Synthetic steroid (STEAR)
Tibolone in Germany: prescription, brands, pricing
This page summarises the situation of Tibolone in Germany under BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte): prescription status, available brands and generics, pharmacy dispensing, and online options in EUR. Tibolone belongs to the Synthetic steroid (STEAR) class.
- Regulator
- BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
- Currency
- EUR
About Tibolone
Tibolone is approved (in countries where licensed) for treatment of moderate-to-severe vasomotor menopausal symptoms and prevention of postmenopausal osteoporosis in women at least 12 months past their last natural menstrual period. Germany classifies medications into rezeptpflichtig (prescription), apothekenpflichtig (pharmacy-only) and freiverkäuflich (general sale). The two-tier non-Rx system is unusual and widely used.
Mechanism and action
Tibolone is a prodrug; on absorption it is rapidly converted to three active metabolites (3α-OH-tibolone, 3β-OH-tibolone and Δ4-tibolone) with different tissue-selective activity.
Brands and generics in Germany
In Germany, Tibolone is typically dispensed as one internationally recognised brand along with their corresponding authorised generics. German Apotheken are independent owner-pharmacist businesses by law, with strong professional standards. Statutory health insurance (gesetzliche Krankenversicherung) covers most prescription costs. Brand-to-generic substitution is decided by the pharmacist under local BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) equivalence rules, and the price difference in EUR is usually substantial.
Online and tele-prescribing access
Mail-order pharmacies (DocMorris and others) are well-established in Germany for both Rx and OTC medications, operating under the same regulatory framework as bricks-and-mortar Apotheken. For Tibolone specifically, the legal online options in Germany depend on its Rx-or-OTC classification under BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte).
Frequently asked questions
Is Tibolone available in Germany? ▾
Yes — Tibolone and its brands are available in Germany through pharmacies authorised by BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), in various strengths depending on the commercial product. Authorised generics offer a lower-cost alternative with the same active substance.
Do I need a prescription for Tibolone in Germany? ▾
Germany classifies medications into rezeptpflichtig (prescription), apothekenpflichtig (pharmacy-only) and freiverkäuflich (general sale). The two-tier non-Rx system is unusual and widely used. The exact status of Tibolone (Rx or OTC) is determined by BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte); most active ingredients in the Synthetic steroid (STEAR) class require prescription, although there are exceptions by country and formulation.
How much does Tibolone cost in Germany? ▾
The price in EUR depends on the manufacturer (brand vs authorised generic), the strength and the pack size. Generics are typically substantially cheaper than brands and serve as the economic reference for ongoing use.
Products with Tibolone in Germany
Tibolone in other countries
The information on this website is provided for reference and educational purposes only. It does not replace consultation with a qualified healthcare professional.