EST
US - DailyMed
25-8-2017
![BUPRENORPHINE (Buprenorphine) Tablet [REMEDYREPACK INC.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE (Buprenorphine) Tablet [REMEDYREPACK INC.]
Updated Date: Aug 25, 2017 EST
US - DailyMed
1-8-2017
![BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL Tablet [REMEDYREPACK INC.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL Tablet [REMEDYREPACK INC.]
Updated Date: Aug 1, 2017 EST
US - DailyMed
1-8-2017
![BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [Mallinckrodt, Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HCL AND NALOXONE HCL (Buprenorphine And Naloxone) Tablet [Mallinckrodt, Inc.]
Updated Date: Aug 1, 2017 EST
US - DailyMed
14-7-2017
![BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL Tablet [Mylan Pharmaceuticals Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL Tablet [Mylan Pharmaceuticals Inc.]
Updated Date: Jul 14, 2017 EST
US - DailyMed
3-7-2017
![BUPRENORPHINE Patch [Rhodes Pharmaceuticals L.P.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE Patch [Rhodes Pharmaceuticals L.P.]
Updated Date: Jul 3, 2017 EST
US - DailyMed
30-5-2017
![BUPRENORPHINE Patch, Extended Release [Teva Pharmaceuticals USA, Inc.]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE Patch, Extended Release [Teva Pharmaceuticals USA, Inc.]
Updated Date: May 30, 2017 EST
US - DailyMed
23-5-2017
![BUPRENORPHINE HYDROCHLORIDE Tablet [Bryant Ranch Prepack]](/web/assets/global/img/flags/us.png)
BUPRENORPHINE HYDROCHLORIDE Tablet [Bryant Ranch Prepack]
Updated Date: May 23, 2017 EST
US - DailyMed